I recently posted on Public health snoopers detect vapour aerosol at vape conference and fake a particulates scare. I mentioned that I thought the subterfuge involved was unethical and contemptuous, but didn’t really explain why. My main point in that post was to focus on why this was bad science and why there was no basis to justify a policy recommendation to ban vaping wherever smoking is banned. Also, I mostly had a hostile instinctive reaction about it, rather than a fully worked through perspective worth sharing.
I’ve now had an opportunity to reflect on it more carefully. This is partly because I was contacted by a senior figure at the university (someone I respect) pointing out that the study been assessed against a flowchart encoding USDHHS definitions and regulations, and that they had concluded there was no human subjects aspect of this study. Without a human subject dimension, there is no requirement to seek an approval from an Institutional Review Board (IRB), a committee that governs the ethical acceptability of research.
So I gathered my thoughts and responded:
Dear______
Thank you for taking the trouble to respond and engage. I very much appreciate that.
Firstly, I did not focus my comments on the ethical aspects of this. My main concerns are threefold:
- That measurement of PM in itself provides little of value without meaningful comparators and some reason to believe that the PM measured are actually harmful – these particulates are very different physically and chemically from those thought to cause harm.
- The attempt to retrofit a basis for health concern by mentioning toxins that were not measured in Soule et al but are found at extremely low levels in credible experiments undertaken elsewhere – at least when these use realistic vaping conditions.
- The inclusion of a policy recommendation that was not, and never could be, supported by these measurements for the multiple reasons given in my post.
On the ethics, I did what I think we should all do and asked myself: does this feel right? It didn’t and doesn’t feel right to me. I don’t doubt that by selective interpretation it is possible to navigate the HHS human subject flow charts. But here are the issues that trouble me and I think if you’d faced more robust challenge these would have meant you not securing approval. Carl V. Phillips has written about this here, and I won’t repeat his excellent analysis. Rather I will just give you my own unvarnished reactions:
- A vaping event is a human construction, comprising human participants and involving measurements of a byproduct of human behaviour in which the participants have a great deal of interest, and which is subject to considerable controversy. Many will feel quite victimised by research of this nature, especially given the three major concerns I list above, and that the research was to be used in a way that would adversely affect their perceived interests (see point 3 above). Many participants would rightly view this as a hostile act against them and their wellbeing. There is a human element to this that is quite different to examining cells in a petri dish or passing gases through a mass-spectrometer. It would be wise to acknowledge rather than dismiss that.
- If no humans were involved, why were concealment and subterfuge necessary parts of the experimental design? The experimental design shows a deliberate effort to avoid the objections of participants by concealing the monitoring equipment – the human subjects, and avoiding their engagement, are thus integral to the design. A particular approach has been taken to addressing their objections: not explaining the value of the research, but concealing it.
- There was always the opportunity to ask the organisers for permission and a further option to inform the participants if the organisers agreed. Perhaps you could pose the rhetorical question: why did the team choose not do this? – and see where it leads. It would certainly have been preferable, may have allowed for better science, and more strands of study etc. It would have avoided the criticisms you are now facing. So I suggest you examine carefully the reasons they didn’t ask. If it is because they thought the organisers would say no, then there are two additional issues to consider: what reasons would the organisers have for saying no, and why the team think their objections are irrelevant (i.e. that it is okay simply not to ask them)?
- This research created at least two breaches of the implicit contract offered by the organisers (or ‘breaches of trust’ if a less legalistic term is preferred). I assume the investigators signed up to attend the event, which I assume was a private function that required payment. The right to attend was sold with the implicit contract that it granted permission to attend the event as a participant – not to conduct contentious research there. A second breach of contract was also created between the organisers and participants, who attended in good faith expecting to be part of a vaping event, not part of an experiment detrimental to their interests. Misleading people in this way is unethical in my view. How do you know that you haven’t harmed the organiser by doing this? How do you know you haven’t added to the already large stock of distrust in this field?
- I come back to my original concern – I think the approach of the investigators betrays a contemptuous attitude to people who are, for the most part, successfully dealing with the health risks of smoking and finding their lives rejuvenated and wish to see others do the same. They are the ‘public’ in ‘public health’ and it would help if everyone professionally engaged in this field treated them with more empathy and respect, and approached their work with more humility.
- If they were confident that their interpretation of the rules was correct (i.e. there were no human subject aspects to the study) then why not take that conclusion to an IRB and defend it? Surely it is obvious that this interpretation could be disputed (as I have above), so why not have it challenged and validated or rejected? The trouble is that the team has incentives to avoid ethical scrutiny: to save time; to avoid restrictions or costs; and to avoid the risk of having the work stopped altogether. So I would expect biases in the way the team approached the DHHS flowchart – and, therefore, a need for a some counter-balancing challenge. The team should have gone for an IRB review precisely because issues of human subject involvement is, at best, ambiguous (nb. this point added in a follow up email).
Best regards
Clive Bates
I hope they respond to these observations, or, at least, reflect on their professional approach. (I won’t publish any response to this without their permission).
Further reading: Serious ethical concerns about public health research conduct; the case of vape convention air quality measurement – Carl V. Phillips
“I won’t publish any response to this without their permission”
You should. You’d be following their lead after all.
Not to defend them, but had the DHHS funded researchers informed and requested permission of the event organizers (to study air samples), I suspect the organizers might have agreed, and that several cloud chasers would have had competitions blowing vaper clouds directly into the air testing equipment to see how high they could get the numbers to go (just as drinkers did when the MI alcohol control agency installed a breathalizer in bars hoping to prevent drinkers from exceeding drinking limits for driving).
This same research team from VCU has had ethical lapses in the past.
Six years ago, VCU’s Tom Eissenberg held a press conference urging FDA to ban all e-cigs (a month after Judge Richard Leon struck down FDA’s e-cig ban as unlawful) after he absurdly claimed that all e-cigarettes emitted no nicotine (citing the results of his badly done study, whereby he and other never vapers recruited and instructed other never vapers to use e-cigarettes incorrectly, and found negligible levels of cotinine in their blood).
After I and others confronted Eissenberg that his study was badly conducted and urging him to ethically retract his false claims (i.e. that e-cigs emit no nicotine, and that FDA should ban e-cigarettes because they emit no nicotine), Eissenberg blamed the news media for purportedly misrepresenting what he said (even though the news media reported exactly what Eissenberg told them at the press conference).
It took Eissenberg’s team two years before they acknowledged that e-cigarettes emit nicotine (in a letter to a journal) when they published preliminary study results (in which vapers were allowed to vape as they chose instead of how VCU researchers told them to vape) and called for FDA to ban e-cigarettes once again, but that time is was because some vapers (who signed up for the study just so they could blow as much vaper into the machine as possible, to prove the original study results were false) had higher blood cotinine levels than typical cigarette smokers.
But of course, Eissenberg has never admitted that his original research was flawed, and he told me to stop sending him e-mails that urged him to do so.
FDA was so thrilled with Eissenberg’s policy activism urging FDA to ban e-cigs that they awarded him with a seat on their TPSAC and rewarded VCU with millions of dollars of federal grants (including for this recent unethical study).
Ethically, I don’t see the difference between what they did and what Repace’s minions do when they take their little backpack smoke-sniffers into bars at $50,000 a pop to show the “87% drop in Air Pollution after a smoking ban” in such bars.
You DO mention this: “they had concluded there was no human subjects aspect of this study.” which reminded me of this particularly cute little line used in the sniffer study applications/descriptions: “No risk is expected to volunteers in collecting the data or to anyone in the restaurants during data collection via the air monitor.”
Quote from Marquette Michigan’s study at:
http://www.co.marquette.mi.us/departments/health_department/docs/Marquette_Air_Report_Repace_2011.pdf
Funny how “no safe level of exposure” is ignored when the grant hungry researchers send children (i.e. young grad students) into smoky bars with hidden sniffer backpacks, eh? Guess morality gets flexible when you’re collecting $50K to $75K a pop for few hours “work” in cities all over the world, eh?
The quote on the volunteers risk has an interesting history in and of itself. I’ve cited it numerous times around the Internet over the past five years or so and also featured it in “TobakkoNacht — The Antismoking Endgame.”
Guess what? I just discovered that the link has been REMOVED… and not just erased from its normal home on the Web, but *ALSO* removed from the Internet Archives of the “Wayback Machine” at archive.org! There’s evidently a VERY diligent “Winston Smith” at work trying to cover up historical evidence with some diligent airbrushing and erasing.
Unfortunately for them, I knew it might come to this at some point: archive.org allows “owners” of webpages to “request” their removal from the archive. Soooo…. Guess what? I used an INDEPENDENT archival mechanism to save the evidence, with the full Report available at:
http://www.icyte.com/saved/www.co.marquette.mi.us/498244
You’ll find the quote on page 15 under the “Risk/Incentive” heading.
If you click on the little blue “S” on the upper right of that page you’ll see how the source website has been made “temporarily unavailable.” Amazing, eh? They actually ARE trying to rewrite history and erase evidence of what they’ve done from the entire internet! Sheesh. If I hadn’t specifically saved a copy of the file to my own computer they could simply claim at some point that I’d made it all up! Heh, I guess this is a good example of a real-world instance of “You’re not actually paranoid if they’re really….” (Although, to be fair, Antismokers have played this rewriting game in various more subtle ways so often that
their Orwellianism isn’t that much of a surprise. I actually devoted an entire section to it in TobakkoNacht.)
– MJM
Clive, you wrote, “I hope they respond to these observations, or, at least, reflect on their professional approach. (I won’t publish any response to this without their permission).”
I was quite harsh in criticizing Elizabeth Klein’s research where statistics were separated and juggled and the English language tortured so that the researchers could make the claim that smoking bans caused no economic harm or employment losses in “bars *AND* restaurants” (Emphasis mine.) The trick was to combine the much larger and less affected restaurant database with the much smaller and DECIMATED bar database figures… thereby being able to use the word “and” to hide the suffering of the bars.
Ms. Klein did not appreciate my criticisms and wrote me a quite formal email defending their research decisions and integrity. Poorly in my view, but at least she tried. So when I wrote TobakkoNacht I felt it would only be fair, after ripping her work apart, to give equal time to her and reprint her defense so that readers could judge for themselves.
Guess what? She refused to give me permission to quote from her letter to me!!! Seriously!
Sooo…. I went with the following and suggest you do something similar. From pgs. 129/130 of TobakkoNacht:
=
I have been very harsh in my judgment of Klein and Forster’s research and its presentation, both here and in many Internet postings. After those postings and after several email exchanges with me about the preceding studies, Dr. Klein sent me an email in which she presented and strongly stated a defense of her work. While I personally did not feel that the defense was adequate, I thought it would be only fair to present it here in full as a counterpoint – despite its 600-word length.
I wrote her, saying
“I appreciated the care you put into [your email] in which you defended your research work. In my writings, I *do* try to achieve some degree of balance while still strongly arguing my points. I’m wondering if I may have your permission to present your side of the issue in my future writings by reprinting your email? I think it would be more effective and present your case more truly than if I simply tried to rephrase it.”
Her response, in thirteen words, was a blanket refusal for me to share her email. Unfortunately, it seems to be illegal to publicly share email without permission, even if it is an official response from a public figure funded by public funds about their public work. I was tempted simply to leave it at that, but I think I should at least note that her two-page epistle stated a robust defense of the researchers’ reasons for their research design and an assertion of their general integrity. Part of it seemed sincere, part did not. Overall, the sense I got from a good part of her email was almost one of desperation; the sort of “Not me!” response that a little boy gives when he’s caught next to the broken cookie jar on the floor.
If Dr. Klein ever does give me permission to share her statement of defense in her own words, I will be happy to consider it for any future edition of TobakkoNacht. I truly do feel it’s important to allow people to respond when they are criticized as extensively as in this particular case. My original conclusion to this section read as follows:
“So I leave it for my readers to judge. You’ve seen my analysis, you’ve seen the headlines and references to news stories about the original research, the original studies are available online, and Dr. Klein’s defense of her work is presented above. Do you think it is an adequate defense in the face of how that work has been presented and used? Or is it not?”
Due to her reluctance to share her own words here, I guess all I can ask now is this: do you, reader, after all you’ve read here, feel that any defense she might have offered could really have been adequate? Or not? And if it was adequate, do you think she would have been so reluctant to share it publicly?”
So, as you see Clive, if they do NOT allow you to share their response, that can be more condemning in sum than anything they might have said.
– MJM
Let’s imagine a different study….. researchers go, without guests permission, into hotel rooms and take swabs, for DNA analysis, of bed sheets. I bet that wouldn’t be seen as ethical.
To clarify my use of the term “unethical study” at the end of my post above, I was referring to the authors’ deceitful comparison of particles emitted by vaping to completely different particles emitted by combustion of cigarettes and tobacco, to the authors’ falsely claiming the study’d findings justify vaping bans, and to the title’s claim that the vaping event was a “natural setting”.
But I don’t necessarily consider it unethical to conduct air tests in public places (without permission or knowledge of the owner/manager/organizer), as dozens of air tests have been conducted that way to measure levels of secondhand smoke in bars, restaurants and other public places during the past 30 years.
Please note that these types of vaping events are typically open to the public (except that no minors are allowed) and don’t charge an admission fee (as organizers typically make money by charging vendors rental fees for their booths).