The Institutional Review Board (IRB) evaluates research using human participants that is conducted by members of the St. Mary’s College of Maryland community. The IRB operates under the guidelines enacted by the Office of Human Research Protection, a branch of the U.S. government’s Food and Drug Administration.
The IRB reviews all human subject research including proposed changes in previously approved human subject research. The IRB has the authority to approve, require modification in, or disapprove all human subject research.
The IRB also has the authority to suspend or terminate the approval of previously approved human subject research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected, serious harm to subjects.
What research projects need to be approved by the IRB?
For additional information, see:
Does all research with human participants require an IRB review?
For a complete list of exempt research, see:
Why have you told me that my project needs to be reviewed?
- All research involving human subjects must receive an ethics review by the IRB if the subjects are being recruited from outside the instructor’s classroom and the research project is not an in-class demonstration.
- An evaluation of the ethics involved in in-class research demonstrations and experiments remains entrusted with the individual instructor.
What is an expedited review?
For additional information on expedited reviews, see:
How do I get my project reviewed by the IRB?
Where can I obtain the IRB form and instructions?
How do I submit an IRB proposal?
IMPORTANT: Make sure to include any appendixes (e.g., consent form(s), debriefing statements, copies of surveys, list of interview questions, and other materials being presented to participants) at the end of the file, include a page break between each appendix and attach ONE file to an e-mail message and send it to firstname.lastname@example.org. Your IRB proposal is NOT complete if it does not contain your consent form(s) and other relevant information!
If it is impossible to submit the proposal electronically, print and complete “hardIRBForm.pdf” and submit the original form and 4 copies (plus appendixes) to the current IRB chair via campus mail or to his or her office.
What kinds of ethical issues does the IRB consider?
· risks to subjects are minimized;
· risks are reasonable in relation to anticipated benefits;
· selection of subjects is equitable;
· informed consent is sought from each subject;
· informed consent is appropriately documented.
Additional criteria where appropriate:
· data collection is monitored to ensure subject safety;
· privacy and confidentiality of subjects is protected;
· additional safeguards are included for vulnerable populations.
What is informed consent?