Tag: ethics

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I’m so excited about sharing the very first Show-and-Tell post within a highly educational series!

I’m sure by the title you can tell what this post is going to be about. But first…

And then…

I want to tell you about my methodology of assessing 17 social, behavorial, education research (SBER) IRB protocol templates from various institutions.

Being in the compliance field, I am also passionate about research. More importantly, passionate about doing research ethically and in a reproducible way. I am briefly going to summarize how I analyzed 17 SBER IRB protocol templates from various institutions for commonalities:

1. I went to Google and typed in “IRB Templates”.
   • From here, I only reviewed templates with the following keywords:
     • “SBER”
     • “Social/Behavioral”
     • “Social/Behavioral/Educational”
2. My initial plan was to stop once I browsed through 10 pages. Which I did and was hoping to have 50 records for review.
   • But…I encountered obstacles:
     • Some institutions had templates for consent and recruitment, but not for the protocol (perhaps this is an internal document in the electronic IRB submission system)
     • Some institutions relied on Federal agency templates (which is completely fine, but I said I would do my search on institutions)
     • Some institutions only had one type of protocol template (i.e., no difference between SBER or biomedical research) – again this is completely fine depending on the nature of the research at your institution
     • Some institutions required an institutional login to access their templates (hear, hear for additional security!)
     • Some institutions had protocol templates based on review type (exempt, expedited, vs. full board) – this is interesting to me because I wonder how these institutions have trained their investigators to know which template to use
     • Some institutions may have had SBER protocols, but I was limited by the keywords I selected
       • Could I have assumed that surveys/focus groups/observations fall under SBER? Sure…but how do I know they aren’t also applicable to a biomedical component? Further, I set my keywords and that does not fit the criteria
3. After going through 20 (LONG) pages of results, I decided to stop once I reviewed 17 institutions’ SBER protocol templates.
4. As I reviewed each template, I gathered the following data points:
   • A link to their PDF for future reference
   • Their institution only to avoid duplicate values (once I had 19 unique values – this column was deleted)
   • Sections within their protocol template
5. Then, with iterative prompting in my personal ChatGPT-4 account, the GPT summarized the recurring themes within the protocol templates.
   • If you would like to review any of my references, please leave me a comment or email me at tmohseni@renovationinirbeducation.org.

Now that you know my methodology, I also want to share a poll I created via Renovation in IRB Education’s LinkedIn page:

Though only one person voted (thank you!), they gave me some great insight. This is a common issue I see. Providing too little detail doesn’t give the IRB reviewer an idea of what the proposed research is about. More importantly, by providing little detail, you lose the significance behind your very important research!

Now, let’s take a deep dive into the various sections of a SBER protocol template. At the end, I will have a list of of applicable Office of Human Research Protections (OHRP) guidance documents and Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommendations. You should consult with your institution’s IRB if you have any questions about the resources provided at the end of this post (or the recommendations within this post to ensure it is applicable to your institution):

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Title

This should hopefully be one of the easiest parts of your SBER IRB protocol! The title of your protocol should give the IRB reviewer a sense of what your IRB protocol will be about.

Is there a grant associated with your study?

If so, I recommend reviewing sponsor requirements. Some sponsors may require that your protocol title must be the same title as your grant.

Principal Investigator (and Study Team)

The institution must know who is the lead investigator (i.e., the principal investigator (PI)) for the SBER study. This is typically a faculty or staff member. If the research is student-led, then the student should check with their institution to see if they can be listed as the PI. Some institutions may be fine with this, but require a faculty member to be listed on the protocol as well. The protocol should also list all study team members associated with your study. Whether they are affiliated with your institution or an external collaborator, IRBs want to ensure that everyone has received the proper IRB/human subjects research training.

Institution Team Members

These are team members that are affiliated with your institution.

External Collaborators

These are team members that are not affiliated with your institution. If the collaborator is affiliated with an institution, they will need to reach out to their IRB. The collaborator’s IRB may require that the collaborator submit a study for review. Conversely, the collaborator’s IRB may not considered them engaged in research. You may not know this, but institutions have flexibility in how to apply the regulations.

Stay tuned for an upcoming post that will discuss the reliance process and the single IRB mandate!

Background and Objectives

This is also known as:

• The study significance and rationale (i.e., purpose) for the proposed research
• The study aims and hypothesis

This is where you briefly introduce the purpose of your proposed study. If your research is funded, the study aims should be consistent with your grant. This is also where you would include your research question(s) and hypothesis. You should also provide a summary of research currently available (i.e., publications) to provide justification for the proposed study. I caution you here to avoid any technical terms or jargon. Remember, IRB reviewers aren’t as connected to your project as you are.

Therefore, this section should be written in a way that anyone can understand:

• The main idea of the proposed research
• Any published research that is related to the proposed research
• Any current studies that are related to the proposed research (i.e., the ID number of any active studies related to the proposed research)
  • This helps IRB reviewers when they are making a determination for your study with respect to risk (i.e., no greater than minimal risk or above minimal risk)

Inclusion and Exclusion Criteria

As the section heading implies, this is where you would describe:

• Criteria that makes the individual eligible for the proposed study
• Criteria that makes the individual ineligible for the proposed study

Special Populations

If not obvious, you want to provide the scientific rationale for any exclusions of special populations. Special populations under The Common Rule (45 CFR 46) are:

• Subpart B — Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• Subpart C — Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• Subpart D — Additional Protections for Children Involved as Subjects in Research

There are other examples of special populations that aren’t covered in the regulations. An individual can be part of a special population if they can be considered vulnerable in the research:

• Individuals with impaired decision-making capacity
• Economically or educationally disadvantaged persons
• Socially disadvantaged
• Terminally ill or very sick
• Racial or ethnic minorities
• Institutionalized persons (e.g., persons in correctional facilities, nursing homes, or mental health facilities)
• Dual role relationships (the investigator could be a manager or professor to the employee and/or student participant)

What is “vulnerability” in a research setting?

Below is a summarized table of when vulnerability can occur in a research setting:

Number of Participants

In this section, you would indicate the number of anticipated participants you plan to enroll in your proposed study.

Recruitment Methods

Here, I like to take the “Five W’s” approach:

• Who are you recruiting?
• Why are you recruiting these potential participants?
• What materials will be used for recruitment?
• Where will potential participants be recruited?
• When will recruitment begin?

Let’s look at these components one piece at a time.

The first question should be a concise statement of your inclusion criteria. When IRB reviewers ask who you will be recruiting, they aren’t looking for specific names. They are looking for the population of interest that will help answer your research question(s).

The second question is aiming towards providing justification for the population of interest. How will this particular population help you answer your research question(s)? What is it about this population that would benefit from the proposed research?

For the third question, IRB reviewers are trying to understand what materials you will be using to recruit participants. Will potential participants be contacted via email? What about social media? Do you plan to do in-person recruitment where you will distribute fliers related to your study?

Typically, the fourth and fifth questions are a combined statement. Something to keep in mind is in-person recruitment. Say you are going to an event where you plan to distribute recruitment fliers for the proposed research. Do you have permission to distribute recruitment fliers for research purposes? You will want to make note of any site permissions you have obtained for the proposed research. The IRB reviewer will likely want to review the site permission documentation as well. Be sure to include any explicit permissions within your submission.

Informed Consent

The consent process should outline key information from the investigator that should be provided to participants. The key information here should facilitate the participant’s comprehension and voluntariness of potential participation in your study. Though there are standard required elements of consent (and additional requirements depending on your study), at minimum, your consent form should include:

• The study activities
• The duration of time the activities will take
• Explanation of risks and benefits
• Compensation and any limits to receiving it
• Protections and limits of confidentiality

Stay tuned for a blog post describing the consent process in MUCH greater detail!

Risk and Benefit Assessment

Risk

Remember when I said IRB reviewers look at previous applications similar to the proposed research?

To reiterate, IRB reviewers when they are making a determination for your study with respect to risk (i.e., no greater than minimal risk or above minimal risk). Minimal risk (as defined by 45 CFR 46.102(j)) 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. When the proposed research has risks, the investigator must have risk mitigation measures in place.

Let’s look at the example below:

Say you are conducting an anonymous survey regarding the mental health of college students. The IRB reviewer will review the survey questions to see if any of these questions could cause distress to participants. Then, the IRB reviewer will look at your protocol to see if:

• The possibility of distress from answering these survey questions was disclosed
• Distress mitigation measures (e.g., a list of mental health/therapy resources)

The key here is that any potential benefits (whether direct or indirect) should outweigh the proposed study’s risks.

Direct Benefit and Indirect Benefit

First, let’s define direct benefit and an indirect benefit:

Direct Benefit	Indirect Benefit
Refers to a positive outcome that directly results from the intervention being studied and is experienced by the research participants themselves	A positive outcome that arises from the research process but is not directly related to the intervention itself, often benefiting society at large or future research, rather than the individual participant in the study

Now, let’s look at a couple of examples:

• Direct benefit: In a behavioral intervention testing a new stress relieving technique, a direct benefit would be the participant experiencing symptom relief from applying said technique to their daily routine
• Indirect benefit: In a study on a new educational program, an indirect benefit could be the increased awareness of the topic among the wider community due to the research dissemination

It is also important to note that compensation is not considered a benefit.

Study Design and Procedures

The IRB reviewer should be able to read and understand exactly what you are proposing to do with participants. Let’s pretend you’re wanting to conduct a survey to see how folks feel social media impacts their mental health. This section should include the following details:

• A statement of how the survey will be disseminated (paper or electronic)
  • If electronic, indicate if the collection of IP addresses or email addresses will be disabled (as this is identifiable information)
• A statement regarding how long it should take to complete the survey
• A statement of whether participants are allowed to skip questions they are not comfortable answering

Stay tuned for the blog post related to online research considerations for a more detailed explanation of this!

For all study procedures, consider the five questions below:

• Who on the study team is conducting the specific procedure?
• What is the specific procedure?
• How will the specific procedure occur?
• When will the specific procedure occur?
• Where will the specific procedure occur?

It is only important to note how the data collected from the specific procedures will be analyzed.

Compensation

As mentioned above, compensation is not a benefit. Rather, compensation is a token of appreciation for participating in the research. It is not required to provide compensation. If you do not plan to offer compensation, you would simply include a statement regarding this. If you do plan to offer compensation, ensure the following details are included:

• The amount of compensation
• The form of compensation (e.g., if it is a gift card, identify where the gift card is to)
• The justification for the amount of compensation
• When and how compensation will be provided to participants

It is important to note that IRBs are not reviewing the amount of compensation to determine if it’s “enough”. IRBs review compensation amounts to ensure the amount is not coercive. As we know from the section above, coercion can make any individual vulnerable in research.

Privacy, Confidentiality, Data Management, and Future Use of Data

Privacy and Confidentiality

First, let’s define the difference between “privacy” and “confidentiality”:

Privacy	Confidentiality
Refers to the right to control access to ourselves and our personal information	Refers to agreements made between investigators and participants, through the consent process, about if and how researchers will protect participant’s information

Now, this section of a research protocol is vital for ensuring ethical standards are upheld and participant trust is maintained. Below are key elements researchers should address to create a robust plan for protecting participant data:

• Outline how participant privacy will be safeguarded throughout the project
  • For instance, provide private and secure environments for interviews or survey completion
• Specify where and how all data types—paper, electronic, or multimedia—will be stored and managed
  • Data must be stored securely, such as in password-protected databases or locked filing cabinets in restricted-access areas
  • Highlight additional security measures like data encryption for electronic records
  • Clearly state who will have access to the data, limiting it to essential study personnel to minimize risk
• For studies involving audio or video recordings, specify the retention period and handling procedures
  • For example, recordings may be deleted after transcription and verification or within six months of collection
  • During retention, secure storage methods, such as encrypted drives or locked cabinets, should be employed to prevent unauthorized access
• If a master list or key is used to link participant identities to data, describe its management
  • Explain how it will be securely stored separately from study data (e.g., on a different encrypted server or in a separate locked cabinet)
  • Identify who will have access to the master list and ensure access is limited to essential personnel
  • Additionally, specify when the master list will be destroyed
• State the minimum retention period for study data, typically three years after project completion, as per regulatory requirements
  • Except for master lists or keys and audio/video recordings, which should be destroyed at the earliest opportunity, all other data should be securely retained until the retention period ends
  • To maintain confidentiality, include methods for secure destruction, such as shredding paper files or securely wiping electronic data
• If data will be shared or moved outside your institution, provide a detailed plan (such as a data use agreement)
  • Specify the type of data that will be shared, the recipient(s), the circumstances under which sharing will occur, and the timeline for these actions
  • Include any additional security measures to ensure data confidentiality during transfer

Data Management

For this aspect, the IRB reviewer will look for:

• A statement of the types of study data collected
• A statement of who has access to study data
• A statement of how data will be stored
• A statement of when data will be destroyed
• A statement of how study data will be de-identified (if applicable)
• A statement of how identifiable study data will be managed

Stay tuned for a future blog post regarding methods on how to de-identify your study data!

Future Use of Data

This section requires explanation only if you plan to share data outside of your institution. The investigator should provide a plan for any data movement or sharing outside of their institution. This section should also specify what data will be provided, to whom, under what circumstances, and when. This should also be disclosed in the consent form.

Withdrawal of Participants

 If a participant requests to withdraw from the study, the investigator should describe:

• The scenarios under which they will be able to delete the participant’s data
• The scenarios under which they will not be able to delete the participant’s data

Let’s look at a couple of examples:

• If you are conducting an anonymous survey, you likely would have no way of identifying the participant’s individual responses. Therefore, when a participant opts to withdraw, there would be no way to delete their data (i.e., their responses).
• If you are conducting interviews, you could delete a participant’s interview transcript when a master list is in existence. However, you may not be able to do so until after the master list is destroyed.

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I hope you found the first post of this blog-series helpful! Did you find this post informative for your SBER IRB protocol application? If so, please scroll on down and leave a comment below!

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OHRP and SACHRP Resources

• A New Interpretation of the “Engaged in Research” Standard
• Attachment A: Initial Considerations for Single IRB Review: Points to Consider
• 45 CFR 46.114 (Cooperative Research)
• Correspondence on “Non-engaged” Scenarios
• Determining When Institutions are Engaged in Research (January 13, 2009)
• Engagement of Institutions in Human Subjects Research (2008)
• Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federal Wide Assurance (FWA) (January 13, 2009 OHRP Letter)
• Extending an FWA to Cover Collaborating Investigators (2005)
• Use of a Central Institutional Review Board (OHRP Letter, 2010)
• Use of a Central IRB: Announcement (2010)
• Recommendations on 87 FR 58752: Institutional Review Boards; Cooperative Research
• Recommendations on the Draft Guidance for Use of Single Institutional Review Board for Cooperative Research
• Attachment D – Granting Exceptions or Single IRB Review for Multi-Site Research
• Attachment F: Recommendations Regarding the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research
• Appendix C: OHRP Procedures for a 407 Panel Process for Multi-Site Research
• Attachment A: Consideration of Local Context with Respect to Increasing Use of Single IRB Review
• Appendix A: Who is a “prisoner” under Subpart C, Research Protections for the “Subsequently Incarcerated,” identification of prisoner representative, prisoner representative on IRBs in multi-site studies
• Appendix B: Recommendations regarding risk in research involving children
• November 9, 2006 SACHRP letter to HHS Secretary on Children’s Research
• Appendix A: Recommendations relative to research involving children
• February 4, 2009 SACHRP referencing OHRP resources, and socio-behavioral research in subpart B
• Attachment: Recommendations Regarding Research Involving Individuals with Impaired Decision-making
• August 5, 2011 SACHRP Letter to the HHS Secretary (Including recommendations and FAQ’s on the topic of parental permission, child assent, and documentation of informed consent)
• Attachment E: Recommendations Regarding Research Uses of Newborn Dried Bloodspots and the Newborn Screening Saves Lives Reauthorization Act of 2014
• Attachment B: Commentary on FDA Draft Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” released December 9, 2014, docket number FDA-2013-D-1275-0002
• Attachment D – Parental Permission in Research involving Children
• SACHRP Recommendations on Draft Guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs”
• SACHRP Recommendations for the Ethical Review and Inclusion of LGBTQI+ Participants in Human Subjects Research
• Children as Research Subjects and the HHS “407” Process
• Children: Information on Special Protections for Children as Research Subjects
• Prisoner Involvement in Research (2003)
• Children: Research with Children FAQs
• Prisoner Research FAQs
• Attachment C: Approved by SACHRP July 20, 2011- SACHRP Recommendation regarding application of 45 CFR 46 and 21 CFR 56 to early processes in research, such as identifying potential subjects, contacting subjects and recruiting subjects
• Consideration of the Principle of Justice 45 CFR part 46
• Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
• Informed Consent Checklist (1998)
• Informed Consent of Subjects Who Do Not Speak English (1995)
• Informed Consent Posting Instructions (2022)
• Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006)
• Informed Consent Requirements in Emergency Research (OPRR Letter, 1996)
• Informed Consent Tips (1993)
• Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
• Use of Electronic Informed Consent: Questions and Answers
• Informed Consent FAQs
• Attachment A: FAQs, Terms and Recommend. on Informed Consent
• August 5, 2011 SACHRP Letter to the HHS Secretary (Including recommendations and FAQ’s on the topic of parental permission, child assent, and documentation of informed consent)
• Attachment D: FAQ’s Terms and Recommendations on Informed Consent and Research Use of Biospecimens
• Attachment A: Approved by SACHRP July 20, 2011 – Guidance on Applying the Regulatory Requirements for Research Consent Forms: What Should and Should Not be Included?
• Attachment D: Informed Consent and Waiver of Consent
• Attachment A: SACHRP Commentary on the FDA Draft Guidance Entitled, “Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors,” released July 15, 2014, docket number FDA-2006-D-0031
• Attachment A: Minimal Risk Informed Consent Models
• Attachment C – Recommendations for Broad Consent Guidance
• Attachment D – Recommendations for a Broad Consent Template
• Attachment C – Updated FAQs on Informed Consent for Use of Biospecimens and Data
• Attachment A – FAQs Relating to Recommendations on Broad Consent
• Attachment E – Transition Provisions and Informed Consent Req.
• Attachment C -New “Key Information” Informed Consent Requirements
• Attachment A – New Information Provided to Previously Enrolled Research Subjects
• Attachment A1 – Reconsent Appendix 1
• Attachment A2 – Reconsent Appendix 2
• Attachment A – New Information Provided to Previously Enrolled Research Subjects
• January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk”
• Attachment A – Addressing Ethical Concerns Offers of Payment to Research Participants
• Appendix: Understanding Minimal Risk
• Certificates of Confidentiality – Privacy Protection for Research Subjects: OHRP Guidance (2003)
• Coded Private Information or Biospecimens Used in Research, Guidance (2018)
• Attachment B: Recommendations on Certificates of Confidentiality
• Attachment B – European Union’s General Data Protection Regulations
• Attachment B -Prev.Approved Rec. Implem.EU GDPR (SACHRP Mar.2018)
• Appendix B: Reconsider the de-identification standard, reduce the number of data categories, and focus on safeguards in recording and publishing data
• Appendix C: Clarify that the February 2004 Guidance addresses only what is permissible under the HIPAA Privacy Rule not a “best practices” standard for recruitment methods
• Appendix D: Application of the Privacy Rule to research databases and repositories needs further refining to align it with existing Common Rule requirements
• Appendix E: HIPAA’s compound authorization requirements elevate form over substance, confuse subjects, and diminish the informed nature of their consent and authorization
• Appendix F: Administrative burden of IRB waiver of the authorization requirement for research not required to receive IRB review is unnecessary
• Appendix G: HIPAA’s transition provisions exempting research where informed consent was obtained are not helpful
• Appendix H: Clarify in guidance that IRB alteration of HIPAA’s authorization requirement may be sought and granted for international research
• Summary Table of Recommendations on the HIPAA Privacy Rule
• Attachment C: Return of Individual Results and Special Consideration of Issues Arising from Amendments of HIPAA and CLIA
• Attachment A – NIH Data Sharing Policy
• NIH Genomic Data Sharing Policy: NIH Request for Public Comments
• DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data
• Issues to Consider in the Research Use of Stored Data or Tissues (1996, 1997)
• Attachment A – IRB Authority to Restrict Use of Data Collected and Developed in Research
• Attachment A: SACHRP comment regarding the June 4, 2013 FDA Request for Comment relating to the availability of masked and de-identified non-summary safety and efficacy data
• Withdrawal of Subjects from Research Guidance (2010)