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Uninformed Consent or Misinformed Consent

Posted by bryte on September 14, 2014, at 0:28:15

In reply to Teleconsent: Not Just a Check Box, posted by Dr. Bob on July 24, 2014, at 8:30:09

Uninformed Consent or Misinformed Consent

In a presentation to the 16th World Congress of Psychiatry (Sept. 14-18, 2014), University of Chicago associate professor of psychiatry Dr. Robert Hsiung extrapolates data obtained from a rudimentary social media project he owns to inform questions related to adequacy of teleconsent in telepsychiatry. The data and the context in which they were gathered better inform an appreciation of methods whereby informed consent procedures can exculpate at least the conscience of a researcher who manipulates human subjects without peer oversight.

Dr. Hsiung has eluded oversight from the University Institutional Review Board by operating his social media project under ownership of a private limited liability corporation of which he is the sole member. Operating as a private for-profit enterprise outside the community guidance of an Institutional Review Board, Dr. Hsiung prompts users for agreement to conclusions contrary to those of an IRB that he claims once approved his project as research.

This message explores how systematic consent to misinformation exposes consent procedures that imply exculpatory benefits for an investigator while negating claims about the sufficiency of human subjects' understanding of research or quasi-clinical procedures.

1. Decisional Capacity

In an abstract of his WCP16 presentation, Dr. Hsiung claims "One workable way of assessing decision-making capacity online is with a quiz." The statement introduces no new knowledge. Quizzes have often been part of but never all of informed consent procedures: Carpenter et al.(Arch Gen Psychiatry, 2000, 57:533-538), Dunn and Jeste (Neuropsychopharmacology, 2001, 24:595-607), Dunn et al. (Am J Psychiatry; 2001; 18:1911-1913), Dunn et al. (Am J Geriatric Psychiatry, 2002 Mar-Apr;10(2):207-11.), or Wirshing et al. (Am J Psychiatry; 1998; 155: 1508-1511)

As a sole means, a quiz rarely reveals in-depth information about the decision-making capacity of a subject. An impaired, inebriated, apoplectic, obsessed, deluded, pained, anxious, confused, underaged or otherwise compromised subject can easily pass a simple multiple-choice quiz.

IRB procedures otherwise might require an open-ended question that encourages participants to express their belief about a study. The answer to that question would be scrutinized by qualified assessment personnel. Decisional capacity of those whose answers do not pass initial assessment might be more carefully assessed by way of a cognitive test such as the Mini-Mental State Examination

1(a) Quiz Results No Better than Chance Results

Provided unlimited opportunities with no deliberate effort to discover the reason for incorrect answers to particular questions, Dr. Hsiung's quiz provides less information about decisional capacity than would a simple two-digit combination lock.

Dr. Hsiung's quiz tells users which of their answers were incorrect then provides instructions how to retake the quiz. When retaking the quiz, identified wrong answers can easily be changed using mere guesses. Three of the questions are essentially true or false, Boolean choices between two possible answers. Three questions involve three choices, three offer four choices and one offers five choices.

Dr. Hsiung says "The mean number of attempts before eventually passing was 2.1." With a total of 31 possible answers to 10 questions, the mean number of attempts required to match 10 options with guesswork would be 3.1 -- even if the options were meaningless signals such as shapes, numbers or digits. A two-digit combination lock with 10 options for each digit could always be opened in 99 tries, with 50 tries being the statistical mean level of effort.

The quiz may offer a means to select users who submit the answers Dr. Hsiung wants them to submit, but does not elucidate an understanding of whether users believe the information is correct. The answers serve more to exculpate the test-giver's understanding than test the subjects' understanding.

2. Consent to Research, Treatment, or Neither?

The presence of an informed consent form implies a user is consenting to something. To what do they consent?

Dr. Hsiung states in the abstract of his presentation that "It is possible to obtain valid informed consent online." Yet he fails to explain what it is for which users are prompted to give informed consent. Is it mere participation in a social media forum? Social media forums -- at least those operated as public message boards are seldom if ever considered treatment for which informed consent is required.

Do users consent to receive some form of treatment to which the WCP16 abstract alludes? By whom do they receive treatment? Dr. Hsiung claims they receive something but maybe not treatment from an online patient community. Whose patients are these? Dr. Hsiung's patients? Do users know their fellow community members are patients? Is patient status a prerequisite of group participation? No.

Do users provide informed consent to participate in research as Dr. Hsiung said in 2001? In a 2001 message the University of Chicago IRB characterized his social media forum as research. "They have in fact deemed this research... It's now considered research," Dr. Hsiung wrote.

Or do users consent only to expose their messages and any other measure of their participation in Dr. Hsiung's site to publication in a clinical study while he claims, "This site is not currently considered research."

http://www.dr-bob.org/babble/admin/20010718/msgs/2216.html
http://www.dr-bob.org/babble/consent.html

Controversy over informed consent apparently first arose when users questioned Dr. Hsiung's publication of a paper that cited content of their posts. At the time, he had not sought IRB approval. He apologized to users and expressed hopes that nobody was harmed. He made no explicit effort to make whole anyone who was harmed.

In that paper 2000 publication, based on activities deemed as research by Dr. Hsiung's IRB, yet published without informed consent of human subjects, Hsiung admitted he chooses to administer his forum in a way that does not minimize harm to individual users. He admits he eschews widely used social media administrative approaches that would "have the advantage of being less embarrassing."
(The Best of Both Worlds: An Online Self-Help Group Hosted by a Mental Health Professional Robert C. Hsiung. CyberPsychology & Behavior. December 2000, 3(6): 935-95)

In that unapproved human-subject-research publication, Hsiung asserted his more embarrassing administrative methods offer an advantage of allowing others to participate in the process. Yet a brief review of his forum's administrative discussion page reveals allowing others to participate in the process often involves deploying the same embarrassing public sanctions against those who participate. His embarrassing sanctions are sometimes imposed on those who he says could make him feel put down.

Does the informed consent process warn users of the potential harm that can result from Dr. Hsiung's use of more embarrassing public sanctions? No. Here merely advises users they might be blocked from participating.

Would an institutional review board require Dr. Hsiung to provide an informed consent process that includes information detailing how users might incur more than minimal or routine risks of embarrasment than they incur in daily life? Would an IRB require Dr. Hsiung to inform users they consent to be embarrassed by administrative sanctions more than if they participated in a Mayo Clinic forum, or by administrators of facebook, Twitter or Yahoo! Groups?

We cannot know, because Dr. Hsiung at some time between 2001 and 2014 removed his project from oversight by the University of Chicago Institutional Review Board. Why? Users are not informed of the reasons the site was once considered research but is not now considered research. Users are not told whose conflicting considerations are referenced in the contradictory messages posted then and now.

To gain permission to write on his forum, users are required to agree between two choices in the informed consent process: either the site is for support and education OR the site is for research. No third choice AND -- is offered. Dr. Hsiung's Boolean question on that key decision avoids gathering information about the extent to which users believe the site is both a research project and a mutual-support forum. The informational page that precedes the quiz explicitly states it is not research.

As support for his claim that publication of case studies from a project he operates and in which he systematically manipulates users with embarrassing administrative sanctions does not comprise research, Dr. Hsiung elsewhere on the site has posted a now-defunct link to the US Dept. of Health and Human Services page that explains what is research. The administrative rule he claims says his project is not research is the same rule that informed his employer's opinion that his project does comprise research.

3. Uninformed Consent: What is Missing?

USDHHS rules say "No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights." 45 CFR 46.116

As an example of prohibited exculpatory language in informed consent documents, the USHHS offers "By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research."

On nearly every page of his site but not in the informed consent quiz or consent information pages, Dr. Hsiung publishes the following exculpatory claim: "Submitting a message gives me permission to use it as I wish."

Terms of service on most social media sites include non-exclusive transfer of copyrights that allow the site to show users' content to other users. The difference between those common social media copyright terms and terms of Dr. Hsiung's social media research project is that his terms do not allow users to withdraw or delete content they have posted.

Dr. Hsiung asserts a right not only to publish case studies that he individually deems not to be research and not to require oversight by an IRB. He denies users a right to delete original versions of messages he has cited in research publications, or to delete contextual content that could further expose users to public scrutiny after messages from research publications are reviewed in the context of other messages a group member posted.

Dr. Hsiung's policy of refusing to allow members to delete their messages from his forum is not explained in his informed consent form. Dr. Hsiung posts an informed consent form that could lead readers to believe an IRB has approved his forum. Elsewhere on his site, in fact, he says an IRB has approved his research. He does not inform readers the IRB approved it then but now, for some reason, does not review or approve his research methods.

4. Informed Consent: One is Never Enough

In few circumstances are one physician's lone decisions about how, when and why informed consent must be obtained sufficient. Informed consent procedures required for medical treatments are different than those required for research. The vast majority of the medical community concludes that, at least when the specter of research can taint a clinician's administration of treatment procedures, independent review is required.

Dr. Hsiung asserts that his social media project does not comprise a treatment procedure. Whatever informed consent process he deploys may nonetheless insinuate to users his project is somehow qualitatively different than any other topical social media forum. His published research asserts a qualitative difference, but does not explain what better quality he offers or how he measures qualitative differences. The most substantial difference he offers vis a vis other social networks are his more embarrassing administrative sanctions.

The presence of a physician's name and participation in a social media community could cause a placebo benefit. A physician's present could prompt users to believe they are getting better care by going to the doctor. They might not know, unless informed, that the doctor does little more than tell users to shut up more loudly and more publicly than they would be told to shut up in other social media forums used by hundreds of millions of users around the world.

While Dr. Hsiung claims his active manipulation of the online milieu which comprise the primary source of material for his case studies does not comprise research, the IRB at the institution that employs him at one time disagreed. If he were required to submit informed consent procedures for IRB review, users might learn that their unfounded beliefs about the benefit of a physician's presence could affect their outcomes by way of a placebo effect. Users might be informed that a placebo belief about the benefit of a physician's presence could influence their choice of Dr. Hsiung's forum vis a vis other sources of peer support.

A recent review of literature on informed consent related to placebo effects concluded: "Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials." (Bishop et al 2012)

(Bishop FL, Adams AEM, Kaptchuk TJ, Lewith GT (2012) Informed Consent and Placebo Effects: A Content Analysis of Information Leaflets to Identify What Clinical Trial Participants Are Told about Placebos. PLoS ONE 7(6): e39661. doi:10.1371/journal.pone.0039661 )

Conclusions

Dr. Hsiung's failure to explain the extent to which his social media project comprises peer support, treatment procedure, case study or research undermines the basis for his conclusion that "It is possible to obtain valid informed consent online." In no case can informed consent be obtained from human research subjects in a two-sided relationship between only the subject and the researcher. Independent review is always required.

Dr. Hsiung's omission of details about his severed relationship with independent research reviewers compromises both the merits of conclusions he bases on his unsupervised case study, and the quality of any informed consent he ostensibly obtains from users of social media sites he hosts. Failure to post, in this thread, information about how he plans to use this latest non-research research about informed consent raises important questions about an investigator's commitment to informing human subjects about how their participation will be used.

Publication of papers and presentations at prestigious conferences infer a mantel of credibility on the researcher as much as, or more than, such presentations might advance science or improve patient care. Consistent refusal to participate in institutional review procedures raises important questions about whether an academic, researcher and clinician intends to serve students, science and patients, or intends to enhance the individual's own professional reputation and prestige.


_____________________________________________________

(Revised and reposted to correct punctuation errors resulting from Web formatting, along with additional typographical and readability corrections)


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poster:bryte thread:1068731
URL: http://www.dr-bob.org/babble/admin/20140902/msgs/1071118.html