Policies

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)

• Download Policy 102
• Purpose: Describes the UR-HRPP program.
• Related resources:
  • UR-HRPP Overview page
  • UR-HRPP Training Requirements page

Policy 103: Organizational Structure of the HRPP

• Download Policy 103
• Purpose: Describes the administrative structure to support the UR-HRPP.
• Related resources:
  • UR-HRPP Overview page
  • OHSP Organizational Chart

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.

Policy 105: HRPP Emergency Preparedness

• Download Policy 105
• 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.

Policy 201: Education Program

• Download Policy 201
• Purpose: Describes institutional training requirements and educational opportunities for individuals within the UR-HRPP.
• Related resources:
  • Training Overview page
  • Required HSP Training page

Policy 301: RSRB Scope and Authority

• Download Policy 301
• Purpose: Defines the role and responsibilities of the University’s Research Subject Review Board (RSRB).
• Supporting guidelines:
  • Determining Engagement in Research
  • Determining Human Subject Research
• Related resources:
  • Overview of the RSRB (IRB) page
  • Scope of the RSRB (IRB) page
  • Research vs QI Determination Checklist

Policy 302: RSRB Membership and Composition

• Download Policy 302
• Purpose: Describes the composition of the RSRB and the role/responsibilities of the RSRB members.
• Supporting guidelines:
  • Board Member Terms of Appointment, Evaluation and Re-Appointment
• Related resources:
  • Membership of the RSRB (IRB) page

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.

Policy 401: Functions of the RSRB Office

• Download Policy 401
• Purpose: Describes the operations of the RSRB administrative 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

• Download Policy 403
• Purpose: Describes the process for communicating RSRB determinations to Investigators, University personnel, and regulatory bodies.
• Supporting guidelines:
  • Notification of RSRB Determinations
  • Institutional and Regulatory Reporting of Suspension, Termination, Non-Compliance & UPIRTSO
• Related resources:
  • RSRB (IRB) Review Process page

Policy 404: Criteria for RSRB Approval of Research

• Download Policy 404
• Purpose: Describes the criteria for approval of research that will be followed by the RSRB.
• Related resources:
  • RSRB (IRB) Review Process page
  • Criteria for IRB Approval Guide

Policy 405: HRPP Maintenance of Records

• Download Policy 405
• Purpose: Describes the requirements and procedures for maintaining adequate documentation of RSRB activities.

Policy 501: Levels of RSRB Review

• Download Policy 501
• Purpose: Describes the review levels assigned to an application by the RSRB based on risks posed to the subjects by research activities.
• Supporting guidelines:
  • Exempt Status Determination
  • Expedited Review of Research
  • Convened Board Review of Research
• Related resources:
  • RSRB (IRB) Review Process page

Policy 502: Types of RSRB Submissions

• Download Policy 502
• Purpose: Describes the types of submissions received and reviewed by the RSRB and the materials required for review.
• Related resources:
  • Click IRB Resources page
  • RSRB (IRB) Review Process page

Policy 503: Ancillary Committee Reviews

• Download Policy 503
• Purpose: Describes the institutional committees that review research activities, in addition to the RSRB.
• Supporting guidelines:
  • Ancillary Committee Contacts
• Related resources:
  • OHSP Explains: Ancillary Committee Review

Policy 504: IRB Reliance and Collaborative Research

• Download Policy 504
• Purpose: Establishes the requirements when University of Rochester (UR) researchers collaborate with an unaffiliated institution(s) or Investigator(s) to ensure UR ethical, regulatory and institutional requirements for the protection of human subjects are met.
• Supporting guidelines and forms
  
  • • RSRB Fee Structure
    • IRB Reliance Request Form
    • When the University of Rochester (RSRB) is the Reviewing IRB
    • Single IRB Plan in a NIH Grant Application
    • PI Oversight for Multi-Site Research
    • When the University of Rochester Relies on a Non-University of Rochester IRB
    • Guideline for Review of External (Non-UR) Investigators

Policy 505: Departmental Scientific and Resource Review

• Download Policy 505
• Purpose: Establishes the requirements and process for departmental scientific review of research protocols.  Includes a link to the “Scientific Review Standards Checklist” that may be used for documenting scientific review determinations.
• Supporting guidelines and forms
  • Scientific and Resource Review of Human Subject Research
  • Scientific and Resource Review Checklist

Policy 506: Data and Safety Monitoring

• Download Policy 506
• Purpose: Establishes the requirements for a Data and Safety Monitoring Plan in research involving human subjects.
• Related resources:
  • Data and Safety Monitoring Plan page

Policy 601: Research Involving Children

• Download Policy 601
• Purpose: Defines the ethical and regulatory considerations required by the RSRB when reviewing research involving children, and to indicate when consent, permission and assent of the subject is required.
• Supporting guidelines:
  • Assessing Capacity to Consent in Children
  • SADCR Review of 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

• Download Policy 604
• Purpose: Defines the ethical and regulatory considerations required by the RSRB when reviewing research involving adult subjects who may be decisionally impaired and unable to make an informed decision regarding participation in research, and to identify the circumstances when the RSRB may permit use of a legally authorized representative.  Includes a link to the “Research Proxy Template”.
• Supporting guidelines and forms:
  • Assessing Consent Capacity in Adults with Decisional Impairment
  • Institutional Review of Research Involving Adults with Decisional Impairment
  • Research Proxy Form

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

• Download Policy 606
• 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

• Download Policy 607
• Purpose: Establishes the requirements for the emergency use of investigational products. See additional links for emergency use checklists and reporting forms.
• Supporting guidelines and forms:
  • Emergency Use Physician Checklist
  • Emergency Use Report to RSRB
  • Emergency Use Follow-Up Report to RSRB

Policy 608: Research Involving Genetic Testing and Gene Transfer

• Download Policy 608
• Purpose: Outlines additional protections required by New York State when research involves genetic testing (as defined by NYS), and the additional requirements when conducting research involving gene transfer.
• Supporting guidelines and forms:
  • Internal Review of Human Gene Transfer Research
  • Human Genomic Data Sharing and Institutional Certification

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.
• Supporting guidelines and forms:
  • Checklist for RSRB Review of Research Supported by the DoD

Policy 701: Informed Consent

• Download Policy 701
• Purpose: Describes requirements for Investigators to obtain informed consent and to document the consent process, including requests for waivers or alterations of consent, and the requirements for the RSRB to evaluate the consent process.
• Supporting guidelines:
  • Informed Consent
• Related resources:
  • Consent Overview page
  • Documentation of Consent page
  • Enrolling Non-English Speaking Subjects page

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

• Download Policy 703
• Purpose: Describes the requirements and mechanism for RSRB review and approval of research recruitment materials, as well as methods for subject payment.
• Supporting guidelines
  • Recruitment Methods and Materials
  • Payment to Subjects to Recruit Other Subjects (Peer Recruiters)
  • Subject Payment
  • Accounts Payable Research Subject Payments Policy & Procedures
  • Advarra Participant Payment Website

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.

Policy 801: Reporting Research Events

• Download Policy 801
• Purpose: Outlines the process for the Investigator’s assessment of research events or problems and subsequent reporting requirements to the RSRB.
• Supporting guidelines:
  • Reporting Research Events
• Related resources:
  • Click IRB Resources page

Policy 802: Non-Compliance in Human Subjects Research

• Download Policy 802
• Purpose: Outlines the process for reporting non-compliance to the RSRB, the consistent investigation and review of such reports by the RSRB, and reporting of RSRB determinations.
• Supporting guidelines:
  • RSRB Review of Allegations of Non-Compliance

Policy 901: Investigator Responsibilities

• Download Policy 901
• Purpose: Describes the responsibilities and requirements of the Principal Investigator to ensure research is conducted in accordance with federal regulations and University policies and guidelines. Includes links to related summary sheets of responsibilities.
• Supporting guidelines:
  • Exempt Responsibilities Summary Sheet
  • Non-FDA Regulated Responsibilities Summary Sheet
  • FDA-Regulated Responsibilities Summary Sheet
  • Investigators Leaving the Institution
  • De-Identification of Data for Publishing/Presentation

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.