Friday, October 04, 2019

Undertaking ethical psychiatric research in the global south’s prayer camps – is that even possible?


Psychiatrists associated with elite institutions in the global north teamed up with counterparts in Ghana with a view to determining what impact the use of gold standard of care drugs plus ‘faith healing’ protocols would have vs ‘faith healing’ only. The venue of their research was an evangelical prayer camp where the ‘faith healing’ protocol consisted in keeping many psychiatric patients in chains, making them pray and making them fast. [i]

[This man lived in a Prayer Camp – he is drinking from a dirty container which staff put water in for him to drink. He slept, ate, and defecated beside the tree where he was chained ((c) 2012 Nick Loomis/Human Rights Watch] 
Comprehensive Mental Health Bill Passed in Ghana has yet ... 
The randomised trial discovered that those patients who were subjected to mainstream drugs did better than those who received only ‘faith healing’. The results, ultimately, were not overwhelmingly positive for patients in either group, which may have had to do with the short duration of the trial and/or the lack of efficacy of some of the mainstream drugs used. There were some improvements in the group provided with drugs, but apparently that had no impact on the amount of time they spent chained to the floor in said ‘faith healing’ facility. 

Let me say at the outset that I do think the researchers went into this research project with the best of intentions, likely hoping they would be able to show that more patients would improve faster if they received mainstream psychiatric drugs when compared to ‘faith healing’ only. In turn that should have led to the unchaining of more such patients than if they were subjected to ‘faith healing’ only. It should have also impacted positively on what is offered to patients like them, going forward. They were clearly aware of the problems to do with undertaking a clinical research project ethically under the circumstances, ie psychiatric patients chained to the floor in a ‘faith healing’ facility. The objective of this Editorial is not to castigate them as irresponsible researchers exploiting a small group of chained-up psychiatric patients in Ghana.

Several ethical issues arose, based on their own reporting of their trial method and the difficult circumstances under which they proceeded with their trial. They claimed essentially that the trial participants were volunteers who had entered the prayer camp voluntarily and who had given voluntary first-person informed consent to trial participation.  A neutral observer can’t help but wonder, to what extent a psychiatric patient chained to the floor is truly able to give voluntary consent to anything. It turns out, by the researchers own (honest) reporting, there were some patients who were apparently unable to respond to their questions. Clearly those patients then were also unable to consent to trial participation, and yet, some of them were apparently enrolled regardless. One has reason to doubt that they entered the facility voluntarily. 

Given that a significant number of trial participants were reportedly illiterate, the information was read to them, and their consent (bar that of those deemed unable to provide first person informed consent) was then taken to be sufficiently informed. Apparently, nobody validated whether those patients had a reasonable understanding of the trial method and of their options vis a vis their participation. Apparently, when family ‘consent’ (aka authorisation) was sought this occurred often by phone. No paperwork existed that would have validated that authorisation. No record exists to evaluate the interactions between the researchers or their intermediaries and the people on the other end of the phone line, people they took to be family members. 

Of course, another issue is the existence of, effectively, a placebo arm (ie the ‘faith healing’ arm) when a gold standard of clinical care was provided as part of the trial (ie the active agent in the other arm). These issues have been litigated elsewhere, so I will not repeat those arguments on this occasion.

When I read about this trial I couldn’t help but wonder whether ethical research is possible under circumstances this academic situated in the global north considers barbaric. On the one hand, it’s a fact that in the global south many such prayer camp equivalents exist, and the care provided to – often impoverished – psychiatric patients is indefensible on professional grounds, and yet, that is also all there is. 

Anybody concerned about the well-being of psychiatric patients finding themselves in such facilities, voluntarily or by coercion, should be supportive of research aimed at improving their lot. And yet, there are obvious questions about the how-to in terms of how this research team went about recruiting trial participants. I have flagged some of those questions. The broader question is though, whether ethical research is possible in such contexts at all.

UDO SCHUKLENK

[This is a draft version of an Editorial that is going to be published in Developing World Bioethics 2019; 19(4)]

[i] Ofori-Atta, A, Attafuah, J, Jack, H, Baning, F, and R Rosenheck. 2018. Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial. British Journal of Psychiatry 212: 34-41.

Wednesday, August 14, 2019

How we operate the review process at Developing World Bioethics

Developing World Bioethics branding bannerI had the great fortune of attending the World Congress of Bioethics in December 2018 in Bengaluru, India. Besides my participation in two panels, I also hosted – jointly with Brian Collins, our Editor at Wiley‐Blackwell, the publisher of Developing World Bioethics – a workshop on academic publishing. It was meant to give prospective authors an opportunity to ‘meet the Editor’ so to speak, to acquire insight in the academic publishing enterprise, and last but not least, to ask us pretty much any questions that they might have, in so far as they relate to the publication processes of the journal.
There seemed to be a number of misconceptions about how peer review operates generally, and vis a vis this journal in particular. For instance, concerns were raised that ‘big name’ authors, or at least senior academics, might receive preferential treatment, and the question was asked whether such academics’ names should be added as authors to submitted manuscripts in order to improve the manuscript's acceptance chances.

Let me say, at the most basic, this journal is bound by the International Council of Medical Journal Editors guidelines on authorship.1 I would strongly encourage you to look those up and ensure that you and your co‐authors all meet those criteria. In multi‐author submissions each of you would have to confirm that each of you individually meets those criteria. If you decide to add a name of someone as an author who does not meet those standards, then you and they would have to proactively lie to us during your submission process, because you would be asked what each of you contributed to the paper, and how each of you met the criteria set out in the mentioned guidelines on authorship. I would strongly discourage you from any deception in this context.

The journal's Managing Editor, Andy F. Visser, will then pass the received manuscript on to both of us, myself, and Debora Diniz, the Co‐Editors of the journal, asking us for a determination on whether the paper should be send out for external peer review or whether we should reject it outright. The policy at this journal is that both the Managing Editor as well as the journal's Co‐Editors are always aware of the author(s) identities.

The Co‐Editors of the journal make then a decision on whether or not a submitted paper is prima facie worthy of peer review. That means that we will ascertain whether the submitted paper is within the remit of the journal, whether the analysis seems coherent, and whether references follow academic standards. If we think the submitted paper does not meet those standards it will be rejected by us without further peer review.

Once we have decided that a manuscript is worthy of external review, each of us as Co‐Editors chooses their own preferred peer reviewer. We do this without consulting each other, mostly in order to avoid any undue influence on or from each other. Reviewers are typically chosen with a view to receiving quality feed‐back with regard to the specialist subject area of the paper in question. As Co‐Editors we might have specialist expertise in a number of areas within bioethics, but certainly we don't have that kind of expertise with regard to most papers submitted to this journal. That's one of the reasons for external review.

We communicate our choices back to the Managing Editor who then invites our chosen reviewers to review the manuscript in question. At that point in time the manuscript is anonymised, the reviewers have access to the article but all author identifying information is removed.

There are other models of peer review, so why have we chosen this model? We try to avoid influencing reviewers’ decisions by removing author identifying information. We know today that anything from an author's name (because it's linked to fame, notoriety, sex, ethnicity, religion, etc) to their academic affiliation can bias reviewers. We prefer our reviewers are not subjected to such information, irrelevant as it is when it comes to reviewing the quality of a particular submission. A graduate student's submission will be treated no different than a submission by the most influential bioethicist alive today. There are other reasons to do with the size of our comparably small field. For instance, a junior academic might be negatively affected if their weak submission was rejected by a reviewer who also happens to be on an appointments committee that decides on whether or not the author of the rejected paper should be shortlisted for a job interview.

Equally, when we receive the reviews and pass them on to the author(s) with our editorial decision, the reviewers’ names are stripped off the reviews. In order to facilitate frank reviews it is counterproductive for reviewers to know, for instance, that during the next conference that they will be attending there will be authors who are supremely frustrated that their reviews led to a rejection.
The system of peer review we operate ensures that reviewer biases are reduced as much as is feasible, and it protects reviewers’ ability to provide us as Co‐Editors with frank reviews. We do think that it also protects authors, especially authors whose content has been rejected, from having to face their reviewers in person during the next academic conference that they are attending. Then there is the risk that a rejected author tries to get even with a reviewer if – by chance – they happen to get invited to review the submission of a now‐author turned reviewer.

To cut a long story short, we maintain a process of peer review where neither the reviewers nor the authors know each others’ identities. The main motive for this policy is to remove biases from the review process.

Wiley Blackwell has produced a fair number of useful tools2 that you can access if you wish to find out more about academic publishing generally, and peer review in particular.3

Also worth noting, this journal follows the procedures and policies laid out in a series of flowcharts produced by the Committee on Publication Ethics.4

Do keep in mind, Editors are human beings, much like you. Mistakes can happen. Nothing should stop you from communicating your concerns to us. We will always aim to deal promptly and transparently with your concerns.

1) http://www.icmje.org/recommendations/browse/roles‐and‐responsibilities/defining‐the‐role‐of‐authors‐and‐contributors.html
2) https://authorservices.wiley.com/author‐resources/index.html
3)  https://authorservices.wiley.com/author‐resources/Journal‐Authors/submission‐peer‐review/peer‐review.html  
4)  https://publicationethics.org/guidance/Flowcharts

2019 Google Scholar Metrics for Bioethics Journals

Quite possibly the below table will be displayed in odd ways on your screen. 

Usual CoI blurb applies. I co-edit two of the journals in this list. List up-dated August 2019. Any mistakes are my own, please alert me if you discover discrepancies between what I am reporting and what you're able to find on google scholar.


                                                                                                                           h5               h5-median

  1. Nursing Ethics                                                                              37          51 
  2. Science and Engineering Ethics                                                         36           52
  3. Journal of Medical Ethics                                                             34          44 
  4. The American Journal of Bioethics                                              31        39
  5. bmc medical ethics                                                                       30           43 
  6. Bioethics                                                                                       25         35 
  7. Hastings Center Report                                                                 24          35  
  8. Journal of Law, Medicine and Ethics                                                 23         37     
  9. Medicine, Health Care and Philosophy                                        23         35
  10. Neuroethics                                                                                   19         27
  11. Journal of Empirical Research on Human Research Ethics         19          26
  12. American Journal of Bioethics Neuroscience                              18            27
  13. Journal of Bioethical Inquiry                                                                     18        25
  14. Nursing Philosophy                                                                          18      22 
  15. Cambridge Quarterly of Healthcare Ethics                                            17          22 
  16. Journal of Medicine and Philosophy                                              16          22 
  17. Kennedy Institute of Ethics Journal                                                16          22
  18. Health Care Analysis                                                                     15       22
  19. Public Health Ethics                                                                                 15          19
  20. NanoEthics                                                                                               14         20 
  21. Theoretical Medicine and Bioethics                                                         14          18 
  22. Developing World Bioethics                                                                    13          17
  23. Journal of Medical Ethics and History of Medicine                           12         25 
  24. HEC Forum                                                                                       12         20
  25. American Journal of Bioethics Empirical Bioethics                                12          14 
  26. Indian Journal of Medical Ethics                                                     11       17
  27. The Journal of Clinical Ethics                                                        11          15
  28. Ethik in der Medizin                                                                         9           14
  29. Perspectives in Biology and Medicine                                                9        14
  30. Narrative Inquiry in Bioethics                                                                8              12
  31. International Journal of Feminist Approaches to Bioethics              8         11
  32. The New Bioethics                                                                           8            11
  33. Ethics, Medicine and Public Health                                                 7           10 
  34. South African Journal of Bioethics and Law                                         7            7
  35. Christian Bioethics                                                                            5          7
  36. Ethics and Medicine                                                                        5             6 
  37. Asian Bioethics Review                                                                   4           7
  38. JAHR - European Journal of Bioethics                                             4          5
  39. Journal international de bioethique                                                  4             5
  40. National Catholic Bioethics Quarterly                                              4             5
  41. Chinese Medical Ethics                                                                   2             2




*h5-index is the h-index for articles published in the last 5 complete years. It is the largest number h such that h articles published in 2014-2018 have at least h citations each
**h5-median for a publication is the median number of citations for the articles that make up its h5-index

Thursday, January 24, 2019

Certainty is not a defensible standard for policy making in the context of assisted dying


Image result for certaintyI mentioned in a Bioethics editorial a while ago that new frontiers are opening in the assisted dying debate. As an increasing number of jurisdictions decriminalize assisted dying in some shape or form, ethical arguments against all models of assisted dying are seen increasingly as settled in favour of this practice. I suggested in said editorial that the focus of the academic debate has shifted toward a new set of questions: the scope of assisted dying (i.e., who should be eligible), the status of advance directives, and the issue of conscientious refuser accommodation.[1] It seems my prediction wasn't far off the mark. The Canadian Academies have produced a voluminous expert panel report focusing extensively on scope (mature minors, mental illness) as well as the issue of advance directives. I highly recommend it to your attention.[2]

Unfortunately, as is so often the case with these sorts of panels, it is unclear how its members were appointed: Why was a particular member appointed and not someone else? What criteria were used to determine who would and who would not be chosen? And, indeed, did the funder of the report, the Government of Canada, have a veto right on particular potential expert members? All of this matters if the sponsor of the report, in this case the Canadian Academies, wants to meet basic standards of public reasonableness and accountability. After all, the Government of Canada is currently defending its restrictive assisted dying legislation in the Supreme Court of Canada. The expert panel was tasked with summarizing the state of knowledge, but not with providing policy guidance to the government. It is not inconceivable that the government hopes to use evidence from these ostensibly authoritative reports in the Court. For that reason alone, transparency about the procedures guiding the appointment of experts drafting reports financed by that same government is important.

The chairperson of the group drafting the report on mental illness and assisted dying, Kwame McKenzie, made a statement to Canadian news media in support of current government policy that excludes competent people who suffer from refractory mental illness from access to assisted dying. He reportedly cautioned that ‘no one can be completely certain that a mentally ill patient is never going to get better’.[3] Which takes me to the actual topic of this blogpost: certainty as a standard for health policy making. Complete certainty, if that were ever possible in the context of health and disease, where most decision making is based on probability as opposed to certainty, might be a defensible threshold if nobody were harmed by the implementation of such a high standard. If the setting of a high standard were cost neutral, there would be no good reason not to have such a standard.

Of course, in the real world, such an elevated standard comes at a cost. A high price is paid by those patients who have decisional capacity and live with refractory mental illness that renders their lives not worth living to them, who would avail themselves of assisted dying if it were available to them.[4] Regulatory attempts influenced by Dr McKenzie's demand for certainty would result in a restrictive eligibility policy harming precisely those patients who will, in reality, never get better. It is uncontroversially true that that is the case for many patients, particularly those suffering from refractory depression. Dr McKenzie's take is identical to the policy favoured by the government sponsor of this report. High suicide rates among this particular group of patients suggest that many of these patients vote with their feet while well intentioned experts and policy makers implement policies that are detrimental to what is arguably in their best interest.[5]

Ultimately, policy makers implement legislation aimed at overriding competent patients’ choices simply because they disagree with their choices. The justification for such strong paternalistic action rested so far on vacuous labels, such as ‘vulnerability’, under the cover of which individual agency was removed wholesale from a whole class of patients with legal capacity. This is now apparently complemented by demands for certainty. If medical practice and health policy depend on certainty as a conditio sine qua non, going forward, no further regulatory action can be taken on any subject. In fact, the current assisted dying legislation, as it requires that death of the assistance‐seeking person is ‘reasonably foreseeable’, would have to be reconsidered, given that we can never be certain that death would actually be forthcoming. The decriminalization of the possession and use of cannabis in Canada, that was recently legislated by the Government of Canada, would have to be reconsidered, because we cannot be certain what the consequences of that will be for a whole range of issues. 

The lesson to be taken from the demand for certainty is this: mentally ill people with legal capacity are treated unjustifiably as special cases by mental health experts and policy makers. They are being stigmatized in the name of protecting them. Strong paternalism is inflicted on them in ways that would not be considered acceptable in a liberal, modern 21st century society if it affected others who
have legal capacity, but are not afflicted by the mental illness label.




[1] Schuklenk, U. (2017). New frontiers in end‐of‐life ethics (and policy): Scope, advance directives and conscientious objection. Bioethics, 31, 422–423.
[2] Canadian Academies. (2018). Medical assistance in dying: Expert panel on medical assistance in dying. Ottawa. Available at: https://www.scienceadvice.ca/reports/medical‐assistance‐in‐dying/ [Accessed Jan 6, 2019].
[3] Harris, K. (2019, Jan 3). The next frontier in the right to die: advance requests, minors and the mentally ill. CBC News. Available at: https://www.cbc.ca/news/politics/maid‐assisted‐death‐minors‐mental‐illness‐1.4956388 [Accessed Jan 6, 2019].
[4] Rooney, W., Schuklenk, U., & van de Vathorst, S. (2018). Are concerns about irremediableness, vulnerability, or competence sufficient to justify excluding all psychiatric patients from medical aid in dying? Health Care Analysis, 26, 326–343.
[5] Schuklenk, U., & van de Vathorst, S. (2015). Treatment‐resistant major depressive disorder and assisted dying. Journal of Medical Ethics, 41, 577–583.

Undertaking ethical psychiatric research in the global south’s prayer camps – is that even possible?

Psychiatrists associated with elite institutions in the global north teamed up with counterparts in Ghana with a view to determining wha...