Vulnerable populations: Effective June 2, 2020, online/virtual research involving vulnerable populations is now permissible provided the study participant has access to the necessary technology. New protocols must involve surveys or online interviews only. No face to face research is permissible at this point in time.
Vulnerable populations include those defined 45 CFR 46 Subparts B (Pregnant Women), Subpart C (Prisoners), and Subpart D (Children), and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons.
Importantly, researchers must delay research involving face-to-face interactions until the CDC and VDH relax recommendations for social distancing.
Any changes to existing protocols must be submitted to the PHSC for review before implementing said changes.
NTE Faculty may submit protocols to PHSC with the inclusion of a letter of support from his/her Department/Program chair.
NTE Faculty must "cc" Department/Program chair on the "Basic Info" page of the PHSC protocol form in the Protocol and Compliance Management system.
Note: If your protocol is for the School of Education, whether new, modification, or renewal of a previously approved protocol, please use the EDIRC form.
To request Protection of Human Subjects Committee (PHSC) approval for a project, login to the Protocol and Compliance Management System. Normal processing time for a protocol that does not require a convened meeting is approximately three to four weeks from time of submission.
Generalizable Knowledge: If information collected by your project is to be kept in house (that is, not to be shared with the public), or it is collected for pedagological reasons,( i.e., teaching purposes), it is not considered research by the committee thus does not require committee approval.
For questions about PHSC procedures or forms, please email [[cacorb, Cindy Corbett]] or call 1-3966.
UPDATE: 2020 Edition of International Compilation of Human Research Standards
- Committee Membership
- Instructions for Submitting a Human Subjects Proposal
- PowerPoint overview on Charles Center Student IRB protocol submission
- Sample Informed Consent Form
Completion of training is required of all PHSC members and PIs, staff, and students involved in human subjects research prior to the submission of a research protocol. Please register your affiliation with "William & Mary".
Once registered, please select the learner group to which you belong: AREA I: Humanities-PHSC, AREA II: Social & Behavioral Research-PHSC, AREA III: Biomedical Research Investigators-PHSC, School of Education/EDIRC or Charles Center Student IRB.
Additionally, PHSC requires Responsible Conduct of Research training modules to be completed before the protocol submission. RCR, or Research Ethics, also is available by AREA of discipline so select one of the following training groups: AREA I Disciplines-Research Ethics (ID-68959), AREA II-Research Ethics (ID:68962), AREA III-Research Ethics (ID:68963).
Certificates of completion of these two training groups are required to be appended to the PHSC protocol submission.
For Committee Members
- Points for Committee Members and Proposal Writers to Consider in the Evaluation of Human Research Proposals
- Charge to the Protection of Human Subjects Committee
- A Guidebook of Policies and Procedures for Research Involving Human Subjects at William & Mary (doc or pdf)
- OHRP Human Subject Assurance Training
Federal Policy for the Protection of Human Subjects (45 CFR 46)
- "To what does this policy apply?" (45 CFR 46.101)
- "General requirements for informed consent" (45 CFR 46.116)
Helpful Information and links
- Human Subjects Protection--NIH Office for Human Research Protections (OHRP)--contains basic documents concerning the protection of human subjects
- Office of Human Subjects Research
- DOE Office of Science, Protecting Human Subjects Page
- The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.