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

20 May

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

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.”


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

13 Responses to “Study by NYU and PACE: another failure in obtaining ethical approval?”

  1. _Arthur May 21, 2011 at 00:02 #

    I was under the impression that PACE only tabulated non-confidential (public) records, from the VICP archives.

    *I* could do the same count, from the internet, without any special access.

    Am I wrong ? As usual, I hope so.

  2. Dedj May 21, 2011 at 00:22 #

    From what I can gather, the PACE study included novel primary research in the form of a phase of direct contact and a questionairre, which could only have been conducted with personally identified individuals.

    So, no, you could not have done it from the internet, using only public records, without access to personally identified individuals.

    Mary Holland, Louis Conte, Robert Krakow, and Lisa Colin, Unanswered Questions from the Vaccine
    Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, 28
    Pace Envtl. L. Rev. 480 (2011)
    Available at:

    pg 512 by their counting.

  3. Sullivan May 21, 2011 at 01:31 #


    the response rate for their application of the “Social Communication Questionnaire” was 27% (pretty low), but they did attempt to collect data from human subjects.

    You could not have done this with purely existing internet-available data.

  4. _Arthur May 21, 2011 at 16:01 #

    Ah, OK, thanks. Still, a questionnaire about general health and social skills ought not to require an IRB, right ?

  5. Chris May 21, 2011 at 17:48 #

    Arthur, it does if it has any identifying information. Steps need to be made to ensure the privacy of those who answer the questions. Several years ago a survey of certain social habits was done in a small town, when it was reported many of the participants were identifiable. It was not good.

    (a science talk at my kids’ high school included one by the person who trains researchers at our local university researchers on ethics and IRBs, that was one of many stories and situations she explained)

  6. daedalus2u May 21, 2011 at 17:48 #

    Arthur, if the individuals are identifiable, then it absolutely does require an IRB.

    And it isn’t “a questionnaire about general health and social skills”, it is a clinical instrument used to screen for autism. It is a diagnostic test.

    Diagnostic tests can be administered by clinicians as a part of treatment. When such tests are administered in an attempt to generate systematized knowledge, it is research and requires an IRB.

    The outcome of the Pace study is exactly why IRBs are supposed to be involved in research, to prevent the exploitation of the research subjects. They were trolling for subjects to speak publicly and to write letters that could be used to further the agenda of the authors. They conflate the terms “autism” and “autism-like”. Why do they do that? I think to further their agenda of scamming someone.

    In my opinion it is pretty clear that their agenda is to generate “data” that can be used to scam someone for money, either the VCIP, Congress, vaccine manufacturers, or if that fails, parents of children with autism.

    I think that no half decent IRB would have allowed this study to go forward as it did. They would have required actual clinicians who actually know what the difference between “autism” and “autism-like” mean.

  7. Dedj May 21, 2011 at 17:58 #

    Why not?

    Part of the purpose of an IRB is to review how you have safeguarded the well-being of your subjects.

    Like it or not, questionaires and interviews can have an effect on the interviewee, especially ones that are in relation to a stressful and traumatic event and time period.

    Primary research involving human subjects should require an IRB, if only to declare that the risk of harm is minimal.

    The SCQ is a brief and minimally invasive questionaire, but it was administered after a concerted effort to identify and trace the subjects through personally identifying information.

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  10. Nancy September 25, 2016 at 20:56 #

    IRB Committe Membership: There must be at least one member with a “main interest” (not professional expertise) the scientific arena and a minimum of one member with a nonscientific primary concern on the committee (a parent of a study subject meets the last description). IRB approval is usually not required unless the outcomes are intended to be published or the project may potentially expose the patient to harm (Wakefield and the others did not need an IRB prior to beginning the research). The information on the IRB came directly from the ANA.

    • Sullivan (Matt Carey) October 4, 2016 at 19:24 #

      Wakefield absolutely needed ethics approval. That’s why he sought it.


  1. Law and Ethics | Lee's Rambling Blog - May 22, 2011

    […] Study by NYU and PACE: another failure in obtaining ethical approval? ( […]

  2. Science-Based Medicine » Anti-vaccine warriors vs. research ethics - June 2, 2011

    […] News Beat and Sullivan are already all over this issue, but I thought I’d throw in a bit from my perspective, given […]

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