Posted by bryte on September 1, 2014, at 5:29:42
In reply to Re: discussion, posted by pontormo on August 31, 2014, at 21:17:42
> From what I 've read, HRPPs only apply to human research, and from what Bob has said, he's not doing any research on psychobabble now.
Read more.
"Submitting a message gives me permission to use it as I wish."
http://www.dr-bob.org/babble/admin/20140304/msgs/1068731.html
He failed to mention in the post linked there that he is presenting those research findings - another "case study" as he describes his systematic evaluations - at the XVI World Congress of Psychiatry in Madrid later this month.
In as much as he did not include an HRPP IRB in reviewing his methods and informed consent process, his research presented at XVI WCP might not be acceptable for consideration as research in programs regulated by CFR Title 45 Part 46.
Even if these ongoing publications were mere "case studies" and US HHS exempts case studies, as Dr. Hsiung claims without citing any authority other than CFR 45 part 46.102(d), his conclusion is flawed because quiz answers provided here do not inform participants' capacity to give adequate informed consent to research.
Informed consent at this site requires participants to agree that "The current purpose of this group is: (NOT) to collect research data" but that "Dr. [Robert Hsiung] may publish a case study in an academic journal that includes your message."An IRB might reach a different conclusion, but we do not know because we are not directed in our supposedly informed consent to a related IRB that could tell us what any institutional body concluded. An IRB might conclude that to systematically and repeatedly "publish a case study that includes ... messages" involves systematic collection and evaluation of research data.
An IRB might or might not conclude that such incongruent questions require participants to agree to incongruent conclusions. An IRB might asking mentally disabled individuals to such an incongruent, nuanced offers a promise of group participation as an incentive for consenting to research that could expose them to risks.
An IRB might conclude that the incongruent nuance deliberately or inadvertently selects participants with compromised decision-making capacity, or otherwise forces compromise in decision-making capacity as an initial selector for research compliance. But we do not know, because an IRB has not reviewed the quiz passed off here as informed consent.
>So that really doesn't apply at the moment.
To you. At this moment. Or maybe it does now that you know about his current research. Or non-research citing your involvement to be presented at the World Conference on Psychiatry this month.
Either way, others have different views.
> If he were to do research, I'm sure he would go through all the relevant protective procedures, if only because they're required.
That has not always been the case. It not be the case now. He appears to designate himself the arbiter of what is relevant. Did an HRPP review his use of participants at this website in methods used to reach the conclusion to be presented at XVI WCP that "It is possible to obtain valid informed consent online" -- Implicitly proven possible by using his novel, minimal and unapproved methods?
If it were a case study, and not research, it would present a question - not a conclusion. A case study would ask "is it possible" - not conclude "it is possible."
"Cases are designed to confront readers with specific real-life problems that do not lend themselves to easy answers." http://research-ethics.net/discussion-tools/cases/
You consented, but apparently were misinformed or were not informed that your participation here was currently being used as part of a research method to be presented at the World Congress of Psychiatry that supports a conclusion on the subject of informed consent.The first element of CFR Title 45 informed consent requires: "(1) A statement that the study involves research..."
Dr. Hsiung's purported informed consent requires that we agree with him that his research findings based on evaluation of interaction with us do not comprise research.
To support his claim that the systematic methods he uses to investigate and evaluate subjects including informed consent, online mental health support groups, and reactions to suicide among an online support group are not research, Dr. Hsiung cites CFR 46.102(d):
"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities."
"(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information."
Dr. Hsiung's public admonishments, his conversations with participants that produce statements for ostensibly non-research "case study" publication in peer-reviewed research journals and his collection of quiz answers for presentations at global psychiatric conferences are data collected through intervention and interaction with individual participants. He evaluates data obtained through his interaction with individuals.His collection of e-mail addresses and internet addresses sufficient to intervene when he believes he observes a psychological emergency comprises identifiable private information. Public records created when he utilizes local authorities to respond to perceived emergencies create situations where individuals might not anticipate the limitations of his effort to "protect the privacy of subjects and to maintain the confidentiality of data. @46.111(a)(7)"
46.111(b) says an IRB must be assure that "When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, ... mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects."
There is no age test here, so children may be involved. We do not know. Where the forum is accessed in Europe, those European participants in Dr. Hsiung's systematic evaluations of "an online self-help group hosted by a mental health professional" may not "discontinue participation at any time without... loss of benefits to which the subject is otherwise entitled. [46.116(a)(8)]" The benefit they lose is the European right to be forgotten because Dr. Hsiung claims a perpetual, irrevocable right to do as he wishes with his human subject's written statements.
Dr. Hsiung's individual impression might be that he is not conducting research when he systematically collects material from human subjects for published case studies. He might individually conclude that it he is not conducting research when he publicizes individual's online statements for which he has required them to relinquish all rights - including Europe's newly recognized right to be forgotten.
But he cites no authority that has approved his conclusion other than a federal regulation that, to an average reader, can appear to contradict his conclusion. Contrary to naming an authoritative panel that supports his conclusion, he represents himself as an expert to peers for the purpose of advancing his conclusion.
> His colleagues have much more information about him than any of us can possibly have-- and their choosing him, as well as his volunteering to do this work, says a lot.
Many a misguided investigator has "volunteered" to try methods independently for which they could not otherwise secure institutional approval.
Publication is a requisite of an academic career. That says something, too. It says a lot that most healthcare providers who offer online health forums choose more typical social network practices that do not so much involve a personal brand and personalized, public admonishment of participants when they offer online support and educational services.
> I just find his biosketch incredibly reassuring-- and I hope you've taken at his credentials-- Most people would I think come to have a lot of confidence in him and his judgment and his caring from that.
>
> He himself says that he's not perfect-- that he can only do the best he can do to be fair and make good decisions. That's really all we can ask of anyone.
If "we" is limited to yourself and those who agree with you, yes. Excluding yourself and those others if you will, we can ask more of people than that they use their own best judgement or that they do what they think is "good.""...the judgment of the investigator is not sufficient as a basis for reaching a conclusion concerning the ethical ...set of questions." -- 1963 NIH Panel that investigated research at the Jewish Chronic Disease Hospital in Brooklyn.
We ask of health research professionals that they rely on the judgement of their community. Most institutions with IRB panels require that the oversight community include actuarial scientists trained to assess risks involved with novel activities that can affect the health of participants. Actuaries are involved when institutions require research projects to be insured. They require insurance in part to protect their institutions against liability arising from research errors. They may require insurance because they consider themselves ethically obligated to indemnify participants for harm.
Title 45 Part 46 requires "(6)For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;"
The pre-quiz statement on this site, which subjects might or might not understand before answering 10 multiple-choice questions states "It may be hard to deal with issues like suicide that come up."
Does "more than minimal risk" include contagious psychopathology in a group where suicide is something that can "come up" because the researcher allows and promotes that discussion in public groups for reading by non-enrolled invitees, accessible by search engines and promoted by social-media republication? And who publishes ostensibly non-research case studies about multiple members who have committed suicide, including evaluation of how he manages public discussion of those adverse events among the group?
Title 45 Part 46.102(i) says "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
When health research is involved - and especially when the research involves defining informed consent, we can ask more of researchers than that they "...be fair and make good decisions" according to their own discretion.
"Ethical lapses are almost never cases of bad people, doing bad things, for no good reason. Rather, they are good people, doing bad things, for good reasons," says Marcia Angell, MD former Editor-in-Chief, NEJM
Dr. Hsiung will tell the XVI WCP that "Valid informed consent requires assessment of decision-making capacity."
His methods only address decision making capacity of participants. He does not address decision making capacity of the researcher.His methods imply that a capacity of exactly one person might be adequate. CFR Title 45 says otherwise. It says valid informed consent requires the decision making capacity of a compliant IRB. Formal decision making capacity of more than one person is required to determine the sufficiency of informed consent.
As NIH Director James Shannon said in a 1966 statement endorsed by Surgeon General William Steward, "The investigators judgment must be subject to prior peer review to ensure an independent determination of risks and benefits and ...voluntary informed consent,"
Research -- or non-research as we are required to state when we relinquish all rights to content posted here -- that uses methods not reviewed by an IRB cannot reasonably inform the question of whether answers by unidentified participants to unapproved questions demonstrate participants' capacity provide informed consent to a process directed by a lone investigator whose informed consent methodology as not been subject to review.
I believe the hosts' claim of a nuanced claim of a difference between case study and research serves his professional advantage more than it benefits the group as a whole. At best, avoiding IRB review allows him material for professional publication, which is a quid pro quo professional benefit for whatever service he provides here.
I anticipate a greater "probability and magnitude of discomfort anticipated in the research ... greater in and of themselves than those ordinarily encountered in daily life".. for myself and for other participants - especially those who "for how long" have persistently expressed discomfort about inconsistent administration.
To state it succinctly, the adequacy of informed consent must be based upon research to which participants have given informed consent. If participants gave consent to a "case study" that was not research and not subject to IRB review, their agreements do not inform their capacity to give informed consent to research.
>...while I've disagreed with decisions, haven't lost the sense that this place is valuable.
> But I'm sorry that you don't find it so.
>
> pontormo
>There may be little I can do to relieve your sorrow in that regard, but value is not an either-or question.
And now, one more obligatory "I-statement."
In so far as Dr. Hsiung at once invites discussion of his administration and admonishes some invitees who he says might make him feel accused, I consider it inappropriate and unethical for an academic or an investigator to intervene against public discussion of the researcher's ethics in the administration of academic and research processes they conduct with no formal oversight.
As states the Research Ethics Program, UC San Diego in Resources for Research Ethics Education discussion of case studies in the consideration of ethics "unethical behavior is defined by a failure to engage in the process of ethical decision-making. It is always unacceptable to have made no reasonable attempt to define a consistent and defensible basis for conduct."
poster:bryte
thread:1070154
URL: http://www.dr-bob.org/babble/admin/20140304/msgs/1070606.html