Institutional Review Board

The policies and procedures of the Randolph College IRB are derived from Title 45 Part 46 of the Department of Health and Human Services (DHHS) Code of Federal Regulations (CFR), Protection of Human Subjects. The policies and procedures set forth in the Randolph College IRB website are the Standard Operating Procedures for the Randolph College IRB. All research conducted on human subjects by students, faculty, and staff, whether on or off campus, must be reviewed.

Meetings

IRB meetings will be held virtually on an as-needed basis.

Protection of Human Subjects at Randolph College

Randolph College affirms that in the pursuit of knowledge individual rights must be preserved. The IRB policies and procedures are designed to comply with the federal law protections for human subjects involved in research. All systematic biomedical, behavioral, or social research directly involving human subjects which is associated with this college must comply with the policies and procedures set forth below and must be properly reviewed and approved by the IRB before the research begins. The IRB policies apply not only to research done in academic departments, but also to all systematic biomedical, behavioral, or social research executed by any office or department at Randolph College.

Another important aspect of the human subjects’ protection program is that Randolph College be in compliance with its Federalwide Assurance agreement with the U.S. Office for Human Subjects Protections (OHRP). Compliance with this formal agreement, signed by the College President and administered by the Vice President for Academic Affairs, entails applying the ethical principles of the Belmont Report to all human subjects research, regardless of its funding source. This agreement also stipulates that Randolph College will apply the federal policy known as “the Common Rule” to “all of its human subjects research” as well as subparts B, C, and D of the Department of Health and Human Services Code of Federal Regulations 45 CFR 46. In addition, Randolph College’s IRB policies are designed to conform with §32.1-162.16-20 of the Code of Virginia and other State laws related to the protection of human subjects of research.

Protection against Harm

Investigators are responsible for identifying, justifying, and minimizing the risks of real or potential harm accruing to human subjects involved in their proposed research; such risks include physical, psychological, and social harm. Physical harm may range from unnecessary discomfort or inconvenience to physical pain or disfigurement. Psychological harm includes emotional distress, loss of self-esteem, and impairment of the subject’s ability to judge behaviors or make decisions. Social harm includes damage to reputation and social or legal standing.

Protection against Coercion and Deceit

Investigators must respect a subject’s right to autonomy and guard against unnecessary deception. Therefore, investigators are required to obtain in writing the informed consent of their subjects, except as otherwise approved in advance by the IRB. In obtaining “informed consent,” investigators must meet the following conditions:

1. Before agreeing to participate in the study, prospective subjects must be given the most detailed and accurate description of the study as the research design will allow.
2. Consent and subsequent participation cannot be coerced, and prospective subjects must be provided with written and oral reassurance that they are free to refuse to participate or to withdraw from the study at any time.
3. If parties other than the investigators identified with the study are to have access to the individual contributions of the participants, prospective subjects must be provided with a written statement identifying these parties.
4. Under no circumstances may prospective subjects be misled or uninformed as to any risks associated with the study.
5. When the design of the study necessitates concealment or deception on other matters, investigators are ultimately required to reveal to participants the reasons for the action.
6. Any other conditions required by law.

The IRB is legally required to determine whether the proposed “informed consent” contains the necessary types of information. Ideally, prospective subjects should understand all features of the research that reasonably might be expected to influence willingness to participate. Furthermore, at the conclusion of the study, investigators should freely provide to participants, upon request, information explaining the purposes of the study, the genuine nature of the design, and the results. This access to information should be clearly stated in writing on the consent form that the participants sign. If a prospective subject is less than eighteen years of age, the prior informed consent of a parent or legal guardian is required and the conditions prescribed herein pertain also to the parent or guardian.

Protection against Violations of Privacy and Personal Integrity

Investigators must respect the privacy and human dignity of subjects. Research participants possess the right to decide how much of themselves to share with others. When possible, subjects should participate anonymously. If the research design precludes the anonymity of research participants, then information that is traceable to the individual subjects or to their contributions to the study must be treated with strict confidentiality. Once obtained, personal data about subjects may not be revealed to any third parties or the public in such a way as to make possible the identification of individual participants. A statement explaining the anonymity or confidentiality of information associated with the individual participants and their contributions to the research must be presented in writing to proposed subjects prior to their participation. Investigators should make every effort to preserve the personal integrity and dignity of human subjects, including refraining from research that could conceivably humiliate or belittle participants. The repeated use of particular groups as subjects (e.g. members of certain academic courses) merely for convenience is also discouraged.

Acknowledgements

Randolph College is grateful to the Internal Review Boards of the University of Richmond and Agnes Scott College for permission to incorporate some language from their policies, procedures, and websites.

Sources

The Department of Health and Human Services
The Office of Human Research Protections