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Undergraduate StudentIRB

The StudentIRB committee is intended for undergraduate research primarily originating from the Charles Center and Department Honors research .

Please select the StudentIRB template in the Protocol and Compliance Management System.

All other undergraduate research involving human subjects, including research done in courses, should be submitted to PHSC for review.

CITI TRAINING
Faculty Advisors and students must complete the CITI Human Subjects training for their area of discipline (AREA I, II, or III). Also, Responsible Conduct of Research  and COI through CITI is required.  Both the Faculty Advisor and the student's CITI certificates of training completion must be uploaded to the protocol form.

Common Rule

The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The new Common Rule broadens the types of research that may be determined to be exempt from IRB review.  Researchers must submit to the IRB program for a determination that activities are exempt from IRB review. Another example: the collection of identifiable, sensitive information from adults may also be exempt; however, this new category requires a limited IRB review to determine that appropriate privacy and confidentiality protections are in place.  

Consent forms must be concise while also giving the full context of a study, including its risks and benefits, so potential participants have all the information they need to make an informed decision. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens. 

The StudentIRB research at William & Mary is restricted to the "Exempt" category of research. The term "Exempt" does not affect the requirements for Informed Consent and protection of human subjects.

The definition of "Exempt," as it applies to undergraduate student research with human subjects, means that:

• The undergraduate student researcher must not cause harm to research participants: "harm" may apply to one's physical, psychological or emotional well-being, reputation, and/or employability.
• The research is anonymous; and
• The proposed research must fall under at least one of the following six categories for the Charles Center StudentIRB to authorize the research project:

1) Research conducted in established or commonly accepted educational settings, involving standard educational practices, such as:(a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:(a) the information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and (b)any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing employability or reputation.

3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph #2 (above) if:  (a) the human subjects are elected, or appointed public officials or candidates for public office, or (b)federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and after that.

4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.

5) Research and demonstration projects which are conducted by or subject to the approval of  (federal) department or agency heads and which are designed to study, evaluate, or otherwise examine:(a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (d) possible changes in methods or levels of payment for benefits or services under those programs.

6) Taste and food quality and consumer acceptance studies, if: (a) wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

*W&M IRB Registration is required for all exempt research
*Exemptions do not apply to research involving prisoners (45 CFR Part 46, Subpart C)
*Exempt Category 2 does not apply to research with children (45 CFR Part 46, Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed.

All undergraduates with funding through the StudentIRB conducting research on human subjects must work collaboratively with the faculty advisor of record for the research protocol. 

As the Primary Investigator of record, it is the duty of the faculty advisor to review the protocol (and all associated documents) with the undergraduate student before submission to the online Protocol and Compliance Management system. 

These are required for Charles Center Undergraduate StudentIRB protocol:

• The student must be an undergraduate whose research is funded by the Charles Center OR a student conducting Department Honors research.
• An advisor must oversee research design prior to protocol submission and agree to serve as W&M faculty member-of-record for StudentIRB review.
• An advisor must complete the CITI human subjects training in their area of expertise: AREA I: Humanities-PHSC, AREA II:  Social & Behavioral Research or AREA III: Biomedical Research Investigators-PHSC,  and Responsible Conduct of Research.
• Students must complete the StudentIRB training module and the Responsible Conduct of Research  course in CITI before protocol submission.
• Students must attach the CITI certificates of training (pdf) completion to the protocol submission. Note: this training takes a significant amount of time and MUST be completed before submitting the protocol.
• If a questionnaire or survey is to be used in the research, all questions must be attached to the protocol (PDF) for StudentIRB review or it will be returned for revisions.  This will delay approval for the protocol.
• Informed Consent must be attached to the protocol as PDF.
• When obtaining the Informed Consent participant signature there must be a witness signature as well.

The Informed Consent form must include the following:

1. Brief statement of study: scope, aims, purpose.
2. What is expected of the research subject (to include expected duration of subject's participation).
3. A statement that there are no perceived risks associated with participation with this research project.
4. A statement advising research subject if there are any anticipated benefits to the subject.
5. A statement describing the extent, if any, to which confidentiality of record(s) will be maintained.
6. A statement that the subject has been advised that participation is voluntary and he/she may discontinue participation at any time without penalty/
7. A statement confirming that the research subject is 18 years old or older.
8. A statement advising the research subject that he/she may receive a copy of research results.
9. The name of the faculty advisor for the research and contact information for whom to contact for answers pertinent to questions about the research and research subject's rights.
10. A statement disclosing the source of funding (if any) in the Informed Consent form and attach to the protocol submission.
11. A statement indicating the research has been reviewed by William & Mary Student IRB on (date), is determined to be "Exempt," and will expire on (date).
12. A statement that subject may report dissatisfactions with any aspect of this study to Dr. Jennifer Stevens, Chair of the Protection of Human Subjects Committee, by telephone (757-221-3862) or email (jastev@wm.edu)