Drexel University has applied for accreditation of our Human Research Protection Program (HRPP) to the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Drexel University has applied for HRPP accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) www.aahrpp.org . Drexel University strives to adhere to the highest ethical standards in its protection of human research participants in addition to ensuring compliance with all relevant federal regulations and state law.
Information about AAHRPP
AAHRPP was founded in 2001 by the Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Association of State Universities and Land-Grant Colleges, National Health Council, and Public Responsibility in Medicine and Research.
The AAHRPP website contains a number of useful documents such as information on AAHRPP's history and formation, its approach to evaluation, and standards for accrediting human research protection programs.
The Accreditation Process
AAHRPP has designed an accreditation process to help organizations consistently meet ethical principles and standards for protecting research participants.
While preparing its written application, Drexel University’s HRPP conducted a lengthy self-assessment of its operations, including the operations of the three Drexel University IRBs, to assure that they complied with AAHRPP's accreditation standards.
The application was submitted in October 2012 and was reviewed and accepted by the AAHRPP Accreditation Manager January 2013.
Policies and Guidance Posted on HRPP Website
As a result of the self-assessment, the Drexel University HRPP and IRBs wrote and revised policies and procedures, investigator guidance, and forms applicable to the conduct of human subject’s research.
Those policies and procedures, investigator guidance, and forms, which reflect any changes required to comply with accreditation standards, are now available on the HRP website. Please take a look at the website at your convenience and email any questions or comments to firstname.lastname@example.org.
The Site Visit
The site visit will take place March 25 – 27, 2013
Interviewees will be provided with materials and prep sessions to help them succeed.
A team of AAHRPP professionals will spend three days on campus reviewing Drexel University’s HRPP which includes the Institutional Review Boards’ (IRBs) operations. The site visit will include interviews, selected by the agency, of IRB members, investigators, research coordinators, and administrators and staff of the IRBs and other individuals involved with the HRPP.
Site Visit Agenda
Interviewees: The site visit agenda will be provided once finalized. Please review to find the time and place of your interview. The two columns indicate that two interviews will be occurring concurrently in different rooms throughout the site visit. The interview room numbers will be included on the final agenda.
TEAM A: IRB Conference Room, Office of Research
3 Parkway Building, 10th Floor, Suite 10444
TEAM B: Legal Conference Room, Office of the General Counsel
3 Parkway Building, 10th Floor, Suite 10627
Site Visit Start Time
The site visit will begin 8:00 a.m. each day. The site visitors should arrive at the site location ten (10) minutes prior to the start time in order to prepare for the visit.
Interviews are designed to help the site visitors understand the roles, responsibilities, and interactions among individuals as well as components of Drexel University and the relationships between these components and the HRPP.
Each interview will be conducted by a team of two site visitors. If multiple people are listed for the interview, the interview will be conducted as a group interview. Each interview will be limited to only those people listed on the agenda for that interview.
Interviewees will be provided with a binder that includes: information for review, tips on how to approach your site visit interview, and lists of possible site visit interview questions. You will be provided with additional materials as we move forward in the process. The DU AAHRPP team will be conducting group and 1:1 prep sessions over the next several weeks.
An overview of the new updates to the Drexel University HRPP will be provided on March 5, 2013 from 2:00 p.m. to 4:00 p.m. in the Geary B Conference Room, Center City Campus. New updates to the Drexel University HRPP will be provided.
Dr. Delia Wolf, M.D., J.D., Assistant Dean for Regulatory Affairs and Research Compliance and Director for Human Research Administration at Harvard School of Public Health, will present: “Establishing a Comprehensive Human Research Protection Program – Culture Change via AAHRPP Accreditation” and “Quality Assurance and Improvement in Reviewing and Conducting International Research.”
There will be live-video conferencing provided on the University City Campus, Korman Center, Room D-105 and the Saint Christopher’s Hospital for Children, Di George Auditorium, Queen Lane Campus, Auditorium A and Doylestown.
AAHRPP Site Visitors
Dr. Wesley Byerly, Pharm.D. - Team Leader
Assistant System-wide Compliance Officer
The University of Texas System
Ms. Michele Kennett, J.D., M.S.N., L.L.M.
Director Human Subject Protections
University of Missouri – Columbia
Dr. Francis Di Mario, M.D.
Medical Director Human Research Protection Program
Connecticut Children’s Medical Center Corporation
Ms. Kristin Craun, M.P.H., C.I.P.
Director, University Park IRB
University of Southern California
More information will be available on the Office of Research website within the next few weeks. It will contain a number of useful documents such as information on AAHRPP's history and formation, its approach to evaluation, and standards for accrediting human research protection programs. It will also be updated frequently with useful links to assist with the accreditation preparation.
If you should have any questions about the accreditation site visit or interview preparation, please call 215-255-7803 or email email@example.com.
Thank you for your continued contribution to the Drexel University Human Research Protection Program!