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 - PDF” You can find the pre-2018 Common Rule by reviewing subpart A of 45 CFR part 46 - PDF 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).
DISCLAIMER:
- This document is not an official version of the revised Common Rule regulatory text. The official regulator text can be found here.
- There may be minor discrepancies (e.g., capitalization of words, spacing of paragraphs) between the regulatory text that appears below and the regulatory text in the official version published in the Federal Register.
- The regulatory text below is an unofficial comparison of the pre-2018 Common Rule regulatory text to the amended 2018 Common Rule regulatory text.
- Links to preamble excerpts from the January 19, 2017 final rule are also to an unofficial version of that preamble. There may be minor discrepancies (e.g., capitalization of words, spacing of paragraphs) between the text that appears in a preamble excerpt and the text published in the preamble to the January 19, 2017 final rule as published in the Federal Register.
- Preamble language operates as the agency’s contemporaneous interpretation and explanation of the regulatory requirements, and is not part of the enforceable regulatory requirements themselves. As such, the agency interpretation of the substantive regulatory requirements may change from what a preamble indicated. For the most accurate information about OHRP's current thinking on a revised Common Rule provision, check the "Guidance" section of the OHRP website.
Key:
[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
Subpart A— Basic HHS Policy for Protection of 45 CFR part 46 Human Research Subjects
Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
Sec.
§46.101 To what does this policy apply?
§46.102 Definitions for purposes of this policy.
§46.103 Assuring compliance with this policy--research conducted or supported by any Federal Ddepartment or Aagency.
§46.104 Exempt research.
§46.105 [Reserved]
§46.106 [Reserved]
§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 iInstitution.
§46.113 Suspension or tTermination of IRB aApproval of rResearch.
§46.114 Cooperative rResearch.
§46.115 IRB rRecords.
§46.116 General rRequirements for iInformed cConsent.
§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 Ddepartment or Aagency.
§46.121 [Reserved]
§46.122 Use of Federal funds.
§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 provided detailed in paragraph (b) of this section §46.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal Federal department or agency which that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by federal Federal 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 federal government outside the United States Federal 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.
(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.
(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.
(b) [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:
Read an excerpt from the revised Common Rule preamble about why the location of the exemption categories changed.
(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.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(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:
(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.
(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:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed or ; (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.
(c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy. and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.1
(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 Federal department or agency but not otherwise covered by this policy, comply with some or all of the requirements of this policy.
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 which that provide additional protections for human subjects.
(f) This policy does not affect any state or local laws or regulations which (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and which that 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 which that may otherwise be applicable and which that 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. [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.] 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 FEDERAL REGISTER Federal Register 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 or of research activities otherwise covered by this policy., provided the alternative procedures to be followed are consistent with the principles of the Belmont Report.2Except 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, or to the equivalent office within the appropriate Federal department or agency, and shall also publish them in the FEDERAL REGISTER Federal Register or in such other manner as provided in department or agency procedures.1The 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.
Read an excerpt from the revised Common Rule preamble about department or agency discretion in applying this policy.
(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.
Read an excerpt from the revised Common Rule preamble about harmonization of department and agency guidance.
(k) [Reserved]
(l) Compliance dates and transition provisions:
(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.
(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.
(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.
(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.
- (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.
(5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research:
- (i) Research initially approved by an IRB on or after January 21, 2019;
- (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and
- (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
(m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other dissimilar circumstances.
[82 FR 7259, 7273, Jan. 19, 2017, as amended at 83 FR 28518, June 19, 2018]
Read an excerpt from the 2018 Common Rule preamble about the severability provision.
Footnote 1 in the pre-2018 Common Rule explained the extent to which the pre-2018 Common Rule exemptions applied to subparts B-D of the HHS human subjects regulations at 45 CFR 46.
Information about the applicability of the 2018 Common Rule exemptions to subparts B-D of 45 CFR 46 can be found in the 2018 Common Rule at §46.104(b).
1 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.
1The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ,. The Belmont Report: Ethical Principles. Washington, DC: U.S. Department of Health and Guidelines for the Protection of Human Subjects of Research (Apr. 18, Services. 1979)..
2 Id.
Read an excerpt from the revised Common Rule preamble about department or agency discretion in applying this policy.
(j)(a) Certification means the official notification by the institution to the supporting Federal department or agency component, 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.
(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.
Read an excerpt from the 2018 Common Rule preamble discussing the definition of clinical trial.
(a)(c) Department or agency head means the head of any federal Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated.
Read an excerpt from the 2018 Common Rule preamble discussing the definition of department or agency head.
(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).
Read an excerpt from the 2018 Common Rule preamble discussing the definition of federal department or agency.
(f)(e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Data(i) Obtains information or biospecimens through intervention or interaction with the individual, or(2) Identifiable and, uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
(2) Intervention includes both physical procedures by which data information or biospecimens are gathered (for example, e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
(3) Interaction includes communication or interpersonal contact between investigator and subject.
(4) 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 which that has been provided for specific purposes by an individual and which that the individual can reasonably expect will not be made public (for example, e.g., a medical record).
(5) Identifiable private information must be is private information for which the individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.).
(6) 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 biospecimen).
(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.
Read an excerpt from the 2018 Common Rule preamble discussing all changes to the definition of human subject.
(b)(f) Institution means any public or private entity, or department 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.
(c)(i) 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. If 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.
Read an excerpt from the 2018 Common Rule preamble discussing changes to the definition of legally authorized representative.
(i)(j) 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.
(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.
Read an excerpt from the 2018 Common Rule preamble discussing the definition of public health authority.
(d)(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
Read an excerpt from the 2018 Common Rule preamble discussing changes to the definition of research.
(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.
(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).
(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.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
(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.
(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).
§46.103 Assuring compliance with this policy -- research conducted or supported by any Federal Department department or Agency agency .
Read an excerpt from the 2018 Common Rule preamble discussing changes to the assurance requirements.
(a) Each institution engaged in research which that is covered by this policy and which, with the exception of research eligible for exemption under §46.104, and that is conducted or supported by a federal Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in of 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 Ffederal-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.
(b) Departments Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance approved that it will comply with the requirements of this policy, 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 provided 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: (if such certification is required by §46.103(d)).
(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).
(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.
(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.
(4) Written procedures which the IRB will follow
(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of
(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 (ii) any suspension or termination of IRB approval.
(c)(b) 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.
(d)(c) The department or agency head will 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.
(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 may limit the period during which any particular approved assurance or class of approved assurances shall remain effective or otherwise condition or restrict approval the assurance.
(f)(d) Certification is required when the research is supported by a federal Federal department or agency and not otherwise exempted or waived under §46.101(b) or §46.101(i). An institution with an approved assurance) or exempted under §46.104. For such research, institutions shall certify that each application or proposal for proposed research study covered by the assurance and by §46.103 of this Policy section has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be as prescribed by the Federal department or agency to which component supporting the application or proposal is submittedresearch. Under no condition shall research covered by §46.103 of the Policy be supported this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB. Institutions 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,
(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), (d)(7), or (d)(7) or (8)) that the application or proposal has been approved by the takes place at an institution in which IRB. If the certification oversight is conducted by an IRB that is not submitted within these time limits, the application or proposal may be returned to the operated by the institution, the institution. and 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).
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
§§46.104 --46.106 [Reserved] Exempt research.
Read an excerpt from the 2018 Common Rule preamble about exempt research.
(a) Unless otherwise required by law or 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 in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category.
(b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D.: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows:
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.
(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.
(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.
(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.(c) [Reserved.]
(b)(d) Unless otherwise required by department or agency heads, research activities Except as described in which the only involvement paragraph (a) of human subjects will be in one or more of this section, the following categories of human subjects research are exempt from this policy:
Read an excerpt from the 2018 Common Rule preamble about the exemption categories.
(1) Research, conducted in established or commonly accepted educational settings, involving that specifically involves normal educational practices, such as (i) 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 research on regular and special education instructional strategies, or (ii) and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
This exemption was found in the pre-2018 Common Rule at §46.101(b)(1), and has been modified in the 2018 Common Rule.
(2) Research that only includes interactions involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless (including visual or auditory recording) if at least one of the following criteria is met:
(ii)
This exemption was found in the pre-2018 Common Rule at §46.101(b)(2), and has been modified in the 2018 Common Rule.
(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:
(i) the human subjects are elected or appointed public officials or candidates for public office; or(ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
The exemption found in the pre-2018 Common Rule at §46.101(b)(3) has been deleted in the 2018 Common Rule.
(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:
(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;
(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
(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).
(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.
This exemption is new to the 2018 Common Rule.
(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:
(i) 4) Research involving the collection The identifiable private information or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources identifiable biospecimens are publicly available or if the ;
(ii) I information , which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be identified, ascertained directly or through identifiers linked to the subjects. , the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(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
This exemption is new to the 2018 Common Rule.
(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.
This exemption is new to the 2018 Common Rule.
(5) Research and demonstration projects which that are conducted or supported by or a Federal department or agency, or otherwise subject to the approval of department or agency heads, and which (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 are designed to study, evaluate, improve, or otherwise examine:
This exemption was found in the pre-2018 Common Rule at §46.101(b)(5), and has been modified in the 2018 Common Rule.
(ii) [Reserved]
(6) Taste and food quality evaluation and consumer acceptance studies,:
(ii)
This exemption was found in the pre-2018 Common Rule at §46.101(b)(6), and is unchanged.
(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).
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)).
(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:
(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
(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
(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.
The exemption at §46.104(d)(8) is new to the 2018 Common Rule.
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
§46.105-46.106 [Reserved.]
§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 (professional competence), and the diversity of the its members, including consideration of 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. In addition to possessing the professsional competence necessary to review specific research activities, the The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) 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 vulnerable category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, pregnant women or handicapped individuals with impaired decision-making capacity, or mentally disabled economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(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.
(c) (b) 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.
(d)(c) 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.
(e)(d) 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.
(f)(e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which that which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
§46.108 IRB functions and operations.
Read an excerpt from the 2018 Common Rule preamble describing changes to the section pertaining to IRB functions and operations.
(a) In order to fulfill the requirements of this policy each IRB shall:
(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)
(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).
(2)(1) Designation of one or more IRBs established in accordance with the requirements of this policy, and for which provisions are made for Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties.;
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.(3)(2) A Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, or 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.;
Section 46.108(a)(2) was found in the pre-2018 Common Rule at §46.103(b)(3).
(4)(3) Written Establish and follow written procedures which the IRB will follow for:
(ii)
(iii)
Section 46.108(a)(3) of the 2018 Common Rule was found in the pre-2018 Common Rule at §46.103(b)(4)
(5) (4) Written Established and follow written procedures for ensuring prompt reporting to the IRB , ; appropriate institutional officials, and ; the department or agency head ; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of
(ii)
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 (see as described in §46.110), an IRB must 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.
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
§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 policy., 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 (d)(8)).
(b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) 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 covered requiring review by this policy the convened IRB at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research. except as described in §46.109(f).
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.
(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
(ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)(3)(i)(C),
(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:
(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.
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).
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
§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 Secretary, of HHS, has established, and published as a Notice in the FEDERAL REGISTER Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list Secretary will be amended evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal departments and agencies, through periodic republication by the Secretary, HHS, and after publication in the FEDERAL REGISTER 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)(1) An IRB may use the expedited review procedure to review either or both of the following:
(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)
(c) Each IRB which that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which that 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 which that are consistent with sound research design and which that do not unnecessarily expose subjects to risk, and
(ii) whenever Whenever 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 (for example, e.g., 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 conductedand. The IRB should be particularly cognizant of the special problems of research involving involves a category of subjects who are vulnerable populations to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons individuals 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 , §46.116.
(5) Informed consent will be appropriately documented, or appropriately waived in accordance with, and to the extent required by §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.
(ii) [Reserved.]
(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:
(ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §46.117; and
(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.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons individuals 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 0990-0260.)
§46.114 Cooperative research.
Read an excerpt from the 2018 Common Rule preamble describing changes to the cooperative research provision.
(a) Cooperative research projects are those projects covered by this policy which that 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.
(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.
(2) The following research is not subject to this provision:
(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.
(c) With the approval of the department or agency head For research not subject to paragraph (b) of this section , an institution participating in a cooperative project may enter into a joint review arrangement, rely upon on the review of another qualified 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 documents forms, 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 activities., including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in §46.109(f)(1).
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in §46.103(b)(3)§46.108(a)(2) .
(6) Written procedures for the IRB in the same detail as described in §46.103(b)(4) §46.108(a)(3) and §46.103(b)(5)(4).
(7) Statements of significant new findings provided to subjects, as required by §46.116(b)(5) §46.116(c)(5).
(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.
(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).
(b) The records required by this policy shall be retained for at least 3 years, and records relating to research which that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at reasonable times and in a reasonable manner.
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
§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).
(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. Except as provided elsewhere in this policy, no investigator may involve:
(1) Before involving a human being as a subject in research covered by this policy unless the , an investigator has obtained shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.
(2) An investigator shall seek such informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
(3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.
(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.
(5) Except for broad consent obtained in accordance with paragraph (d) of this section:
(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.
(6) No informed consent, whether oral or written, may include any exculpatory language through which the subject or the legally authorized 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 institution, or its agents from liability for negligence.
(a)(b) Basic elements of informed consent. Except as provided in paragraph (c) (d), (e), or (d) (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative:
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 which that 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 which that 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; 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 entitled. ; and
(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(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.
(b) (c) Additional elements of informed consent. When appropriate Except as provided in paragraph (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:
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) which that are currently unforeseeable;
(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s 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 which that may relate to the subject’s willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study. ;
(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;
(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
(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).
(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:
Read an excerpt from the 2018 Common Rule preamble describing the elements of broad consent.
(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;
(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;
(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;
(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);
(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;
(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
(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.
(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.
(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.
(2) Alteration. An IRB may approve a consent procedure which does not include that omits some, or which alters, some or all, of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that: 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.
(1)(3) Requirements of 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:
(i) public (A) Public benefit or service programs;(ii) procedures (B) Procedures for obtaining benefits or services under those programs;(iii) possible (C) Possible changes in or alternatives to those programs or procedures; or(iv) possible (D) Possible changes in methods or levels of payment for benefits or services under those programs; and
(f) General waiver or alteration of consent.
Read an excerpt from the 2018 Common Rule preamble discussing changes to the general waiver or alteration of consent provision.
(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 (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.
(2) Alteration. An IRB may approve a consent procedure which does not include that omits some, or which alters, some or all, of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: 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.
(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;
(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:
(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
(h) Posting of clinical trial consent form
Read an excerpt from the 2018 Common Rule preamble describing the posting of clinical trial consent forms.
(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.
(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.
(e)(i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable federal Federal, state, or local laws which (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be legally effective.
(f)(j) Emergency medical care. 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 federal Federal, state, or local law. (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
§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 informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. A written copy shall be given to the person signing the informed consent form.
(b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following: (1) A written consent document that embodies the elements of informed consent required by form that meets the requirements of §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read it the informed consent form before it is signed; or alternatively, this form may be read to the subject or the subject's legally authorized representative.
(2) A short form written informed consent document form stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. subject'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. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the subject's legally authorized 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 subject's legally authorized representative, in addition to a copy of the short form.
(2) (ii) 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 context. ; or
(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.
(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives 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 Federal 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. These applications need not be reviewed by an IRB before an award may be made. However, except Except for research exempted or waived under §46.101(b) or (i)§46.101(i) or exempted under §46.104, 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 Federal department or agency component supporting the research.
§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.
In Except for research waived under §46.101(i) or exempted under §46.104, in 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 submitted, by the institution, to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component.
§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department department or Agency agency .
(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal 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 Federal 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 Federal 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 of either the conducting or supporting Federal department or agency 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.
