An IRB (Institutional Review Board for human participants) is a group of at least five individuals with varying backgrounds to promote complete and adequate review of research studies. An IRB conducts the initial and annual reviews of a research study.

Research is defined as a systematic investigation, including pilot research, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research that needs to receive IRB approval before the research can begin.

A human participant is a living individual about whom a researcher obtains data through intervention or interaction (interviews) with the individual, or through identifiable private information (data with identifiers).

Exempt does not mean exempt from IRB review. The IRB, rather than the researcher, determines when research is exempt. Researchers proposing exempt research should submit an IRB application requesting exempt review. Examples of exempt research include educational tests, surveys, or interviews without individual identification or the use of existing data, documents, or other records without individual identifiers.

If an investigator's (faculty and students) research project involves any human participants (including observation, interviews, surveys, and data collection), an IRB application must be submitted. (IRB approval cannot be given retroactively.)

It is recommended that PIs look at the Research Determination Form.

At times it is difficult to determine if a project constitutes research under the federal definition of research. The purpose of this form is to solicit sufficient preliminary information from the project staff for the IRB to provide a determination regarding whether the federal human subjects protection regulations apply to the project.
Research involving the use of existing data may not need an Exempt IRB approval. Researchers should submit a Research Determination Form and provide as much information as possible on how thoroughly the data have been de-identified.

Human participant training must be completed by the principal investigator, faculty advisor, and key personnel before an IRB application can receive approval. CUNY uses the Collaborative IRB Initiative Training (CITI) program. The CITI program is a web-based human subjects training program designed and updated by a number of IRB professionals and is housed at the University of Miami. It is used by hundreds of institutions to satisfy the federal regulations training requirement. The direct link is www.citiprogram.org.

There are three review categories depending on the potential risk to the participants:
Full Review (high risk) needs full IRB review
Expedited Review (minimal risk) needs two IRB members to review
Exempt Review (low or no risk) and is reviewed by the Chair of the IRB

Purpose, methodology, adequate handling of the informed consent, whether the research deals with high risk or sensitive issues and, if so, whether the benefits outweigh the risks, and the degree to which confidentiality is both assured and protected.

Anonymity means the researcher has no record of the identity of the participants. For example, having participants mail back questionnaires or hand them back in a group, without names or other unique identifiers. Or working with data where all the identifiers have been removed.

Confidentiality means the researcher knows the identity of the participants but will keep the participants' identity and all identifying characteristics confidential.

Research participants may be exposed to physical, psychological, social, and economic risks. Very few studies involve no risk.

Yes.