Jim Gearhart

by Jim Gearhart

Research Protections in China: How Peking University Does It

Just after DIA China finished, three of us from Quorum and Kinetiq had the chance to visit the Peking University Health Science Center (PUHSC) and meet members of its human research protection program (HRPP). It was a welcome opportunity to learn how a leading university in China provides ethical oversight of research that involves people.

Within the school’s general HRPP program the IRB/ethics committee provides an essential first review of proposed research. The IRB serves as a hub and, as necessary, refers issues to other standing committees. The other offices are a Quality Assurance Office (QAO); Education and Training office (ETO); a Technology Transfer Office (TTO); a Biosafety Committee (BSC; primarily for radiology); an Academic Committee (ACC); and a Research Integrity Office (RIO).

On the PUHSC Campus

The PUHSC campus houses about 8,000 graduate and undergraduate students across five schools (Basic Medical Sciences, School of Pharmaceutical Sciences, School of Public Health, School of Nursing, and the Institution of Medical Humanities). The school opened its gates in 1912 as Beijing Medical University, and merged with the larger Peking University in 2000.

We found that the university grounds provided welcome respite from Beijing’s crowded, bustling streets. Within the PUHSC’s walls, trees shaded the quieter lanes and rows of China roses blossomed in pinks and yellows. Most of the students walked or biked to their classes, but at least one student glided silently past on a unicycle hoverboard.

Establishing Human Subject Protections in China

PUHSC/Beijing Medical University was the first school to establish an ethics committee/IRB for reviewing research. According to Yali Cong, PU IRB Chair, the school formed its IRB in the 1990s to oversee a joint study with the U.S. Centers for Disease Control on folic acid and pregnancy. Now, over twenty years later, IRBs are widespread throughout Chinese research institutions.

In the past ten years, Chinese authorities have been strengthening the regulations around IRBs. The Ministry of Health has issued guidelines, local governments have their requirements, and the China Food and Drug Administration (CFDA) periodically issues policies about IRB reviews. (This presentation provides some good background about the regulations around IRBs in China.) In addition to these domestic requirements, the PU IRB remains committed to meeting international guidelines, such as those from the ICH and the Declaration of Helsinki.

Not only did Peking University establish China’s first university-based IRB, it also is the first Chinese university to receive AAHRPP accreditation. IRB Accreditation is still relatively new in China; so far four hospitals and one university—Peking University—have received AAHRPP accreditation.

Comparing East and West

During our meeting we discussed the respective operations, challenges, and day-to-day issues our IRBs face.

  • Both sides acknowledged the tension in IRB membership between general experience and specialized knowledge. On either side of the ocean, we found that we arrange for external experts to advise IRB members.
  • Another area of shared interest was the continuing review of research. We each constantly seek to reconcile the amount of information that collects between approval and renewal against organizing that data most effectively for IRB members.
  • PU IRB committee members were interested in Quorum’s model of central IRB review. The PUHSC has ten affiliated hospitals, and each has its own ethics committee. Some research from the hospitals might require two IRB reviews, one at Peking University and one at the hospital itself. The PU IRB committee members are exploring ways to avoid such redundant reviews, if possible.

The day with our Chinese counterparts passed far too quickly, but we appreciated the glimpse at their operations and accomplishments. As clinical research continues to reach across borders, we welcome opportunities such as this to learn and to share experiences about the ethical oversight of research.

 

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