If The Bioethics Commission Is Not Too Busy…There’s A NIDA Study Worth Investigating

In the latest (August 3) issue of Science, there’s a letter to the editor and response (paywall) concerning a study on heroin cravings published in the April 13, 2012 issue (abstract free, article behind paywall).  The research in question was conducted in China, relying in part on human subjects in Chinese drug detention centers.  These drug detention centers are effectively prisons in many cases.  While eleven of the 13 scientists named as authors are from Peking University, the other two authors are from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.  Human Rights Watch (who wrote the letter) got involved due to previously documented abuses of people in these centers, raising a concern that the research may have benefited from test subjects who did not participate voluntarily.  If true, this would be a violation of informed consent procedures, and, with the involvement of federally employed researchers, possibly a violation of federal regulations.  For instance, federally funded research involving prisoners must be approved by a review panel that includes one prisoner who volunteers to serve on the panel.  Also, since prisoners are a vulnerable population, research involving them should ensure some promise of benefit (which was absent in the abuses in Guatemala).  The alleged abuses would also be a violation of Chinese law.

In the letter, Human Rights Watch requests that both Science and the federal government investigate the possibility of ethical violations in this particular study.  Eight of the study authors signed the response to the letter, indicating that they saw no indication of the abuses Human Rights Watch is concerned about.  Only those authors who participated in the human subjects research signed the letter.  The two NIDA employees did not sign.  According to NIDA, this was because they did not participate in the human studies.  But Reuters, in its reporting, sees an apparent contradiction with an earlier statement that the two had participated in data analyses and assisted in preparing the manuscript.  Science is, at least for now, satisfied with the response to the letter, as well as an internal editorial review.

I suspect that even if I did have access to the research article and the response to the letter to the editor, that I could not effectively conclude one way or another if there’s a violation of law and/or ethics here.  But it looks off, and regular readers may remember that I think dealing with the appearance of impropriety is important to preserving the value of scientific information.  Given the Bioethics Commission did work on the issues of international studies and human subjects protection (during the time the manuscript was likely being written), perhaps they could weigh in, assuming they were asked by the President and/or the Secretary of Health and Human Services (the Cabinet Secretary with jurisdiction over NIDA).  I’m guessing someone in at least one of those offices is reading the letters section of Science.  Maybe we’ll see that confirmed soon.

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