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Unanswered questions from Pace law journal study:
Ethical standards for research on human subjects

May 20th, 2011 · 9 Comments · Careless sourcing

Did the anti-vaccine group whose paper recently appeared in the Pace Environmental Law Review seek ethical approval to study human subjects? Apparently not.

In  Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, members of the Elizabeth Birt Center for Autism and Legal Advocacy (EBCALA) administered the Social Communication Questionnaire (SCQ) to the parents or caregivers of 22 children. The subjects were chosen from among approximately 2,500 vaccine injury cases settled by the US Federal Court of Claims since 1989.

According to US Department of Health and Human Services rules, research on human subjects is subject to prior approval by an Institutional Review B0ard (IRB). Pace University has two IRBs, according to the DHHS’s Office of Human Research Protection database. “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.”

IRB approval for research on human subjects, even studies that only administer an autism screening questionnaire,  is a universally-accepted ethical standard, with the exception of rogue nation states such as North Korea, Libya and Somalia.

According to the Pace University Institutional Review Board (IRB) website, “The IRB was established to protect the rights and privacy of human participants in research that is conducted by members of the Pace University community – faculty, students, and staff – and by external parties who wish to conduct research on any Pace University owned and/or operated site.”

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.”

But according to Pace University, that determination needs to be made by an IRB member, not the study’s co-author:

“If an investigator believes that his/her project qualifies for exemption, he/she should submit one copy of the completed signed Proposal Form (included in application packet) and associated materials. A designated member of the IRB must “concur” that the project qualifies for exemption. An investigator cannot exempt him/herself.”

Conte did not respond to an email asking if EBCALA sought IRB approval for its study. A call to EBCALA’s Brooklyn office was not returned. There is no mention of an IRB in the study.

Rubenstein distanced Pace Law School or Pace University from the study, and said her office would have no further comment on the article. “Pace had no participation in the paper. Pace Law students assisted with legal research of the vaccine court decisions and creating an objective database of the case holdings and facts, but neither Pace Law School nor any of our students had anything to do with the article or its findings or conclusions nor do we express any opinion on the article or its findings.”

In another email, Rubenstein wrote “It is accurate to say that the ARTICLE, which was published in the Pace Environmental Law Review, found that some of the children compensated by the vaccine court had autism.” She ended her final email with “I’m afraid I cannot answer any more questions about this. I’ve told you everything I know.”

Curiously, the Birt Center authors acknowledge Pace’s assistance in the study in language that cleared peer review:

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.

Under the heading “Subsequent Investigation”, we find this:

The authors began a research project with Pace Law School students to locate and analyze VICP cases assessing whether the VICP had in fact compensated vaccine-­induced brain damage, including autism, while perhaps not using that term specifically.

And on the next page:

The authors, with the assistance of Pace Law students, created a database of VICP published decisions that used relevant terms related to autism.

EBCALA’s website makes this claim:

EBCALA also partnered with Pace Law School to undertake a study of the Vaccine Injury Compensation Program of the Court of Federal Claims.

A press release issued by the Center for Personal Rights prior to last Tuesday’s EBCALA press conference claimed that Pace’s involvement went even deeper. Its headline read:

Major Law School to Join Autistic Children, Parents and Activists to Announce Historic First Study that Links Vaccines and Autism.

The Center for Personal Rights sponsored last year’s anti-vaccine rally in Grant Park that featured disgraced UK gastroenterologist Andrew Wakefield. Wakefield lost his medical license last year for, among other things, performing autism research without ethical approval.

Established in 1982, the Pace Environmental Law Review (PELR) was one of the first scholarly environmental law journals. It is run by Pace Law School JD candidates. PELR adopted a peer-review process two years ago to select articles for publication. According to the Pace Law spokesperson, submissions are reviewed internally, and then forwarded to academics, practitioners, and experts in the field, including members of Pace Law School’s faculty.

Peer reviewers have “wide discretion in selecting articles for publication,” according to the school’s website. Optional criteria for article review include such questions as “Does the author demonstrate a comprehensive knowledge of the subject matter being discussed?”, “Has the author sufficiently supported his arguments?”, “Is there any part of the article that is purely speculative?”, and “Were sound scientific research methodologies employed?”

The Birt Center study has come under withering criticism from science bloggers and others.

“The authors are trying to stretch the definition of ‘autism’ to include whatever they might like,” writes an academic researcher at Photon in the Darkness. “The reason that the DSM-IV (and, presumably the DSM-V) require a certain number of behaviors or findings in each category to qualify as a diagnosis of ‘autism’ or ‘pervasive developmental disorder’ is precisely to make a distinction between ‘autism’ and ‘autism-like symptoms.’”

 

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9 responses so far ↓

  • 1 Prometheus // May 20, 2011 at 11:50 am

    So, it would appear that the absence of the standard “…the study design was approved by the XXX IRB…” language wasn’t merely an editing oversight.

    It may be that the authors, being unfamiliar with standards of scientific research, simply didn’t know that a survey or questionnaire consitutes “human research”. Still, I seem to remember that “ignorance of the law is not an excuse”. Surely lawyers (and a law school) would know that.

    Frankly, I think that the lack of IRB approval fits well with the rest of this “study”, which seems to be more interested in getting the “right” answer (i.e. the answer that they wanted to find) than in discovering whether autism was more common among people compensated by the VICP. In their eagerness to show that the Omnibus Autism Proceedings and the VICP were “biased”, the authors disregarded a number of practises essential to good science.

    I doubt that anything will come of this – Pace University seems to be as ignorant of the rules of scientific ethics as the authors. Still, it is interesting to note that if I had done this, I (and potentially my university) would be in jeopardy of losing any and all federal grants for years.

    Prometheus

  • 2 Mike Stanton // May 20, 2011 at 12:00 pm

    One would have expected a better response from PACE, one that showed some recognition of their duty to provide proper guidance to their students in navigating the ethics surrounding human subject research.

    In distancing themselves from the study they are distancing themselves from responsibility for their students who participated in the research.

  • 3 Darold Treffert // May 20, 2011 at 12:12 pm

    The lack of IRB approval is but one problem with this ‘study’. Throughout they continually morph ‘autistic-like’ with ‘autism’, as if there is no difference. There is. A number of my patients with savant syndrome have organic brain syndrome, or some disability other than autism, as their underlying disability but have autistic-like symptoms (echolalia, hand flapping, OCD) etc. but are not autistic.
    The Poling decision used “autistic features” not autism as the reference to autism. The authors admit the ‘search’ for autism included use of that term “when perhaps not using that term specifically”. Elsewhere they refer to “terms related to autism”, 21 of whom had ‘autism-like features.

    Persons can have Parkinson-like symptoms without have Parkinson’s disease, or ‘diabetic-like symptoms’ without being diabetic or have Alzheimer’s like symptoms (feature of dementia) without having Alzheimer’s disease.
    In a search for cause we must distinguish ‘autism’ narrowly defined from ‘autism-like’ symptoms. There is a critical distinction causally, treatment-wise and prognostically.

    The authors further undercut their study with their own words: “Only complete with complete medical supervised diagnosis could fully confirm autism and that is beyond the scope of this study.

    This study is not the only one to suffer from the failure to distinguish between autism and autistic-like symptoms. Indeed until we do that carefully and scientifically we will not know the real prevalence of autism itself, figures currently inflated by failure to make that critical distinction

  • 4 Autism Blog - Study by NYU and PACE: another failure in obtaining ethical approval? « Left Brain/Right Brain // May 20, 2011 at 3:01 pm

    [...] 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 [...]

  • 5 Club 166 // May 24, 2011 at 6:49 pm

    Yes, it is true that this study would require review by an independent IRB. I happen to think that requiring IRB approval for such studies as surveys and oral histories is way over the top, but that is the law.

    As others have stated, I think that this study’s true faults lie elsewhere. Some of the problems are as follows:

    1) First, in (deliberately?) conflating autism and autism-like symptoms.

    2) Second, by inferring a diagnosis of autism from results of one questionnaire, when diagnosis of autism requires both in depth interviews of parents and others who work with the child, as well as unbiased observation.

    3) By using a legal finding of the Vaccine court (which has a much lower standard of proof than regular civil court) as a surrogate for scientific proof, which is wholly different.

    4) By repeating the falsehood that increases in the incidence of autism “proves” that something is going on, while failing to even acknowledge the effects of diagnostic substitution, broadening of the definition of autism, and the effect of greater awareness of the public and physicians towards recognizing the disorder.

    I think that not getting IRB approval was probably just a side effect of not being researchers, and not having anyone properly advise them of what the rules are. Which means that they also probably didn’t know how to read and interpret the scientific literature or design a proper study with any sort of controls for bias.

    Joe

  • 6 Jack Hep // May 25, 2011 at 8:06 am

    Interesting slant on the news that autism, though not mentioned specifically in the successful cases (lawyers had apparently realised that the very mention of the condition precluded success) was present in terms of the summation of symptoms. If it wags its tail and barks its usually a dog; if the apparent vested interests controlling the courts in the “land of the free” (could said control evidence yet another rogue state?) know a dog when they see one, why not accept the inevitable, open to flood gates, and let’s see the real quantity of autistic spectrum disorders destroying each new generation in this rogue state.

  • 7 Liz Ditz // May 25, 2011 at 10:47 am

    Somewhat off-topic for this post, but apropos to the previous commenter: new post from ToddW at Harpocrates Speaks: Help! I have Polio!

    Now, there are some who might argue that there is a distinction, medically speaking, between polio and polio-like symptoms, but they are clearly held in the grip of Big PharmaTM. Don’t let them fool you. I know I have polio because I have polio-like symptoms. And since there is no meaningful distinction between the terms “polio” and “polio-like symptoms,” then the only possible answer is that the cause of my distress is nothing else but polio. I’m sure the folks at Age of Autism will back me up on this one.

  • 8 Science-Based Medicine » Anti-vaccine warriors vs. research ethics // Jun 2, 2011 at 12:01 am

    [...] I didn’t discuss. In fact, I thought of it as I read it, but I wasn’t sure. What I (and others) have noticed is that there was no statement in the article that approval had been obtained from [...]

  • 9 Antivaccine cranks in Michigan: MLive.com gives Mary Tocco a platform [Respectful Insolence] | Gaia Gazette // Aug 13, 2014 at 5:37 am

    […] Not exactly. Try again. In reality, yes, there are “table injuries” for which the Vaccine Court automatically […]

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