Annotated Comparison of the Pre-2018 Common Rule with the Revised Common Rule

The Federal Policy for the Protection of Human Subjects (also known as the "Common Rule" and codified for HHS at 45 CFR part 46, subpart A) was originally promulgated in 1991 and amended in 2005.  This version of the Common Rule is referred to as the "pre-2018 Common Rule" or “pre-2018 Requirements”  You can find the pre-2018 Common Rule by reviewing subpart A of 45 CFR part 46 as published in the 2016 edition of the Code of Federal Regulations (CFR).

A comprehensive revision to the Common Rule was published in the Federal Register on January 19, 2017 (82 FR 7149).  The revised Common Rule has been amended twice, in an interim final rule published on January 22, 2018 (83 FR 2885), and in a final rule published on June 19, 2018 (83 FR 28497). The revised Common Rule is referred to as the “2018 Requirements."

About this page:

This page is intended to compare the text of the pre-2018 Common Rule with the text of the revised Common Rule. This page also provides links to excerpts from the January 19, 2017 revised Common Rule preamble (unless otherwise specified).

Key:

 End Insertion [Text] = Regulatory language new to the 2018 Common Rule

[Text] = Regulatory language in the pre-2018 Common Rule that has been moved to a new location or deleted in the 2018 Common Rule

[Text] = Regulatory language found in both the pre-2018 Common Rule and the 2018 Common Rule

 = Annotation symbol indicating a link to an explanatory excerpt from a preamble to the 2018 Common Rule.  Unless otherwise specified, preamble links are to an unofficial version of the January 19, 2017 revised Common Rule preamble.


 = Annotation symbol indicating that a provision of pre-2018 Common Rule moved to another location in the 2018 Common Rule


 = Annotation symbol indicating extra information in this document to aid readers

Start InsertionSource: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted. End Insertion

Sec.

§46.101 To what does this policy apply?

§46.102 Definitions Start Insertion for purposes of this policy End Insertion .

§46.103 Assuring compliance with this policy--research conducted or supported by any Federal Start DeletionD End Deletion Start Insertiond End Insertion epartment or Start DeletionA End Deletion Start Insertiona End Insertion gency.

§46.104 Start InsertionExempt research. End Insertion

§46.107 IRB membership.

§46.108 IRB functions and operations.

§46.109 IRB review of research.

§46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

§46.111 Criteria for IRB approval of research.

§46.112 Review by Start Deletioni End Deletion Start InsertionI End Insertion nstitution.

§46.113 Suspension or Start Deletiont End Deletion Start InsertionT End Insertion ermination of IRB Start Deletiona End Deletion Start InsertionA End Insertion pproval of Start Deletionr End Deletion Start InsertionR End Insertion esearch.

§46.114 Cooperative Start Deletionr End Deletion Start InsertionR End Insertion esearch.

§46.115 IRB Start Deletionr End Deletion Start InsertionR End Insertion ecords.

§46.116 General Start Deletionr End Deletion Start InsertionR End Insertion equirements for Start Deletioni End Deletion Start InsertionI End Insertion nformed Start Deletionc End Deletion Start InsertionC End Insertion onsent.

§46.117 Documentation of informed consent.

§46.118 Applications and proposals lacking definite plans for involvement of human subjects.

§46.119 Research undertaken without the intention of involving human subjects.

§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Start DeletionD End Deletion Start Insertiond End Insertion epartment or Start DeletionA End Deletion Start Insertiona End Insertion gency.

§46.121 [Reserved]

§46.122 Use of Federal fundsStart Insertion. End Insertion

§46.123 Early termination of research support: Evaluation of applications and proposals.

§46.124 Conditions.

§46.101 To what does this policy apply?

(a) Except as Start Deletionprovided End Deletion Start Insertiondetailed End Insertion in Start Deletion paragraph (b) of this section End Deletion Start Insertion §46.104 End Insertion , this policy applies to all research involving human subjects conducted, supportedStart Insertion, End Insertion or otherwise subject to regulation by any Start Deletionfederal End Deletion Start InsertionFederal End Insertion department or agency Start Deletionwhich End Deletion Start Insertionthat End Insertion takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Start Deletionfederal End Deletion Start InsertionFederal End Insertion civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Start Deletionfederal government outside the United States End Deletion Start InsertionFederal Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy. End Insertion

Start Deletion(1) Research that is conducted or supported by a federal department or agency, whether or not it is regulated as defined in §46.102, must comply with all sections of this policy. End Deletion

Start Deletion(2) Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in §46.102(e) must be reviewed and approved, in compliance with §46.101, §46.102, and §46.107 through §46.117 of this policy, by an institutional review board (IRB) that operates in accordance with the pertinent requirements of this policy. End Deletion

(b) Start Insertion[Reserved] Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: End Insertion


Section 101(b) was the location of the exemptions in pre-2018 Common Rule. For the purposes of this comparison, changes to the 2018 Common Rule exemption text appear in section 104.



Read an excerpt from the revised Common Rule preamble about why the location of the exemption categories changed.


Start Deletion End Deletion

Start Deletion(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. End Deletion


Start Deletion(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: End Deletion


Start Deletion(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and End Deletion
Start Deletion(ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
End Deletion


Start Deletion(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: End Deletion

Start Deletion(i) the human subjects are elected or appointed public officials or candidates for public office; or End Deletion
Start Deletion(ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

End Deletion

Start Deletion(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. End Deletion

Start Deletion(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: End Deletion

Start Deletion(i) Public benefit or service programs; End Deletion
Start Deletion(ii) procedures for obtaining benefits or services under those programs; End Deletion
Start Deletion(iii) possible changes in or alternatives to those programs or procedures; or End Deletion
Start Deletion(iv) possible changes in methods or levels of payment for benefits or services under those programs. End Deletion

Start Deletion(6) Taste and food quality evaluation and consumer acceptance studies, End Deletion

Start Deletion(i) if wholesome foods without additives are consumed or ; End Deletion Start Deletion
(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. End Deletion

(c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policyStart Deletion. End Deletion Start Insertionand this judgment shall be exercised consistent with the ethical principles of the Belmont Report.¹ End Insertion

(d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Start InsertionFederal End Insertion department or agency but not otherwise covered by this policyStart Deletion, End Deletion comply with some or all of the requirements of this policy. End Insertion



Read an excerpt from the revised Common Rule preamble about department or agency discretion in applying this policy.



(e) Compliance with this policy requires compliance with pertinent federal laws or regulations Start Deletion which End Deletion Start Insertionthat End Insertion provide additional protections for human subjects.

(f) This policy does not affect any state or local laws or regulations Start Deletionwhich End Deletion Start Insertion(including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that End Insertion may otherwise be applicable and Start Deletionwhich End Deletion Start Insertionthat End Insertion provide additional protections for human subjects.



Read an excerpt from the revised Common Rule preamble about state and local laws that provide additional protections for human subjects.



(g) This policy does not affect any foreign laws or regulations Start Deletion which End Deletion Start Insertionthat End Insertion may otherwise be applicable and Start Deletion which End Deletion Start Insertionthat End Insertion provide additional protections to human subjects of research.

(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. Start Deletion [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] End Deletion In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the Start DeletionFEDERAL REGISTER End Deletion Start Insertion Federal Register End Insertion or will be otherwise published as provided in department or agency procedures.



Read an excerpt from the revised Common Rule preamble about research conducted in foreign countries covered by this policy.



(i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes Start Deletionor End Deletion Start Insertionof End Insertion research activities otherwise covered by this policyStart Deletion. End Deletion Start Insertion, provided the alternative procedures to be followed are consistent with the principles of the Belmont Report.² End Insertion Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office, Start Insertionor to the equivalent office within the appropriate Federal department or agency, End Insertion and shall also publish them in the Start DeletionFEDERAL REGISTER End Deletion Start InsertionFederal Register End Insertion or in such other manner as provided in department or agency procedures.Start Deletion¹ End Deletion Start InsertionThe waiver notice must include a statement that identifies the conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles of the Belmont Report. End Insertion


The content of what appeared as footnote 1 in §46.101(i) of the pre-2018 Common Rule (pertaining to the applicability of the exemptions to the subparts) is found in the revised Common Rule at §46.104(b).



Read an excerpt from the revised Common Rule preamble about department or agency discretion in applying this policy.


Start Insertion


(j) Federal guidance on the requirements of this policy shall be issued only after consultation, for the purpose of harmonization (to the extent appropriate), with other Federal departments and agencies that have adopted this policy, unless such consultation is not feasible.

End Insertion

Read an excerpt from the revised Common Rule preamble about harmonization of department and agency guidance.


Start Insertion


(k) [Reserved]

End Insertion Start Insertion

(l) Compliance dates and transition provisions:

End Insertion
Read the preamble to the final rule delaying the general compliance date of the revised Common Rule explaining the compliance dates and the transition provision.


Start Insertion
(1) Pre-2018 Requirements. For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations. End Insertion


“As published in the 2016 edition of the Code of Federal Regulations” refers to subpart A of 45 CFR 46 initially promulgated in 1991, and amended in 2005 (i.e., the pre-2018 Common Rule). You can find this document here

Start Insertion
(2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this [part/subpart]. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for §46.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.

 End Insertion Start Insertion(3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section:
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to §46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under §46.101(b) of the pre-2018 Requirements before January 21, 2019.
End Insertion
Start Insertion(4) Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section determines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination.
(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:

(A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:
(1) Section 46.102(l) of the 2018 Requirements (definition of research) (instead of §46.102(d) of the pre-2018 Requirements);
(2) Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of §46.103(f) of the pre-2018 Requirements); and
(3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of §46.103(b), as related to the requirement for continuing review, and in addition to §46.109, of the pre-2018 Requirements); and

(B) Beginning on January 21, 2019, comply with the 2018 Requirements.
(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.

Start Deletion

¹ End Deletion Start Deletion Institutions with HHS-approved assurances on file will abide by provisions of Title 45 CFR part 46 subparts A-D. Some of the other departments and agencies have incorporated all provisions of Title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed. End Deletion

¹The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Start Deletion, End Deletion Start Insertion. End Insertion Start DeletionThe End Deletion Belmont ReportStart Deletion: Ethical Principles End Deletion Start Insertion. Washington, DC: U.S. Department of Health End Insertion and Start DeletionGuidelines for the Protection of End Deletion Human Start Deletion Subjects of Research End Deletion Start Deletion(Apr. 18, End Deletion Start Insertion Services. End Insertion 1979Start Deletion). End Deletion Start Insertion. End Insertion

Start Insertion² End Insertion Start InsertionId. End Insertion

§46.102 Definitions Start Insertion for purposes of this policy End Insertion .

Definitions have been reorganized in alphabetical order, several new definitions have been added, and one definition found in the pre-2018 Common Rule has been removed.


Start Deletion(j) End Deletion Start Insertion(a) End Insertion Certification means the official notification by the institution to the supporting Start InsertionFederal End Insertion department or agency Start Insertion component End Insertion , in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.



Read an excerpt from the 2018 Common Rule preamble discussing changes to the definition of certification.



Start Insertion(b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing the definition of clinical trial.


Start Deletion
(a) End Deletion Start Insertion(c) End Insertion Department or agency head means the head of any Start Deletionfederal End Deletion Start InsertionFederal End Insertion department or agencyStart Insertion, for example, the Secretary of HHS, End Insertion and any other officer or employee of any Start InsertionFederal End Insertion department or agency to whom Start Insertionthe End Insertion authority Start Insertion provided by these regulations to the department or agency head End Insertion has been delegated.



Read an excerpt from the 2018 Common Rule preamble discussing the definition of department or agency head.


Start Insertion
(d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing the definition of federal department or agency.



Start Deletio(f) End Deletion Start Insertion(e)(1) End Insertion Human subject means a living individual about whom an investigator (whether professional or student) conducting research Start Deletion obtains End Deletion Start Insertion: End Insertion

Start Deletion (1) Data End Deletion Start Insertion(i) Obtains information or biospecimens End Insertion through intervention or interaction with the individual, Start Deletionor
End Deletion Start Deletion(2) Identifiable End Deletion Start Insertion and Start Deletion , End Deletion uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable End Insertion private information Start Insertion or identifiable biospecimens End Insertion .

Start Insertion (2) End Insertion Intervention includes both physical procedures by which Start Deletiondata End Deletion Start Insertion information or biospecimens End Insertion are gathered (Start Deletionfor example, End Deletion Start Insertione.g., End Insertion venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.


Throughout the 2018 Common Rule, many references to “data” have been changed to “information,” “biospecimens,” or both when appropriate.



Start Insertion(3) End Insertion Interaction includes communication or interpersonal contact between investigator and subject.

Start Insertion(4) End Insertion Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information Start Deletionwhich End Deletion Start Insertionthat End Insertion has been provided for specific purposes by an individual and Start Deletionwhich End Deletion Start Insertionthat End Insertion the individual can reasonably expect will not be made public (Start Deletionfor example, End Deletion Start Insertione.g., End Insertion a medical record). End Deletion

Start Insertion(5) End Insertion Start InsertionIdentifiable private End Insertion information Start Deletion must be End Deletion Start Insertionis private information for which End Insertion the Start Deletionindividually identifiable (i.e., the End Deletion identity of the subject is or may readily be ascertained by the investigator or Start Insertion End Insertion associated with the informationStart Deletion) in order for obtaining the information to constitute research involving human subjects.) End Deletion Start Insertion. End Insertion

Start Insertion (6) End Insertion Start Insertion An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimenStart Deletion) End Deletion . End Insertion

(7) End Insertion Start InsertionFederal departments or agencies implementing this policy shall:
End Insertion


Start Insertion(i) Upon consultation with appropriate experts (including experts in data matching and re-identification), reexamine the meaning of "identifiable private information," as defined in paragraph (e)(5) of this section, and "identifiable biospecimen," as defined in paragraph (e)(6) of this section. This reexamination shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. If appropriate and permitted by law, such Federal departments and agencies may alter the interpretation of these terms, including through the use of guidance.

(ii) Upon consultation with appropriate experts, assess whether there are analytic technologies or techniques that should be considered by investigators to generate "identifiable private information," as defined in paragraph (e)(5) of this section, or an "identifiable biospecimen," as defined in paragraph (e)(6) of this section. This assessment shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. Any such technologies or techniques will be included on a list of technologies or techniques that produce identifiable private information or identifiable biospecimens. This list will be published in the Federal Register after notice and an opportunity for public comment. The Secretary, HHS, shall maintain the list on a publicly accessible Web site. End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing all changes to the definition of human subject.





Start Deletion(b) End Deletion Start Insertion(f) End Insertion Institution means any public or private entityStart Insertion, or department End Insertion or agency (including federal, state, and other agencies).

(g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy.

(h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Start Deletion(c) End Deletion Start Insertion(i) End Insertion Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. Start InsertionIf there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing changes to the definition of legally authorized representative.


 

Start Deletion(i) End Deletion Start Insertion(j) End Insertion Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.



Read an excerpt from the 2018 Common Rule preamble discussing the definition of minimal risk.


 

Start Deletion End Deletion Start Insertion(k) Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing the definition of public health authority.


 

Start Insertion(d)(l) End Insertion Research means a systematic investigation, including research development, testingStart Insertion, End Insertion and evaluation, designed to develop or contribute to generalizable knowledge. Activities Start Deletionwhich End Deletion Start Insertionthat End Insertion meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program Start Deletionwhich End Deletion Start Insertionthat End Insertion is considered research for other purposes. For example, some demonstration and service programs may include research activities. Start Insertion For purposes of this part, the following activities are deemed not to be research: End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing changes to the definition of research.





Start Insertion(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing the first carve-out from the definition of research pertaining to scholarly and journalistic activities.


 

Start Insertion(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing the second carve-out from the definition of research pertaining to public health surveillance activities.


 

Start Insertion(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing the third carve-out from the definition of research pertaining to certain criminal justice and criminal investigative activities.


 

Start Insertion(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing the fourth carve-out from the definition of research pertaining to certain authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.


 

Start Insertion

(m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.



Read an excerpt from the 2018 Common Rule preamble discussing the definition of written or in writing.


End Insertion Start Deletion

(e) Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

End Deletion

§46.103 Assuring compliance with this policy -- research conducted or supported by any Federal Start Deletion Department End Deletion Start Insertion department End Insertion or Start DeletionAgency End Deletion Start Insertion agency End Insertion .




Read an excerpt from the 2018 Common Rule preamble discussing changes to the assurance requirements.


 

(a) Each institution engaged in research Start Deletionwhich End Deletion Start Insertion that End Insertion is covered by this policy Start Deletionand which End Deletion Start Insertion, with the exception of research eligible for exemption under §46.104, and that End Insertion is conducted or supported by a Start Deletionfederal End Deletion Start InsertionFederal End Insertion department or agencyStart Insertion, End Insertion shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements Start Deletionset forth in End DeletionStart Insertion of End Insertion this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Start InsertionF End Insertion Start Deletionf End Deletion ederalStart Insertion- End Insertion wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office.

Start Deletion(b) Departments End Deletion Start InsertionFederal departments End Insertion and agencies will conduct or support research covered by this policy only if the institution has Start Insertionprovided End Insertion an assurance Start Deletionapproved End Deletion Start Insertionthat it will comply with the requirements of this policy, End Insertion as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB Start Deletionprovided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include: End Deletion Start Insertion(if such certification is required by §46.103(d)). End Insertion


Many of the requirements found in §46.103(b) in the pre-2018 Common Rule have been modified and moved to §46.108(a) in the 2018 Common Rule. For simplicity, changes made to the pre-2018 Common Rule provisions at §46.103(b) are shown in §46.108(a) of this comparison document. They are shown below as deletions to represent their movement.




Start Deletion(1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to department- or agency-supported or regulated research and need not be applicable to any research exempted or waived under §46.101(b) or (i). End Deletion

Start Deletion(2) Designation of one or more IRBs established in accordance with the requirements of this policy, and for which provisions are made for meeting space and sufficient staff to support the IRB's review and recordkeeping duties. End Deletion

Start Deletion(3) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant. Changes in IRB membership shall be reported to the department or agency head, unless in accord with §46.103(a) of this policy, the existence of an HHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office for Human Research Protections, HHS, or any successor office. End Deletion

Start Deletion(4) Written procedures which the IRB will follow

Start Deletion(i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; End Deletion
Start Deletion(ii) for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and End Deletion
Start Deletion(iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.

End Deletion


Start Deletion(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of End Deletion

Start Deletion(i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and End Deletion
Start Deletion(ii) any suspension or termination of IRB approval. End Deletion


Start Deletion(c) End Deletion Start Insertion(b) End Insertion The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes.

Start Deletion(d) End Deletion Start Insertion(c) End Insertion The department or agency head Start Deletionwill evaluate all assurances submitted in accordance with this policy through such officers and employees of the department or agency and such experts or consultants engaged for this purpose as the department or agency head determines to be appropriate. The department or agency head's evaluation will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's research activities and the types of subject populations likely to be involved, the appropriateness of the proposed initial and continuing review procedures in light of the probable risks, and the size and complexity of the institution. End Deletion

Start Deletion(e) On the basis of this evaluation, the department or agency head may approve or disapprove the assurance, or enter into negotiations to develop an approvable one. The department or agency head End Deletion may limit the period during which any Start Deletionparticular approved End Deletion assurance Start Deletionor class of approved assurances End Deletion shall remain effective or otherwise condition or restrict Start Deletionapproval End Deletion Start Insertionthe assurance End Insertion .

Start Deletion(f) End Deletion Start Insertion(d) End Insertion Certification is required when the research is supported by a Start Deletionfederal End Deletion Start InsertionFederal End Insertion department or agency and not otherwise Start Deletionexempted or End Deletion waived under Start Deletion§46.101(b) or End Deletion §46.101(i)Start Deletion. An institution with an approved assurance) End Deletion Start Insertion or exempted under §46.104. For such research, institutions End Insertion shall certify that each Start Deletionapplication or proposal for End Deletion Start Insertionproposed End Insertion research Start Insertionstudy End Insertion covered by the assurance and Start Deletionby §46.103 of End Deletion this Start DeletionPolicy End Deletion Start Insertionsection End Insertion has been reviewed and approved by the IRB. Such certification must be submitted Start Deletionwith the application or proposal or by such later date as may be End Deletion Start Insertion as End Insertion prescribed by the Start InsertionFederal End Insertion department or agency Start Deletionto which End Deletion Start Insertioncomponent supporting End Insertion the Start Deletionapplication or proposal is submitted End Deletion Start Insertionresearch End Insertion . Under no condition shall research covered by Start Deletion§46.103 of the Policy be supported End Deletion Start Insertion this section be initiated End Insertion prior to receipt of the certification that the research has been reviewed and approved by the IRB. Start DeletionInstitutions without an approved assurance covering the research shall certify within 30 days after receipt of a request for such a certification from the department or agency, End Deletion

Start Insertion(e) For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to §46.104(d)(2)(iii), (d)(3)(i)(C), End Insertion Start Deletion(d)(7), End Deletion Start Insertion or (d)(7) or (8)) End Insertion that Start Deletionthe application or proposal has been approved by the End Deletion Start Insertion takes place at an institution in which End Insertion IRBStart Deletion. If the certification End Deletion Start Insertionoversight is conducted by an IRB that End Insertion is not Start Deletionsubmitted within these time limits, the application or proposal may be returned to the End Deletion Start Insertionoperated by the institution, the End Insertion institutionStart Deletion. End Deletion Start Insertionand the organization operating the IRB shall document the institution’s reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol). End Insertion

(Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion )

Start Deletion§§ End Deletion Start Insertion End Insertion 46.104Start Deletion --46.106 [Reserved] End Deletion Start Insertion Exempt research. End Insertion


Exemptions were located in §46.101(b) of the pre-2018 Common Rule. In this comparison, all changes made to exemptions are shown in their corresponding 2018 Common Rule locations below.




Read an excerpt from the 2018 Common Rule preamble about exempt research.


 

Start Insertion(a) End Insertion Unless otherwise required by Start Insertionlaw or by End Insertion department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the Start Deletion following End Deletion categories Start Insertionin paragraph (d) of this section End Insertion are exempt from Start Insertionthe requirements of End Insertion this policyStart Insertion, except that such activities must comply with the requirements of this section and as specified in each category. End Insertion


Language in §46.104(a) of the 2018 Common Rule was previously found in the pre-2018 Common Rule in the introductory language to §46.101(b).



Start Insertion
(b) Use of the exemption categories for research subject to the requirements of subparts B, C, and DStart Deletion. End Deletion : Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: End Insertion



An explanation of the applicability of the exemptions to the subparts was found in the pre-2018 Common Rule in footnote 1.





Read an explanation from the 2018 Common Rule preamble about the applicability of the exemptions to subparts B, C, and D.


 

Start Insertion(1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. End Insertion

Start Insertion(2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners. End Insertion

Start Insertion(3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D.

 End Insertion

Start Insertion(c) [ReservedStart Deletion. End Deletion ] End Insertion

Start Deletion(b) End Deletion Start Insertion(d) End Insertion Start Deletion Unless otherwise required by department or agency heads, research activities End Deletion Start Insertion Except as described End Insertion in Start Deletionwhich the only involvement End Deletion Start Insertionparagraph (a) End Insertion of Start Deletionhuman subjects will be in one or more of End Deletion Start Insertionthis section, End Insertion the following categories Start Insertionof human subjects research End Insertion are exempt from this policy:



Read an excerpt from the 2018 Common Rule preamble about the exemption categories.


 

(1) ResearchStart Insertion, End Insertion conducted in established or commonly accepted educational settings, Start Deletioninvolving End Deletion Start Insertionthat specifically involves End Insertion normal educational practicesStart Deletion, such as (i) End Deletion Start Insertion that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most End Insertion research on regular and special education instructional strategies, Start Deletionor (ii) End Deletion Start Insertionand End Insertion research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. End Insertion



This exemption was found in the pre-2018 Common Rule at §46.101(b)(1), and has been modified in the 2018 Common Rule.




Read an excerpt from the 2018 Common Rule preamble discussing changes to the exemption for research conducted in established or commonly accepted educational settings.


 

(2) Research Start Insertionthat only includes interactions End Insertion involving Start Deletionthe use of End Deletion educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview proceduresStart Insertion, End Insertion or observation of public behaviorStart Deletion, unless End Deletion Start Insertion(including visual or auditory recording) if at least one of the following criteria is met End Insertion End Insertion :

(i) Start InsertionThe End Insertion information obtained is recorded Start Insertionby the investigator End Insertion in such a manner that Start Insertionthe identity of the End Insertion human subjects Start Deletioncan End Deletion Start Insertioncannot readily End Insertion be Start Deletionidentified End Deletion Start Insertionascertained End Insertion , directly or through identifiers linked to the subjects; Start Deletionand End Deletion
(ii) Start Deletionany End Deletion Start InsertionAny End Insertion disclosure of the human subjects' responses outside the research Start Deletioncould End Deletion Start Insertionwould not End Insertion reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, Start Insertioneducational advancement, End Insertion or reputationStart Deletion. End Deletion Start Insertion; or End Insertion
Start Deletion(4) End Deletion Start Insertion(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

End Insertion


This exemption was found in the pre-2018 Common Rule at §46.101(b)(2), and has been modified in the 2018 Common Rule.





Read an excerpt from the 2018 Common Rule preamble discussing changes to the exemption for research that includes only interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior.


 

Start Deletion(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: End Deletion


Start Deletion(i) the human subjects are elected or appointed public officials or candidates for public office; or End Deletion
Start Deletion(ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. End Deletion



The exemption found in the pre-2018 Common Rule at §46.101(b)(3) has been deleted in the 2018 Common Rule.





Read an excerpt from the 2018 Common Rule preamble discussing the deletion of the pre-2018 Common Rule’s exemption for surveys and interviews of public officials.


 

Start Insertion

(3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

End Insertion

Start Insertion(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; End Insertion

Start Insertion (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects' at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or End Insertion

Start Insertion(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7). End Insertion

Start Insertion(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
 End Insertion

Start Insertion(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. End Insertion



This exemption is new to the 2018 Common Rule.






Read an excerpt from the 2018 Common Rule preamble discussing the exemption for research involving benign behavioral interventions in conjunction with the collection of information from an adult subject.


 

Start Insertion(4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing the exemption categories for secondary research use of identifiable private information and identifiable biospecimens for which consent is not required.


 

Start Insertion (i) End Insertion Start Deletion4) Research involving the collection End Deletion Start Insertion The identifiable private information End Insertion or Start Deletionstudy of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources End Deletion Start Insertion identifiable biospecimens End Insertion are publicly available Start Deletionor if the End Deletion Start Insertion ; End Insertion



The exemption at §46.104(d)(4)(i) was found in the pre-2018 Common Rule as part of §46.101(b)(4), and has been modified in the 2018 Common Rule.




Read an excerpt from the 2018 Common Rule preamble discussing changes to the exemption for research involving the collection or study of identifiable private information or identifiable biospecimens that are publicly available.


 

Start Insertion (ii) I End Insertion Start Deletioni End Deletion nformationStart Insertion , which may include information about biospecimens, End Insertion is recorded by the investigator in such a manner that Start Insertion the identity of the human End Insertion subjects cannot Start Insertion readily End Insertion be Start Deletionidentified, End Deletion Start Insertion ascertained End Insertion directly or through identifiers linked to the subjectsStart Deletion. End Deletion Start Insertion , the investigator does not contact the subjects, and the investigator will not re-identify subjects; End Insertion



The exemption at §46.104(d)(4)(ii) was found in the pre-2018 Common Rule as part of §46.101(b)(4), and has been modified in the 2018 Common Rule.




Read an excerpt from the 2018 Common Rule preamble discussing changes to the exemption for research involving the collection or study of information (which may include information about biospecimens) that has been or will be collected and is recorded without identifiers.


 

Start Insertion (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations' or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or End Insertion


 



This exemption is new to the 2018 Common Rule.






Read an excerpt from the 2018 Common Rule preamble discussing the new exemption for research involving certain activities regulated by HIPAA.


 

Start Insertion (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
 End Insertion


This exemption is new to the 2018 Common Rule.






Read an excerpt from the 2018 Common Rule preamble discussing the new exemption for research conducted by a government agency using government generated or government collected data obtained for nonresearch activities.




(5) Research and demonstration projects Start Deletionwhich End Deletion Start Insertionthat End Insertion are conducted Start Insertionor supported End Insertion by Start Deletionor End Deletion Start Insertiona Federal department or agency, or otherwise End Insertion subject to the approval of department or agency headsStart Deletion, and which End Deletion Start Insertion (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that End Insertion are designed to study, evaluate, Start Insertionimprove, End Insertion or otherwise examineStart Deletion: End Deletion



This exemption was found in the pre-2018 Common Rule at §46.101(b)(5), and has been modified in the 2018 Common Rule.




Read an excerpt from the 2018 Common Rule preamble discussing the new exemption for research and demonstration projects conducted or supported by a federal department or agency.



Start Deletion(i) Public End Deletion Start Insertionpublic End Insertion benefit or service programsStart Deletion; End Deletion
Start Deletion (ii) End Deletion Start Insertion, including End Insertion procedures for obtaining benefits or services under those programsStart Deletion; End Deletion
Start Deletion (iii) End Deletion Start Insertion, End Insertion possible changes in or alternatives to those programs or proceduresStart Deletion; End Deletion Start Insertion, End Insertion or
Start Deletion (iv) End Deletion possible changes in methods or levels of payment for benefits or services under those programs. Start InsertionSuch projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. End Insertion

Start Insertion (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. End Insertion
Start Insertion(ii) [Reserved] End Insertion



(6) Taste and food quality evaluation and consumer acceptance studiesStart Deletion, End Deletion Start Insertion: End Insertion

(i) Start Deletionif End Deletion Start InsertionIf End Insertion wholesome foods without additives are consumedStart Insertion, End Insertion or
(ii) Start Deletionif End Deletion Start InsertionIf End Insertion a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.



This exemption was found in the pre-2018 Common Rule at §46.101(b)(6), and is unchanged.





Read an excerpt from the 2018 Common Rule preamble discussing the exemption for taste and food quality evaluation and consumer acceptance studies.


 

Start Insertion(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8). End Insertion



The exemption at §46.104(d)(7) is new to the 2018 Common Rule.







Read an excerpt from the 2018 Common Rule preamble discussing the two exemptions that require broad consent (§46.104(d)(7) and (8)).


Read an excerpt from the 2018 Common Rule preamble discussing the exemption for the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use (§46.104(d)(7)).


 

Start Insertion(8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: End Insertion

Start Insertion(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d); End Insertion
Start Insertion(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117; End Insertion
Start Insertion(iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and End Insertion
Start Insertion(iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

 End Insertion


The exemption at §46.104(d)(8) is new to the 2018 Common Rule.






Read an excerpt from the 2018 Common Rule preamble discussing the exemption for specific secondary research studies for which broad consent is required (§46.104(d)(8)).


 

Start Insertion(Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion ) End Insertion

Start Insertion§46.105-46.106 [ReservedStart Deletion. End Deletion ] End Insertion

Start Deletion§46.106 [Reserved.] End Deletion

§46.107 IRB membership.



Read an excerpt from the 2018 Common Rule preamble discussing IRB membership and modifications to references to vulnerability


 

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members Start Insertion(professional competence), End Insertion and the diversity of Start Deletionthe End Deletion Start Insertionits End Insertion members, including Start Deletionconsideration of End Deletion race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Start DeletionIn addition to possessing the professsional competence necessary to review specific research activities, the End Deletion Start Insertion The End Insertion IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments Start Insertion (including policies and resources) End Insertion and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a Start Deletionvulnerable End Deletion category of subjects Start Insertion that is vulnerable to coercion or undue influence End Insertion , such as children, prisoners, Start Deletionpregnant women or handicapped End Deletion Start Insertionindividuals with impaired decision-making capacity, End Insertion or Start Deletionmentally disabled End Deletion Start Insertioneconomically or educationally disadvantaged End Insertion persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these Start Insertioncategories of End Insertion subjects.

Start Deletion(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. End Deletion

Start Deletion(c) End Deletion Start Insertion (b) End Insertion Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

Start Deletion(d) End Deletion Start Insertion(c) End Insertion Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

Start Deletion(e) End Deletion Start Insertion(d) End Insertion No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

Start Deletion(f) End Deletion Start Insertion(e) End Insertion An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues Start Deletion which End Deletion Start Insertionthat End Insertion which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRBStart Insertion. End Insertion

§46.108 IRB functions and operations.


The contents of the 2018 Common Rule at §46.108(a) were found in the pre-2018 Common Rule in §46.103(b). Changes to the pre-2018 Common Rule at §46.103(b) are shown below.





Read an excerpt from the 2018 Common Rule preamble describing changes to the section pertaining to IRB functions and operations.


 

Start Insertion(a) End Insertion In order to fulfill the requirements of this policy each IRB shall:

Start Deletion(a) Follow written procedures in the same detail as described in §46.103(b)(4) and, to the extent required by, §46.103(b)(5) End Deletion

Start Deletion(1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to department- or agency-supported or regulated research and need not be applicable to any research exempted or waived under §46.101(b) or (i). End Deletion

Start Deletion(2) End Deletion Start Insertion(1) End Insertion Start DeletionDesignation of one or more IRBs established in accordance with the requirements of this policy, and for which provisions are made for End Deletion Start InsertionHave access to End Insertion meeting space and sufficient staff to support the IRB's review and recordkeeping dutiesStart Deletion. End Deletion Start Insertion; End Insertion



Section 46.108(a)(1) of the 2018 Common Rule was found in the pre-2018 Common Rule at §46.103(b)(2).


The requirements found in the pre-2018 Common Rule at §46.103(b)(1) and a portion of the requirements found in the pre-2018 Common Rule at §46.103(b)(2) have been deleted in the 2018 Common Rule. 




Start Deletion(3) End Deletion Start Insertion(2) End Insertion Start DeletionA End Deletion Start InsertionPrepare and maintain a current End Insertion list of Start Insertionthe End Insertion IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certificationsStart Deletion, End Deletion Start Insertion or End Insertion licensesStart Deletion, etc., End Deletion sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institutionStart Deletion; End Deletion Start Insertion, End Insertion for exampleStart Deletion: End Deletion Start Insertion, End Insertion full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultantStart Deletion. Changes in IRB membership shall be reported to the department or agency head, unless in accord with §46.103(a) of this policy, the existence of an HHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office for Human Research Protections, HHS, or any successor office. End Deletion Start Insertion; End Insertion



Section 46.108(a)(2) was found in the pre-2018 Common Rule at §46.103(b)(3).






Start Deletion(4) End Deletion Start Insertion(3) End Insertion Start DeletionWritten End Deletion Start Insertion Establish and follow written End Insertion procedures Start Deletionwhich the IRB will follow End Deletion Start Insertionfor: End Insertion

(i) Start Deletionfor conducting End Deletion Start InsertionConducting End Insertion its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
(ii) Start Deletionfor determining End Deletion Start InsertionDetermining End Insertion which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and
(iii) Start Deletionfor ensuring End Deletion Start Insertion Ensuring End Insertion prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that Start Deletionsuch changes in approved End Deletion Start Insertioninvestigators will conduct the End Insertion researchStart Deletion, during the period for which End Deletion Start Insertionactivity in accordance with the terms of the End Insertion IRB approval Start Deletionhas already End Deletion Start Insertionuntil any proposed changes have End Insertion been Start Deletion given, may not be initiated without IRB review End Deletion Start Insertion reviewed End Insertion and Start Deletionapproval End Deletion Start Insertionapproved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.




Section 46.108(a)(3) of the 2018 Common Rule was found in the pre-2018 Common Rule at §46.103(b)(4)






Start Deletion(5) End Deletion Start Insertion (4) End Insertion Start DeletionWritten End Deletion Start Insertion Established and follow written End Insertion procedures for ensuring prompt reporting to the IRBStart Deletion , End Deletion Start Insertion ; End Insertion appropriate institutional officialsStart Deletion, and End Deletion Start Insertion ; End Insertion the department or agency headStart Insertion ; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency End Insertion of

(i) Start Deletionany End Deletion Start Insertion Any End Insertion unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and
(ii) Start Deletionany End Deletion Start Insertion Any End Insertion suspension or termination of IRB approval.




Section 46.108(a)(4) was found in the pre-2018 Common Rule at §46.103(b)(5)






(b) Except when an expedited review procedure is used (Start Deletionsee End Deletion Start Insertion as described in End Insertion §46.110), End Insertion Start Insertion an IRB must End Insertion review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

Start Insertion(Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion ) End Insertion

§46.109 IRB review of research.



Read an excerpt from the 2018 Common Rule preamble describing changes to §46.109 (IRB review of research).


 

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policyStart Deletion. End Deletion Start Insertion, including exempt research activities under §46.104 for which limited IRB review is a condition of exemption (under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and ( End Insertion Start Deletiond)( End Deletion Start Insertion8)).

(b) An IRB shall require that information given to subjects Start Insertion(or legally authorized representatives, when appropriate) End Insertion as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.

(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(e) An IRB shall conduct continuing review of research Start Deletion covered End Deletion Start Insertion requiring review End Insertion by Start Deletionthis policy End Deletion Start Insertionthe convened IRB End Insertion at intervals appropriate to the degree of risk, Start Deletionbut End Deletion not less than once per year, Start Deletionand shall have authority to observe or have a third party observe the consent process and the research. End Deletion Start Insertionexcept as described in §46.109(f). End Insertion



The last segment of text found in the pre-2018 Common Rule at §46.109(e) has been moved to §46.109(g) in the 2018 Common Rule.


 

Start Insertion(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: End Insertion

Start Insertion(i) Research eligible for expedited review in accordance with §46.110; End Insertion
Start Insertion(ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)(3)(i)(C), Start Deletion (d)(7), End Deletion Start Insertion or (d)(7) or (8);
Start Insertion(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: End Insertion
Start Insertion(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. End Insertion
Start Insertion(2) [ReservedStart Deletion. End Deletion ]

End Insertion

Start Insertion (g) An IRB shall have authority to observe or have a third party observe the consent process and the research. End Insertion



The language in §46.109(g) of the 2018 Common Rule was found in the pre-2018 Common Rule as a portion of §46.109(e).


 

Start Insertion(Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion ) End Insertion

§46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.



Read an excerpt from the 2018 Common Rule preamble describing changes to the expedited review procedures.


 

(a) The SecretaryStart Deletion, End Deletion Start Insertion of End Insertion HHSStart Deletion, End Deletion has established, and published as a Notice in the Start DeletionFEDERAL REGISTER End Deletion Start Insertion Federal Register End Insertion , a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Start Deletionlist End Deletion Start InsertionSecretary End Insertion will Start Deletionbe amended End Deletion Start Insertionevaluate the list at least every 8 years and amend it End Insertion , as appropriate, after consultation with other Start Insertionfederal End Insertion departments and agenciesStart Deletion, through periodic republication by the Secretary, HHS, End Deletion Start Deletion and after publication End Insertion in the Start DeletionFEDERAL REGISTER End Deletion Start Insertion Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.

(b)Start Insertion(1) End Insertion An IRB may use the expedited review procedure to review Start Deletioneither or both of End Deletion the following:

Start Deletion(1) End Deletion Start Insertion(i) End Insertion Start Deletionsome End Deletion Start InsertionSome End Insertion or all of the research appearing on the list Start Deletionand found by End Deletion Start Insertiondescribed in paragraph (a) of this section, unless End Insertion the reviewerStart Deletion(s) to involve no End Deletion Start Insertiondetermines that the study involves End Insertion more than minimal riskStart Deletion, End Deletion Start Insertion; End Insertion
Start Deletion(2) End Deletion Start Insertion(ii) End Insertion Start Deletionminor End Deletion Start InsertionMinor End Insertion changes in previously approved research during the period Start Deletion(of one year or less) End Deletion for which approval is authorizedStart Deletion. End Deletion Start Insertion; or End Insertion
Start Insertion(iii) Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (d)(8) End Insertion
Start Insertion(2) End Insertion Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the Start Insertionnon-expedited End Insertion procedure set forth in §46.108(b).



(c) Each IRB Start Deletionwhich End Deletion Start Insertionthat End Insertion uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals Start Deletionwhich End Deletion Start Insertion that End Insertion have been approved under the procedure.

(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.

§46.111 Criteria for IRB approval of research.



Read an excerpt from the 2018 Common Rule preamble describing changes to the criteria for IRB approval of research.


 

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied

(1) Risks to subjects are minimized:

(i) By using procedures Start Deletionwhich End Deletion Start Insertionthat End Insertion are consistent with sound research design and Start Deletionwhich End Deletion Start Insertionthat End Insertion do not unnecessarily expose subjects to risk, and
(ii) Start Deletionwhenever End Deletion Start InsertionWhenever End Insertion appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (Start Deletionfor example, End Deletion Start Insertione.g., End Insertion the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conductedStart Deletionand. End Deletion Start Insertion The IRB End Insertion should be particularly cognizant of the special problems of research Start Deletioninvolving End Deletion Start Insertion involves a category of subjects who are End Insertion vulnerable Start Deletionpopulations End Deletion Start Insertionto coercion or undue influenceStart Insertion, such as children, prisoners, Start Deletionpregnant women, mentally disabled persons Start Insertionindividuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.



Read a description from the 2018 Common Rule preamble discussing changes to the references to vulnerability.


 

(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by Start Deletion , End Deletion §46.116.

(5) Informed consent will be appropriately documentedStart Deletion, End Deletion Start Insertionor appropriately waived End Insertion in accordance withStart Deletion, and to the extent required by End Deletion §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Start Insertion(i) The Secretary of HHS will, after consultation with the Office of Management and Budget’s privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data.
(ii) [Reserved.]

End Insertion
Start Insertion

(8) For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:

End Insertion
Start Insertion(i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d); End Insertion
Start Insertion(ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §46.117; and
End Insertion Start Insertion (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. End Insertion


(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, Start Deletionpregnant women, mentally disabled persons Start Insertionindividuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.



Read a description from the 2018 Common Rule preamble discussing changes made to the references to vulnerability.


 

§46.112 Review by institution.

Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.

§46.113 Suspension or termination of IRB approval of research.

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.

(Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion )

§46.114 Cooperative research.



Read an excerpt from the 2018 Common Rule preamble describing changes to the cooperative research provision.



Start Insertion(a) End Insertion Cooperative research projects are those projects covered by this policy Start Deletionwhich End Deletion Start Insertionthat End Insertion involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

Start Insertion(b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. End Insertion

Start Insertion (2) The following research is not subject to this provision: End Insertion

Start Insertion(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

 End Insertion

Start Insertion(c) End Insertion Start Deletion With the approval of the department or agency head End Deletion End Insertion Start Insertion For research not subject to paragraph (b) of this section End Insertion , an institution participating in a cooperative project may enter into a joint review arrangement, rely Start Deletionupon End Deletion Start Insertionon End Insertion the review of another Start Deletionqualified End Deletion IRB, or make similar arrangements for avoiding duplication of effort.



The language found in the 2018 Common Rule at §46.114(c) was found in the pre-2018 Common Rule as part of §46.114(a).


 

§46.115 IRB records.



Read an excerpt from the 2018 Common Rule preamble about changes to the IRB recordkeeping requirements.


 

(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:

(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent Start Deletiondocuments End Deletion Start Insertionforms End Insertion , progress reports submitted by investigators, and reports of injuries to subjects.

(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.

(3) Records of continuing review activitiesStart Deletion. End Deletion Start Insertion, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in §46.109(f)(1). End Insertion

(4) Copies of all correspondence between the IRB and the investigators.

(5) A list of IRB members in the same detail as described in Start Deletion§46.103(b)(3) End Deletion Start Insertion§46.108(a)(2) End Insertion .

(6) Written procedures for the IRB in the same detail as described in Start Deletion §46.103(b)(4) End Deletion §46.108(a)(3) and Start Deletion§46.103(b)(5) End Deletion Start Insertion(4) End Insertion .

(7) Statements of significant new findings provided to subjects, as required by Start Deletion§46.116(b)(5) End Deletion Start Insertion §46.116(c)(5) End Insertion .

Start Insertion(8) The rationale for an expedited reviewer's determination under §46.110(b)(1)(i) that research appearing on the expedited review list described in §46.110(a) is more than minimal risk. End Insertion

Start Insertion(9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in §46.103(e). End Insertion

(b) The records required by this policy shall be retained for at least 3 years, and records relating to research Start Deletion which End Deletion Start Insertionthat End Insertion is conducted shall be retained for at least 3 years after completion of the research. Start InsertionThe institution or IRB may maintain the records in printed form, or electronically. End Insertion All records shall be accessible for inspection and copying by authorized representatives of the Start InsertionFederal End Insertion department or agency at reasonable times and in a reasonable manner.

(Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion )

§46.116 General requirements for informed consent.



Read an excerpt from the 2018 Common Rule preamble summarizing all changes made to §46.116 (the general requirements for informed consent).





Start Insertion (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is described in paragraph (f) of this section. End Insertion Except as provided elsewhere in this policyStart Deletion, no investigator may involve End Deletion Start Insertion: End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing changes to the language found in the pre-2018 Common Rule as the introductory language of §46.116 (enumerated in the 2018 Common Rule at §46.116(a)). 



Start Insertion (1) Before involving End Insertion a human Start Deletionbeing as a End Deletion subject in research covered by this policy Start Deletionunless the End Deletion Start Insertion , an End Insertion investigator Start Deletionhas obtained End Deletion Start Insertion shall obtain End Insertion the legally effective informed consent of the subject or the subject’s legally authorized representative.

Start Insertion(2) End Insertion An investigator shall seek Start Deletionsuch End Deletion Start Insertion informed End Insertion consent only under circumstances that provide the prospective subject or the Start Insertion legally authorized End Insertion representative sufficient opportunity to Start Insertiondiscuss and End Insertion consider whether or not to participate and that minimize the possibility of coercion or undue influence.

Start Insertion(3) End Insertion The information that is given to the subject or the Start Insertionlegally authorized End Insertion representative shall be in language understandable to the subject or the Start Insertionlegally authorized End Insertion representative.

Start Insertion(4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. End Insertion

Start Insertion(5) Except for broad consent obtained in accordance with paragraph (d) of this section:
End Insertion

Start Insertion (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate. End Insertion

Start Insertion(6) End Insertion No informed consentStart Deletion, whether oral or written, End Deletion may include any exculpatory language through which the subject or the Start Insertionlegally authorized End Insertion representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institutionStart Insertion, End Insertion or its agents from liability for negligence.

Start Deletion(a) End Deletion Start Insertion(b) End Insertion Basic elements of informed consent. Except as provided in paragraph Start Deletion(c) End Deletion Start Insertion(d), (e), or Start Deletion(d) End Deletion Start Insertion (f) of this section, in seeking informed consent the following information shall be provided to each subject Start Insertionor the legally authorized representative End Insertion :



Read an excerpt from the 2018 Common Rule preamble discussing changes to the basic elements of informed consent.


 

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures Start Deletionwhich End Deletion Start Insertionthat are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others Start Deletionwhich End Deletion Start Insertionthat may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; Start Deletion and

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitledStart Deletion. End Deletion Start Insertion; and End Insertion

Start Insertion (9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: End Insertion

Start Insertion (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

End Insertion

Start Deletion(b) End Deletion Start Insertion(c) End Insertion Additional elements of informed consent. Start DeletionWhen appropriate End Deletion Start InsertionExcept as provided in paragraph (d), (e), or (f) of this section, End Insertion one or more of the following elements of informationStart Insertion, when appropriate, End Insertion shall also be provided to each subject Start Insertionor the legally authorized representative End Insertion :



Read an excerpt from the 2018 Common Rule preamble describing the changes to the additional elements of informed consent.


 

(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) Start Deletionwhich End Deletion Start Insertionthat End Insertion are currently unforeseeable;

(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s Start Insertionor the legally authorized representative’s End Insertion consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research Start Deletionwhich End Deletion Start Insertionthat End Insertion may relate to the subject’s willingness to continue participation will be provided to the subject; Start Deletion and End Deletion

(6) The approximate number of subjects involved in the studyStart Deletion. End Deletion Start Insertion; End Insertion

Start Insertion (7) A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; End Insertion

Start Insertion (8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and End Insertion

Start Insertion (9) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). End Insertion

Start Insertion(d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in paragraphs (b) and (c) of this section. If the subject or the legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject’s legally authorized representative: End Insertion



Read an excerpt from the 2018 Common Rule preamble describing the elements of broad consent.


 

Start Insertion(1) The information required in paragraphs (b)(2), (b)(3), (b)(5), and (b)(8) and, when appropriate, (c)(7) and (9) of this section; End Insertion

Start Insertion (2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted; End Insertion

Start Insertion (3) A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens; End Insertion

Start Insertion(4) A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite); End Insertion

Start Insertion (5) Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject is identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies; End Insertion

(6) Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and End Insertion

Start Insertion (7) An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm. End Insertion

Start Insertion(e) Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials. End Insertion


Read an excerpt from the 2018 Common Rule preamble discussing changes to the elements of waiver or alteration of informed consent involving public benefit and service programs.

 

Start Insertion(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens. End Insertion

Start Insertion(2) Alteration. End InsertionAn IRB may approve a consent procedure Start Deletionwhich does not include End Deletion Start Insertionthat omits some End Insertion , or Start Deletionwhich End Deletion altersStart Deletion, End Deletion some or allStart Insertion, End Insertion of the elements of informed consent set forth Start Deletionabove, or waive the requirements to obtain informed consent provided the IRB finds and documents that: End Deletion Start Insertion in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section. End Insertion

Start Deletion(1) End Deletion Start Insertion(3) Requirements End Insertion Start Deletion of End Deletion Start Insertionfor waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: End Insertion

Start Insertion(i) End Insertion The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

Start Insertion Start Deletion(i) public End Deletion Start Insertion (A) Public End Insertion benefit or service programs;
Start Insertion Start Deletion(ii) procedures End Deletion Start Insertion (B) Procedures End Insertion for obtaining benefits or services under those programs;
Start Insertion Start Deletion(iii) possible End Deletion Start Insertion (C) Possible End Insertion changes in or alternatives to those programs or procedures; or
Start Insertion Start Deletion(iv) possible End Deletion Start Insertion (D) Possible End Insertion changes in methods or levels of payment for benefits or services under those programs; and

Start Deletion(2) End Deletion Start Insertion(ii) End Insertion The research could not practicably be carried out without the waiver or alteration.



Start Insertion (f) General waiver or alteration of consent. End Insertion



Read an excerpt from the 2018 Common Rule preamble discussing changes to the general waiver or alteration of consent provision.


 

Start Insertion(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph End Insertion (d) Start Insertionof this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.End Insertion

Start Insertion(2) Alteration. End Insertion An IRB may approve a consent procedure Start Deletionwhich does not include End Deletion Start Insertionthat omits some End Insertion , or Start Deletionwhich End Deletion altersStart Deletion, End Deletion some or allStart Insertion, End Insertion of the elements of informed consent set forth in Start Deletionthis section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: End Deletion Start Insertion paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section. End Insertion

Start Deletion(1) End Deletion Start Insertion (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: End Insertion
Start Deletion(1) End Deletion Start Insertion(i) End Insertion The research involves no more than minimal risk to the subjects;
Start Insertion End Insertion Start Deletion(3) End Deletion (ii) The research could not practicably be carried out without the Start Insertionrequested End Insertion waiver or alteration;
Start Insertion(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; End Insertion
Start Insertion End Insertion Start Deletion(2) End Deletion Start Insertion (iv) End Insertion The waiver or alteration will not adversely affect the rights and welfare of the subjects; Start Insertionand End Insertion
Start Insertion End Insertion Start Deletion(4) End Deletion Start Insertion (v) End Insertion Whenever appropriate, the subjects Start Insertionor legally authorized representatives End Insertion will be provided with additional pertinent information after participation.


Start Insertion

(g) Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:




Read an excerpt from the 2018 Common Rule preamble describing IRB approval of research involving screening, recruiting, or determining eligibility of prospective subjects.

 

Start Insertion(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
 End Insertion

Start Insertion(h) Posting of clinical trial consent form End Insertion



Read an excerpt from the 2018 Common Rule preamble describing the posting of clinical trial consent forms.


 Start Insertion
(1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.


(2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.

(3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

End Insertion

Start Deletion(e) End Deletion Start Insertion(i) End Insertion Start InsertionPreemption. End Insertion The informed consent requirements in this policy are not intended to preempt any applicable Start Deletionfederal End Deletion Start InsertionFederal End Insertion , state, or local laws Start Deletionwhich End Deletion Start Insertion(including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that End Insertion require additional information to be disclosed in order for informed consent to be legally effective.

Start Deletion(f) End Deletion Start Insertion(j) End Insertion Start InsertionEmergency medical care. End Insertion Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Start Deletionfederal End Deletion Start InsertionFederal End Insertion , state, or local lawStart Deletion. End Deletion Start Insertion (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe). End Insertion

Start Insertion (Approved by the Office of Management and Budget under Control Number 0990-0260Start Deletion. End Deletion ) End Insertion

§46.117 Documentation of informed consent.



Read an excerpt from the 2018 Common Rule preamble discussing changes to the requirements for documentation of informed consent.


 

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written Start Insertioninformed End Insertion consent form approved by the IRB and signed Start Insertion (including in an electronic format) End Insertion by the subject or the subject's legally authorized representative. A Start Insertion written End Insertion copy shall be given to the person signing theStart Insertion informed consent End Insertion form.

(b) Except as provided in paragraph (c) of this section, the Start Insertioninformed End Insertion consent form may be either of the following:

(1) A written Start Deletionconsent document that embodies the elements of End Deletion informed consent Start Deletionrequired by End Deletion Start Insertionform that meets the requirements of End Insertion §46.116. Start DeletionThis form may be read to the subject or the subject's legally authorized representative, but in any event, the End Deletion Start InsertionThe End Insertion investigator shall give either the subject or the Start Insertionsubject's legally authorized End Insertion representative adequate opportunity to read Start Deletionit End Deletion Start Insertionthe informed consent form End Insertion before it is signed; Start Deletionor End Deletion Start Insertionalternatively, this form may be read to the subject or the subject's legally authorized representative. End Insertion

(2) A short form written Start Insertioninformed End Insertion consent Start Deletiondocument End Deletion Start Insertionform End Insertion stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the Start Deletionsubject's legally authorized representative. End Deletion Start Insertionsubject's legally authorized representative, and that the key information required by §46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. End Insertion When this method is used, there shall be a witness to the oral presentation. Start DeletionAlso, the IRB shall approve a written summary of what is to be said to the subject or the representative. End Deletion Only the short form itself is to be signed by the subject or the Start Insertionsubject's legally authorized End Insertion representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the Start Insertionsubject's legally authorized End Insertion representative, in addition to a copy of the short form.

(c)Start Insertion(1) End Insertion An IRB may waive the requirement for the investigator to obtain a signed Start Insertioninformed End Insertion consent form for some or all subjects if it finds Start Deletioneither End Deletion Start Insertionany of the following End Insertion :
Start Deletion(1) End Deletion Start Insertion (i) End Insertion That the only record linking the subject and the research would be the Start Insertion informed End Insertion consent Start Deletiondocument End Deletion Start Insertion form End Insertion and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject Start Insertion (or legally authorized representative) End Insertion will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; Start Deletionor End Deletion

Start Deletion(2) End Deletion Start Insertion (ii) End Insertion That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research contextStart Deletion. End Deletion Start Insertion ; or
End Insertion Start Insertion (iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. End Insertion

Start Insertion(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects Start Insertion or legally authorized representatives End Insertion with a written statement regarding the research.

(Approved by the Office of Management and Budget under Control Number 0990-0260)

§46.118 Applications and proposals lacking definite plans for involvement of human subjects.



Read an excerpt of the 2018 Common Rule preamble describing applications and proposals lacking definite plans for involvement of human subjects.


Certain types of applications for grants, cooperative agreements, or contracts are submitted to Start Insertion Federal End Insertion departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Start Deletion These applications need not be reviewed by an IRB before an award may be made. However, except End Deletion Start InsertionExcept End Insertion for research Start Deletionexempted or End Deletion waived under Start Deletion§46.101(b) or (i) End Deletion Start Insertion§46.101(i) or exempted under §46.104, End Insertion no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Start Insertion Federal End Insertion department or agency Start Insertion component supporting the research End Insertion .

§46.119 Research undertaken without the intention of involving human subjects.



Read an excerpt of the 2018 Common Rule preamble describing research undertaken without the intention of involving human subjects.





Start DeletionIn End Deletion Start InsertionExcept for research waived under §46.101(i) or exempted under §46.104, in End Insertion the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submittedStart Deletion, End Deletion by the institutionStart Deletion, End Deletion to the Start InsertionFederal End Insertion department or agency Start Insertioncomponent supporting the research End Insertion , and final approval given to the proposed change by the Start Insertion Federal End Insertion department or agency Start Insertion componentEnd Insertion .



§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Start DeletionDepartment End Deletion Start Insertiondepartment End Insertion or Start DeletionAgency End Deletion Start Insertion agency End Insertion .

(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Start InsertionFederal End Insertion department or agency through such officers and employees of the Start InsertionFederal End Insertion department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

(b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.



§46.121 [Reserved]




§46.122 Use of Federal funds.

Federal funds administered by a Start InsertionFederal End Insertion department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.



§46.123 Early termination of research support: Evaluation of applications and proposals.

(a) The department or agency head may require that Start InsertionFederal End Insertion department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy.

(b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).



§46.124 Conditions.



Read an excerpt of the 2018 Common Rule preamble describing changes to the section on conditions.


 
With respect to any research project or any class of research projects the department or agency head Start Insertionof either the conducting or supporting Federal department or agency End Insertion may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects.