IRBs review proposals before a research project begins to decide if it follows ethical principles and federal regulations.

Institutional Review Boards

What Is an Institutional Review Board (IRB)?

An IRB is a committee inside a university or other organization receiving federal funds to acquit inquiry that reviews research proposals. The IRB reviews the proposals before a projection is submitted to a funding agency to determine if the enquiry project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authorisation to corroborate, disapprove or require modifications of these projects.

Who Serves on an IRB?

An IRB consists of at least five members of varying backgrounds. IRB members should accept the professional experience to provide appropriate scientific and ethical review. An IRB must have at to the lowest degree one scientist fellow member and at least one member whose primary concerns are nonscientific. Additionally, there must be one fellow member who is not otherwise affiliated with the institution (a community representative). The IRB should strive for appropriate representation in gender and racial and cultural heritage besides.

Where Does an IRB Get Its Authorization?

In 1974, the Department of Wellness Education and Welfare promulgated the regulations on the Protection of Human Subjects that established the IRB. IRBs are administered on a federal level by the Part for Homo Research Protections (OHRP), an part within the Department of Health and Human Services. OHRP assists IRBs in their work and receives and investigates claims of inappropriate research practices.

The establishment that the IRB serves provides authoritative back up for its activities including designation of an private within the institution to oversee research and IRB functions. The institution also files an "Assurance" with the federal government that describes the procedures and guidelines that the IRB must follow.

What Kind of Inquiry Projects Practice IRBs Review?

IRBs are charged with reviewing all federally funded enquiry projects involving homo subjects with a few exceptions (e.g., reviews of records or surveys in which subjects cannot exist individually identified or when disclosure of subjects' responses could non place them at risk of criminal or civil liability and is not damaging to subjects financially, vocationally or socially). However, based on the procedures set forth in the Institutional Assurance, the IRB may review all research projects, regardless of the source of funding.

How Does an IRB Make Its Decisions?

Before an investigator can receive federal funds to conduct a enquiry project, the protocol (research procedures) is reviewed by the IRB. The researcher provides the IRB with all the necessary materials to carry their review including a full clarification of the proposed project, materials the subjects volition use (surveys, questionnaires, tests, etc.), a description of the mode in which subjects will be recruited and provide consent to participate in the project (including a consent course), and how the subjects' confidentiality will be maintained.

The IRB examines all these materials to decide if the research participants are adequately protected. The IRB'due south consideration is based primarily on weighing the risks and benefits of the inquiry. Risks may exist concrete, psychological, social or economic. Benefits include both those to the individual research participant and to social club equally a whole. The IRB too considers the population beingness studied — Does it crave additional protections? Would this population assess the risks and benefits differently?

What Does An IRB Do Afterward Reviewing the Project?

After examining the materials the researcher provides to the IRB, they must decide if the benefits of the research accept been maximized and the risks minimized, and brand a final determination whether the benefits justify the risks to the subjects. If the IRB finds that this is the case, they may approve the protocol. Alternatively, the IRB may request that the researcher make specific changes to the procedures and approve the protocol contingent on these changes or enquire that the protocol exist revised and resubmitted. Finally, the IRB may decide to disapprove of the project. Institutional officials may disapprove enquiry protocols that have IRB approval, but they may not grant approval of research projects that take been disapproved by the IRB.

In addition to reviewing new enquiry protocols, IRBs also review continuing projects or those that have changes in their procedures. Standing projects are reviewed yearly (or more than oft if the IRB feels it is necessary).

How Does an IRB Protect Special Populations?

The Code of Federal Regulations requires that IRBs give special consideration to some classes of subjects: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons. The IRB carries out this charge in a number of ways. In many cases, the IRB may approve of research with these subjects only when it involves minimal risk or when the benefits utilize to the subject area directly. Additionally, if the IRB frequently reviews protocols involving one of the special groups, they may have a community member whose primary interests are with one of these groups.

Who Has Access to IRB Records?

The institution and the IRB maintain records of IRB activities including copies of the research protocols reviewed, minutes from meetings and correspondence. All records must be fabricated available for review by OHRP.

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Date created: September 2017

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