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 research 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 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 research 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.

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

For further information, review the Policies and Procedures document, including the Frequently Asked Questions section.