The Charles Center StudentIRB committee is intended specifically for undergraduate research originating from the Charles Center. All other undergraduate research involving human subjects, like all other human subjects research, should be submitted to PHSC for review.
According to 45 CFR 46, the Code of Federal Regulations, The U. S. Department of Health and Human Services has mandated that research involving human subjects must be approved by an Institutional Review Board (IRB) registered with the Office of Human Research Protections to ensure the safety and the appropriate use of humans as subjects in research studies.
Charles Center undergraduate student research at The College of William & Mary is restricted to the "Exempt" category of research only. The term "Exempt" does not affect the requirements for Informed Consent and protection of human subjects.
The definition of "Exempt," as it applies to Charles Center undergraduate student research with human subjects means the proposed research must fall under at least one of the following four categories for the Charles Center StudentIRB to authorize the research project.
- The undergraduate student researcher must not cause harm to research participants: "harm" may apply to one's physcial, psychological, emotional well-being, reputation, and/or employability.
- Secondary Data: research involving the collection or study of existing data, documents, or records if these sources are publicly available may be considered Exempt.
- Research conducted in established or commonly accepted educational settings, involving normal education practices.
- Research and demonstration projects, which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or othewise examine: 1) public benefit or service programs, 2) procedures for obtaining benefits or sevices under those programs, 3) possible changes in or alternatives to those programs or procedures.
All undergraduates conducting human subjects research through the Charles Center must name the faculty Advisor of record for the research protocol within the Protocol and Compliance Management system. As the PI of record, it is the duty of the named faculty advisor to review the protocol (and all associated documents) with the undergraduate student prior to submission to the online Protocol and Compliance Management system.
Checklist of required components to Charles Center Undergraduate StudentIRB protocol:
- Student must be an Undergraduate.
- Advisor must oversee research design and agree to serve as W&M faculty member on record for STUDENTIRB review.
- Title to Protocol submission to Charles Center Undergraduate STUDENTIRB must begin as follows: 1) "Monroe Project:xxxx", 2) "Community Studies:xxxx", 3) "Sharpe Program: xxxx", 4) "WMSURE Program:xxxx" or 5) "Charles Center Summer Research:xxxx" to facilitate STUDENTIRB review.
- If a questionnaire is to be used in the research, all questions must be submitted for STUDENTIRB review.
- Informed Consent form (docx)
- Brief statement of study: scope, aims, purpose.
- What is expected of the research subject (to include expected duration of suject's participation).
- A statement that there are no perceived risks associated with participation with this research project.
- Advise research subject if there are any anticipated benefits to the subject.
- Statement describing the extent, if any, to which confidentiality of record(s) will be maintained.
- Be sure the subject is advised that participation is voluntary and he/she may discontinue participation at any time without penalty.
- Be sure the research subject is 18 years old or older.
- Advise the research subject he/she may receive a copy of research results.
- Name the faculty Advisor and provide contact information for whom to contact for answers to pertinent questions about the research and research subject's rights.
- If the research is funded by the Monroe Center, disclose source of funding in the Informed Consent form.
- Statement indicating the research has been reviewed by the The College of William & Mary StudentIRB on (date), determined to be "Exempt," and expires on (date).