The IRB at Bard
Institutional Review Boards function in three ways:
- by educating the community about commonly accepted standards for the ethical treatment of volunteer research participants;
- by fostering discussion about how those general principles apply in particular cases and the balance between the risks to research participants and the long-term benefits of the research;
- by reviewing ongoing research to ensure that it complies with commonly accepted and legally mandated practices and standards;
Disciplines, departments, programs, teams, and individuals can develop a range of principles, practices, and standards to govern the conduct of their research. The IRB can serve as a resource in the said development.
The United States Department of Health & Human Services has identified instances of research it defines as “regulated research.” In these instances, IRB review and approval is required to ensure compliance with the to guidelines set for by either the Office of Human Research Protection (OHRP) or the Food and Drug Administration (FDA). “Regulated research” is that which involves “research” and “human subject participants,” though the OHRP and FDA have specific definitions for each of those terms to help determine which set of guidelines the “regulated research” must follow.
At Bard College, almost all “regulated research” activity falls into the category governed by the OHRP. The ORHP definition of “regulated research” involves the following criteria:
- Research that is defined as: “A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
- Human subject participation that is defined as: “A living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens or ( obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
All research carried out by Bard College faculty, staff, and students that meet the above-defined criteria of “regulated research” must be carried out in accordance with Bard College IRB policies, which includes seeking and securing IRB approval (or exemption in cases where an exemption is warranted). The IRB will not consider proposals for research that has already been conducted.
Before data collection can begin on a project that constitutes “regulated research”, the IRB must review and approve the methods and procedures that will be used. This includes:
- Faculty research;
- Senior projects;
- Class projects that serve as pilot studies;
- Independent student research (e.g., research conducted outside course requirements and program/graduation requirements);
When a project is approved, the consent forms will be given a date stamp including the duration of approval (1 year, renewable). Once a project is approved, the approved research procedures and all content of approved recruitment, consent, research, and debriefing material should not be altered. If subsequent changes are necessary, an amendment must be filed specifying the changes. Approval for these changes must be received by the researcher before those changes can be implemented as part of data collection.