Human Research Protection Programs get high marks

Research is at the heart of Harvard T.H. Chan School of Public Health’s mission and perhaps nothing better reflects the School’s commitment to safeguarding research subjects than recent news that the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded full reaccreditation to Harvard T.H. Chan School of Public Health and Harvard University Faculty of Medicine.

Reaccreditation did not come easily. Currently there are more than 1,900 studies involving human subjects being led by researchers across Harvard Chan School, Harvard Medical School, and Harvard School of Dental Medicine, all of which are managed by the Office of Regulatory Affairs and Research Compliance (ORARC) at the Chan School. These studies cover a wide range of fields and subjects, including longitudinal observational studies as well as clinical trials in the U.S. and 92 countries around the world

“We could not have achieved this success without the continued support, dedication, and determination from all parties involved in our Human Research Protection Program (HRPP), which includes faculty investigators, research staff, Institutional Review Board members and staff, the Quality Improvement Program, and the Schools’ leadership,” said Delia Wolf, associate dean for regulatory affairs & research compliance. “In preparation for AAHRPP reaccreditation, we have not only ensured compliance with regulatory requirements and ethical standards, but also improved the efficiency and effectiveness of our Human Research Protection Programs.”

Ensuring that the school met the rigorous standards set by AAHRPP required a concerted effort that was led by the Office of Regulatory Affairs and Research Compliance. AAHRPP site visitors interviewed 45 representatives from the research community including IRB members, chairs and staff, investigators and study coordinators, and administrative leadership from the Longwood Medical Area.

Before any study that involves human participants or their data can begin, it must be assessed by an Institutional Review Board, or IRB, for regulatory and ethical compliance. These administrative groups are meant to ensure that the rights, privacy, and welfare of study participants are safeguarded throughout the study. Having proper IRB processes is critical to achieving AAHRPP accreditation.

After its extensive review, AAHRPP deemed the Office of Regulatory Affairs and Research Compliance’s First Time Principal Investigator Onsite Review conducted by the Quality Improvement Program as an “Area of Distinction.” AAHRPP specifically noted that the program provides an innovative approach to orienting new researchers to regulatory requirements and educating them on the resources available at the school. Moreover, the AAHRPP report said that the schools’ faculty, IRB office, and IRB review specialists are “service oriented, knowledgeable, well respected and demonstrate a strong commitment to the protection of human participants.” AAHRPP did not issue a single citation.

“There’s nothing more important than ensuring that faculty, students, and staff adhere to the highest standards of ethics and quality to ensure the safety and dignity of all participants,” said Michael Grusby, executive dean for administration and acting dean for academic affairs. “AAHRPP reaccreditation highlights the hard work of the School’s faculty, staff, and our IRBs and elevates the overall quality of our research endeavors.”