Human Subject Research Forms and Instructions
Amendments/Modifications to your protocol
- Making Changes to your protocol (requirements for paper and e-Protocol submissions)
Adverse Events
- Significant Adverse Event Report Form
- Event Tracking Log
- Adverse Event (AE) Report for an e-Protocol submission
- Adverse Event Reporting Decision Tree
Baystate Medical Center and UMass Collaborative Human Subjects Research
- Registration Form for Collaborative Human Subjects Research
- IRB Guidance - IRB Review of Collaborative Research with UMass and Baystate
Continuation/Final Report Form
- Continuation/Renewal Instructions for e-Protocol submissions
- Final Report Instructions for e-Protocol submissions
Protocol Deviation/Violation Report Form
Unanticipated Problems Involving Risk to Subjects or Others Problem Report Form
Consent Form Templates
Additional Templates - Below are the informed consent templates for studies that include the procedures listed. Please use as necessary.
- Complex Biomedical
- Focus Groups
- International Affective Picture System (IAPS)
- Magnetic Resonance Imaging (MRI)
- Muscle Biopsy
- Online Survey
- Video Use
- VO2 Max
- Assent Form Template/Samples
Reviewer Checklists