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Human Participant Program Site Visits Pending
Written by Michelle Stickler, ORP

Penn State is in the process of seeking accreditation for its human participant research program through the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Accreditation improves the overall quality of research by consistently applying high ethical standards and practices. The accreditation process rigorously assesses and affirms organizations' compliance with federal regulations. When an organization earns accreditation, the global benchmark for human research protection is raised. Penn State hopes to demonstrate that its human participant research program is an exemplary one that advances knowledge while protecting the rights and welfare of those who choose to participate in the research.

A single application has been submitted on behalf of: (1) The Office for Research Protections (ORP), responsible for the review, approval and oversight of human research protocols at all colleges and campus locations, except the Penn State College of Medicine (COM), and (2) The Human Subjects Protection Office (HSPO), advocating for the protection of the rights and welfare of human participants involved in research conducted by Penn State College of Medicine and Penn State Milton S. Hershey Medical Center. A team of expert reviewers is expected to spend several days at each location for an onsite visit in May of 2006 to evaluate the program and determine accreditation status.

The site visit conducted by AAHRPP reviewers will include visits with randomly selected Penn State researchers who conduct human participant research. The reviewers will want to discuss the investigators' research projects paying particular attention to the recruitment process, how informed consent is administered and how participants' rights are respected throughout the length of their involvement in the research study. The site visitors may want to review study records as well. To help prepare investigators for a possible site visit, the Office for Research Protections (ORP) will offer the following educational tools:

  • An Investigator Manual will be available on the ORP website by February 1st. The Investigator Manual includes information about submitting applications and levels of review, required elements for informed consent documents, the consent and assent processes, research with special populations (e.g., minors, prisoners), HIPAA, and FDA regulated research.
  • Lists of the Top 10 most important pieces of information to know will be available on the ORP website by March 1st.
  • Three educational sessions are scheduled for investigators to learn more about the issues most likely to be discussed or reviewed by the AAHRPP site visitors. The session dates are:
    • March 22, 3:30 p.m. in 102 Kern Building
    • March 28, 12:00 p.m. in 102 Kern Building
    • April 12, 12:00 p.m. in 102 Kern Building
    Please plan to attend one of the information sessions to ensure you are prepared if you are selected for a visit.