Respectful Insolence

A couple of weeks ago, the anti-vaccine movement took a swing for the fences and, as usual, made a mighty whiff that produced a breeze easily felt in the bleachers. In brief, a crew of anti-vaccine lawyers named headed by Mary Holland, co-author of Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children, published a highly touted (by Generation Rescue and other anti-vaccine groups, that is) “study” claiming to “prove” that the Vaccine Injury Compensation Program (VICP) had actually compensated children for autism. As is typical with such “studies” generated by the anti-vaccine movement, it was bad science, bad law, and just plain bad all around. The authors intentionally conflated “autistism-like” symptoms with autism, trying to claim that children with neurological injury with “autism-like” symptoms actually have autism. Never mind that there are specific diagnostic criteria for autism and that, if the children actually had autism many of the would have been given a diagnosis of autism. Never mind that what they were doing was akin to claiming that all patients with “Parkinson’s-like symptoms” have Parkinson’s disease. (Hint: They don’t.) Never mind that all they did was to demonstrate a prevalence of autism spectrum disorders among the VICP-compensated children that was clearly within the range of what would be anticipated if there were no relationship between vaccines and autism. Never mind all that. This was Holland’s big chance, but it went over like the proverbial led balloon. No one bit, other than FOX News.

The study rapidly faded into the obscurity it so richly deserves, in spite of mighty efforts by Generation Rescue, SafeMinds, and the likes of Ginger Taylor to keep it alive and use it as a rallying point to persuade legislators to pass anti-vaccine-friendly legislation. You could feel the frustration in its backers as Holland’s study, into which groups like Generation Rescue had apparently poured their hopes of being vindicated, crashed and burned.

However, there’s one aspect of this study that I didn’t discuss. In fact, I thought of it as I read it, but I wasn’t sure. Do you know what it is? I won’t try to keep you in suspense. (After that lengthy introduction, I’d better not.)

What I (and others) have noticed is that there was no statement in the article that approval had been obtained from the relevant institutional review boards (IRBs) to do human subjects research. For those not familiar with what an IRB is, an IRB is a committee that oversees all human subject research for an institution. It is the IRB’s responsibility to make sure that all studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that (1) risks are minimized and that the risk:benefit ratio, at least as well as it can be estimated, is very favorable; (2) to minimize any pain, suffering or distress that might come about because of the experimental therapy; and (3) to make sure that researchers obtain truly informed consent. During the course of a study, regular reports must be made to the IRB, which can shut down any study in its institution if it has concerns about patient welfare.

Of course, I know this all because I happen to be involved in human subjects research. It’s part of what I do while doing research in breast cancer. Clinical trials are obviously human subjects research. After all, their very purpose is to test a new drug or treatment on human subjects in order to determine if it works. However, human subjects research encompasses a lot more than just clinical trials; in fact, it encompasses almost any research study that involves either human subjects or human subjects’ protected health information (i.e., medical charts). Basically, any human subject experimentation requires approval by a properly constituted IRB. There is no documentation in Holland et al that IRB approval had been obtained, either from the for NYU (given that Mary Holland is a research scholar at the NYU School of Law) and/or Pace University, given that Pace Law School is cited as having “provided significant research support for this study” 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.

Autism News Beat and Sullivan are already all over this issue, but I thought I’d throw in a bit from my perspective, given that I actually have to work with IRBs and, before my career is over, will probably be roped into serving on an IRB. In any case, as is true of any researcher who is involved in human subjects research, I had to undergo specific training regarding the “rules of the road,” so to speak, as a requirement of being an investigator on any study involving human subjects research.

How is human subjects research defined? According to 32 CFR 219.102(d), research means “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge,” and according to 32 CFR 219.102(f) a human subject is defined as ” 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.”

Under these criteria, I believe that the Pace study clearly qualifies as human subjects research. First of all, as poorly designed as the study was, it was clearly intended as a systematic investigation designed to contribute to generalizable knowledge and testing a hypothesis, namely that autism is associated with vaccine-induced brain injury. The authors claim to have found data in the VICP-compensated cases indicating that there is a higher incidence of autism in these children. Never mind that they found nothing of the sort, they set out to test that hypothesis and their methods were designed to support it. Moreover, as Autism News Beat pointed out, 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. This clearly makes the parents who answered the questionnaire (and their children) human subjects, as identifiable protected health information about the children is being solicited and used to test their hypothesis.

To be fair, I have to point out that there are types of studies that are exempt from full IRB approval. In fact, there are six categories of so-called “exempt” studies. I frequently use category four, which involves the use of already existing clinical information that has been de-identified. I also note that this particular exemption involves research that does not involve interacting with living humans about their health information; rather, these sorts of studies tend to involve chart reviews or the examination of human tissue specimens that have already been collected. Be that as it may, there is one potential exemption that EBCALA might claim. First, number two:

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

  1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
  2. any disclosure of the human subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.

Unfortunately for Holland et al, the first “unless” probably kills this exemption. The information they obtained was obtained in a manner such that the human subjects can be identified. The second “unless” might or might not kill the exemption; I note that both criteria are used to decide whether an exemption is not permissible. However, even if this research could potentially be considered exempt – and I highly doubt that a reputable IRB operating within the law and the Common Rule would find it exempt, particularly since IRBs are charged with taking special care to protect human subjects considered to be vulnerable, such as children, and that the survey is in fact a screening/diagnostic tool, making the results protected health information – it should also be noted it is not the investigators who get to decide whether a protocol is exempt or not and therefore whether a protocol requires IRB evaluation and approval. Period. Investigators do not have the power to determine whether their research falls under one of these exempt categories; only the IRB can make that determination, usually in an expedited review that determines whether a potentially exempt protocol meets the standards of one of the categories that are exempt from full IRB approval. It’s right there in the rules:

Only the IRB may determine which activities qualify for an exempt review. Investigators do not have the authority to make an independent determination that research involving human subjects is exempt and must contact the IRB concerning the status of proposed research or changes in ongoing research.

Also note that the research cannot begin until after IRB approval is obtained.

Personally, unlike the case with the Geiers, my guess is that as lawyers Holland et al were simply ignorant that what they were doing constituted human subjects research and that’s why they didn’t bother with a little thing (to them) like obtaining IRB approval before doing their study. Indeed, when Autism News Beat inquired at Pace Law School about whether the EBCALA study had IRB approval, this is what he was told:

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 reveals Conte’s utter cluelessness about human subjects research. Investigators interacted with the parents of these children, administering a questionnaire to them for purposes of looking for data to support their hypothesis. It’s human subjects research until judged otherwise–by an IRB, not by Conte, Holland, or any of the other of the merry band of anti-vaccine lawyers who put this travesty of a study together. Not surprisingly, attempts to get Conte to respond to e-mails regarding IRB approval of the study were not returned.

Of course, ignorance of the law is no excuse; as lawyers the authors of Holland et al should know. I also find it rather hard to believe, whether or not they were ignorant of federal law and regulations regarding human subjects research, that at some point either Holland and her coauthors weren’t made aware somehow by someone that what they were doing constituted human subjects research under federal law. Surely someone must have realized this, given that questionnaires about protected health information were being administered to living human beings. If they did not, then, quite frankly, I find the level of incompetence and lack of concern about basic ethical standards that every investigator in the U.S. who engages in human subjects research knows as basic information because they are required to know them and abide by them as part of ethics and the law.

This lack of concern about such niceties of the ethical treatment of human subjects is nothing new in anti-vaccine studies. Andrew Wakefield demonstrated it with his callous treatment of children at a party, whom he basically bribed for blood samples and whose fear he made light of. The Geiers père et fils demonstrated it when they created an IRB to oversee their own research, sat on that IRB themselves with Dr. Geier himself chairing the committee (a massive conflict of interest), and packed it with their anti-vaccine cronies.

There’s one more “out” that Holland et al might try for, and that’s to say that their research was not federally funded and is therefore not covered by the Common Rule. However, most universities that accept federal funding for research agree to be bound by the Common Rule for all research carried out by their faculty, students, and trainees. Even if Holland et al tried to justify their failure to obtain IRB approval this way and argue that they are not legally bound to follow the Common Rule, their failure to obtain IRB approval for their study and submit to IRB oversight is a massive ethical failing. I characterized Holland et al as evidence that that when the anti-vaccine movement can’t win on science, it will appeal to the law. It also appears that when it can’t win on ethics, it will appeal to the law as well.

While Holland et al tout “unanswered” questions about autism and the VICP, the only question I have is: Will Pace University and NYU will investigate how such a study could be performed without its investigators obtaining the requisite IRB approval? Or will they sweep this massive ethical (and possibly legal) breach under the rug and hope it goes away?

Comments

  1. #1 Mu
    May 24, 2011

    Who would have thought that a law school knows the law, or that the three lawyer authors would take personal responsibility for their actions.

  2. #2 Jud
    May 24, 2011

    or that the three lawyer authors would take personal responsibility for their actions

    It’s rather amazing that attorneys working in the health field would be unaware of this in the first place. In the second place, it is also amazing they wouldn’t have sounded out fellow lawyers on any potential problems with what they were planning. If it were me, I certainly would have done so.

    I’m wondering about a potential workaround. Assuming the subjects have given those who did the study the usual authorizations, would that save the exemption from application of the “unless” clauses? (I haven’t looked at any law on this, just idly speculating.)

  3. #3 Beamup
    May 24, 2011

    @ Jud:

    As I understand it, the IRB would have to approve the form of those authorizations at the very least.

  4. #4 Marry Me, Mindy (fkaPablo)
    May 24, 2011

    So the identities of the subjects is known because they were pulled from publicly available outcomes of court cases?

  5. #5 delurking
    May 24, 2011

    “Assuming the subjects have given those who did the study the usual authorizations, would that save the exemption from application of the “unless” clauses? (I haven’t looked at any law on this, just idly speculating.)”

    No. If you do research involving giving questionnaires to people who can be identified, you have to get IRB approval. There is no waiver that you can ask the subjects to sign that will eliminate the requirement.

  6. #6 Orac
    May 24, 2011

    So the identities of the subjects is known because they were pulled from publicly available outcomes of court cases?

    That’s one way they are known. The other way they are known is because members of the research crew actually administered a developmental screening tool (survey) to their parents, and the answers given on the survey constitute protected health information.

  7. #7 Todd W.
    May 24, 2011

    @Jud

    Human subjects research covered by the Common Rule require IRB review before any research-related interactions with subjects takes place. I’m not sure whether the IRB of note would have given this study an exemption (need to look a bit more closely). It’s relatively low risk, at least physically. However, the risk of loss of confidentiality and the nature of the information collected (diagnoses, compensation, etc.) could have social implications that bump the level of risk up somewhat. If not exempted, it would at the very least have had to go through full committee review before starting. Annual continuing reviews may have been expedited. At least, that’s what I feel would probably have occurred if the investigators had actually followed the law.

  8. #8 Denice Walter
    May 24, 2011

    If your central tenet, your *jewel in the crown*, your *raison d’etre* has been unceremoniously , um, dispatched, i.e. relying upon the “study” that propagated the entire “vaccines cause autism” movement will no longer be even remotely feasible to the general public, you need to have other irons in the fire. So post-Wakefield, they scramble to get the anti-vax message out: here are a few ways that I’ve encountered-

    1.Legal manoeuvres: “research” by survey, press conferences, protests. I venture that there will be attempts to “play” the system as well by going to court, after all, Krakow is involved.

    2. Legislative action: attempts to change childhood vaccination requirements, state by state. ( LKH, others) If you haven’t research data, try lobbying your reps.

    3. Expanding your venue: John Stone appears to have become very interested in the effects of anti-psychotics (last week, AoA) and in the high rate of “Chronic illness” in children ( see AoA). Similarly, LKH ( @ NJCVC) opposes mandated and tracked flu vaccination for health care workers. Doesn’t that say it all?

    In short, desperation sends them off in all directions at once. IRB’s were the last thing that they were considering.

  9. #9 Marry Me, Mindy (fkaP)
    May 24, 2011

    The other way they are known is because members of the research crew actually administered a developmental screening tool (survey) to their parents, and the answers given on the survey constitute protected health information.

    OK, sending out a survey as part of a research study clearly requires IRB oversight. But just using and summarize the information from the publicly available sources would not be considered human subjects research, right?

  10. #10 Todd W.
    May 24, 2011

    @Pablo

    OK, sending out a survey as part of a research study clearly requires IRB oversight. But just using and summarize the information from the publicly available sources would not be considered human subjects research, right?

    Depends on the type of information collected and the source of that information. Publicly available sources might be exempt (e.g., using a phone directory). If they had stuck only with the court rulings and not had any interaction with the claimants or their families, they might have been okay. As with my comments above, I’d need to take a bit of a closer look at things, myself, so, take this all with a grain o’ salt.

  11. #11 Marc
    May 24, 2011

    The general lack of ethics on the anti-vax side is really telling. I was looking at an NVIC page where they have a post on the moral justification for opting out of vaccines. They imply that Nuremberg requires informed consent (true) but since vaccine manufacturers cannot test for rare side effects because the power to determine those require near population-sized samples, then it is impossible for informed consent to exist. Aside from the mind-meltingly dumb definition of informed consent (the standard is “significant risks,” after all), what is really telling is they use a quote from professor Art Caplan of University of Pennsylvania as part of their argument. Only problem is Caplan is a board director on medical ethics at Penn with Paul Offit, and has written on such subjects as the ethical justification for requiring vaccinations and is in strong favor of vaccinations. This is something Barbara Loe Fisher should be aware of, since I’m sure she couldn’t help noticing her favorite lawsuit target is on the board of the institution with the person she’s quoting.

    It just goes to show that these people will use, abuse, and torture any smidgen of fact they can find to serve their misguided purposes. Not that this is a shock to anyone who has read Scienceblogs for any length of time….

  12. #12 Orac
    May 24, 2011

    Depends on the type of information collected and the source of that information. Publicly available sources might be exempt (e.g., using a phone directory). If they had stuck only with the court rulings and not had any interaction with the claimants or their families, they might have been okay. As with my comments above, I’d need to take a bit of a closer look at things, myself, so, take this all with a grain o’ salt.

    More importantly, if there is any question whatsoever whether what is being proposed constitutes human subjects research, it is the IRB that decides whether the research is exempt or does not constitute human subjects research, not the investigator.

  13. #13 JohnV
    May 24, 2011

    What are the potential consequences for the institutions that allowed this research to take place without IRB approval?

  14. #14 Todd W.
    May 24, 2011

    @JohnV

    A range of possibilities. Assuming that the study is found to be noncompliant, disciplinary action may just be isolated to the investigator(s) or could even go so far as to have all human subjects research at the institution shut down for a certain period. More info on compliance can be found at the Office for Human Research Protections.

  15. #15 Ted
    May 24, 2011

    Attorney/Professor Holland should know better. She’s merely channeling her anger by trying to sell more books and being hailed as a “Warrior Mommy”.Perhaps she also has a Messianic complex.
    Funny, in terms of playing the media, they’ve only managed to get on…Fox, which is attempting to build a strange coalition of birthers, antivaxxers, earth warming deniers, breast-feeding is bad for you disciples, etc. – with the purpose of advancing Luddism via distortion. Either she’s complicit in the network of Murdoch,Ailes and Rove and their sensationalism or she’s an unwitting dupe.

  16. #16 René Najera
    May 24, 2011

    This is no joke, folks. Don’t let the anti-vaccine people tell you that it’s not serious if an actual violation did occur. Those laws and regs are in place because abuse can and has happened. Can you imagine the noise that would be raised if Big Pharma studies were done without an IRB? Or, for example, if people conducting the study were one degree or less removed from those on the IRB? *wink, wink*

    What’s fair is fair. If “they” want to counter the evidence offered by “us”, then they need to jump through the same hoops when it comes to proper research, proof, evidence, and all those niceties of science.

  17. #17 AutismNewsBeat
    May 24, 2011

    Robert F. Kennedy, Jr. is a professor at Pace Law School. He actually scheduled a press conference in mid-April, to take place in front of the White House, to talk about the Pace Law journal study. He ended up cancelling the event at the 11th hour – Pace’s reason was “the article hasn’t passed review yet.”

  18. #18 Prometheus
    May 24, 2011

    The ironic part of this is that, had they gone to the university IRB, they probably would have gotten an “expedited” review and approval.

    I’ve been involved in a few survey/questionnaire-based studies and the only thing that the IRB wanted to see was our plan to keep the identities of the participants confidential. Keeping paper records secured in a lock filing cabinet or password-protecting computer records was all that was required of us.

    I can’t imagine why Holland et al didn’t get IRB approval, except that they – unbelievable as it seems – didn’t realise that they were conducting human research.

    At my university, all faculty in the College of Liberal Arts and Sciences (CLAS) are told – annually – that any research that involves collecting medical, biological, chemical or sociological data from people needs to be submitted to the IRB for review. They have an “expedited review” process for research that “probably” is exempt, but – as mentioned above – only the IRB can make the determination that research is exempt.

    My guess is that Pace and NYU will ignore this “minor” ethical lapse and hope that it goes away. Predictably, the “vaccines-cause-autism” and anti-vaccination agitators have dismissed the lack of IRB approval as “irrelevant” and “a technical error”.

    Prometheus

  19. #19 Jud
    May 24, 2011

    However, the risk of loss of confidentiality and the nature of the information collected (diagnoses, compensation, etc.) could have social implications that bump the level of risk up somewhat.

    In the usual run of things, yes. But we’re dealing here with parents who would be happy if the information regarding their children were plastered all over the Times Square news crawl. These are people who are convinced that by publicizing what happened to their own kids, they’re saving other children from disabling physical/mental injury.

    Though I’m not in favor of rubber-stamp IRBs, I am in favor of both regulators and IRBs taking context into account (e.g., when regulators found hospital efforts to track the success of checklists in preventing instances of patient harm did not, after all, constitute human subjects research).

  20. #20 Roadstergal
    May 24, 2011

    In the usual run of things, yes. But we’re dealing here with parents who would be happy if the information regarding their children were plastered all over the Times Square news crawl.

    And how would the kids in question feel? Now, and as they grow up?

  21. #21 Todd W.
    May 24, 2011

    @Jud

    Just a quick comment regarding social implications. Keep in mind that loss of confidentiality may not be limited to just publicizing things in the way that the parents may wish. For example, suppose part of the health information collected revealed information about certain habits, like drug use, or psychological diagnoses of the parents? Might the legal authorities decide to have a chat with them? What impact might the information have on their employment or their insurance rates? Might any of the information cause negative consequences among their social group, like being ostracized?

    Even though the parents might not think about these things, the researchers should and the IRB definitely needs to take them into account. It’s an aspect that people tend to overlook.

    As for your example of hospitals looking at the use of checklists to improve patient outcomes, that may fall under assessment of institutional procedures and not be subject to review, unless, of course, they plan to publish their findings. If it’s internal-only, it might not fall under the jurisdiction of IRB regulations. But, I haven’t reviewed that sort of thing, so I’m working from memory of classes and training I received.

  22. #22 Mandos
    May 24, 2011

    While this definitely doesn’t fall under that category, there are a lot of gray areas about what is human subjects research. For example, linguists ask each other about grammatical acceptability judgements. In theory, that is a question about the state of the contents of a human mind. However, you might require hundreds of IRB approvals (or “exemptions”) for each unique one-sentence “study”…that would go into a journal article in that field.

    I can easily imagine someone not thinking of their work as “human subjects” work if they aren’t bio/psych people. I’m guessing violations go on all the time in comp sci and engineering depts when it comes to things like UI design work.

  23. #23 Marc
    May 24, 2011

    Prometheus opined:
    “Predictably, the “vaccines-cause-autism” and anti-vaccination agitators have dismissed the lack of IRB approval as “irrelevant” and “a technical error”. ”

    It’s funny how this selective ignoring works. Not only would they jump all over this if Big Pharma had this kind of lapse, but they are jumping all over the Danish study because a minimal contributor absconded with research funds AFTER the study was published. Any hint of impropriety is hammered on and hammered on until it’s a pulpy mess all over AoA, but nah–this is just a “technical oversight” and a “nothing to see here” non-issue.

    Right….

  24. #24 lilady
    May 24, 2011

    @ Todd W.: Thanks for the link to the Office for Human Research Protections.

    In that rather lengthy article it states that an institution must have an IRB policy in place along with an IRB manual that details the policy and procedures that the IRB committee members must follow. Do we even know that these are in place at Pace Law School?

    I viewed the press conference and commented about it on Orac’s blog “Another swing for the fences and a miss be the anti-vaccination movement” (May 11, 2011). First of all…law students and the “lead investigator” Lou Conte (ex-cop and parent of triplets all who are diagnosed with autism) do not have the skill set to read medical records; they are totally unqualified to be medical researchers.

    A poster on that same blog (Dr. Susan Lawson) berated some of the posters as being heartless because her child was one of those children who was compensated for brain injury/autism. Jay K. another “heartless” poster located the actual case and provided us with the child’s diagnosis (encephalitis-not autism). I in turn located Dr. Lawson’s blog (juliagrimesjourney.blogspot) where Dr. Lawson provided her child’s diagnosis of encephalitis-not autism. Dr. Lawson on her blog confirmed that she did in fact provide a completed questionnaire/survey to “an autism researcher”. Me thinks that Dr. Lawson and the “autism researcher”/law student/ex-cop have fudged the facts about young Julia’s diagnosis.

    Another Law to look at would be the Health Insurance Portability and Accountability Act (HIPAA) enacted in 1996, specifically the sections dealing with “privacy of patient records and test results”. Reporting laboratories, private physicians, clinics and hospitals were in a dither over that law, until it was pointed out to them that public health officials are exempted from the privacy sections, during the course of an investigation of an infectious disease. There is no such exemption for law students or ex-cop investigators attempting to conduct a scientific study.

  25. #25 trrll
    May 24, 2011

    In the usual run of things, yes. But we’re dealing here with parents who would be happy if the information regarding their children were plastered all over the Times Square news crawl.

    Perhaps, perhaps not. I suppose you could survey them to find out. But you’d probably need to run the survey by the IRB first.

  26. #26 Todd W.
    May 24, 2011

    @lilady

    Do we even know that these are in place at Pace Law School?

    Yes. Pace Law School is part of Pace University, which has an IRB in place. They would be the ones to review it at that institution. NYU (home of M. Holland’s NYU School of Law) also has an IRB (a couple, actually – one for the School of Medicine and one for everyone else).

  27. #27 lilady
    May 24, 2011

    Oops, omitted from my posting above. Lawyers representing clients who are suing for a tort, do get their clients’ medical records with a signed Release Form. Defense lawyers are provided medical records during the “discovery” period prior to the tort trial.

  28. #28 wholly father
    May 24, 2011

    The lack of IRB oversight is particularly problematic in this case. Most of the patients, by definition, fall within the criteria for “vulnerable” populations. Vulerable patients include children, and patients with cognative impairment (among others). Reseach on these patients is subject to paticularly strict IRB scrutiny. In my opinion, it is unlikely that direct contact with the parents would have been deemed exempt by most IRBs. As a previous poster mentioned, it is up to the IRB, not the investigator, to determine if IRB review is or is not required.

  29. #29 Peebs
    May 24, 2011

    I find it intriguing that none of the usual AV apologists have seen fit to post on this.

  30. #30 Matthew Cline
    May 24, 2011

    I also find it rather hard to believe, whether or not they were ignorant of federal law and regulations regarding human subjects research, that at some point either Holland and her coauthors weren’t made aware somehow by someone that what they were doing constituted human subjects research under federal law. Surely someone must have realized this, given that questionnaires about protected health information were being administered to living human beings.

    A likely scenario: they found out after the project was already underway, and didn’t want to scrap the project and start it all over again.

  31. #31 Dedj
    May 24, 2011

    Or: they added the questionaire phase after the VICP data failed to demonstrate support for their hypothesis.

  32. #32 BA
    May 24, 2011

    I concur with Prometheus’ suggestion that the study would likely have gone through the IRB as an expedited review and been approved. With so many examples of anti-vaccination influenced ethical lapses you’d think that for so little cost the effort would have been made here.

  33. #33 Orac
    May 24, 2011

    I suspect the study would likely ultimately have been approved after some tweaking and back-and-forth with the IRB, but I highly doubt it would have been granted an exemption.

  34. #34 wholly father
    May 24, 2011

    Since the study involved an interview, I think many IRBs would require written informed cosent.

  35. #35 Orac
    May 24, 2011

    Indeed.

  36. #36 Todd W.
    May 24, 2011

    @wholly father

    The interview isn’t what would make informed consent required. Written informed consent is required for every subject in every covered study unless: 1) the study is exempt, 2) the IRB finds that IC can be waived according to specific regulatory criteria or 3) the IRB finds that the study meets criteria for a waiver from the Secretary of HHS. Only in rather extreme circumstances would IC be waived (e.g., studying something in an emergency setting).

    I can’t really see an IRB waiving informed consent for this study.

  37. #37 wholly father
    May 24, 2011

    Todd W

    I agree with you. There are certain common circumstances for which informed consent is waived. For example, studies that involve review of medical records for which informed consent would be impossible are granted waivers. My point was that the study in question did not meet these criteria

  38. #38 LW
    May 24, 2011

    The question that crosses my mind is whether they didn’t need IRB approval because they didn’t actually administer the questionnaires as claimed. We are talking about fans of Wakefield here, right?

  39. #39 Autistic Lurker
    May 24, 2011

    Is there some website to look-up for a canadian IRB?

    For my final project at a trade school, I’d like to build a dynamic brain atlas website (I did some work in neuroimaging) and I will use scientific publications (actually, PET and fMRI coordinates from the studies) from pubmed central and given that humans subjects were involved in these studies, I don’t want to run afoul of an IRB for the project.

    I must say that I’m not going at any university where there is human research work.

    A.L.

  40. #40 Skeptiverse
    May 25, 2011

    @A.L.

    From the information above it appears that IRB’s are for singular institutions and are not state based. Each Australian university has a similar system of oversight though i am unsure of the details. I think your best your best option is to have a chat with the officials at your trade school.

    in my opinion though it does not look like you would require IRB approval because you yourself are not carrying out the human subjects research and are using publically available data. The studies you use have been published and it is likely they would have gone through any pre-approval required under their systems.

  41. #41 Todd W.
    May 25, 2011

    @A.L.

    Most of what was said above is for the U.S. I’m not sure what the regulations are in Canada. From the little bit you said, I don’t think you would need IRB review, but I would actually go a bit further than Skeptiverse and suggest that you visit with some IRB folks from the nearest university.

    As to IRBs being institution-based vs. state-based, they are, indeed, based at institutions. Just about every university is going to have one, as will research hospitals. I believe there are also some commercial IRBs that researchers can use if they aren’t affiliated with any particular institution and will not be conducting their research at such an institution.

  42. #42 Vickie
    May 25, 2011

    In addition to institutional based IRBs there are also independent IRBs such as Western IRB. When you go the the web site for WIRB there is a lot of information on protection of human subjects, oversight, forms, etc….

  43. #43 rtcontracting
    May 25, 2011

    Peebs:

    I find it intriguing that none of the usual AV apologists have seen fit to post on this.

    The anti-vaxers are too busy saving children to be bothered by trivial things like “ethics” (and the law).

  44. #44 Autistic Lurker
    May 25, 2011

    @Skeptiverse, @Todd W.

    Thanks you very much. I do intend to speak to some members of an IRB here but wasn’t sure where to look them up. Thinking about it, I may ask some of my professors where I used to do my neuroscience major or else, ask my psychiatrist (he’s an MD/PhD conducting human research).

    As for a commercial IRB, I’d prefer not going that route unless I find some way to recoup the cost of my project.

    A.L.

  45. #45 Prometheus
    May 25, 2011

    Autistic Lurker,

    If you’re using images from published articles, you won’t need IRB approval, since those are already publicly available. However, you will need a release from each publisher (or copyright holder, if different) before you can use them outside of a class project (assuming that “fair use” in Canada is materially similar to that in the US).

    According to our local office of research integrity, no IRB approval is needed to use data that are publicly available (e.g. in published articles, “public use” databases, etc.) with the caveat that data that were obtained in illegal or unethical ways (e.g. hacked databases, data put on-line without the subject’s consent, etc.) are not considered “publicly available” even though they may have a billion “hits” on the website where they are posted.

    Again, note that IRB approval does not eliminate the need to comply with copyright law.

    Prometheus

  46. #46 Autistic Lurker
    May 25, 2011

    @Prometheus

    I’m late to comment but thanks you for your comment. I do intend to go live with the website but I will need to balance the features of the website with the number of publication I’ll need authorization (potentially 900 publications just for memory).

    A.L.