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.’”