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.