November 21, 2014 - The State University of New Jersey (Rutgers)

Dear Dr. Neubauer:

The Office for Human Research Protections (OHRP) conducted an on-site evaluation of the human subjects protection program (HRPP) at Rutgers, The State University of New Jersey (Rutgers) from September 8-10, 2014.  The evaluation was conducted as part of our program to evaluate human subjects protection programs of institutions that receive Department of Health and Human Services (HHS) support for research in compliance with 45 CFR Part 46.

The evaluation, conducted by five OHRP staff and an expert consultant, included interviews with senior HRPP officials, institutional review board (IRB) Chairs and vice-chairs, IRB members, Human Research Protections Office (HRPO) staff and principal investigators who conduct HHS-supported research.  The site-visit team reviewed IRB files for over 30 HHS-supported research studies, IRB meeting minutes for the past year and IRB written procedures.

Based on our observations, Rutgers officials, HRPO leadership, IRB chairs and members conveyed a sincere commitment and concern for the protection of human research subjects. We note that on July 1, 2013, the New Jersey Medical and Health Sciences Education Restructuring Act went into effect, and led to the merger of Rutgers with the University of Medicine and Dentistry of New Jersey (UMDNJ).  Currently, Rutgers continues to support nine IRBs across three campuses (Rutgers Arts and Sciences campus, New Brunswick Rutgers Health Sciences campus and Newark Rutgers Health Sciences campus) using both paper-based and electronic IRB systems.

Despite the continued transitioning that we observed, including staff relocation and setting up of offices, the IRB records were well organized.  IRB members and staff had access to and participated in good human research protections (HRP) training such as webinars, national conferences and on-site training.  We were impressed to learn of multiple outreach efforts provided by IRB staff directors and staff for researchers, such as HRP newsletters, IRB Office walk-in hours to support researchers and school-based training workshops.

Recommendation

Based on our observations and the information provided during interview, we make the following recommendation regarding Rutgers’ human subject protection program:

Overall, we found that the eIRB system contained all pertinent information about a research study.  However, finding IRB meeting minutes that correspond with a specific submission was a challenge.  Specifically, a protocol submission included the date that the submission was reviewed by the IRB, but when searching for those minutes under the “Meeting Minutes” tab, a person may have to review multiples sets of meeting minutes for that date to find the meeting minutes that correspond with that submission.  Several individuals that we interviewed expressed similar concerns. You may wish to consider including a link in the submission to the corresponding meeting minutes or specify in the submission which IRB panel reviewed the submission.

At this time, there should be no need for further involvement by our office in this matter. Please notify us if you identify new information which might alter this conclusion.

We appreciate the continued commitment of your institution to the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

Lisa Buchanan, MAOM
Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Telephone: 240-453-8298
FAX: 240-453-6909
E-mail: Lisa.Buchanan@HHS.gov

cc:
Ms. Michelle H Watkinson, Human Protections Administrator, Rutgers, The State University of NJ (Rutgers)
Dr. Robert Fetchner, IRB Chairperson, Rutgers
Dr. Paula Bistak, Chief/Executive Director, Human Subjects Protection Program, Rutgers

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, National Institutes of Health (NIH)
Ms. Sarah Carr, Office Science Policy, NIH