Using Human Subjects in Research

Human Subjects Research

The Mary Baldwin University Institutional Review Board (IRB) is responsible for the oversight of all research activities at the College that involve human subjects.  The Mary Baldwin IRB is registered with the Department of Health and Human Services (DHHS) (IRB00004838 and IOR0004078).  Mary Baldwin has a Federal Wide Assurance (FWA # 00008717) from the Office of Human Research Protection at DHHS.

How do I know if I need IRB approval for my research or senior project?
Any member of the Mary Baldwin community – faculty, staff, or student – who is planning to conduct a research project that involves the collection of specimens or data from living human participants must become familiar with the Policies and Procedures of the Mary Baldwin University IRB.  Students should consult with their faculty advisors to determine whether the project must go through the approval process.  Faculty and staff should consult with the IRB Chair.

If your proposed project involves human subjects research, you must obtain formal IRB approval PRIOR to beginning data collection.  Most external funding agencies require that IRB approval be in place prior to the submission of a grant proposal. 

 What constitutes research?
“Research” is defined as “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge” (45 CRF 46.102d).

Independent projects, including pilot studies, senior theses, dissertation projects, and class projects aimed for publication, that involve the primary (first-time) collection and analysis of human data or specimens are typically considered to be human subjects research.  Educational evaluation projects that are conducted solely for the purpose of program improvement are generally not considered to be human subjects research.  Oral histories and other such memoir-gathering projects have not traditionally been considered to be human subjects research, but faculty advisors should be aware of cases and assess cases in which risks to informants may warrant IRB review.

Both funded and unfunded human subjects research must be reviewed, as must research that takes place on or off the Mary Baldwin campus, including work done outside of the United States.

What about class-based or lab projects whose primary focus is to teach students how to do research rather than to lead to publication or to the development of generalized knowledge?
Faculty in charge of such projects should discuss them with the IRB Chair on at least a biannual basis to determine whether they fall within the category of human subjects research.  Even when formal review is not required, it is important that the rights of participants participating in such projects are protected.

What is the point of IRB review?  In addition to assuring compliance with federal regulations, IRB review is designed to help researchers minimize foreseeable risks to participants’ physical and mental health, financial standing, employability, and/or reputation as a result of voluntary participation in research activities.

What if my research falls into the “exempt” category?  Does that mean it does not need to be reviewed by the IRB?   No.  “Exempt” means “exempt from full committee review.” Not all members of the IRB need to meet in person to discuss projects that fall into this category.  IRB review is still required, however, for any project that meets the definition of human subjects research.

Who will review my research, and how will it be reviewed?  After reading the “Mary Baldwin Policies and Procedures on Human Subjects Research,” you should complete a protocol review form and follow the instructions for submitting it.  After your protocol has been reviewed, you and your advisor will be contacted by a member of the IRB committee.

Proof of satisfactory completion of appropriate training is required prior to commencing work on an IRB-approved research project.