Beginning today, the UNMC Institutional Review Board (IRB) kicks off a series of informational articles detailing improvements to its human research protection program. Articles will run in UNMC Today each Wednesday. Today’s article provides an overview of the program and the IRB’s plans to seek national accreditation.
The Institutional Review Board (IRB) is responsible for reviewing all research involving human subjects, which takes place at UNMC, the University of Nebraska at Omaha or The Nebraska Medical Center before such research can begin. We operate under HHS and FDA regulations, through a Federalwide Assurance (FWA) filed with the HHS Office for Human Research Protection (OHRP). Since both the clinical research enterprise and the regulatory environment are constantly evolving, the Board must respond to current medical and ethical issues as well as changes in regulatory guidance and standards. We are continually looking for ways to improve our human research protection program, as well as our services to the campus community.
In the last several years, the press has reported many serious problems involving research trials throughout the country. These reports have encouraged the public perception that participating in research exposes subjects to harm (even death) and researchers are not responsible. Several congressmen and others at the federal level have begun to suggest that the government needs to take strong action to reign in the research community. To show that the research community is accountable for the ethical and safe treatment of subjects, the Association of American Medical Colleges (AAMC) and six other national organizations have joined together and formed a national accreditation group, the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Through AAHRPP, institutions have the opportunity to apply for national IRB accreditation.
What does IRB accreditation mean to UNMC?
NU President Dennis L. Smith, Ph.D., mandated that the UNMC/UNO and UNL human subject research protection programs (HRPP) obtain AAHRPP national accreditation. We fully agree with President Smith’s decision as accreditation has the potential to:
- improve our HRPP
- enhance the quality of our research
- help us maintain compliance with federal regulations
- help to instill confidence in sponsors about the quality of our program, and
- help to build public trust
What does accreditation process involve?
The application for accreditation by AAHRPP involves completion of an extensive self-study, followed by a site visit by outside experts associated with AAHRPP. As a result of the self-study, we have been making many changes to our HRPP. We are hoping to submit the self-study this fall and anticipate the site visit will occur in early 2005.
What exactly is AAHRPP looking for?
AAHRPP focuses on 5 “domains,” or categories, to evaluate the human research protection programs (HRPP):
- the organization (UNMC, The Nebraska Medical Center, and UNO)
- the research review unit (UNMC IRB)
- the investigator
- the sponsor
- the participant
Each of the domains is subdivided into standards, and further into elements, which are based on current HHS and FDA regulations and associated guidance, as well as the basic ethical principles of respect for persons, beneficence, and justice found in the Belmont Report.
As a result of our desire to improve the human research protection program at UNMC, UNO, and The Nebraska Medical Center, as well as meet the requirements for accreditation, there are many changes to announce over the next several weeks. Watch UNMC Today for additional updates.