06.17.2025: Human Ethics, Initial and Renewal Form updated

Summary

The Human Ethics initial and renewal form were updated. Changes to the forms are described below.

Full Description

Initial Form

Summary of updates per section

Changes Across the Form: 

• When indicated, documents should be uploaded as a WORD DOCUMENT (e.g. consents, surveys, etc.)
• Links updated to reference the the W&M IRB Guidance page.

Overview

Question added that asks if protocol was previously approved in compliance.wm.edu

Getting Started

• GS4 - Multiple options can be checked if applicable

Study Design and Procedures

• DP3 - updated instructions to provide more guidance for researchers
• DP4 - Audio and Video now have follow up questions when selected; question now requires a response

Data Collection and Security

• Section replaced the "Identifiable Data/HIPAA" section from previous version
• Various questions that were included throughout the previous version were combined into this section 
• All the questions relate to data management and security whether identifiable, de-identified, or anonymous 

Data Management and Security Guidance

Renewal Form

Summary of updates 

• Question added to summarize modifications/amendments
• Question added about study participant status at time of renewal
• Question added about enrollment totals at time of renewal
• Questions added if research is FDA-regulated