Attachment A – Recommendation on Minimal Risk Informed Consent Models
APPENDIX I – Sample Consent Materials for Minimal Risk Research
The model documents below were written to provide examples of informed consent forms that would be appropriate in the context of minimal risk research and reflect the goal of reducing the length and complexity of the consent forms used for non-exempt minimal risk research activities. All of the models comply with 45 CFR 46.116 and none would require a waiver of some or all elements of informed consent. All are acceptable and may be considered appropriate depending on the circumstances, and other approaches would be appropriate for each of the cases as well.
These examples were developed to embody previous SACHRP recommendations regarding informed consent, including “Guidance on Applying the Regulatory Requirements for Research Consent Forms: What Should and Should Not be Included?”[1] and “Recommended Guidance on Minimal Risk Research and Informed Consent”[2]. They demonstrate how informed consent materials for minimal risk research can be developed in a manner that is succinct while maintaining regulatory compliance. The models are intentionally provided in different formats (e.g., layout, fonts) to demonstrate the acceptability of multiple approaches to presenting information to prospective subjects.
Each model is preceded by a brief description of the research scenario and a list of key features regarding the contents of the consent document and requirements for documentation of consent. Several of the models do not include documentation of informed consent and rely on an oral process. When oral consent will be used, consideration should be given to the training of research staff on implementing an effective informed consent process.
Example 1 - Information Sheet on Participation in Research to obtain consent orally
|
Scenario: Key Features:
Analysis: The specifics of the study would be summarized in a “Points to Consider document” (the consent script) that has been IRB approved and is used by the investigator as the basis of the oral consent conversation and process. There is no written informed consent document; rather, there is an oral process. All prospective subjects may be given this Information Sheet, depending on circumstances of the research. The IRB would need to consider information contained in the protocol and other materials submitted for review. To proceed under this approach, the IRB would need to grant a waiver of documentation of consent, which it could do under 45 CFR 46.117(c)(2) as 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. |
Information Sheet on Participation in Research
You are being asked to be a participant in a research study. The researcher is going to discuss with you:
- The nature and purpose of the research;
- That your participation is voluntary;
- The research procedures;
- Any reasonably foreseeable discomforts or risks*;
- Any benefits to you from your participation*;
- Alternatives to participation*;
- The extent to which privacy and confidentiality will be maintained;
- Any questions you may have; and,
- That you can change your mind about participating at any time without penalty.
*Note: These items may be omitted if they do not apply and a waiver of element by the IRB is not required. Many minimal risk research studies will not have reasonably foreseeable risks or discomforts and will not provide benefits to subjects.
Example 2 – Simplified Consent Document with No Documentation of Consent
|
Scenario: A minimal risk research study involving completion of a questionnaire and four computer-based tasks. Key Features:
Analysis:
To proceed under this approach, the IRB would need to grant a waiver of documentation of consent, which it could do under 45 CFR 46.117(c)(2) as 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. The complete regulatory language regarding “penalty or loss of benefits to which the subject is otherwise entitled” (45 CFR 46.116(a)(8)) is not used in an effort to simplify consent and eliminate confusion. There is a presumption that “penalty” can be interpreted to include loss of benefits. |
CONSENT TO PARTICIPATE IN RESEARCH
Study Title: Behavioral Learning Testing in Healthy Volunteers (The BLT Study)
Principal Investigator:
____________________________________________________
Introduction and Purpose
We would like you to consider taking part in research involving four computer tasks that help us understand how people learn. Eventually we hope to use similar tasks in research on how the brain works. You do not have to participate, and you can stop at any time without penalty.
Procedures
As part of this research, you will first be asked questions about your mood and anxiety level. This will take about 30 minutes.
The four computer tasks will require you to interact with videogame-like screens and react to pictures, faces and sounds. Some of these things are intended to be annoying (like a car alarm) or bothersome (like a scary face).
You may take part in some or all four tasks. Completing all four tasks will take about three hours. You will be paid $15 to $75 depending on the number of tasks you attempt.
Confidentiality
All information we collect about you will be kept confidential to the extent possible. The information may be shared with ….
Questions
If you have questions about this study or need to report any problems please call 800-867-5309 and ask to speak to someone about the BLT study.
If you have any complaints, suggestions, or questions about your rights as a research volunteer, contact the staff in the University Office of Research Integrity at 1-866-777-9311. You may discuss your rights as a research participant with a representative of our Institutional Review Board (IRB).
Example 3 – Simplified Consent Document with Documentation of Consent
|
Scenario: A research study that involves a review of medical records and the completion of a questionnaire on use of complementary medicine. The objective of the research is to see whether there is a link between hypertension as disclosed in the medical records and the use of complementary medicine techniques. Key Features:
Analysis:
The complete regulatory language regarding “penalty or loss of benefits to which the subject is otherwise entitled” (45 CFR 46.116(a)(8)) is not used in an effort to simplify consent and eliminate confusion. There is a presumption that “penalty” can be interpreted to include loss of benefits. In this example there is documentation of informed consent. Documentation is included because the research will require access to medical records, and documentation of consent may expedite that access. Individual IRBs may choose to waive documentation based on local practices. HIPAA requirements will need to be addressed through either a separate HIPAA authorization or through the use of a combined form incorporating elements required by HIPAA into the research consent document. |
Study title: Complementary Medicine and High Blood Pressure
You are being invited to be in this research study because you have high blood pressure. Please feel free to ask questions at any time. Your participation is voluntary and you can stop at any time without penalty.
We are doing this research study to learn more about the use of complementary medicine and its effect on high blood pressure control. Examples of complementary medicine include yoga, acupuncture, chiropractic care and herbal medicines.
If you agree to participate in this study:
- We will collect information from your medical records. We will only collect information about your blood pressure including the medications you take, and, information about you including age, sex, race and ethnicity.
- We will ask you to fill out a questionnaire about your use of complementary medicine. It will take about 15 minutes to answer the questions. You do not have to answer any questions that you do not wish to answer.
We will only keep information that could identify you long enough to match your responses with your medical records. We do not plan to share this information with anyone who is not connected to this research study.
We will take steps to protect you confidentiality, but there is a small risk that your information could be accidentally disclosed to people not connected to the research.
If you have any questions about the study, you can reach the investigator at the following number: xxx-xxx-xxxx
If you have any questions about your participation in this research, you can call the Institutional Review Board (IRB) at xxx-xxx-xxxx. The IRB is a committee that has reviewed and approved this research study.
If you agree to participate in this research study, please sign below:
___________________________
Participants Printed Name
___________________________
Participants Signature
Example 4 – Simplified Consent Document Utilizing Two Columns of Text
Scenario: A research study involving the collections of basic demographic information and recent health history, as well as a single blood draw.
Key Features:
- minimal risk
- healthy adults
- no identifiable information will be collected
- no genetic testing will be done
- the research will not lead to the creation of any sensitive information
- any remaining samples will be destroyed at the end of the study
Analysis:
This example presents the information in column style rather than traditional consent document formatting. There are no regulatory requirements for style and design. Alternative formatting may allow investigators to present information in pamphlet style or other alternative formats.
Selected elements of consent are not included in accordance with previously approved SACHRP recommendations. Omitted elements include the following:
- alternatives to participation
- benefits to subjects or others
- research related injury
To proceed under this approach, the IRB would need to grant a waiver of documentation of consent, which it could do under 45 CFR 46.117(c)(2) as 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.
In this example, the common discomforts associated with blood draw have not been described as risks.
There is an assumption that the associated discomforts are well known to prospective participants and therefore an explicit discussion is not necessary. Consistent with previous SACHRP recommendations, risks or burdens that are immaterial or obvious to potential participants need not be explicitly addressed in the consent form or dialogue. Some IRBs may decide to include this risk language due to factors including the subject population involved and local practices.
The complete regulatory language regarding “penalty or loss of benefits to which the subject is otherwise entitled” (45 CFR 46.116(a)(8)) is not used in an effort to simplify consent and eliminate confusion. There is a presumption that “penalty” can be interpreted to include loss of benefits.
CONSENT TO PARTICIPATE IN RESEARCH
Study Title: Immune System Blood Draw Study
Principal Investigator:
_____________________________________________________
Introduction
You are being asked to be in this research study because you are an adult with no known illnesses.
Your participation in this study is voluntary. Please ask any questions you may have about participating in this study.
Purpose
We are doing this study to learn more about how the body fights infection.
Procedures
If you agree to participate in the study we will ask you some questions about yourself and your health history. We will also use a needle to take about 2 teaspoons of blood. It will take about an hour to complete the study.
We do not plan to tell you what we find when we analyze your blood. When we finish our tests we will destroy any leftover blood.
Benfefits
You will not benefit from participation in this study.
Withdrawal
You can withdraw from this study at any time without penalty.
Confidentiality
Your identifiable information will not be included on the blood sample. If study results are published you will not be identified.
Questions
If you any questions about this study please call 800-867-5309 and ask to speak to someone about the Immune System Blood Study.
If you have any complaints, suggestions, or questions about your rights as a research volunteer, contact the staff in the University Office of Research Integrity toll free at 1-866-600-6789.
Example 5 – Simplified Model with Information Provided in Bullet-list Format
Scenario: A research study designed to determine the optimal placement of a prototype device that measures how an experienced adult smoker smokes and samples waterpipe tobacco smoke in real-time.
The study will involve experienced water pipe tobacco smokers using a water pipe without the device and also with the device installed in various components of the water pipe. In addition, demographic information, including medical history, smoking history, and marijuana and alcohol use history will be collected in order to ensure participants meet inclusion/exclusion criteria and also so that the participant sample can be characterized precisely.
Key Features:
- minimal risk
- Non-pregnant adults who self-identify as experienced smokers.
Analysis:
This consent form reduces the elements of consent to a list of bullets addressing the required elements of informed consent.
Selected elements of consent are not included in accordance with previously approved SACHRP recommendations. Omission of these elements does not require a waiver from the IRB. Omitted elements include the following:
- alternatives to participation
- benefits
- research related injury
Due to the technical aspects of this study even experienced waterpipe users may benefit from a consent process that includes tools such as a waterpipe outfitted with the device.
There are no additional risks introduced by the research for experienced adult water pipe tobacco smokers, therefore risks are not included in the consent document. However, as this study involves administration of tobacco, some IRBs may determine that the research is greater than minimal risk. In this case, we have made an assumption that the study is minimal risk in non-pregnant adults who self-identify as experienced smokers.
To proceed under this approach, the IRB would need to grant a waiver of documentation of consent, which it could do under 45 CFR 46.117(c)(2) as 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.
Title: REALTIME water pipe tobacco smoke sampling device
IRB Number:
Investigator:
- The purpose of this research study is to test a device called REALTIME that will sample tobacco smoke from a water pipe.
- You do not have to participate in this study. If you choose to participate you may stop at any time without any penalty. You may also choose not to answer particular questions that are asked in this study.
- You will be asked questions about your general health, smoking history, and marijuana and alcohol use.
- If you are a woman you will need to provide a urine sample that will be tested immediately for pregnancy. If you are pregnant you cannot participate.
- All information will be confidential. There is always a small risk of accidental disclosure.
- Your participation will require three, 2-hour sessions separated by at least 48 hours. You may not use any tobacco products or nicotine containing products (like gum or the patch) for at least 12 hours before each session. You will take a simple breath test to make sure that you have complied with these restrictions. We will also ask you to stop eating 1 hour before each session.
- In each session you will be asked to smoke a water pipe in the laboratory. We want you to smoke as you normally would and we will use your preferred brand/flavor of tobacco. The water pipe will be loaded only once in each session, and we ask that you use it for at least 45 minutes, though you may take as many or as few puffs as you like during that period. The water pipe will be started with a single charcoal disk, but you may add additional ½ disks as you like.
- You will receive $30 after the first session, $70 after the second, and $100 after the third session.
- You can contact Dr. Smith with any questions about the study at 987-654-3210
- If you have any complaints, suggestions, or questions about your rights as a research volunteer, contact the staff in the University Office of Research Integrity toll free at 1-866-600-6789.
Example 6 – Simplified Consent Language with Documentation of Consent
|
The study will involve individual interviews and focus groups to discuss issues related to religion. Participation may last up to one year. Interviews and focus group discussions will focus on the experiences of adults in relation to religious certainty, doubt and questioning. Key Features:
Analysis: Selected elements of consent are not included in accordance with previously approved SACHRP recommendations. Omission of these elements does not require a waiver from the IRB. Omitted elements include the following:
A signature block for documentation and a separate endorsement for recording is included. IRBs could elect to waive written documentation. The complete regulatory language regarding “penalty or loss of benefits to which the subject is otherwise entitled” (45 CFR 46.116(a)(8)) is not used in an effort to simplify consent and eliminate confusion. There is a presumption that “penalty” can be interpreted to include loss of benefits. |
You are being asked to be in a research study by investigators at XYZ University. We are studying the experiences of Americans in relation to religious certainty, doubt, and questioning. We are also interested in the nature of faith and the nature of religion in America in the 21st century.
If you agree to be in our study we will talk with you for several hours. You will also be asked to be in small focus-group discussions. You do not have to be in the study if you don’t want to: it is your choice. You can also agree to be interviewed but not be in a focus group. You can change your mind at any time and there will be no penalty. You and [name] will decide together how many interviews you will have, and when they will occur. The interviews may happen over the span of a year, if you agree.
We know that religious doubt can be a very sensitive topic. You do not have to share any information that you are not comfortable sharing. You can stop the participating in conversation at any time. Also, some people may be upset or angry if they hear others in the focus groups expressing views different from their own.
We will be careful to keep your information confidential, and we will ask you and all the focus group members to keep the discussion confidential as well. There is always a small risk of unwanted or accidental disclosure. The conversations and the focus groups will be recorded and transcribed only with your permission. Any notes, recordings, or transcriptions will be kept private by the primary investigator (name). The files will be encrypted and password protected. You can decide whether you want your name used.
If you have questions or concerns at any time about the research, you can contact [PI name] at ___ .
If you have any complaints, suggestions, or questions about your rights as a research volunteer, contact the staff in the University Office of Research Integrity toll free at 1-866-600-6789.
Name: ________________________________________
I give my consent to participate in this study:
_______________________________________ Date: ___________________
Signature
I give my consent to have discussions recorded:
_______________________________________ Date: ___________________
Signature
Example 7 and 8 – Two Approaches to Simplified Consent
|
Examples 7 and 8 provide two approaches to informed consent for a research study to assess the benefits of a peer mentoring program. Either approach would be acceptable for this scenario. Key Features:
Analysis: Each of these examples is intended for the same research scenario and present the same information but in different formats. One example is formatted like a letter and could be provided in advance of the consent discussion. The second example is an outline that the researcher would use to guide the consent discussion. The documents could also be used together as part of one longer consent process, in which prospective subjects receive the letter version (Example 7), but the in-person consent discussion is guided by script (Example 8). Both examples begin with an introduction of the researcher. In each example this is appropriate. If the information is transmitted in by letter (example 7), it would be appropriate to begin the communication with a formal introduction of the researcher and the project. Selected elements of consent are not included in accordance with previously approved SACHRP recommendations. Omission of these elements does not require a waiver from the IRB. Omitted elements include the following:
To proceed under this approach, the IRB would need to grant a waiver of documentation of consent, which it could do under 45 CFR 46.117(c)(2) as 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. |
Example 7 - Letter format:
Dear Participant,
My name is [ ] and I am a faculty member in the Community Leadership Development Center at the University of the Midwest. I am conducting a study of first generation students to assess the academic and social benefits of peer mentoring.
I am looking for student participants who are currently serving as a mentor or mentee and would be willing to discuss their experiences. If you agree to take part in this study, you will be asked to participate in a focus group to discuss your experience as either a mentor or mentee in the center’s peer mentorship program.
Participation is voluntary and you may skip any questions you do not wish to answer. You can also stop participating at any time without penalty. Your decision to participate will have no impact in your participation in mentoring programs.
Your responses may help us understand more about first generation college students and the types of programs that will impact their academic achievement.
There will be separate sessions for mentors and mentees. The sessions for the focus group will be between 30-45 minutes, will be voice-recorded, and conducted in Research Hall. Names will not be recorded. Due to the nature of a focus group, I cannot guarantee privacy as other subjects present in the group will know what was said and by whom. The recordings will be destroyed once the analysis is complete. You will not be paid for taking part in this study, nor will you receive course credit.
If you are interested in participating or have questions about the study, please feel free to contact at 800-555-1234, [email protected]. If you have any complaints, suggestions, or questions about your rights as a research volunteer, contact the staff in the University Office of Research Integrity toll free at 1-866-600-6789.
Example 8 – Bulleted List of Talking Points to be Followed by the Individual Conducting the Consent Process
Informed Consent Script
- Introduction: My name is [ ] and I am a faculty member in the Community Leadership Development Center at the University of the Midwest.
- Purpose: I am conducting a study of first generation students to assess the academic and social benefits of the new peer mentorship program provided by the center.
- Requirements for participation: I am asking for student participants who are currently serving as a mentor or mentee. If you agree to take part in this study, you will be asked to participate in a focus group to discuss your experience as either a mentor or mentee in the center’s peer mentorship program.
- Study procedures: There will be separate sessions for mentors and mentees. The sessions for the focus group will be between 30-45 minutes, will be voice-recorded, and conducted in Research Hall. Names will not be recorded. Due to the nature of a focus group, I cannot guarantee privacy as other subjects present in the group will know what was said and by whom. The recordings will be destroyed once the analysis is complete. You will not be paid for taking part in this study, nor will you receive course credit.
- Voluntariness: Participation is voluntary and you may skip any questions you do not wish to answer. You can also stop participating at any time. Your decision to participate will have no impact in your participation in mentoring programs.
- Goal: Your responses may help us understand more about first generation college students and the types of programs that will impact their academic achievement.
- Contact: If you are interested in participating or have questions about the study, please feel free to contact at 800-555-1234, [email protected]. If you have any complaints, suggestions, or questions about your rights as a research volunteer, contact the staff in the University of the Midwest Office of Research Integrity toll free at 1-866-600-6789.
