The protection of human participants is of the utmost importance for practical and ethical reasons. The Institutional Review Board (“IRB”) is an administrative committee of Teachers College (TC) whose purpose is to ensure that the rights and welfare of human subjects of research conducted at or sponsored by TC regardless of the source of funding are protected pursuant to federal regulations (45 CFR part 46 and 21 CFR part 56). Examples of human subjects’ research include surveys, observations of behavior, experiments involving human responses, individual interviews, focus group sessions, and collection of data from existing records.
In taking on this responsibility the IRB ensures human subject research is conducted ethically and in compliance with the Belmont Report, applicable federal, state, local and institutional requirements by performing prospective and continuing review of the protocol, the informed consent process, and the procedures utilized to enroll subjects.
The conduct of research at Teachers College is a shared responsibility. It requires cooperation and collaboration among the institution, investigators and their research staff, the subjects who enroll in research, and IRB members and staff.
The responsibility of ensuring compliance with the TC’s Federal-wide Assurance is vested in the IRB. No research involving human subjects may be conducted at TC without IRB approval. Research approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of TC.
Researchers working with human subjects may not begin recruitment or research until they receive a final IRB approval letter. All research staff and faculty sponsors submitting an IRB protocol must have an updated CITI training certificate on Mentor IRB (awarded within the last three years). Please visit our Training & Certification page for information on how to update CITI certification.
People are autonomous decision-makers. For persons incapable of such self-determination, additional protections should apply.
Maximize possible benefits and minimize possible harms.
Who ought to receive the benefits of research and bear its burdens? To each person:
Certain research activities may be exempt from IRB review if approved by the IRB Chair and confirmed in writing to the Principal Investigator. Research may be exempt from review when the only involvement of human subjects in research falls into one of the approved review categories.
Federal regulations permit the IRB Chairperson to review and approve proposed research through an expedited review process if (a) the research constitutes a minor change in a previously approved research project during an approved period, or (b) the research is not greater than minimal risk and falls into one of the expedited review categories.
If a research project does not precisely fit under the exempt or expedited review categories, it will be subject to full board review. Studies that involve more than minimal risk require review at a fully convened IRB meeting.