Policy RP05- RESEARCH QUALITY IN HUMAN PARTICIPANT RESEARCH

Policy Steward:  Associate Vice President for Research, Director of the Office for Research Protections

Contents:

  • Purpose
  • Policy
  • Applicability
  • Regulatory Agencies
  • Authority of Research Quality Programs
  • Investigator Responsibilities
  • Further Information
  • Cross References

  • PURPOSE:

    The Pennsylvania State University (the "University") is committed to facilitating academic and clinical research in the broad area of general or specific measurements of human development, health, and performance.  The University is dedicated to maintaining the ethical treatment of human participants in all research activities conducted under the auspices of this institution and assumes responsibility for safeguarding their rights and welfare (See Policy RP03 - The Use of Human Participants in Research).  The purpose of this policy is to outline the University's strategies for maintaining the quality and compliance of academic and clinical research with institutional, federal, state and all other applicable regulations and laws.

    POLICY:

    The University's policy for maintaining the quality of academic and clinical research is guided by ethical principles, Federal law, and institutional standards.  The Office for Research Protections and the Office for Research Affairs are responsible for coordinating and implementing quality assurance and quality improvement programs as it relates to human participant research.  These offices have established the Quality Management Program and the Research Quality Assurance Program. These Research Quality programs have responsibility to address quality assurance and quality improvement activities in conjunction with the Human Research Protections Program (HRPP) at University Park and the Human Subjects Protections Office (HSPO) at the College of Medicine, and other offices/programs, as appropriate.

    APPLICABILITY:

    Human participant research conducted at the University includes biomedical and social science research.  The University has established two Research Quality programs (RQ programs). The Quality Management Program is located at the University Park campus and audits human subject research conducted by investigators from all University colleges and campuses except for the College of Medicine. The Research Quality Assurance Program is located at the College of Medicine campus and audits human subject research conducted at the College of Medicine and the Penn State Milton S. Hershey Medical Center and its satellite locations.  The RQ programs do not audit research conducted at the Pennsylvania College of Technology.

    REGULATORY AGENCIES:

    Human participant research is regulated by the Office for Human Research Protections (OHRP) and/or the U.S. Food and Drug Administration (FDA), and the RQ programs take their direction from these governmental authorities through the Institutional Review Board (IRB).  Regulations related to audit or the review of research in 45 CFR 46 (Code of Federal Regulations. Title 45A- Department of Health and Human Services; Part 46 – Protection of Human Subjects) and 21 CFR 56 (Code of Federal Regulations. Title 21, Chapter 1 – Food and Drug Administration, DHHS; Part 56 – Institutional Review Board) are "currently interpreted as granting the institution, the IRB, and/or its representative(s) the authority and responsibility to audit research" to ensure the safety of participants. (Bankert, EA & Amdur, RJ.  2006. Institutional Review Board, Management and Function, p. 53)

    AUTHORITY OF RESEARCH QUALITY PROGRAMS:

    RQ programs have the authority and are mandated by the Organizational Officials to conduct reviews of human participant research and other activities, to include, but not limited to:

    The RQ program staff provides the results of all reviews to the IRB, including any recommendations for corrective actions.  The Organizational Officials, as appropriate, are provided with the results of reviews.

    INVESTIGATOR RESPONSIBILITIES (as they relate to this policy):

    General responsibilities as they relate to quality research (see Policy RP03).

    Cooperate with RQ program staff as they carry out their responsibilities.

    Contact the RQ program staff for guidance as needed.

    Additional responsibilities for sponsor-investigators conducting FDA-regulated research:

    FURTHER INFORMATION:

    For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.

    CROSS REFERENCES:

    RP03 - The Use of Human Participants in Research (Formerly RA14)


    Effective Date: June 8, 2015
    Date Approved: June 4, 2015
    Date Published: June 8, 2015

    Most recent changes:

    Revision History (and effective dates):

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