Jim Gearhart

by Jim Gearhart

Beijing Dispatch: Learning About Participant Protections in China

Three of us from Quorum and Kinetiq are in Beijing at DIA China this week, and we had a chance to hear about how researchers here are implementing human subject protection policies. At a session titled “How to Improve Ethics Quality,” a hospital administrator and a quality assurance professional shared their observations about establishing and assessing human research protection programs in China. We didn’t have an official translator for the session, but we benefited from the generosity of a session attendee who offered to help.

AAHRPP Accreditation for a Chinese Research Hospital

The first speaker was Professor Jun Zhao, Vice President of Jiangsu Province Hospital. Professor Zhao shared experiences in establishing a program for protecting research test subjects (also called human research protection programs or HRPPs) then securing international recognition for that program.

Professor Zhao shared with the audience how the Jiangsu Province Hospital established a human research protection program. The hospital established an ethics committee, or IRB, a separate science review committee, an internal audit committee, and a Data Safety Monitoring Board (DSMB). It sought to establish programs that met international standards, not just the requirements of the China Food and Drug Administration (CFDA). One challenge he described was reconciling those external expectations with local rules. A specific example was developing standards for continuing review that could meet domestic and international requirements.

Professor Jun Zhao recommended that hospitals establish ethics committee panels that specialize in the following areas: stem cell research, gene transfer, and research involving the collection of or research on biospecimens. For us, this recommendation and his others show Jiangsu Province Hospital’s interest in maintaining a robust HRPP.

After establishing its HRPP, Jiangsu Province Hospital sought recognition of the program. The research hospital pursued accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and received it in 2013. According to the AAHRPP website, Jiangsu Province Hospital was the second of five research institutions in China to receive accreditation.

Currently in China, almost every hospital and research center has its own ethics committee. The Jiangsu Province Hospital has participated in a number of pilot programs to provide regional, centralized ethics review of multi-site studies. From these pilots, it’s clear that a challenge for Jiangsu Province Hospital IRB and other Institutional IRBs in China was how to implement and maintain the integrity of their ethics review programs while meeting sponsor demands in China for centralized review of multi-site trials. Maintaining an effective HRPP for reviewing one site at a time is a great success, but the challenge lies in maintaining the same level of effectiveness when reviewing hundreds of sites.

Sponsor Expectations for Ethics Committees in China

Dr. Heidi Liu, a quality assurance professional for Pfizer in China, discussed the ethical standards that a global pharmaceutical company expects from investigative sites in China. When selecting sites for a study, Dr. Liu said a part of the process is assessing the site’s ethics committee. Dr. Liu said she holds those reviewers to international standards—such as those promulgated by ICH, the World Health Organization, and the Declaration of Helsinki—as well as local CFDA requirements.

Instead of having an ethics committee at each site, Dr. Liu encouraged institutions to move toward a multi-site review model. She noted in particular the recommendations from the U.S. Clinical Trials Transformative Initiative (CTTI) about centralizing review of multi-site studies.

We appreciated this informative look at how researchers and sponsors approach ethical oversight of research in China. Later this week we have an opportunity to learn more when we meet Peking University’s ethics committee. Peking University’s HRPP received AAHRPP accreditation in 2015.

 

Tags: , , ,