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Study by NYU and PACE: another failure in obtaining ethical approval?

Posted May 20 2011 6:01pm

One issue that has come up more than once in autism research is the failure to obtain ethical approval for human studies research. Andrew Wakefield started his studies on autistic children before the Royal Free Hospital granted ethical approval. Mark and David Geier failed to obtain Institutional Review Board (IRB) approval before starting one of their studies. According to an article on neurodiversity.com:

None of the IRB members have declared expertise in the field of pediatric endocrinology. Whereas the IRB was registered in March 2006, the research described in the article was conducted between November 2004 and November 2005.

Not only did none of the members of the IRB have expertise in the field, the IRB included the researchers (Mark and David Geier), the mother of one of the children on the “Lupron protocol”, an attorney specializing in vaccine injury, and Anne Geier (wife to Mark, father to David).

Apparently following in these footsteps are the team who recently brought us a study purporting to show a high prevalence of autism amongst children compensated by the vaccine court (for more on this, see 2 ½ Studies: Autism Prevalence and the “Hidden Horde” ). The vaccine-court study author list is Mary Holland, NYU School of Law, Louis Conte, Robert Krakow, and Lisa Colin. The study was published in the PACE Environmental Law Review . Further, “Pace Law School provided significant research support for this study” as noted in the footnotes of the paper:

* Mary Holland, Research Scholar and Director of the Graduate Legal Skills Program, NYU School of Law; Louis Conte, independent investigator; and Robert Krakow and Lisa Colin, attorneys in private practice. Pace Law School provided significant research support for this study. The authors thank former Environmental Law Dean Alexandra Dunn and law students Jillian Petrera, Kyle Caffrey, Sohad Jamal, Alison Kaplan, Georgine Bells, Jonne Ronquillo, Lisa Hatem, Allison Kazi and Adrienne Fortin. The authors also thank volunteers who worked under the direction of Louis Conte. For purposes of disclosure, Robert Krakow and Lisa Colin represent clients and have claims on behalf of family members in the Vaccine Injury Compensation Program.

Ken Reibel, journalist and proprietor of Autism News Beat has an article published today: Unanswered Questions from Pace Law journal study: Ethical Standards for Research on Human Subjects . He poses some very important questions:

1) Does the study methods meet the standards of “human subject” research?
2) Did NYU or PACE (or anyone else) obtain IRB approval?

The answers appear to be yes to the first, no to the second.

From Autism News Beat:

“Human subject” is defined by the DHHS as “a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.”

and,

When asked if the Pace study had IRB approval, Pace Law spokesperson Lauren Rubenstein referred the question to the study’s co-author, Louis Conte. In an email, Rubenstein wrote “Louis Conte has told me that there was no human subjects research in this study.”

Which I interpret to mean that they don’t have IRB approval as they don’t believe they require it. My read is that, yes, they did require IRB approval.

It will be interesting to see what, if anything, comes of this. Will PACE and NYU investigate and let the public know if their people went ahead with human subject research without IRB approval?

For more details: Unanswered Questions from Pace Law journal study: Ethical Standards for Research on Human Subjects

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