Health Sciences Institutional Review Board

Please review the information contained on this web site before submitting proposals to the HSIRB for review.

Proposals will be reviewed on the basis of the research to be conducted and not on one's affiliation with a particular school or faculty.

Research is defined by the regulations as a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.

Submit protocols to the Health Sciences IRB if your protocol involves:

• drugs or
• devices or
• invasive medical interventions or
• retrospective/prospective chart review

For other IRB links go to the Human Research Volunteers website.

Table of Contents

• For HSIRB Members only
• Required Documents for Submission of Proposals
  • Submittal Documents
  • Deadlines for Submission of Full Review Proposals
• Required Documents for Submission of Expedited Review Proposals
  • Acceptable Criteria
  • Submittal Documents
  • Deadlines for Submission of Expedited Review Proposal
• Additional Requirements for Obtaining HSIRB Approval
  • Education / Training Requirements
  • Conflict of Interest
  • Updated! Review Fee for Commercially Sponsored Research
  • Guidelines for Advertising for Research Participants
  • Guidelines for Investigational Drugs and Devices
  • Guidelines for Emergency Compassionate Use
  • Repository
• HSIRB Forms
• HIPAA Information and Forms
• Guidelines for Writing the Research Informed Consent and Assent Documents
  • Basic Elements of Informed Consent
  • Informed Consent Template
  • Informed Consent with HIPAA incorporated template
  • Signature Page and Instructions for Use
  • Assent Form Guidelines
  • Assent Form Template
  • Other Types of Informed Consent
    • Mail Surveys
    • Telephone Surveys
    • Obtaining Consent From Non-Native Speakers of English
      • Sample Consent Template of Non-Native Speakers of English
    • Informed consent guidelines for genetic research
• Guidelines for Data and Safety Monitoring
  • Elements to include in your Data & Safety Monitoring Plan
  • Sample: Protocol Section for Data and Safety Monitoring Plan
  • Recent HSIRB Memo: Guidelines for Data and Safety Monitoring (July 2004)
• Reporting of Serious Adverse Events
  • Serious Adverse Event Form
• Amendments
• Annual Renewal and Approval Period
• HSIRB FAQ'S and Newsletters/Memos
• Links to other Information, University Administration and Regulatory Agencies
• Guidelines for Investigators When Approval is Required From a UB-IRB and the VA-IRB

Contact Information

Health Sciences Institutional Review Board
University at Buffalo
The State University of New York
3435 Main Street
150 Parker Hall
Buffalo, NY 14214-8004

Phone:(716) 829-2752
Fax:(716) 829-3610
Office Hours: 8:00am - 4:30pm, Monday-Friday
E-mail: hs-irb@research.buffalo.edu
WebSite: http://www.research.buffalo.edu/hsirb