That’s an interesting transcript. It managed to decrease my confidence in the ethical frameworks we have set up around medicine; most of the questions were about forms, training for forms, number of institutions to whom the forms were submitted, etc. Only a few of those questions went right to the heart of the ethical problems. Those questions were:
How do you see your obligation to these children?
Are you sure the parents understood what they were doing?
Would you do this to your own child?
There doesn’t seem to be any articulation of the risks during the session, or plans for dealing with them.
Once again I plead that when you see that an expert community looks like they don’t know what their doing, it is usually more accurate to ‘reduce confidence’ in your understanding rather than their competence. The questions were patently not ‘about forms’, and covered pretty well the things I would have in mind (I’m a doctor, and I have fairly extensive knowledge of medical ethics).
To explain:
Although ‘institutional oversight’ in medicine is often derided (IRB creep, regulatory burden, and so on and so forth), one of its main purposes is to act as a check on researchers (whatever their intent) causing harm to their patients, and the idea it is good to have other people besides the researcher (who might be biased) and the patient (who might be less well informed) be the only ones making these decisions. That typical oversight was bypassed here is telling, but perhaps unsurprising as no one would green-light violating a moratorium to subject healthy embryos to poorly tested medical procedures for at best marginal clinical benefit.
A lot of questions targeted how informed the consent was, because this was often relied upon in the presentation (e.g. “Well, we didn’t get the right mutation, but it was pretty close, and the parents were happy for us to go ahead, so we did”).
The ‘read and understand’ question (I’m using the transcript, so maybe there were dumber questions which were edited out) wasn’t a question about whether the patients were literate, but whether they had adequate understanding of (e.g.) the technical caveats which they were giving consent to proceed with (e.g. one mutation was a 15 del rather than a 32 del, which rather than the natural mutation which induces a frame shift and the non-functional protein gives a novel protein with a five aa removal, which may still generate an HIV susceptible protein and some remote chance of other biological effects).
The ‘training’ question is because establishing whether consent is ‘informed’, or providing the necessary information to make it so, isn’t always straightforward (have you ever had a conversation where you thought someone understood you, but later you found out they didn’t?) I did a fair amount of this in medschool, and I don’t think many people think this should be an amateur sport.
(As hopefully goes without saying, having two rounds of consent where in each the consent taker is a researcher with a vested interest in the work going ahead has obvious problems, and hence why we’re so keen on third party oversight).
I also see in the transcript fairly extensive discussion about risks (off-target worries would have been tacit knowledge to the audience, so some of this was pre-empted in the presentation then later picked at), and plans for followup etc.
Nothing you are saying comes as a surprise, but my confidence in the process remains reduced. The problem here is that having a procedure for establishingwhether a patient is informed, all of the weight rests on the procedure, and virtually none on the practitioner. This is the same for all fields of expertise.
I have read many of these kinds of forms as a patient. What we want them to be for is informing the patient; what they are actually for is defending against the accusation that the patient was not informed.
The audience was very much preoccupied with how the procedure for informing the patient was conducted, and seemed to consider this the biggest red flag. I find the fact that the lead scientist kept referring to a form to be the biggest red flag, because it suggests he didn’t engage the ethical issues directly.
Suppose for a moment that he did a much better job informing the patients—proper training, third party verified composition, etc. I don’t think this would have any implications at all for how He Jiankui engaged with the question of whether it was right to do this, but I do expect the audience to have been largely mollified. I see this as a problem.
Watching the Q&A was mindbending, and reminded me why I dislike bioethicists so much. Asking He Jiankui whether the participants were literate enough to read the forms! (You got one question, with so many important things to ask, and that was the point you decided to make?)
Transcript of He Jiankui’s comments at the Second International Summit on Human Genome Editing (plus Q&A).
That’s an interesting transcript. It managed to decrease my confidence in the ethical frameworks we have set up around medicine; most of the questions were about forms, training for forms, number of institutions to whom the forms were submitted, etc. Only a few of those questions went right to the heart of the ethical problems. Those questions were:
How do you see your obligation to these children?
Are you sure the parents understood what they were doing?
Would you do this to your own child?
There doesn’t seem to be any articulation of the risks during the session, or plans for dealing with them.
Once again I plead that when you see that an expert community looks like they don’t know what their doing, it is usually more accurate to ‘reduce confidence’ in your understanding rather than their competence. The questions were patently not ‘about forms’, and covered pretty well the things I would have in mind (I’m a doctor, and I have fairly extensive knowledge of medical ethics).
To explain:
Although ‘institutional oversight’ in medicine is often derided (IRB creep, regulatory burden, and so on and so forth), one of its main purposes is to act as a check on researchers (whatever their intent) causing harm to their patients, and the idea it is good to have other people besides the researcher (who might be biased) and the patient (who might be less well informed) be the only ones making these decisions. That typical oversight was bypassed here is telling, but perhaps unsurprising as no one would green-light violating a moratorium to subject healthy embryos to poorly tested medical procedures for at best marginal clinical benefit.
A lot of questions targeted how informed the consent was, because this was often relied upon in the presentation (e.g. “Well, we didn’t get the right mutation, but it was pretty close, and the parents were happy for us to go ahead, so we did”).
The ‘read and understand’ question (I’m using the transcript, so maybe there were dumber questions which were edited out) wasn’t a question about whether the patients were literate, but whether they had adequate understanding of (e.g.) the technical caveats which they were giving consent to proceed with (e.g. one mutation was a 15 del rather than a 32 del, which rather than the natural mutation which induces a frame shift and the non-functional protein gives a novel protein with a five aa removal, which may still generate an HIV susceptible protein and some remote chance of other biological effects).
The ‘training’ question is because establishing whether consent is ‘informed’, or providing the necessary information to make it so, isn’t always straightforward (have you ever had a conversation where you thought someone understood you, but later you found out they didn’t?) I did a fair amount of this in medschool, and I don’t think many people think this should be an amateur sport.
(As hopefully goes without saying, having two rounds of consent where in each the consent taker is a researcher with a vested interest in the work going ahead has obvious problems, and hence why we’re so keen on third party oversight).
I also see in the transcript fairly extensive discussion about risks (off-target worries would have been tacit knowledge to the audience, so some of this was pre-empted in the presentation then later picked at), and plans for followup etc.
Nothing you are saying comes as a surprise, but my confidence in the process remains reduced. The problem here is that having a procedure for establishing whether a patient is informed, all of the weight rests on the procedure, and virtually none on the practitioner. This is the same for all fields of expertise.
I have read many of these kinds of forms as a patient. What we want them to be for is informing the patient; what they are actually for is defending against the accusation that the patient was not informed.
The audience was very much preoccupied with how the procedure for informing the patient was conducted, and seemed to consider this the biggest red flag. I find the fact that the lead scientist kept referring to a form to be the biggest red flag, because it suggests he didn’t engage the ethical issues directly.
Suppose for a moment that he did a much better job informing the patients—proper training, third party verified composition, etc. I don’t think this would have any implications at all for how He Jiankui engaged with the question of whether it was right to do this, but I do expect the audience to have been largely mollified. I see this as a problem.
Watching the Q&A was mindbending, and reminded me why I dislike bioethicists so much. Asking He Jiankui whether the participants were literate enough to read the forms! (You got one question, with so many important things to ask, and that was the point you decided to make?)