Institutional Review Board

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The IRB evaluates all research projects involving the use of human participants at Randolph-Macon. The focus of the evaluation is on the ethical treatment of the individuals participating in the research process.

The Randolph-Macon guidelines for research with human subjects are based on the three principles outlined in the 1979 Belmont Report: Respect for Persons, Beneficence and Justice. The principle of Respect for Persons acknowledges the dignity and autonomy of individuals. This principle requires that subjects give informed consent to participation in research. The principle of Beneficence requires us to protect individuals by maximizing anticipated benefits and minimizing possible harms. The principle of Justice requires that we treat subjects fairly.

These core principles have been translated into specific guidelines by several organizations, including the Office for Human Research Protections (OHRP) at the Department of Health and Human Services, the American Psychological Association, and the American Sociological Association. The guidelines specified by these organizations mandate the need for Informed Consent, Confidentiality, Debriefing, Limited Deception and Protection from harm.

The IRB Process

The process for approval by the IRB begins when a researcher submits an application to the committee, using the appropriate forms (all forms can be found here). Before submitting an application, please read the instructions carefully and apply them as indicated by the IRB Review: Where Do I Begin? Applications requiring full board review will be evaluated by all members of the IRB for their approval, denial, or conditional approval with necessary changes, as indicated by the board.

Research studies that involve minimal risk to subjects may be reviewed using an expedited process; in these cases, proposals will be reviewed by one or more members of the IRB. An expedited review may result in approval, conditional approval with necessary changes indicated, or referral to the full board for review. Although the IRB is free to make suggestions on methodology and hypotheses, the decision of whether or not to approve a given study is made solely on the basis of ethics and not the quality of the proposed investigation. Similarly, it is not the purview of the IRB to edit a submitted proposal.

Applications must be submitted electronically to the Chair of the IRB (April Marchetti). For further information about the submission process and/or the required documentation please see IRB Review: Where Do I Begin?

Types of IRB Review

The federal regulations, Title 45 CFR Part 46, describe three levels of IRB Review as detailed below. Note that the IRB will make the final determination whether your application is appropriate for exempt, expedited, or full board review. Therefore, all applications, including exempt, must be submitted to the IRB prior of the start of the research. Examples of all three types of research can be found in the Investigator Guidelines and in the Standard Operating Procedures Manual.

meet
the team IRB Committee

Membership

The Institutional Review Board committee consists of at least five members, one of whom is not a member of the institution, and one of whom is a non-scientist. The current IRB membership is as follows: