RP05 Research Quality in Human Participant Research

Contents:

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 as it relates to human participant research protections.

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 Assurance Program and the Research Quality Assurance Program. These Research Quality programs have the responsibility to address quality assurance and quality improvement activities in conjunction with the Human Research Protections Program (HRPP) 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 AssuranceProgram 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 Health Milton S. Hershey Medical Center and other Penn State Health 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:

• Routine and directed reviews prior to IRB approval (for FDA-regulated research) or following IRB approval
• Ongoing reviews throughout the course of FDA-regulated research conducted by a sponsor-investigator (a sponsor-investigator is a person who both initiates and conducts an FDA-regulated study; that is, an individual who (i) holds an IND or IDE; and (ii) serves as the principal investigator in one or more studies conducted under that IND or IDE). 
• Require the investigator to provide written documentation from the FDA for Investigational New Drug (IND) exemption determinations. 
• Observation of the consent process
• Observation of the conduct of research
• Review of all research-related documentation 
• Review of facilities and research personnel regarding suitability and preparedness to conduct research, especially research that is FDA-regulated.
  • At the College of Medicine and Penn State Health, with some limited exceptions, only a licensed physician may be an Investigational New Drug (IND) or Investigational Device Exemption (IDE) holder.
  • At all campuses and colleges except the College of Medicine/Penn State Health, the ability of an investigator to serve as an IND/IDE holder is evaluated on a case by case basis.
• Oversee compliance with clinicaltrials.gov registration and reporting. 

The RQ program staff provides any findings resulting from audits or inspections requested by the IRB as well as findings from not-for-cause audits to the Principal Investigator for submission to the IRB.

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:

• Contact the RQ program for assistance in determining if you are a sponsor-investigator.
• Contact the RQ program staff for assistance in determining whether an IND/IDE is needed.
• Contact the RQ program prior to FDA submission of an IND/IDE application and prior to any required reporting or modifications for an existing IND/IDE.
• Contact the RQ program  prior to the time of submission to the IRB of a new study that will be FDA regulated.
• Work with the RQ program staff to arrange a review to gather information regarding research personnel qualifications and site suitability for the proposed research.
• Meet with the RQ program staff to discuss responsibilities as a sponsor-investigator prior to IRB approval.
• Provide any follow-up information requested by the RQ program staff.

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 

Effective Date: June 8, 2015

Date Approved: June 4, 2015

Date Published: June 8, 2015

Most recent changes:

• March 15, 2022 - Updated name of "Quality Management" to "Quality Assurance" Program; updated to include Penn State Health; updated process change for submission of results; minor editorial changes.

Revision History (and effective dates):

• November 1, 2017 - Clarified "Authority of Research Quality Programs" section.
• June 8, 2015 - New policy.