Policy/Guidance Documents

Office for Human Subject Protection
Policy/Guidance Documents

Research Subjects
Review Board

"... to protect the rights and welfare of human research subjects at the University of Rochester. To accomplish this, we review, approve the initiation of, and conduct periodic review of research involving human subjects."

Research Education
and Training

"To assist researchers in protecting the rights, welfare and safety of human subjects by providing educational opportunities and resources..."

Research Quality Improvement

To assure the rights and well-being of human subjects participating in research are protected
To educate researchers about how to improve study conduct
To provide resources to the Research Community

Policies & Guidelines

Table of Contents

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100 - General Administration

Glossary of OHSP Policy Definitions

Policy 101 Maintenance of Policies

Policy 102 UR Human Research Protection Program

Policy 103 HRPP Organizational Structure - Revised 12/2022

Policy 104 Institutional Conflict of Interest - Revised 12/2022

200 - Research Education

Policy 201 Education Program

Guideline for Training Research Personnel

Guideline for Professional Certification Reimbursement

Guideline for HSP Training for External Research Personnel

300 - RSRB Scope and Organization

Policy 301 RSRB Scope and Authority

Guideline for Determining Engagement in Research

Guideline for Determining Human Subject Research

Determination Form Checklist - Revised 11/2022

Policy 302 RSRB Membership and Composition

Guideline for Board Member Terms of Appointment

Policy 303 Board Member COI

400 - RSRB Functions and Operations

Policy 401 Functions of the RSRB Office - Revised 12/2022

Policy 402 RSRB Meetings

Policy 403 Notification of RSRB Determinations

Guideline for Notification of RSRB Determinations

Guideline for RSRB Institutional Regulatory Reporting

Policy 404 Criteria for Approval of Research

Criteria for IRB Approval Quick Reference Guide

Policy 405 Maintenance of Records

500 - Review of Research

Policy 501 Levels of RSRB Review

Guideline for Determining Exempt Research

Guideline for Expedited Review of Research

Guideline for Convened Board Review of Research

Policy 502 Types of RSRB Submissions

Policy 503 Ancillary Committee Reviews

Ancillary Committee Contact Information Guideline

Policy 504 IRB Reliance and Collaborative Research

UR Guideline for Reviewing IRB

UR Guideline for Relying IRB

UR Guideline for PI Oversight

UR IRB Reliance Request Form

UR Relying Consent Reference Language

Policy 505 Department Scientific and Resource Review

Guideline for Scientific and Resource Review

Scientific and Resource Review Checklist - Revised 04/2023

Policy 506 Data & Safety Monitoring

600 - Reviews Requiring Special Consideration

Policy 601 Research Involving Children

Guideline for Assessing Capacity in Children

Guideline for SADCR Review

Policy 602 Research Involving Pregnant Woman

Policy 603 Research Involving Prisoners

Policy 604 Research Involving Decisionally Impaired

Guideline for Assessing Consent Capacity

Guideline for Institutional Review

Research Proxy Template

Policy 605 FDA Regulated Drugs, Biologics, Supplements

Policy 606 FDA Regulated Devices

Policy 607 Emergency Use of Investigational Products

Emergency Use Physician Checklist

Emergency Use Report to RSRB

Emergency Use Follow Up Report

Policy 608 Research Involving Genetic Testing and Gene Transfer

Guideline for Gene Transfer Research

Guideline for Genomic Data Sharing

Policy 609 Research Supported by DoD

700 - Informed Consent And HIPAA Privacy Rule

Policy 701 Informed Consent

Guideline for Informed Consent

Informed Consent FAQs

Consent Document Sample Language

Consent Form Templates

Policy 702 HIPAA Privacy Rule

Policy 703 Recruitment Materials and Subject Payment

Guideline for Recruitment Methods and Materials

Guideline for Payment to Peer Recruiters

Guideline for Subject Payment

Advarra Participant Payment System Reference Material

Policy 704 FERPA and PPRA

800 - Reporting to RSRB

Policy 801 Reporting Research Events

Guideline for Reporting Research Events

Policy 802 Non-Compliance

Guideline for Review of Non-Compliance

900 - Responsibilities of Investigators

Policy 901 Investigator Responsibilities

Exempt Responsibility Summary Sheet

Non-FDA Regulated Responsibility Summary Sheet

FDA-Regulated Responsibility Summary Sheet

Guideline for Investigators Leaving the Institution

Guideline for De-identification of Data for Publishing

Policy 902 Investigator Conflict of Interest

Investigator Guidance

1000 - Quality Improvement

Policy 1001 Quality Improvement Program

1100 - Miscellaneous Guidelines

Computer and Internet Based Research

Coordinating Center Studies

Data Security Requirements

Data Security Assessment Form

9/29/20 Data Security Seminar Materials Available in Blackboard

Databases, Repositories, Registries

HIV Testing

Home Visits

International Research

Guideline for Listing Study Team on Application

NIH Grant sIRB Language

Populating Legacy Studies in Click IRB

Research Involving Social Media

Residents as Coordinator

Use of Placebo in Clinical Research

GDPR Q and A for Researchers

1200 - Miscellaneous UR Policies/Guidelines

Guideline for Use of REDCap for eConsent

Enrollment Incentive Payments

Research Subject Payments

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Policies/Guidelines

OHSP
HIPAA

Tools

Assurances

University of Rochester FWA00009386
Expires: July 02, 2026
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Highland Hospital
FWA00002728
Expires: May 08, 2028
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FF Thompson Health System
FWA00021650
Expires: March 14, 2024
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St. James Hospital
FWA00029570
Expires: December 29, 2027
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Nicolas H. Noyes Memorial Hospital
FWA00030547
Expires: December 16, 2025
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Research Subjects Review Board

Research Education and Training