Metadata

Content: Key requirements and steps in the IRB approval process

Length: One hour

Purpose: How-to guide on navigating the IRB approval process

Learning goals:

• Understand what is considered human subjects research and falls under jurisdiction of IRB
• Know when you have to engage with IRB and key steps/requirements in the process
• Familiarity with key revisions to Common Rule

Developed by: Elisabeth O’Toole

Key sources: Draws heavily on presentations by Freida Siregar, of Evidence for Policy Design (EPoD) (presented at NH RST 2017) and Lindsey Shaughnessy of IPA (presented at NH RST 2017)

Delivered by: Laura Feeney

Reviewed by: Stephanie Lin; Laura Feeney

Last edited on/by: 10/20/21, Jessica Sashihara, Fatima Vakil, Noreen Giga

Knowledge Assessment Questions

For which changes do you need to submit a modification? Select all that apply.

New study personnel CORRECT

Change in sample size CORRECT

Non-adherence to study protocol

Updated eligibility requirements CORRECT

Change in intervention CORRECT

Next calendar year begins

Informed consent cannot contain language that is: (select all that apply)

Coercive CORRECT

Specific

Undue influence CORRECT

Exculpatory CORRECT

Jargon CORRECT

Explanatory

"If you choose not to participate in this research study, you will no longer receive any medical care.” Assuming medical care is otherwise provided to all individuals, this language is:

Coercive CORRECT

Undue influence

Exculpatory

Jargon

An IRB only needs to review research if there is face-to-face interaction between researcher staff and human subjects.

True

False CORRECT

If research is exempt from IRB review, no application to the IRB is required.

True

False CORRECT

Audience questions and comments, 2018 – IRB, Laura

• Are IRBs paid or volunteered?
• No rules around this, so there’s variation.
• Most IRB members are otherwise affiliated with the institution. Eg, they are healthcare providers, professors, researchers. Sitting on the IRB may be similar to serving on any other committee at work, or they might get a small honorarium (eg, one university gives a $1000 research grant to faculty who are IRB members). Chairs seem to get more money (higher requirements + higher time commitment)
• Community representatives might be volunteers, might get paid per meeting attended, an annual stipend, or any other arrangement. Since they’re not otherwise affiliated with the institution, they’re more likely to be compensated for their time.
• Can I apply to IRBs for a retrospective approval for using pilot data that didn’t originally seek approval for?
• You can apply for anything you want, you just have to justify it and see what the IRB says. You shouldn’t plan to just not apply for IRB approval and hope you can use it later.
• Should a line be added to the consent saying that participant data might be re-used?(with ref to revised new rule)
• You must tell people what you are planning to do with their data.
• Needs to be reviewed after there’s been time for the new rule to shake out / settle in.

Audience questions and comments, + session notes, 2019 – IRB, Laura. Laura’s post-RST responses in bold.

• 19 – research vs practice – maybe make these less extreme/obvious? But I’m not sure – maybe this starting point is helpful. -Clare
• the extreme cases are the point. Anything else is going to fall in the middle, and needs to be described in sufficient detail to the IRB.
• 28 – paused for questions on informed consent; nobody had questions. To break up the lecture, could encourage participation here by instead prompting with: “has anyone encountered challenges during processes of asking for informed consent?” -
• As evidenced by all the questions below, people always end up with a lot of questions or challenges they want to discuss. I think this session is best with some pauses for questions, but not trying to force it. The questions will come.
• Participant question, slide 31 - Jim – are these requirements for waivers of informed consent “and” or “or”? Answer, laura – they’re “and.” They all need to be true.
• ~6+ people have waivers of informed consent, in the room. à question – do you think these requirements are all met? Answer from participant: all except the last one.
• Participant question, slide 33 – if this actually happens, should we pull data and find out who this happened to? Track down people; share what happened? Tell them what steps we’ll take to not have it happen again?
• -        Answer – could be good – depends.
• Participant question, slide 33 – I want to add: about enumerators, encouraging people to take survey – sometimes we subcontract to survey firm. Often enumerators are paid by the survey. This drives incentives. How much do you really control consent process?
• -        Laura answer – if we don’t directly pay enumerators – do have to think carefully about how closely adhering to protocols. Lots of work has been done in thinking through the amount paid to enumerators. Important for you to know how enumerators are paid and trained.
• Would like this to end up in the lecturer / prep notes. I don't think its something I necessarily want to add, but want lecturers to be prepared to answer. This is something fairly important in the survey realm of things. Should at least be familiar enough to be able to answer if it comes up
• Participant question, slide 33 – before we started data collection – testing whether transit subsidies for families in temporary shelter – to see if increased school attendance. Gas cards versus Uber cards. Intake people found very hard to press randomize button. We were able to make the control that everyone was getting a MetroCard – getting /something/.
• -        Laura – yes – having the control group at least get something can help with sticking to protocols.
• Participant question, slide 37 - are you estimating probabilities, or more like “this seems risky”?
• 39 – maybe cut down on repetition – Laura indicated that there may be overlap with previous slide. -Clare
• to consider for next year. not sure whether this was just needing a little more prep time / familiarity with the new slide flow, or the slides, or what.
• 42 – clicker responses – 53% of people chose “expedited” application
• Show of hands: ~30%-50% of participants are responsible for managing their project’s IRB
• Participant question, slide 49 – why would I not say, for every study, “I’ll enroll 1 million subjects” and then I’m always safe because I’m always under? Answer: 1. Basic ethics. 2. Sometimes IRBs ask for exact power calculations. Also, 3. Ex. for IRB for animal studies, IRB is asking “do you really need this many subjects”?
• Participant question, slide 52 – do you need to go through this process if you’re granted exemption? (The process of IRB approval at multiple sites). Laura answer: sometimes this has involved emailing multiple coordinators. Sometimes relatively simple, if data lives in one place. Asking the coordinators is your best bet.
• Participant question, slide 52 – Would you do these simultaneously? Is there a sequence you go through? Laura answer: sometimes these proliferate – sequencing and version control alone can be difficult. Ex. Jesse’s study, 12 IRB approvals needed (4 institutions x 3 protocols). Can sometimes cede review to one IRB.
• Participant question, slide 52 – Jim - For J-PAL, is MIT the IRB of record for much of what we do? Answer – no. Usually it’s whoever is the lead PI. Or wherever the most sensitive data is.
• Participant question, slide 52 –to clarify – if by 2020 you have multiple institutions on an IRB… what do you do? Answer: only for new studies
• Participant question, slide 52 –to clarify –which IRBs? Where? Answer: US context
• Participant question, slide 52 –follow-up question to the 2020 question: I think SmartIRB is a portal where institutions can go.
• add smart IRB to the slides or materials next year
• Usually it’s a negotiation process between IRBs. Will this help? Answer: hopefully.
• Participant question, slide 52 –(? Not sure I heard question) How much variation is there across US institutions and across different countries? Answer: I don’t know how much variation there is. We’ll link to some resources from different countries. 
• �

How involved have you been with the Institutional Review Board review process?

1. I’ve been primarily responsible for managing or coordinating the IRB process.
2. I’ve helped draft language for an IRB submission or amendment.
3. I know when we need to submit an amendment or to report an incident and can flag this for the team.
4. I haven’t been too involved in the IRB review process but know that my project has IRB approval!
5. Not applicable - I haven’t worked on a project that has needed IRB approval yet!

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Add any questions you hope we answer about IRBs throughout the presentation to the chat!

Institutional Review Boards (IRB)

Noreen Giga, Jess Sashihara, Fatima Vakil

J-PAL North America

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J-PAL Research Staff Training USA 2021

Outline

1. Foundations of IRBs: What, why, & principles
2. Elements required in IRBs
3. IRB process
4. Limitations

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Outline

1. Foundations of IRBs: What, why, & principles
2. Elements required in IRBs
3. IRB process
4. Limitations

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Why is IRB approval necessary?

Research Protocols

The Common Rule & IRBs: Origins

Belmont Principles of research ethics

Beneficence

Respect for persons

Justice

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The Common Rule & IRBs: Origins

The Common Rule & IRBs: Today

“I. The Rational of Modernizing the Common Rule.” January 2017. Federal Register, Rules and Regulations. 82(12) https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf

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International Context

• Outside the US, some countries have established ethical guidelines for research
• At the institution level, some universities or institutions have developed their own IRB model

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(Always check with you host institution!)

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Institutional Review Boards

The Institutional Review Board

A group designated by an institution (e.g., a university or non-profit) to approve, monitor, and review research involving human subjects to assure appropriate steps are taken to protect the rights and welfare of those subjects in compliance with the Common Rule

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This Photo by Unknown Author is licensed under CC BY

Who is on the IRB?

• At least 5 members
• Varying backgrounds
• At least one member primarily focused in scientific areas; primarily focused in non-scientific areas; not affiliated with the institution
• Diverse in race, gender, cultural backgrounds
• Sensitive to community attitudes
• Bring in outside experts when reviewing proposals that…
• Are outside area of their expertise
• Involve certain protected populations (e.g., children, prisoners)

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MIT IRB Committee members

Adam Berinsky

Mitsui Professor of Political Science, Director of the MIT Political Experiments Research Lab

Ife Ademolu-Odeneye

Undergraduate student studying Mathematics with Computer Science

Jon P. Daries

Senior Research Analyst, Office of the Provost

Dr. Arolyn Conwill

Postdoctoral Associate, Institute for Medical Engineering and Science

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Dr. Daniel Debowy

Psychiatrist, MIT Medical department

Kate Doria

Senior Data Analyst, Office of the Provost

Evelina Fedorenko

Associate Professor, Department of Brain and Cognitive Sciences

Kelly Flannigan

Review Specialist, Office of Research Subject Protection, Broad Institute for biomedical and genomic research

Angela Fowler-Brown

Medical Doctor, Family Medicine, MIT Medical Department

Michael Kane

Community Representative, Physician, Internal Medicine

Drazen Prelec

Professor of Management, Sloan School of Management

Robert Randolph

Chaplain to the Institute, Office of the Dean for Student Life

Catherine Ricciardi

Nurse Manager, MIT Clinical Research Center

Haley Schilling

Graduate Student, Linguistics & Philosophy

Peter C. Scott

Community Representative

Edward Wack

Asst. Division Head, Homeland Protection and Air Traffic Control, MIT Lincoln Laboratory

What do IRBs review?

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Human Subjects

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Research

Human Subjects Research

Scope of IRB review

Human subjects: living individuals about whom an investigator…

1. obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
• Identifiable information: information for which the identity of the subject may readily be ascertained or by the investigator or associated with the information
• Private information:
• Information about behavior taking place in a context in which an individual can reasonably expect no observation or recording
• Information that the individual provided for a specific purpose and can reasonably expect will not be made public (e.g., a medical record)

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See Human Subjects Decision Chart 1: “Is an Activity Human Subjects Research Covered by 45 CFR Part 46?”

Scope of IRB review

IRBs review research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

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• While still falling under the definition of research, some types of research are exempt* including…
• Research involving only “benign behavioral interventions” and non-identified data
• (more on exemptions later)

* ”Electronic Code of Federal Regulations” §46.104   Exempt research.

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Scope of IRB review: Research vs practice

“Practice” is different from “research”

• The IRB has jurisdiction over certain types of research.
• The IRB framework doesn’t cover independent decisions of the partner organization—actions or programs that “would have happened anyway.”
• Does not review whether a government program is ethical, or a program implemented by an NGO is ethical, etc. Just the research components, if research is added on.

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Research vs practice: The two extremes

In evaluation of Vietnam war: lottery draft was not subject to ethical approval, as researchers did not implement nor have a say in decision-making over the draft process

When a researcher invents and test new vaccine on humans, the “program” (vaccine) is part of research

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Practice ≠ Research

Practice = Research

Research vs practice: Complicated middle ground

Practice ≈ Research

• When a researcher has significant influence over the design and implementation of a program or intervention, in partnership with an implementer or government, the line gets blurry.

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• Describe the extent of researcher involvement to the IRB.
• Consider what would have happened in the absence of a research partnership.

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• IRBs differ, but usually consider it within their purview to review elements of a program changed for the sake of the research.

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You are developing a study on health insurance. You want to interview Dr. Yasmina, a policymaker, to learn about the current regulation. Do you need to submit an IRB to do this interview?

1. Yes
2. No
3. Depends
4. Don’t know

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Following every Research Staff Training, we survey the participants to understand what they think should be improved. Do we need IRB approval?

1. Yes
2. No
3. Depends
4. Don’t know

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You want to run a pilot where you will be test-driving the survey tools and intervention. Do you need to submit an IRB?

1. Yes
2. No
3. Depends
4. Don’t know

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Outline

1. Foundations of IRBs: What, why, & principles
2. Elements required in IRBs
3. IRB process
4. Limitations

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Key documents for IRB approval

1. Research protocol
2. Survey instruments
3. Informed consent scripts
4. Translations
5. Human subjects training certificates (CITI)
6. Other study related documents

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IRB forms at MIT: https://couhes.mit.edu/forms-templates

IRB forms at Harvard: https://cuhs.harvard.edu/forms

IRB forms at IFMR: IFMR IRB Google Drive folder

Research protocol: A chance to think through all aspects of the research design

• Research objectives and purpose (short)
• Research methods (in detail)
• All materials subjects come in contact with: questionnaires (translated), recruitment flyers, apps, experimental tools…
• Study participants
• Sampling frame, sample selection method, number of subjects
• Recruitment process and informed consent
• Assessment of risk (and justification, if applicable)
• Data confidentiality and participant privacy

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Informed consent

Not just a form

It’s a process

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Informed consent

Not just a form

It’s a process

Help someone make a decision about participation.

• Give information that a “reasonable person” would want to have
• Organize the form & info to facilitate understanding of why one might or might not want to participate

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Informed consent

Requirements for Informed Consent:

• Information about the study, study team, etc.
• Invitation to participate
• Benefit of study
• Risk to participants
• Participants must understand implications of participation & voluntarily choose to participate

Informed consent CANNOT include language that is:

• Coercive – “overt or implicit threat of harm”
• Undue influence – “offering excessive or inappropriate reward for participation”
• Exculpatory – “clearing from alleged fault or guilt”
• Jargon

Requirements for Informed Consent, or waivers or alterations to the documentation or gathering of informed consent, are outlined by the Common Rule in section 116 and 117.

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Research Ethics

Discuss:

You provide ongoing training & support to survey enumerators on how to collect informed consent. You learn that some enumerators are skipping over parts of the consent process because they think it’s too long and participants are losing interest. What should you do? How do you advise enumerators to collect informed consent?

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Informed consent & participant data

You must tell people what will happen to their data in the future

When using identifiable private information, you must include one of two statements describing future research:

1. Identifiers might be removed from identifiable private information and then, after this removal, the information could be used for future research or provided to another investigator for future research studies without additional informed consent.
2. Information, even with identifiers removed, will not be used or distributed for further research.

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Informed consent – (waiver of)

In order for there to be a waiver, the IRB must find and document that:

• The research involves no more than minimal risk to the subjects;
• The research could not practicably be carried out without the requested waiver or alteration;
• If the research involves using identifiable private information, the research could not practicably be carried out without using such information in an identifiable format;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
• Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

See Human Subjects Decision Chart 13: “When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)?”

Discuss:

Have you gotten a waiver of some or all parts of consent?

Tell us about it!

Why was it necessary? What justification did you provide? Did you have any difficulty getting the approval?

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Outline

1. Foundations of IRBs: What, why, & principles
2. Elements required in IRBs
3. IRB process
4. Limitations

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IRB process

Initial application & approval

Before starting any human subjects research activities.

Amendments

Before changing almost anything: team members, sample size, surveys, consent forms, donors

Reportable new information (RNI)

In the case of non-compliance, adverse events, added risk, etc.

Continuing review

Frequency varies; some studies require annual review and renewal.

Study closure

All study interventions and study activities are complete, AND

no one is working with identified data.

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Make sure to save ample time for IRB approval.

See Human Subjects Decision Chart 11: “Is Continuing Review Required Under 45 CFR 46.109(f)?”

IRB Lifecycle - example

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Submit: 10/16/20

Approval: 3/2/21

*able to start research activity*

Ask questions to IRB in preparation for submission

Four rounds of questions from IRB and responses from the team

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While waiting to hear back - submit a change form indicating a slight design shift

Amendments & reportable new information

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Human Subjects trainings for all new staff conducting enrollment

IRB Lifecycle - example

Inquiries from IRB

• The need for data about people who did not consent to the study
• Plan for continued support for study participants

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Amendments

• Modification to consent form
• Change in outreach mechanism
• Change in eligibility

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See Human Subjects Decision Chart 2: “Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)?”

An aside on “minimal risk”

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.

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• This does not mean “no risk”

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Limited review & new exemptions

• Eliminates or decreases frequency of continuing review
• Exempt studies can include PII. Interventions can include:
• Benign behavioral intervention: interactions are brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact; not likely to be offensive or embarrassing.
• Some studies of federal public benefit or service programs done in coordination with the federal government.

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• Common Rule text of exempt categories

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Hicks, Lorna. “Final Rule Material: Changes to Exempt Determination Process.” CITI Program. https://about.citiprogram.org/wp-content/uploads/2018/07/Final-Rule-Material-Changes-to-Exempt-Determination-Process.pdf

“Limited IRB Review.” KUNC. http://www.kumc.edu/Documents/hrpp/Topical%20Guidance/KUMC%20Guidance%20on%20Limited%20IRB%20Review.pdf

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Streamlining exempt apps

If you need your IRB application approved very quickly, what kind of application do you submit?

1. Standard Application
2. Expedited
3. Exempt
4. Not Human Subject Determination
5. None of the above

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You don’t yet have any IRB approvals on a study. You think the study might be exempt. What do you do?

1. Nothing; it’s exempt
2. Apply for IRB review
3. Ask your IRB coordinator what to do
4. Don’t know

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See Project Management for how to talk to your PI about this topic!

What are your responsibilities?

1. Ensure you have up-to-date human subjects training (CITI).
2. Familiarize yourself with your research protocols.
3. Keep study up to date in IRB system through:
• Continuing review
• Modifications
• Reportable new information
4. Monitor and ensure compliance of field staff with IRB protocol.
5. Ensure proper protection of PII.
6. When in doubt, discuss questions with your supervisor or the IRB coordinator.

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What are your responsibilities?

Continuing Review: Typically happens once a year. You will want to start this process at least 6-8 weeks before IRB expires. Any delays in continuing review could impact study.

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Modifications: Typically happen throughout the course of the project. Modifications include adding new research personnel and any updates to study protocol.

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Reportable new information: Should be submitted as soon as new information is identified. Provide as much detail on the event as possible. Avoid study jargon that the IRB won’t understand. Be prepared to follow up with additional information and protocols.

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IRB roles and responsibilities (example)

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Tips for navigating IRBs

• Use track changes when requesting an amendment to protocols, a survey, or consent form.
• IRBs may have their own jargon (e.g., a ‘chart review’ study) - check definitions with IRB staff
• Questions from IRB are often just clarifying
• Refer back to 45 CFR 46 – often helpful to understand where questions are coming from.
• Ask if they are worried about a specific problem, or just need clarification on something.

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Tips for navigating IRBs (II)

• Some IRBs ask you to complete a web form in addition to providing an application document. Ensure both are consistent and up to date.
• Create your own study “protocol” with your PI / research team, and use that text to copy/paste into application forms.
• Especially if multiple IRBs involved, this helps with version control.
• Some journals (especially medical) require submission of this “protocol”

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Tips for navigating IRBs (III) - submitting RNIs

Reportable New Information is one of the ways that you will communicate with your IRB. This process will vary by institution - so make sure you check with your PI and IRB coordinator!

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• Submit an RNI as soon as possible after learning about a new event
• Describe what happened:
• what occurred?
• who was impacted?
• what has happened since?
• what other steps will your team take to resolve the event?
• Reach out to others on your team for review
• Submit RNI to your IRB

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In your IRB application, you said you were going to survey 6,000 patients. You cannot find 500 patients and end up surveying 5,500 patients. Do you need to submit a modification?

1. Yes
2. No
3. Depends
4. Don’t know

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Your IRB application has just been approved, but the questionnaire that was submitted missed a key question: “How many cigarettes did you smoke in the last week?” You add the question back in. Do you need to make a modification?

1. Yes
2. No
3. Depends
4. Don’t know

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You are working on a study involving children. You are about to launch your intervention and your implementing partner thinks it’s better to target 1^st graders instead of 3^rd graders. Your PIs agree. Do you need to submit a modification?

1. Yes
2. No
3. Depends
4. Don’t know

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You recently found out that some of your study tablets went missing that may contain PII. What do you do?

1. Submit a modification
2. Submit reportable new information
3. Email your IRB contact
4. Nothing

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Where is IRB approval needed?

At every site where human subjects research occurs. This includes:

• University of all PIs and staff
• Locations of field research (assuming a local IRB exists)

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Institutional Authorization Agreement (IAA)

• aka “ceding review” or “reliance agreements”
• mechanism for one institution engaged in research to delegate IRB review to another institution’s IRB
• simpler alternative to simultaneous review at multiple IRBs
• Revised Common Rule / NIH have requirements for this
• SMART IRB (https://smartirb.org/reliance/) is a platform designed to ease common challenges associated with initiating multi-site research.
• See Participating Institutions for a list of signatory institutions.

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IRB settings

• US review boards operate at the institutional level – universities, hospitals, research orgs (e.g., IPA)
• Outside the US, some review boards operate at the institutional level, others operate at the regional or national level
• Often called Research Ethics Committees (RECs)

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Imagine that Raj Chetty (Harvard) and Amy Finkelstein (MIT) have a study involving human subjects in India, run through IFMR. Raj wants to cede IRB review to MIT. Where is IRB approval needed?

1. Harvard
2. MIT
3. India/IFMR
4. All of the above
5. Depends

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Outline

1. Foundations of IRBs: What, why, & principles
2. Elements required in IRBs
3. IRB process
4. Limitations

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Limitations of IRBs

• Can only review based on the information you provided
• Are composed of individuals – they are fallible!
• Some argue they operate more as minimizing risk to institution than to individuals/subjects
• Do not have scope to review “practice” in the absence of research
• Do not necessarily have scope to review the full societal context
• IRB approval does not protect you from all controversy.

🡪 don’t outsource your ethics

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IRB Response to COVID-19

IRB guidance for COVID-19, in general, was:

• Halt all non-essential research that involved face-to face interactions.
• Move to online/remote interactions wherever possible, even if the research provided essential services or therapeutic benefits.
• Screen study participants for COVID.

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IRBs and institutions are now beginning to allow in-person research to resume

• Subject to having an approved plan for travel, social distancing, training, testing for COVID, reporting, wearing PPE, etc.

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Questions? Comments?

Thank you!

Credits

• Presentation based heavily on slides from Freida Siregar, of Evidence for Policy Design (EPoD) (presented at NH RST 2017)
• Content was also drawn from slides developed by Lindsey Shaughnessy of IPA (presented at NH RST 2017)
• Current version has been edited by Noreen Giga, Jess Sashihara, Fatima Vakil

References

• Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule”: Subpart A of 45 CFR part 46 of the HHS regulations
• Glennerster, R. “Chapter 5 - The Practicalities of Running Randomized Evaluations: Partnerships, Measurement, Ethics, and Transparency.” In Handbook of Economic Field Experiments, edited by Abhijit Vinayak Banerjee and Esther Duflo, 1:175–243. Handbook of Field Experiments. North-Holland, 2017. https://doi.org/10.1016/bs.hefe.2016.10.002.
• Rachel Glennerster and Shawn Powers (2016): Balancing Risk and Benefit: Ethical Tradeoffs in Running Randomized Evaluations.
• “Define intake and consent process.” J-PAL North America Toolkit.
• “Institutional Review Board (IRB) proposals.” J-PAL Research Resource.
• Committee on the Use of Humans as Experimental Subjects. “Forms & Templates.” Massachusetts Institute of Technology. 
• Committee on the Use of Human Subjects. “Forms.” Harvard University.
• IRB forms at IFMR: IFMR IRB Google Drive folder
• Committee for Protection of Human Subjects at UC Berkeley: “Research involving the secondary use of existing data.”
• Key elements of a Social Science IRB proposal:

https://www.southalabama.edu/departments/research/compliance/humansubjects/resources/key.elements.of.a.social.science.research.protocol.pdf

• Human Subjects Decision Charts (updated June 23, 2020): https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html. Office for Human Research Protections.

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References: Common Rule revisions

• Jerry Menikoff, Julie Kaneshiro, and Ivor Pritchard. (2017). “The Common Rule, Updated.” New England Journal of Medicine 376(3).
• MIT IRB Announcement of Common Rule revisions.
• OHRP information on the revision process: “Revised Common Rule.”
• OHRP: “Revised Common Rule Q&As.”
• Rational for updates and summary of input from the public that informed the process: “I. The Rational of Modernizing the Common Rule.” January 2017. Federal Register, Rules and Regulations. 82(12).
• Stephen J. Rosenfeld: ”Informed Consent and the Revised Common Rule.”
• Lorna Hicks: ”Final Rule Material: Changes to Exempt Determination Process.” CITI Program.
• Northwestern IRB Office: “IRB Review of International Research.”
• Andrea S. Nichols. “Research Ethics Committees (RECS)/Institutional Review Boards (IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research be Standardized?” Washington University Global Studies Law Review.

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References: Research Ethics Committees outside the US and international frameworks

• Database of IRBs all over the world that have registered with OHRP. This could provide a sense of what kinds of institutions have IRBs, how many there and the level at which they sit in various countries.
• Regulations/guidelines for human subjects research in 131 countries, compiled by OHRP: “International Compilation of Human Research Standards”
• CIOMS: “International Ethical Guidelines for Health-Related Research Involving Humans” (2017). International framework for ethical principles and how they should be applied, with particular focus on conducting research in low and middle-income countries.
• WHO: “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants” (2011).
• WHO: “Research Ethics Committees: Basic Training for Capacity-Building” (2009).

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University IRB Policies for COVID-19

For reference, links to various university IRB policies relating to COVID, to give a sense of the types of policies across institutions. Check your own institution’s policies.

• MIT: https://couhes.mit.edu/covid-19-updates
• Harvard T. Chan School of Public Health: https://www.hsph.harvard.edu/regulatory-affairs-and-research-compliance/announcements/covid-19-faqs-relating-to-human-subjects-research/
• Harvard Committee on the Use of Human Subjects: https://cuhs.harvard.edu/questions-about-covid-19-and-your-research
• University of Washington: https://www.washington.edu/research/hsd/covid-19/
• University of Michigan: https://research.umich.edu/covid-19/covid-19-research-operations
• University of Chicago: https://sbsirb.uchicago.edu/2021/08/23/current-research-resumption-guidance/
• Northwestern University: https://www.research.northwestern.edu/faq-research-return/
• Berkeley: https://vcresearch.berkeley.edu/covid19/faq#sub1_4

Resuming Research Links

For reference, links to various university IRB policies relating to COVID – ramping up / resuming in-person research, to give a sense of the types of policies across institutions. Check your own institution’s policies.

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• MIT: https://couhes.mit.edu/covid-19-updates
• Harvard T. Chan School of Public Health: https://www.harvard.edu/coronavirus/planning-2020-21/checklist-for-safe-return-to-labs
• Harvard Committee on the Use of Human Subjects: https://cuhs.harvard.edu/instructions-returning-person-human-subjects-research?admin_panel=1
• University of Washington: https://www.washington.edu/research/or/covid-19-guidance-for-a-safe-return-to-in-person-research/
• University of Michigan: https://research.umich.edu/covid-19/research-reengagement
• University of Chicago: https://sbsirb.uchicago.edu/2021/08/23/current-research-resumption-guidance/
• Northwestern University: https://cpb-us-e1.wpmucdn.com/sites.northwestern.edu/dist/2/2819/files/2020/06/IRB-Guidelines-for-Reopening_v6-19-2020.pd
• Berkeley: https://cphs.berkeley.edu/covid-19.html