No 'Veritas' Without Consent

The University takes great pains to protect its good name—any company even tangentially related to education that uses the word “Harvard” faces a high risk of a lawsuit. The University’s caution is understandable; no one wants to see Harvard’s prestige sullied by groups over which the University has no control.

For the same reason, the University ought to give close scrutiny to any research done under its auspices. It was troubling last week to hear that a genetics study recently undertaken by a Harvard School of Public Health researcher in rural China did not properly inform the subjects of their rights. It was even more disturbing that a federal agency concluded that the School of Public Health’s internal review board failed to provide “substantive and meaningful” oversight of a project for which the University received research money.

The University has since improved the way it monitors research, increasing resources devoted to direct oversight. But to reduce the chances of a mistake like this recurring, all University research review boards must be competent and dedicated to giving strict ethical scrutiny to all Harvard-affiliated projects.

The failure to inform human subjects of their rights is unpardonable. The convoluted legal terms of the consent forms, said some peasants, were far too complicated for them to understand. Sometimes the forms were only provided months after the actual research took place, showing blatant disregard for the ethical standard of informed consent. “Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject,” stipulates the Office for Human Research Protections of the U.S. Dept. of Health and Human Services. There is no excuse for these standards to be relaxed simply because China is far away from the investigative eyes of the West.

Had the problems stopped with the lack of information for the human subjects, the conduct of the research would be suspect. Even worse are the unscrupulous methods which the head researcher, Dr. Xu Xiping, employed in finding research subjects. Research subjects were coerced to participate by the Chinese government. And once the Washington Post began investigating his actions, Xu wrote two letters to Chinese government officials urging them to stop the media from delving into the matter.

What makes researchers such as Xu so unscrupulous in obtaining the results they want? The project, a partnership between Harvard and several private businesses, was designed to make money. The businesses hoped for profits, while the University and its researchers received millions in federal funds and private investment. Former coworkers have testified to Xu’s eagerness to make money off of the harvesting of DNA samples in China, and more than once recalled his comparison of DNA to gold—an allegation that Xu denies.

Harvard’s name will inevitably be associated with any research undertaken under its auspices. Instead of only finding out about problems like this after the fact, increased substantive oversight would prevent researchers from neglecting the rights of their subjects. No harm to the Chinese subjects has been reported in this case, but greater scrutiny must be given to projects in which the University has a stake. Harvard’s interest should never endanger the welfare of research subjects.