Letter to the Editor Regarding the 5th Global Forum on Bioethics in Research
by Dirceu B. Greco, Dafna Feinholz, Dirce Guilhem, Carel IJsselmuiden, Bebe Loff, Udo Schuklenk, Juan Carlos Tealdi
2004. The American Journal of Bioethics 4(4):W38

To the Editor:

We the undersigned wish to express our concern about the conduct of the final plenary session of the 5th Global Forum on Bioethics in Research (Paris, 22–23 April, 2004). As we understand it, Mrs. Xiong Lei (Executive Director, Capital Women’s Journalist Association, Beijing, China) had originally been invited to present a case for consideration at the Forum, describing studies conducted by Harvard researchers in China. For reasons that are unclear, it was later decided that the case would not be used. However, subsequently, and at the last minute, Mrs. Xiong Lei was invited to present the case after all. There was no opportunity for discussion.

This case had been publicized in the past and was known to some, though not all, members of the audience. It concerned unethical research carried out in Anhui Province, China, on an impoverished and largely illiterate rural population. The research dealt with

• environmental and occupational epidemiology,
• gene–environmental interaction,
• genetic epidemiology,
• population genetics,
• reproductive health, and
• asthma and chronic obstructive pulmonary disease.

The material presented at the Forum concerned research that focused on asthma and chronic obstructive pulmonary disease.

The Department of Health and Human Services of the United States found the Harvard School of Public Health and its research partners, the Brigham and Women’s Hospital and the Massachusetts Mental Health Research Corporation, to be at fault. The Office for Human Research Protections stated that, among other serious matters, the research participants could face discrimination if medical problems were discovered by their employers. The research did not have ethical approval, informed consent was not obtained, and the research was unlikely to benefit the Chinese participants. Harvard’s president has acknowledged that the research was conducted unethically and has expressed his deep regret. The University has reformed its ethical review processes for studies of this nature. Harvard suspended these studies and reprimanded the principal investigator.

We wish to state our solidarity with the research participants and to

• express our deep concern at the fact that, even now, research of this nature was able to escape ethical scrutiny despite being carried out by eminent institutions obtaining funding from the NIH;
• express our disappointment at the way the discussion was abruptly halted by the chairs of the session;
• invite those organizations responsible for the conduct of the meeting to explain why discussion of this research was not permitted; and
• urge the IAB and WHO to issue a statement in condemnation of this research (and to express their hope that research of this nature will not take place in the future).