William & Mary

11.03.2025: IRB/Human Ethics Initial Form Update

Summary

This announcement describes updates to the initial form that were published on 11/03/2025. Researchers who created an initial form after the updated form was published will utilize the new form.

Full Description

Table describes changes to the Initial Form
Section	Question	Change
Overview	Type of Review/Overview	Added options: Determination if study meets “Human Subjects Research” as defined by as defined by 45 CFR 46 If selected, you will be asked questions to determine if your study requires IRB review/approval Initial IRB Review Form Request to Rely on External IRB (i.e. W&M is a relying institution in an IAA) Site Authorization Request (e.g. W&M is participating as a site for recruitment/study procedures in a study but is not engaged in the research.) 118 Determination (intent to submit to IRB for funding) Students may also use this form if proof is needed to release funds for a Charles Center Grant
Overview	Review W&M IRB Guidance	Added link to IRB guidance page and require PIs to review before submitting
Getting Started	GS3	When selected, options appear to make sure that the PI is aware of the requirements to submit to that board.
Getting Started	GS5	Edited so that it is more general and links to a new section “external sites”
W&M Study Personnel	New PE1a	Asking what roles need to be added to application
W&M Study Personnel	New PE2a, PE3a, PE5a, and PE6a	Requesting additional details about listed personnel
Non-W&M Study Personnel	New NP1	Options added to route PIs so that they can attach reliance agreements depending on the situation. Each option will display different set of questions. If option 2 is selected in NP1, we do not request for them to upload their collaborator’s training if there is a reliance agreement. This is because it is reviewed by the reviewing institution, and only FWA-covered institutions can enter into reliance agreements.
Study Design	DP10	Updated language so it is clearer what each "date" should refer to.
Data Collection and Security	Text moved	Moved HIPAA instructions to above CS7
External Sites	New section & questions	If no, is selected to ES1, the international research section will populate. “Yes” will populate more questions within this section.
International Research	New questions	IR1 – if yes, the section will populate a reduced number of questions. If no, additional questions will appear. Added IR2 (about Export Controls) and IR9 (Local Context Letters/Approval)
Participant Recruitment	RS1, RS7, & RS10	RS1 added question about secondary data sets so a reduced number of questions appear within this sections RS7 wording edited; information from this question has been moved to new "External Sites" section RS10 added (linked to “no” in RS1)
Consent	C1, C3, C3, C3a & C3b	C1: Additional options so that only relevant questions appear C3: If study is "exempt," option to attach "study information sheets" appears C3a and C3b: New questions that guide researchers to attaching the appropriate Informed Consent template
Funding Supplemental Comments/Attachments, and Conflicts of Interest	N/a	Appear as soon as an option is selected in the Overview section
Supplemental Comments/Attachments	New question – S2	S2 asks if the researcher would like to provide feedback to tech office about the form.
PI Assurance	New questions	Moved to be last and can ONLY be completed by the PRINCIPAL INVESTIGATOR. This is to ensure that the PI understands the the duties/responsibilities of the PI. The section is broken into different questions so that it is presented in a clear and organized format. The PI, if serving as a faculty mentor, will need to include the PI will oversee the students.