September 2004, Issue 3

Student Research Involving Humans

Student research that involves human subjects requires Institutional Review Board (IRB) approval. Research includes any systematic investigation designed to develop or contribute to generalizable knowledge, or to develop, test, or evaluate past, present, or future research, whether or not the results are published. This includes research that students conduct for course credit.

Research on human subjects is any research in which the investigator obtains data about a living individual through intervention or interaction with the individual (such as administering medication or having the person fill out a survey), or from identifiable private information that should be protected (including observation of behavior in a nonpublic setting). It also includes any research that uses personal information such as identified/identifiable secondary data or blood/tissue samples. For examples of what is considered human subjects research, go to http://www.tufts.edu/central/research/research.htm.

As soon as you know you might be involved in research involving humans, discuss the proposed research with your advisor or course instructor. Your professor should be your primary source of information about how to develop a realistic protocol and how to go about getting the protocol approved by the IRB. A student may not be listed as the principal investigator (PI). The PI must be a Tufts faculty member and is usually the student's advisor or course instructor. The student may be listed as a co-investigator. If you have any additional questions on protocol development after speaking with your advisor, please call the Health Sciences IRB office at (617) 636-7512 for assistance.

All IRB educational requirements should be completed prior to submitting your protocol to the IRB. A study will not be approved by the IRB until the requirements are met. These requirements can be found at www.tufts.edu/central/research/IRB.htm#education. The summary table of baseline educational requirements may prove especially helpful.

All forms required for human subjects research on the Health Sciences Campus can be found at http://www.tufts.edu/central/research/IRB.htm#forms. After reviewing these documents, the IRB office will decide whether your protocol requires full IRB review or whether it can receive expedited review or be exempted from review. Many student research projects qualify for expedited review or exemption because they involve minimal risk or deal with data that cannot be linked to a specific individual. Categories of exemption can be found at http://www.nemc.org/resadmin/Forms/HIRC/hirc_cat.htm and types of research that qualify for expedited review can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm. Full IRB review normally takes four to six weeks, while expedited review or a determination of exemption can often be done in about two weeks.

All reviews are on a first come/first serve basis. Incomplete applications will delay review, so it is a good idea to have the PI review all material before sending it in.

You may begin your research only after your protocol has been approved by the IRB.

For more information on research involving humans on the Health Sciences Campus, go to http://www.tufts.edu/central/research/IRB.htm

You may also find the Office of Human Research Protection (OHRP) website helpful, at http://www.hhs.gov/ohrp/

The Health Sciences IRB office is located on the 8th floor of 35 Kneeland Street, Boston. The main office phone number is (617) 636-7512.