Review Process for Human Subjects ResearchSome notes from the Office of Research Training Session, March 19, 2004
There are ethical and legal issues regarding using human subjects as topics for research papers. The University of Toledo has policies and these can be found on the UT website under the “Research” link on their home page. Also available on the research link, is a link to the NIH tutorial about submitting approval for human subject research. Students and faculty are encouraged to take the tutorial to become certified.
The need for Human Subjects review started with the Nuremberg Trials after WW II. The Belmont Report (1979) is a more recent statement of the need for a review board. It is available as a videotape at UT. Federal Code, Title 45 “Protection of Human Subjects,” 1991, is the official law on this matter. NIH or National Institute of Health is the responsible body, but each organization creates its own review board and process. Research submitted at more than one institution must go through the review board at both places.
Students or faculty who intend to do research which involves human subjects are required to seek approval from the UT IRB committee before work is started. If there is a question of whether approval is needed, contact the committee members to find out if approval is needed. Sometimes written consent will be needed from the human subjects, depending on the amount of “risk.” Approval lasts only one year. Faculty have the ethical duty of informing student researchers of the policies.
Contacts: Gerald Sherman, Chair of IRB committee (Pharmacy dept.)
Lee Pizzimenti, (Law college)
Barbara Chesney, (Sociology dept.)
v Exempt—some examples, public figures, standard classroom procedures [e.g. course evaluations or assessment portfolio], not for publication (will it be seen outside of the classroom?), written sources are used, rather than firsthand observation
v Expedited review-- subjects over 18, minimal risk, confidentiality (not anonymity)
v Full review—greater risk, such as health risks; under 18 subjects [need written consent and the assent of the child], vulnerable populations or protected groups, such as pregnant women, prisoners, etc.
NIH defines “Research” as a systematic investigation of human subjects. So journalism is usually excluded, but any public demonstration may be included. So student webpages, for example, might need IRB approval. The committee was not sure if service learning projects would need IRB approval as the question had never been posed. In any cases of doubt, contact the IRB.
Submitted by Mike Piotrowski