HIPAA Guidelines

• Notice of Privacy Practices
• Guidelines for HIPAA Authorizations (English Version)
• Guidelines for HIPAA Authorizations (Spanish Version)
• HIPAA Research Activities, Procedures and Guidelines
• HIPAA Research FAQs
• HIPAA Authorization for the Release of Medical Information
• Disclosure Log

* More HIPAA policy and Guidelines are coming, please check back often.

RSRB Forms, Instructions and Guidelines

Letter & Memo

• Placebo Controlled Studies

RSRB Application Forms

• RSRB Electronic Submission System - Click here to access the system

• Behavioral and Social Science Templates
  • Consent form template [For Adult research subjects]
  • Permission form template [For Parents or Guardians of Child research subjects]
  • Assent form template [For child (under age 18 years) research subjects]
  • Rochester Center for Brain Imaging (RCBI) Researchers

• Request for Amendment/Modification

• Exempt Studies
  • Request for Amendment (Change in study previously determined to be Exempt)
  • Information Sheet Template
  • Translator's Declaration
  • Exemption Category Guidelines
  • Sample Data Use Agreement

• RSRB Progress Report (Application for Continuing Review of Research)
• Case Studies Information
• Waiver Request Forms - For use only with studies submitted before the online process.
  • Form 1: Waiver of Documentation of Consent
  • Form 2: Waiver of Consent
  • Form 3: Waiver of HIPAA Authorization
    
• Independent Investigator Agreement
• Serious Adverse Event (SAE) Form
• Surgical Pathology Request for Human Tissue Form

Guidance Documents & Policies

• Guidelines for Writing Research Protocol
• Guidance on Recruitment of Human Research Subjects Through Advertising
• Consent Form Wording for GCRC Procedures
• Investigator Guidance
• Adverse Event Reporting Guidelines
• IRB Approval & NIH/Foundation Grant Applications ("Just In Time" Policy)
• Sponsor Request for IRB Membership Information
• WIRB as IRB of Record for UR
• Support for registration of clinical trials policy
• Legally authorized representative (LAR) policy
• Glossary of Lay Terms
• Glossary of Research Terms