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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
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  • Purpose: Ensures institutional conflicts of interest are identified and managed or eliminated as appropriate within the online IRB review system.
Policy 105: HRPP Emergency Preparedness
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  • Purpose: Establishes an HRPP emergency preparedness process within the UR to ensure the protection of the rights and welfare of human subject research subjects in the event of an emergency or disaster situation.

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
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  • 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
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  • 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
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  • 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

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