More debate on medical ethics
I saw in the Herald that a Tim Dare has responded to the excellent op ed by Dr Shaun Holt on the bureaucratic PC ethics approval system for the most basic of health experiments (the example was honey on a rash).
Now when Dr Holt did his original op ed I noted he provided an actual example of how the system was nonsense, and that he spoke from first hand knowledge, being a Doctor.
So before I even read Tim Dare’s response, I crolled down to the end to find out whether he was someone with a vested interest in defending the status quo. And indeed:
Dr Tim Dare is head of the department of philosophy at the University of Auckland and chairman of the Health Research Council ethics committee.
Interesting. Dr Dare is chairman of the HRC ethics committee (which makes him the ultimate vested interest) but he is also (to quote Rob Muldoon) one of those doctors who makes you sick, not well 
But what does he say:
Dr Holt is moved in part by his experience as a former ethics committee member and researcher. He recently sought approval for a study looking at whether honey helped treat a common childhood skin condition.
“Only 15 children were required,” he reports, “and all the caregivers had to do was to apply the honey, cover with a dressing and see if it seemed to help.”
The ethics committee refused permission, he says, raising more than 40 objections. He gives as an example of its obstructive approach a requirement for Maori consultation.
This is misleading. I was a member and chair of New Zealand’s busiest health research ethics committee for seven years. Some very difficult applications, such as those requiring the development of new policy, took a long time. But the vast majority were dealt with at the meeting following their receipt (within two or three weeks), as required by national guidelines. Even allowing time for letters following that meeting, few were still open six to eight weeks after receipt.
He says this is misleading, but nowhere does he dispute that Dr Holt was refused permission and had over 40 objections to overcome to what appears to be the most simple of experiments.
And rather than quote actual statistics on turn-around, we only get told ” the vast majority” and “few”. I prefer hard numbers. But the issue is not just about time to make a decision, but the hurdles that applicants have to jump through prior to application.
Delays beyond that were often because researchers took time responding to committee requests for clarification or amendment.
So it is their fault. Again no statistics on this.
Dr Dare turns to Dr Holt’s proposal and comments:
Dr Holt’s account of the treatment of his own proposal is also less than complete. Ethics committee minutes are publicly available. The minutes for Dr Holt’s study before the Auckland committee (to see them, run NTX/08/09/085 through Google) indicate that the committee deferred a decision on Dr Holt’s honey project because they were concerned about its validity.
They seem concerned the study did not have enough participants and that parents were required to change dressings and wash the affected area during the study without an indication how Dr Holt would know whether it was the honey or the washing that made the difference. There is mention of Maori consultation, but it is not given as the primary reason for deferral.
These are very ordinary concerns about research validity: one of the legitimate roles of an ethics committee is to ensure that health therapies cannot claim to have been shown effective unless the research is rigorous and sound.
Note that the committee did not decline approval: they deferred a decision. Dr Holt chose to not clarify or amend his study.
It was good of Dr Dare to provide the Google reference as it does provide the minutes of the meeting. But I think the minutes prove Dr Holt’s point. Look at the changes that were demanded for such a simple study:
• Study, as it stands, is a pilot and this needs to be stated in the title, and then reflected in the design, the research question(s) and the PIS and consent form. Alternatively, the researcher may choose to power the study, after consulting a statistician
• Guidelines NAFG to be consulted.
• Part 1: Provide positions/qualifications/organisations of co-investigators
• A3.1: Insert information regarding washing the MC lesion every 2 days (same as PIS).
• A1.2: Explain what type of honey will be used and the justification for using this.
• A3: Study Design: It is planned to dress 1 MC with honey, cover it then, for the next four weeks, wash it every 2 days wash it, dress it with honey and cover it while the other MC is left untouched. Clarify how the researcher will determine which of these interventions is causing any effect seen.
• A3: Randomize over two chosen sites, and include an osmolarity control.
• A3: Explain how participant compliance with study design will be monitored between visits
• A4.1: Explain how the 15 child participants will be assigned in respect of each locality
• B10: Grounds for exclusion to be ‘factual’ not left to doctor.
• B11: Provide worksheet. What information is being collected and why?
• B12: Explain why a dressing known to cause allergic reactions will be used, rather than a non-adhesive dressing, and explain how the cause of any adverse reaction will be ascertained.
• B12: If removed from the study what treatment will be offered to the child?
• B16: Clarify ‘safety reasons’.
• D5/6/7: Data to be kept until age of majority plus 10 years (Health Act – Children)
• E: Researcher to explain how interpreters are accessed, if used
• Section F: Consultation needed from Tauranga Maori Health Providers. Honey is food – are there cultural implications?
• Locality Assessment Cannot be signed by PI. To be redone.
• Pt 4 Declaration: 2: Cannot be signed by PI. To be redone.
• B11: Provide worksheet?
• Provide an information sheet/consent form for children under 15.
• A8.1: Provide itemised budget that justifies the $900 payment to doctors. Without such detail we are unable to assess whether the payment to doctors might act as inappropriate inducement to recruit and retain.
• D4: The committee is concerned that having the initial approach made by the GP increases the potential for conflict of interest and coercion of the participant, given the payment per participant that is proposed.
Hell I would have given up at this point also.
March 16th, 2009 at 12:08 pm
I think Whaleoil would call it Cockwaffle.
March 16th, 2009 at 12:16 pm
I thought Dr.(not medical) Peter Davies would have been in charge of this committee. Nonetheless this is the type of absolute crap that epitomized the Liabour administration…After he has finished with the councils Rodney should tackle this outfit.
March 16th, 2009 at 12:17 pm
Tim Dare indicts himself. Ha ha.
It is funny these types trying to put positive spin on rubbish situations. They weave in and out, trying to obfuscate the basic issue.
Too many managers make simple problems complex.
March 16th, 2009 at 12:39 pm
Baxter’s comparison with councils is apt. This looks very similar to the “requests for further information” one receives when making relatively simple applications for consents and permits.
In my opinion the entire problem is caused by only one simple reason, namely that these ‘processes’ are initiated, designed, and managed by corrupt, incompetent, PC-correct lickspittles. These are typically people without any experience in the real world or a modicum of ordinary common sense, such as career academics, career politicians and their ilk.
Getting rid of this type of red-tape freaks would certainly boost the economy and perhaps lift the dreadful doom and gloom that covers this country like a shroud covers a plague infested corpse.
March 16th, 2009 at 12:45 pm
Fucksakes! Cultural implications of honey??
March 16th, 2009 at 12:48 pm
I’ve worked with Tim before. He’s a very nice guy, and very clever fellow.
(I don’t know anything about ethics, though. Or committees.)
(Well, a bit about committees. I grew up in a Presbyterian church.)
March 16th, 2009 at 12:49 pm
Ryan, if so, then why the rubbish?
March 16th, 2009 at 12:50 pm
It’s all… wait for it… IT’S ALL JUST POLITICAL CORRECTNESS GONE MAD, I TELL YOU!
Loving all of these opinions about it that are informed more by political ideology about red tape than by anything medical
No doubt “the feminazis” have a hand in all of this too…?
March 16th, 2009 at 12:55 pm
Beats me. I don’t know enough about the topic to make a judgement. It’s possible he could explain himself better with further discussion. I just felt compelled to say something nice about him – without saying anything about his letter. Just cos he’s such a decent sort.
March 16th, 2009 at 12:58 pm
Aren’t these people supposed to be checking for safety of participants, not judging the design and effectiveness of the experiment?
March 16th, 2009 at 1:03 pm
I think ethics is supposed to extend a bit beyond safety, but yeah, presumably, unless approval implies some kind of funding.
March 16th, 2009 at 1:20 pm
Whatever happened to Aim, Method, Observation, and Conclusion?
March 16th, 2009 at 1:27 pm
I’m not impressed by the stress placed on ‘Maori Health Providers’ and ‘cultural implications’ but most of the objections seem very reasonable. It looks as if Dr Holt did not fill in his application correctly (‘Provide positions/qualifications/organisations of co-investigators’ – possibly the most fundamental detail you can provide) and failed to explain how his study would proceed (Provide worksheet. What information is being collected and why?) or what it would achieve (clarify how the researcher will determine which of these interventions is causing any effect seen.).
The study sounds innocuous enough but the reality is that carrying out medical experiments on children is a big deal, and any ethics council is going to take such a study VERY seriously. It seems completely reasonable to turn down someone who fails to provide basic details about the nature of their experiment.
March 16th, 2009 at 1:47 pm
Yeah, I’m not sure why this would need iwi approval but other than that it seems reasonable. One of the important factors an ethics committee needs to consider is whether a trial will actually produce meaningful results – both to prevent participants doing pointless experiments and in terms of how the results will be used later on. It seems from those points that this application didn’t explain how they would control for various potential problems. Perhaps there should be a lower bar in that regard for pilot studies that won’t themselves be published (as I presume was never the aim of a 15 person trial!) but as Danyl points out people are going to treat any experiment on children very carefully.
March 16th, 2009 at 1:57 pm
Section F: Consultation needed from Tauranga Maori Health Providers. Honey is food – are there cultural implications?
Sick and tired, sick and fucking tired of this Maori prima inter pares P.C. bullshit.
“Don’t build a motorway there! There’s a Taniwha that lives there!”
“Don’t implement private prisons, the Treaty of Waitangi enshrines Maori rights to plasma TVs!”
“Don’t restructure welfare! Lounging around doing fuck all is an integral aspect of Maori’s rich cultural heritage!”
STOP referencing every little thing that occurs in the public sector to Maori special interest. Maori are a small segment of the population and the rest of us don’t care what the beneficiaries and the criminals think.
March 16th, 2009 at 2:00 pm
My vote is that it all looks reasonable apart from the cultural bit & to be honest why was Dr Holt doing a 15 person trial, that’s meaningless surely in terms of numbers & raises the next question why use the ethics committee unless their approval carried some form of recognition or just plain credibility ( I’m assuming he could have done the trial in some form without the ethics committee approval ). I’ve got to say it sounds like a beatup from a person who just didn’t get what he wanted.
March 16th, 2009 at 2:02 pm
It’s also interesting to look through the other submissions in the same meeting, most of which were approved (although I note ‘Journey back into Body and Soul’ – Exploring the effects of yoga practice in people with Psychosis’ was not).
Read in context it looks as if the 40 objections to Dr Holt’s study had less to do with ‘political correctness gone mad!’ and more to do with the poor quality of his submission.
March 16th, 2009 at 2:23 pm
It’s hard to say, without seeing the forms etc, whether this is a case of forms poorly filled in, or a case of forms poorly designed, and with bits that are mandatory despite them being meaningless in this particular case.
So, for example, providing qualifications of co-investigators. Perhaps the form had a spot for co-investigators, and only the name of them was listed without any qualifications provided (i.e. form very poorly filled in). Or, perhaps the form had a section for co-investigators, Dr Holt had none, so he (reasonably) left it blank. The implication of those two is very different. I imagine that many of the points listed could equally go either way.
It sounds a little to me like someone from outside the system having difficulty in filling in the forms, where someone inside the system just knows what to fill in, and everything goes smoothly. Which is also often the case with councils – if you are experienced you know to write in “no co-investigators” in the co-investigators section, and thereby avoid that question.
If you’re on the committee and you’re doing 40 of these in a day, you’re probably saying to yourself “why can’t this guy get it right, everyone else figured it out.” And if you on the outside looking in, you’re probably saying “why the hell is this so damn hard.” There are many processes that work like this, and it takes someone quite smart and interested in customer service to be able to notice that there is a problem, and harder still, to make the forms work for both groups.
March 16th, 2009 at 2:36 pm
That’s all true Paul – although I generally find its easier to get a member of whatever institution or committee I’m applying to to work through the form with me and help me out, as opposed to throwing a temper tantrum and writing a furious editorial in the nation’s largest newspaper calling for the institution to be disbanded.
March 16th, 2009 at 2:44 pm
Hi all – I’m delighted that my article has brought the issue out into the open. I’ll be responding to Dr. Dare in a letter to the New Zealand Medical Journal. As you may expect, I disagree with most of his article, specifically:
1. They can not find the international guidelines that I referred to which state that you only need 5 members of an Ethics Committee. This is stunning: the guidelines I referred to, ICH-GCP are THE global guidelines for undertaking clinical trials (http://www.ich.org). It is hugely worrying that they did not know about them.
2. I did not say that private Ethics Committees should be the norm – I said that they should be allowed for those who want to use them, and those that do not want to can use the public system.
3. The primary reason that the study was not approved was because they said it was too small. Anyone who knows anything about research knows that the first time you are trying a treatment, based on anecdote and limited data, you start with a pilot study of 10-15 participants. Pilot studies will rarely give you a statistically significant result and they are not designed to – they tell you if it looks like you may be onto something. This was explained clearly to the Committee and they did not understand this, one of the most basic facts in research. It would in fact have been unethical to have started with a massive trial.
4. Yes, the NZ system takes around the same time as overseas systems (60 days, when it could be done in 5 days). The point I was making was that we need to make the system much quicker if we are to attract investment in clinical research in NZ, not be around the same as everyone else. This could easily and quickly create a $100 million industry, retain scientists provide an infrastructure to develop drugs in NZ and would not cost the Government any money. Someone previously asked why this was not raised at the jobs summit, as simple regulatory changes that could create jobs was one of the main goals. I asked to attend to raise this idea but was not invited.
5. Maori consultation. Since around 1998, it has been compulsory to consult with Maori before submitting a study to Ethics. Also, Ethics Committees must have at least 2 Maori members. The idea is to make sure that there are no cultural issues with the research, and in my experience, there very rarely are, and if there were, surely the Maori members of the Committee would pick them up. I consulted as usual for the honey study and attached the letter of support and you can see from the reply that I had to consult with more Maori Health providers. Whilst this was not given as the primary reason for rejection, there was no choice but to do this to get the study approved.
6. Apparently my article is not helpful – I disagree. I’ve had many emails in support from frustrated researchers and no one else is making a stand on this issue at the moment.
And to answer specific comments from above…
“It looks as if Dr Holt did not fill in his application correctly” – I was on an Ethics Committee for 3 years and have made probably 100 applications – I know how to fill the form in! The question re qualifications was particularly bizarre- I gave full contact details of the co-investigators and described their qualifications as General Practitioners. That’s all there was to say and it was I’ve done on every previous application. And the application stated exactly what questions we were asking….but they wanted to actually see the sheet with them written on.
“It seems from those points that this application didn’t explain how they would control for various potential problems.” – again this was bizarre. Molluscum generally lasts for 6-24 months and there are few treatments and those can be painful and scarring. The issue was that they thought that when the honey was cleaned off and every 2 days and more honey was applied, then this cleaning could be treating the condition!! This is beyond belief and could only be a factor if children with molluscum did not wash during the 6-24 months that they have the lesions.
“why use the ethics committee unless their approval carried some form of recognition or just plain credibility” – its a legal requirement that an Ethics Committee approves a clinical trial before it starts. I also think this is a good thing.
“beatup from a person who just didn’t get what he wanted.” – if you think that doctors who have potentially great, simple treatments that can help children, or anyone else, and they shouldn’t be allowed to test them, you’re as bad as they are. I think that’s unethical.
“poor quality of his submission” – see above, I’ve probably seen or submitted as many application as anyone. It was poor quality of the Committee who were not up to the job.
Thanks for the support and for discussing this issue.
Shaun Holt
March 16th, 2009 at 2:49 pm
If funding is sought, fair go. But incorrect form-filling is a time-honoured excuse for doing nothing. The Ministry of Health rolled out that non-compliance rubbish in select committee last year, declining applications due to 47/B being blank instead of having N/A or one of those high priest specialist doctors had to sign off in triplicate.
In the words of Kevin Bloody Wilson, they’re supposed it easy not to making it fuckin’ hard. As I understand it, the study won’t be appearing on the cover of Science or Nature tomorrow. Objections by the committee should only qualify the study, not rule it out. And as for child experiments, we’re throwing Ritalin down our kids’ throats and tinkering with their brain chemistry. A little honey on a scratch is a pretty low-risk bet in comparison.
March 16th, 2009 at 3:07 pm
Oh come ON; THIS is debate on medical ethics? When there is stuff like creating embryos to destroy in research, and cloning, and mixing DNA of human and other species? And little ol’ Godzone calls putting honey on rashes, a question of medical ethics? Hahahahaha.
March 16th, 2009 at 3:34 pm
AAARRRRGGGGGGHHHHHH!!!!!!!!!!!!!!!!
March 16th, 2009 at 4:43 pm
Dr Holt,
Congrat’s on posting, I m curious though, why should NZ lead the rest of the world in reducing the time to get clinical trials approved when the FDA in the US is going through serious questioning over issues like VOIXX. Surely the risk to what reputation we have for clinical research is worth more than any decision that could jeopardise that without strong overseas evidence that such a change works, certainly a $100m industry is not significant enough to damage NZ’s clean green image & I’d argue “clinical trials” gone wrong are not going to make us look good.
Lastly, is what is required not something more akin to a tiered system, adding honey to a dressing seems a particularly safe concept, so could be approved by something more akin to a district court hearing vs high court hearing, for lack of a better analogy. Then if the trail does need to progress to the next level the approval process could move up to the higher level, but initially trials deemed to have insignificant potential side effects could be “fast tracked”.
March 16th, 2009 at 5:09 pm
Hi Nigel. You make some good points, although I’m a little confused by your first one – we can have a quicker, better system for approving research, but there’s no reason why they can’t also be of the highest quality. Australia has a private, faster, fee-paying ethics committee and it works well over there. http://www.bellberry.com.au/. There was nothing wrong with the Vioxx clinical trials as far as I know, but the FDA may well have messed up with their approval. There are many reasons for doing more trials here, not least better access to the best medications. Imagine if you had breast cancer and were able to get Herceptin at no cost on those trials. In all trials, patients have informed consent and can look at it and weigh up the pros and cons of taking part.
And your second point is excellent – great idea.
March 16th, 2009 at 10:12 pm
Shaun, kudos for posting. As I said, hard to tell from the outside whether it is bureaucratic time wasting or forms poorly filled in. Based on your comment, I’m calling it bureaucratic time wasting. That also means further that Tim Dare is obfuscating when he claims there wasn’t a problem with the process, which means he’s part of the problem, not part of the solution.