1. Human Subjects Review: Policies and Procedures

2. Why A Human Subjects Review? It is the policy of this University that all researchers undertaking studies involving human beings as “subjects” shall take all necessary steps to ensure their protection and well-being throughout the study.

3. Role and Function of the Committee on Human Subjects (CPHS) The University Committee for the Protection of Human Subjects has responsibility for reviewing all research involving human participants conducted at or sponsored by CSUMB, regardless of the source of funding.

4. Are the Capstone Projects Research? In most cases: “Research” means a systematic investigation designed to develop or contribute to public knowledge.

5. Are Capstone Projects Subject to Revision? "Research" does not include (a) instruction (b) surveys for evaluating the performance of faculty, staff, and students, or other studies for institutional use only, or (c) student course work or capstone projects, unless...

6. Are Capstone Projects Subject to Revision? unless... … they are to develop or contribute to generalizable knowledge and/or used by other researchers. Even when student work involving human subjects does not constitute research, faculty members who assign or supervise the work are responsible for educating their students to safeguard the well being of the participants.

7. What is a “Human Subject”? “Human subject” (human participant) means a living person about whom a researcher obtains (a) data through "intervention" (for example, vein puncture or cognitive tests) or "interaction" (for example, interviews) with the person, or

8. What is a Human Subject? “Human subject” (human participant) means a living person about whom a researcher obtains (b) identifiable private information (for example, observations or private records). A person may be a "human subject" when a researcher obtains data about the person from a third party as well as from the person directly.

9. What is the Procedure? Researchers will submit a completed application to the Office of Grants and Contracts for Review (see next slide). In most cases, Capstone Projects will be granted a waiver after the initial review, but ALL students must complete the application and submit for approval.

10. Application Form Go to Black Board for both an application form as well as a consent form letter. Close this presentation, return to the unit, to continue with this exercise.

11. Professional Assessment Lab Human Subjects Review Policies and Procedures