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Policies

Explore policy documents and guideline documents for all OHSP policies in the drop-downs below, organized by policy topic.


General administration

Policy 101: Maintenance of Policies
  • Download Policy 101
  • Purpose: Outlines the process for creating and maintaining OHSP policies.
Policy 102: University of Rochester’s (UR) Human Research Protection Program (HRPP)
Policy 103: Organizational Structure of the HRPP
Policy 104: Institutional Conflict of Interest
  • Download Policy 104
  • Purpose: Ensures institutional conflicts of interest are identified and managed or eliminated as appropriate within the online IRB review system.

Training and education

Policy 201: Education Program

RSRB scope and organization

Policy 301: RSRB Scope and Authority
Policy 302: RSRB Membership and Composition
Policy 303: Board Member Conflict of Interest
  • Download Policy 303
  • Purpose: Ensures real or perceived conflicts of interest of RSRB Chairs, Vice Chairs, and Members are identified and managed.

RSRB function and operations

Policy 401: Functions of the RSRB Office
Policy 402: RSRB Meetings
  • Download Policy 402
  • Purpose: Describes the procedures for preparation, conduct and review determinations of RSRB meetings.
Policy 403: Notification of RSRB Determinations
Policy 404: Criteria for RSRB Approval of Research
Policy 405: HRPP Maintenance of Records
  • Download Policy 405
  • Purpose: Describes the requirements and procedures for maintaining adequate documentation of RSRB activities.

Reviews of research

Policy 501: Levels of RSRB Review
Policy 502: Types of RSRB Submissions
Policy 503: Ancillary Committee Reviews
Policy 504: IRB Reliance and Collaborative Research
Policy 505: Departmental Scientific and Resource Review
Policy 506: Data and Safety Monitoring

Reviews requiring special consideration

Policy 601: Research Involving Children
Policy 602: Research Involving Pregnant Women, Human Fetuses and Neonates
  • Download Policy 602
  • Purpose: Defines the ethical and regulatory considerations required by the RSRB when reviewing research involving pregnant women, human fetuses, and neonates.
Policy 603: Research Involving Prisoners
  • Download Policy 603
  • Purpose: Defines the ethical and regulatory considerations required by the RSRB when reviewing research involving prisoners.
Policy 604: Research Involving Adults with Decisional Impairment
Policy 605: Research Involving FDA Regulated Drugs, Biologics, and Supplements
  • Download Policy 605
  • Purpose: Outlines the responsibilities and regulatory requirements when conducting FDA regulated research that involves the use of drugs, agents, biological products, or nutritional products.
Policy 606: Research Involving FDA Regulated Devices
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  • Purpose: Outlines the responsibilities and regulatory requirements when conducting FDA regulated research that involves the use of devices.
Policy 607: Emergency Use of Investigational Drugs, Biologics and Medical Devices
Policy 608: Research Involving Genetic Testing and Gene Transfer
Policy 609: Research Supported by the Department of Defense
  • Download Policy 609
  • Purpose: Outlines additional federal regulatory requirements when conducting Department of Defense supported research.

Informed consent, recruitment, and privacy

Policy 701: Informed Consent
Policy 702: HIPAA Privacy Rule
  • Download Policy 702
  • Purpose: Ensures University of Rochester research activities comply with the standards for protection of health information under the HIPAA Privacy Rule.
Policy 703: Recruitment Materials and Subject Payment
Policy 704: FERPA and PPRA in Human Subject Research
  • Download Policy 704
  • Purpose: Describes the requirements for research involving students and/or is conducted in an educational setting; applies to all research conducted within local Pre-Kindergarten – grade 12 schools /school districts, undergraduate, and graduate education.

Reporting to RSRB

Policy 801: Reporting Research Events
Policy 802: Non-Compliance in Human Subjects Research

Responsibilities of investigators

Policy 901: Investigator Responsibilities
Policy 902: Investigator Conflict of Interest
  • Download Policy 902
  • Purpose: Ensures Investigator financial interests and financial conflicts of interest are identified and managed or eliminated, as appropriate, within the RSRB review system.

Quality improvement

Policy 1001: Quality Improvement Program
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