The Role of IRBs in Protecting Research Participants

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The Role of IRBs in Protecting Research Participants

Research Methods in Psychology · Chapter 2: Ethics and Integrity in ResearchSection 2.7 · lesson 14 of 9411 min · free with a free account

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In this lesson

Institutional mechanisms for ethical oversight of psychological research.

  • Describe how an IRB is built and where its authority comes from
  • Distinguish exempt, expedited and full board review
  • Explain the criteria an IRB applies to a proposal
  • Track the obligations that continue after approval

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Transcript

Everything said in the video, section by section (1,555 words). Read along, or search it.

Ethics and Integrity in Research

How IRBs Protect Participants

Individual researchers cannot be the only thing standing between a study and the people in it. That premise is what created the Institutional Review Board. This section is about how such a board works, and what it is looking for. It is easy to treat ethical review as paperwork you survive. It is far more useful to treat it as a design tool. By the end you will describe how an IRB is built, and where its authority comes from. You will tell exempt, expedited and full board review apart. You will name the criteria a board must satisfy before it approves anything. And you will know what your obligations are after approval. Which is exactly where most researchers stop paying attention.

Why Oversight Exists

Good Intentions Are Not a Safeguard

Start with the reason the whole system exists. Individual researchers, however committed to ethical practice, cannot serve as the sole safeguard for participants. That is not a claim about dishonest people. The history of research ethics shows that well-intentioned researchers can rationalize harmful practices. They can miss significant risks sitting inside their own design. And they can be subject to pressures that compromise their judgment. Financial pressure. Academic pressure. Institutional pressure. Not one of those requires bad faith. They only require being invested in your own work. So the board supplies something the researcher structurally cannot. An independent check on researcher judgment. IRBs are the primary institutional mechanism for translating ethical principles into research practice.

Defining The Board

An Independent Committee With Legal Force

So what is an IRB, concretely? An independent committee, established by a research institution. Its job is to review, approve and monitor research involving human participants. The name changes by country. In other places the same body is a Research Ethics Committee, or an Ethics Review Board. Same function, different letters. In the United States, IRBs are mandated by federal regulations under the Common Rule. That mandate applies to any institution receiving federal research funding. Notice what that does to the board's authority. Review is not an internal courtesy that a department can decide to waive. It is a condition of the funding, which is what gives an IRB decision real force.

Board Composition

Five Members, Deliberately Unalike

The regulations do not simply require a board. They specify who has to sit on it. A minimum of five members, with varying expertise. At least one whose primary concerns are in a scientific area. At least one whose primary concerns are non-scientific. An ethicist, a lawyer, a clergy member. At least one member not affiliated with the institution at all, a community representative. And members with enough expertise for the kinds of research the board actually receives. Also members who reflect the diversity of the community participants are drawn from. The board exists to provide an independent check on researcher judgment. So ask why the regulation insists on a non-scientist, and on an outsider. Your answer to that is the answer to how the whole system is meant to work.

Levels Of Review

How Much Scrutiny a Study Gets

Not every study needs the same amount of scrutiny, and the regulations say so. Three review categories, sorted by the level of risk involved. Exempt review covers minimal risk research in specific named categories. Surveys. Educational testing. Observation of public behavior. Expedited review covers research with no more than minimal risk in specific categories. It also covers minor changes to research that is already approved. The difference is who reads it, the chair or designated reviewers, rather than the full board. Full board review is for research involving more than minimal risk. Also for vulnerable populations, and for special categories of sensitive data. That one goes to a convened meeting, and needs a majority vote of members present. Here is the trap. A study may genuinely be exempt from full review, but the researcher does not make that call. The determination must be made by the IRB.

Criteria For Approval

What the Board Must Find

For a study to be approved, the board has to make a set of findings. Seven of them, set out in the Common Rule. And they work together. Every one has to hold. You cannot trade a strength on one criterion against a weakness on another. The first finding is that risks to participants are minimized. Minimized by using procedures consistent with sound research design. Procedures that do not expose participants to risk unnecessarily. The second is that the risk-benefit ratio is reasonable. Risks must be reasonable against benefits to participants, and against the knowledge to be gained. The third is that selection of participants is equitable, justifiable, and not exploitative of vulnerable individuals. The fourth is that informed consent will be sought and documented appropriately, or a waiver justified.

Remaining Criteria

Data, Privacy and Vulnerability

The last three criteria are about data, and about the people behind it. Where appropriate, a data safety monitoring plan is in place. That applies to research involving interventions. Adequate provisions must protect the privacy of participants. And maintain the confidentiality of the data they hand you. Where applicable, additional safeguards protect the rights and welfare of vulnerable participants. Now notice the qualifiers attached to two of those seven. Where appropriate. Where applicable. Monitoring plans and extra safeguards depend on what kind of study you are running. The other five depend on nothing. They reach every protocol the board sees, including the ones that look harmless.

After Approval

Oversight Does Not Stop at the Decision

Approval feels like the finish line. It is not. IRB oversight runs the length of the study. Think of a protocol as having a life, with checkpoints along it. It starts with submission, where you supply the protocol, the consent documents and a risk level. Then approval, which is the board's decision and not the researcher's. Then continuing review, at intervals appropriate to the level of risk. For most studies that means at least once a year. Along the way, amendments and adverse events both come back to the board. And at the end there is a formal closure report. Each of those is a moment where a study can be changed, paused, or allowed to continue. That is the part people underestimate. Review is continuous, not a gate you pass once.

Ongoing Duties

Continuing Review, Amendments, Adverse Events

Take those ongoing duties one at a time. Continuing review is periodic re-evaluation of research that is already approved. At least annually for most studies, at shorter intervals when the risk is higher. The board asks whether the risk-benefit ratio remains acceptable, and whether new information has emerged. The second duty is amendments. Any significant change goes back to the board before it is implemented. Changes to procedures, to the participant population, to personnel, or to data management. Minor administrative changes can go through expedited amendment review. Substantive changes may require the full board all over again. The third duty is adverse event reporting. An adverse event is an unexpected occurrence that harms participants, or puts them at greater risk than anticipated. Report those promptly, because the board may need to act on them. It can require protocol modifications, extra safeguards, or in serious cases, suspension of the research. And when the study ends, a closure report confirms that collection is complete, and states where the data now lives.

Writing The Application

Getting Through the First Time

Some practical advice for getting an application through. Begin the process well before your planned data collection start date. Ethics review takes time, and building that time into your schedule is part of the design. Describe every procedure in enough detail for a non-specialist to follow. Think about who is reading it. A lawyer, a clergy member, someone from the community. Detail that feels obvious to a specialist is exactly what those reviewers need. Identify the level of risk involved yourself, and justify that assessment. Prepare consent documents at an appropriate reading level, and in all required languages. Include complete information on participant compensation, data security, and confidentiality protections. And when a requirement is unclear, ask before you guess. Your institution's IRB office exists for that, and so does any senior researcher who has been through it.

The Standing Critique

What Critics Say About IRBs

IRBs are not above criticism, and you should be able to argue about them. The standing critique has three parts. That boards are too slow, and too risk-averse. And that they are poorly equipped to review qualitative and social science research. The third charge is the interesting one, because it is about fit rather than speed. Your job is to evaluate that critique rather than simply repeat it. Test it against what you now know. Composition. Review levels. Approval criteria. Then propose two evidence-based reforms of your own. Two readings are suggested if you want to take this further. Oakes, on risks and wrongs in social science research. And Schrag, whose book Ethical Imperialism examines review boards and the social sciences.

Putting It Together

Classify This Study

Try classifying a study yourself. A researcher submits an online survey on political attitudes in university students. No sensitive questions, and no compensation offered. What level of review would you expect? Work it against the categories rather than against your instinct. Minimal risk surveys are named explicitly in the exempt category. Nothing here points to vulnerable populations, or to special categories of sensitive data. So exempt review is the reasonable expectation. But notice carefully what that does not mean. It does not mean skipping the application, because the exempt determination belongs to the board. To close. IRBs evaluate proposals against federal criteria, and classify studies by risk level. Then they keep watching, for the whole life of the study. Understanding that machinery is what lets you design research that deserves to pass it.

About Research Methods in Psychology at UPI Study

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Universities that work with NCCRS

Research Methods in Psychology carries a NCCRS credit recommendation. These universities work with NCCRS; some are UPI Study's signed partners. ACE and NCCRS have over 2,100 cooperating colleges that will consider accepting credits; the final decision is with the universities.

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FAQ

Questions students ask us

About The Role of IRBs in Protecting Research Participants

What is an Institutional Review Board (IRB)?
An Institutional Review Board is an independent committee set up by a research institution to review, approve and monitor research involving human participants. In the United States, IRBs are required under the federal Common Rule for institutions receiving federal research funding; other countries call similar bodies research ethics committees. IRBs exist because even well-intentioned researchers can miss risks in their own designs or face pressures that affect their judgment.
Who has to be on an IRB?
Under the Common Rule, an IRB must have at least five members with varied expertise, including at least one member whose main concerns are scientific, at least one whose main concerns are non-scientific, such as a lawyer, ethicist or member of the clergy, and at least one member not affiliated with the institution. Members should also reflect the diversity of the communities from which participants are drawn.
What is the difference between exempt, expedited and full board IRB review?
Exempt review covers minimal-risk research in specific categories, such as many surveys, educational tests and observations of public behavior. Expedited review covers other minimal-risk research in listed categories and minor changes to approved studies, and is handled by the chair or designated reviewers. Full board review, decided by majority vote at a convened meeting, is for research involving more than minimal risk. Institutions generally require the IRB, not the researcher, to decide the category.
What are a researcher's responsibilities after IRB approval?
Approval starts ongoing oversight rather than ending it. Researchers must submit to continuing review when it is required, often yearly for studies approved by the full board, get approval for significant amendments before making them, promptly report adverse events that harm participants or raise their risk, and file a closure report when the study ends. The IRB can require changes, extra safeguards or suspension if problems arise.

About the Research Methods in Psychology course

How many college credits is Research Methods in Psychology?
Research Methods in Psychology (Psychology 111) carries a NCCRS credit recommendation for 3 semester credits. ACE and NCCRS have over 2,100 cooperating colleges that will consider accepting credits; the final decision is with the universities.
How much does Research Methods in Psychology cost and what is included?
$250, paid once, with lifetime access: all 94 video lessons, a practice quiz after each, the graded work and final exam, and an official transcript when you finish. Students who want several courses choose UPI Study PRO instead.
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