The Randolph-Macon Institutional Review Board (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 committee. 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.
All of the original, signed applications must be submitted by campus mail to Mrs. Barbara Wirth (Provost's Office). In order to expedite the process, the electronic submission of non-signed copies should be sent by email to the Chair of the IRB (Massimo Bardi), and in cc to the Vice Chair of the IRB (Joan Conners). Please be aware that electronic applications cannot be accepted without the signed copies. 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, expedite, 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
Exempt: Only minimal risk research may be classified as exempt. The federal regulations identify six categories (see ATTACHMENT A) of research that are exempt from IRB review. Although investigators do not need IRB approval for research that is classified as exempt, the IRB needs to make the final determination if the exempt status is granted, as such even exempt applications must be submitted.
Expedite: Certain types of minimal risks research may be reviewed without convening a full board meeting of the IRB. Federal regulations identify several types of research (see ATTACHMENT B) that may be reviewed under the expedite category.
Full Board: Research that poses greater than minimal risk to participants, including any research involving vulnerable populations, must be reviewed at a convened meeting of the IRB Committee.