January 2004, Issue 1

Research Involving Humans Requires Special Attention

The Social & Behavioral Sciences IRB (Medford Campus) is administered by the Office of the Vice Provost, located in Ballou Hall at (617) 627-3417. All research involving human subjects, including student research, requires IRB approval. If you're unsure about whether your planned study needs to be approved by the Medford IRB, or even whether it is considered research at all, ask yourself the following questions and then contact Theodore Liszczak at (617) 627-5187 for the final determination.

First, to decide whether it is research, ask yourself:

• Is it a systematic investigation?
• Is it designed to develop or contribute to generalizable knowledge?
• Do I plan to publish the results?
• Is it designed to develop, test, or evaluate past, present, or future research?
• Is it a pilot study?

If you answered "Yes" to any of these questions, there is a good chance your project would be considered research.

Second, to decide whether it is research on human subjects, ask yourself:

• Am I planning to obtain data about a living individual
  • through intervention or interaction with the individual?
  • from identifiable private information (including observation of behavior in a nonpublic setting)?
• Am I planning to use data such as
  • identified/identifiable secondary data?
  • blood/tissue samples?

Third, if you are from the Medford campus and are planning to do human subjects research, you should:

1. Have all key research personnel complete the required NIH educational certification program, which can be found at http://cme.nci.nih.gov/. Note that this educational requirement is under review and may be changed in 2004.

2. Submit the following documents to the Office of Grants and Contracts Administration of the Office of the Vice Provost

a. Human Investigation Review Form
b. Informed consent form (see Guidelines for Consent Forms)
c. Certification of completion of NIH training module.

3. Expect to be informed of the outcome of review within three to four weeks.

4. Start research only after receiving IRB approval.

5. Keep the IRB apprised of project details related to human subjects on a yearly basis (at minimum).

6. The IRB has scheduled meetings. Please submit your protocol at least three weeks prior to the next meeting.

The Office of the Vice Provost recently hosted PRIM&R's IRB 101 On the Road and has additional guides that outline federal regulations pertaining to human subjects research. If you would like copies, please contact Marcy Archfield at (617) 627-3417.

For more information, go to http://www.tufts.edu/central/research/IRBMed.htm.