![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 18 of 18. This is the beginning of the thread.
Posted by Dr. Bob on July 24, 2014, at 8:30:09
Hi, everyone,
I recently went through a year's worth of quiz results and thought some of you might be interested.
Bob
--
Teleconsent: Not Just a Check Box
Objectives As more of psychiatry becomes telepsychiatry, more consent will become teleconsent. Informed consent underlies all medical treatment, but procedures that are standard in person do not necessarily transfer in a straightforward fashion to the Internet. When information is communicated online as opposed to in person, its comprehension is more difficult to assess. People who want to receive treatment may click a check box on a Web page without understandingor even readinginformation about potential risks, benefits, and alternatives.
Methods An online informed consent module was added to an online patient community. What was involved, potential risks and benefits, possible alternatives, and cost were explained (at grade level 6.7), and a 10-item quiz was administered to assess comprehension. The data from one calendar year, June 2013 through May 2014, were analysed.
Results The quiz was attempted 311 times. 288 (93%) times, the user eventually passed. The mean number of attempts before eventually passing was 2.1 (range 1-20), before never passing, 1.4 (range 1-5). Individual questions were answered correctly an average of 88% (range 77-94%) of the time.
Conclusions Valid informed consent requires assessment of decision-making capacity. It is possible to obtain valid informed consent online. One workable way of assessing decision-making capacity online is with a quiz. Quiz results could then be used to improve the process.
Posted by alexandra_k on July 27, 2014, at 18:39:24
In reply to Teleconsent: Not Just a Check Box, posted by Dr. Bob on July 24, 2014, at 8:30:09
i'm not sure if this is interesting / relevant but my uni has recently (just this year?) instituted an online course that we must pass before the end of our first year. it is a bunch of content (which i didn't bother with, honestly) and a multiguess quiz. we must score 100% on it to pass.
it is about plagarism / copyright stuff. i guess... it prevents an 'i didn't know that that was cheating' or 'i didn't know that that was breech of copyright' or 'i didn't know that was in breech of conditions of use' defense in front of disciplinary committee / court.
maybe relevant..
Posted by bryte on September 13, 2014, at 18:18:57
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 be used 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 at one time approved the project.
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 long been part but never all of informed consent procedures. (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 provides in-depth information about the decision making capacity of a subject. An impaired, inebriated, apoplectic, obsessed, deluded, pained, anxious, confused or otherwise compromised subject can easily pass a simple multiple choice test.
IRB procedures might require an open ended question that requires participants to express their belief about a study. The answer to that question would be subject of individual scrutiny by qualified assessment personel. Failure to pass individual assessment might require a cognitive test such as the Mini-Mental State Examination
1(a) Quiz Results No Better than Chance Results
Provided unlimited opportunities with no human intervention 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 provides users information about which answers were incorrect along with instructions how to retake the quiz. When retaking the quiz, wrong answers are identified, where they can easily be changed. Three of the questions are essentially true or false, bolean 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 using this method 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 selects users who provide the answers Dr. Hsiung wants them to provide, but does not elucidate an understanding of whether users believe the information is correct. The answers serve more to exculpate the test-givers 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 social media forum? Social media forums at least those operated as public message boards are seldom considered treatment for which informed consent is required?
Is users consent to receive treatment to which the 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.
Or do users only consent to expose their messages and any other measure of their participation in Dr. Hsiung's site to publication in a clinical study while 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.htmlControversy 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, but made no explicit effort to make whole anyone who was harmed.
In that paper based on activities deemed a 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 have the 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 require an informed consent process to include information detailing how users might incur more than minimal or routine risks 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 exposed in the contradictory messages posted then and now.
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 bolean 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.
Elsewhere on the site, 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 Dr. Hsiung has posted a now-defunct link to the US Dept. of Health and Human Services page that explains what is research. It is the same administrative rule that informed his employer's opinion that his project does comprise research.
3. Uninformed Consent: What is Missing?
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 and Dr. Hsiung's social media research project is that his does not allow users to withdraw content.
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 messages he has posted in research publications, or to delete contextual content that could further expose users to public scrutiny when messages from research publications are reviewed in the context of other messages the author might have posted.
Dr. Hsiung's policy of refusing to allow members to withdraw their messages from his published pages is not included 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 for some reason, does not now review or approve his research methods.
4. Informed Consent: One is Never Enough
In few circumstances are one physician's lone decisions about how and to what informed consent must be obtained sufficient. Informed consent procedures required for medical treatments and for research differ. 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 claims assert a qualitative difference, but do 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 physicians name and presence in a social media community could cause a placebo benefit. A physician's present could prompti\ users to believe they are getting better care by going to the doctor even though 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 review, users might learn that their unfounded beliefs a placebo effect about the benefit of a physician's presence could affect their outcomes, and hence influence their choice of Dr. Hsiung's forum vis a vis other sources of peer support.
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 from human research subjects be obtained 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 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 raises important questions about an investigators commitment to informing human subjects about how their participation is used.
Publication of papers and presentation at prestigious conferences infer a mantel of credibility on the researcher as much as, or more than, the presentation might advance science or patient care. Consistent refusal to participate in institutional review procedures raises important questions about whether an academic, researcher or clinician intends to serve students, science and patients, or intends to enhance the individual's own professional reputation and prestige.
Posted by SLS on September 13, 2014, at 19:01:26
In reply to Uninformed Consent or Misinformed Consent, posted by bryte on September 13, 2014, at 18:18:57
Your investment of time and energy in putting together your post is very much appreciated.
What would you like to see happen as the result of your efforts?
- Scott
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.htmlControversy 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)
Posted by bryte on September 14, 2014, at 0:51:17
In reply to Re: Uninformed Consent or Misinformed Consent » bryte, posted by SLS on September 13, 2014, at 19:01:26
> Your investment of time and energy in putting together your post is very much appreciated.
>
> What would you like to see happen as the result of your efforts?
>
>
> - Scott
>
>Thank you for the encouragement. I reposted a slightly revised version, primarily because quotation marks were dropped from the first version. Other revisions could improve clarity.
What I would like to see happen as a result of my effort is no different than would I might prefer to happen without my effort. The DHHS rulemaking bodies, and the UofC IRB offer better insight than I can offer into best practices in informed consent.
The most likely result of my effort could be that worldwide peers who consider Hsiung's "More than a Checkbox" talk might have more information about the basis of his claims related to informed consent.
Posted by Dr. Bob on October 15, 2014, at 16:17:59
In reply to Uninformed Consent or Misinformed Consent, posted by bryte on September 14, 2014, at 0:28:15
> 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.
2.1 is significantly less than 3.1, so that would seen to be evidence that the options aren't meaningless signals.
> Social media forums -- at least those operated as public message boards are seldom if ever considered treatment for which informed consent is required.
This isn't treatment, but there are risks. I think an informed consent process protects prospective participants.
> 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."And as an example of acceptable language they offer:
> > By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.
http://www.hhs.gov/ohrp/policy/exculp.html
> (Revised and reposted to correct punctuation errors resulting from Web formatting, along with additional typographical and readability corrections)
Thanks for time and effort you invested in your critique. I welcome different points of view. Would you be interested in participating in a panel at a conference?
Bob
Posted by bryte on October 16, 2014, at 2:27:21
In reply to Re: Informed or Uninformed or Misinformed Consent, posted by Dr. Bob on October 15, 2014, at 16:17:59
> > 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.
>
> 2.1 is significantly less than 3.1, so that would seen to be evidence that the options aren't meaningless signals.It says nothing about what the signals mean to whomever takes the test. The best clue those data could offer would be that half the people who take the quiz might understand the questions and half are doing nothing more than guessing while eliminating wrong answers when prompted.
If half of those who took the test answered every question correctly first time because they understood their answers, and half took the quiz by guesswork along with prompts revealing incorrect answers, the mean number of required attempts would be 2.05 (Mean 1/Mean 3.1). That is not significantly different than the 2.1 mean reported.
-----------------
> This isn't treatment, but there are risks. I think an informed consent process protects prospective participants.
What does it protect participants from, and how? Does it protect those who to pass the test by rote, guesswork, hints and brute force?
From Informed Consent: Its Origin, Purpose,Problems, and Limits:
"Although the doctrine of informed consent promotes ideals worth pursuing, a successful implementation of these ideals in practice has yet to occur. What has happened in practice is that attorneys, physicians, and hospital administrators often use consent forms mainly to protect physicians and medical facilities from liability." (Nancy Kettle, University of South Florida, 2002 Graduate Thesis.)
http://scholarcommons.usf.edu/cgi/viewcontent.cgi?article=2522&context=etd
-----------------
> > USDHHS rules say "No informed consent, whether oral or written, may include any exculpatory language...
> > As an example of prohibited exculpatory language in informed consent documents, the USHHS offers "... I give up any property rights..."
>
> And as an example of acceptable language they offer:
> By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.Exactly... for the "research described."
Consent requirements at this forum claim this is not research, much less describe the research or disclose that it was considered research last time the owner submitted the work to the authority of a legitimate IRB.
-----------------
> Would you be interested in participating in a panel at a conference?
>
> BobA person with no significant clinical experience other than student counseling, who has worked primarily as an assistant professor for 25 years after obtaining a medical license, and who has published no peer reviewed research beyond unsupervised musings about the person's own Web forum that relies on 14-year-old social-media technology is not someone I would recognize as a reliable source for information about psychiatric informatics and telecommunication in the post Web 2.0 era.
Appearances at conferences might help an assistant professor keep a job, but those credentials are not consistent with those of a person who is advancing science, improving clinical practice or elevating standards of care. That would not be someone I would want to join in a conference panel. I would be more interested in providing written comments to an independent editorial panel after reviewing a manuscript prior to publication.
Posted by Dr. Bob on October 18, 2014, at 21:20:26
In reply to Re: Informed or Uninformed or Misinformed Consent, posted by bryte on October 16, 2014, at 2:27:21
> > > 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.
> >
> > 2.1 is significantly less than 3.1, so that would seen to be evidence that the options aren't meaningless signals.
>
> It says nothing about what the signals mean to whomever takes the test. The best clue those data could offer would be that half the people who take the quiz might understand the questions and half are doing nothing more than guessing while eliminating wrong answers when prompted.That would still be better than everyone just guessing. Though of course not as good as being sure that everyone understood. Are you confident that everyone understands when informed consent is obtained in person?
> > This isn't treatment, but there are risks. I think an informed consent process protects prospective participants.
>
> What does it protect participants from, and how? Does it protect those who to pass the test by rote, guesswork, hints and brute force?
>
> From Informed Consent: Its Origin, Purpose,Problems, and Limits:
>
> "Although the doctrine of informed consent promotes ideals worth pursuing, a successful implementation of these ideals in practice has yet to occur. What has happened in practice is that attorneys, physicians, and hospital administrators often use consent forms mainly to protect physicians and medical facilities from liability." (Nancy Kettle, University of South Florida, 2002 Graduate Thesis.)I haven't meant to claim that this is a successful implementation of ideals. What I claim is that it's more ideal than a check box.
> > Would you be interested in participating in a panel at a conference?
>
> I would be more interested in providing written comments to an independent editorial panel after reviewing a manuscript prior to publication.I understand the appeal of being a reviewer. Participating in a conference might lead to invitations to be a reviewer. Or maybe you receive enough of those already. Either way, it's up to you.
I've presented with members of the Babble community before and would be happy to do so again. It's an opportunity for the Babble and psychiatric communities to get to know each other better.
Bob
Posted by bryte on October 18, 2014, at 22:32:57
In reply to Re: Informed or Uninformed or Misinformed Consent, posted by Dr. Bob on October 18, 2014, at 21:20:26
> That would still be better than everyone just guessing. Though of course not as good as being sure that everyone understood. Are you confident that everyone understands when informed consent is obtained in person?You seem to have persistent difficulties distinguishing individuals from groups and recognizing the particular relevance of individual circumstances. You know as well as I that in-person informed consent procedures provide for recognition of individuals unable due to incapacity or impairment to make truly informed consent. You might recognize that unethical practitioners can get those individuals through the process.
One wonders if your claim that 31 radio buttons are "more than a checkbox" is based on an assumption that in-person informed consent can be cheated, so why bother.
> I haven't meant to claim that this is a successful implementation of ideals. What I claim is that it's more ideal than a check box.What you claimed was "One workable way of assessing decision-making capacity online is with a quiz." The rebuttal was that a quiz tests quiz-taking skills in the context of the difficulty of the quiz, but provides no reliable assessment of decisional capacity among a significant minority of those quizzed.
> I understand the appeal of being a reviewer. Participating in a conference might lead to invitations to be a reviewer. Or maybe you receive enough of those already. Either way, it's up to you.Anonymous review of manuscripts is a pro-bono service that offers little or no appeal of reward for the reviewer.
> I've presented with members of the Babble community before and would be happy to do so again. It's an opportunity for the Babble and psychiatric communities to get to know each other better.
Is systematically asking guests of your forum to surrender their privacy part of your role as an medical-professional administrator, or is it more about providing support and education?
Posted by Dr. Bob on October 23, 2014, at 0:57:55
In reply to Re: Informed or Uninformed or Misinformed Consent, posted by bryte on October 18, 2014, at 22:32:57
> > I've presented with members of the Babble community before and would be happy to do so again. It's an opportunity for the Babble and psychiatric communities to get to know each other better.
>
> Is systematically asking guests of your forum to surrender their privacy part of your role as an medical-professional administrator, or is it more about providing support and education?1. It depends what you mean by privacy. I don't think the Babblers in Toronto had to tell me their real names, and they certainly didn't have to tell the audience. It's possible they did have to tell the APA as part of the conference registration process. OTOH, I and the audience did see what they looked like.
2. Different people weigh costs and benefits differently. To you, preserving your privacy might be more important than getting to know the psychiatric community, or allowing the psychiatric community to get to know you. I can respect that.
Bob
Posted by bryte on October 26, 2014, at 0:29:08
In reply to Re: privacy, posted by Dr. Bob on October 23, 2014, at 0:57:55
> 2. Different people weigh costs and benefits differently. To you, preserving your privacy might be more important than getting to know the psychiatric community, or allowing the psychiatric community to get to know you. I can respect that.
>
> BobPerhaps you overestimate your role as a representative for what you see as a "psychiatric community" and fail to recognize that the fraction of a "psychiatric community" to which you would introduce me may comprise a small fraction of the community of licensed psychiatrists, much less be a significant aspect of a healing community, of which what you consider a psychiatric community might or might not be a part.
If you are interested in getting to know more of your peers and letting your peers get to know you, Chicago has a robust community of drug dealers. Try a peer-to-peer sit-down with some of them.
Posted by Dr. Bob on October 26, 2014, at 23:01:00
In reply to Re: privacy, posted by bryte on October 26, 2014, at 0:29:08
> Perhaps you overestimate your role as a representative for what you see as a "psychiatric community" and fail to recognize that the fraction of a "psychiatric community" to which you would introduce me may comprise a small fraction of the community of licensed psychiatrists
Perhaps you overestimate what I saw as my role. I assumed you could introduce yourself to others at the meeting.
Bob
Posted by bryte on October 27, 2014, at 3:23:03
In reply to Re: privacy, posted by Dr. Bob on October 26, 2014, at 23:01:00
> Perhaps you overestimate what I saw as my role. I assumed you could introduce yourself to others at the meeting.
>
> BobPerhaps you overestimate your ability to backpedal and deflect attention from aspects of a dialogue that do not serve your preferences.
I correctly estimated what you stated was your role when you invited me to "get() to know the psychiatric community, or allow() the psychiatric community to get to know (me)." You represented yourself as the agent who would direct my introduction to "the psychiatric community."
Your invitation was twofold - you first suggested my participation "in a panel at a conference" which could be any panel, whether or not you were "presenting" then more specifically referenced that you "presented with members of the Babble community before and would be happy to do so again." You represented these introductions as a settings in which you "present."You invited me to "get to know" what is in reality a limited, indefinite subset that you described definitely as "the" psychiatric community.
There are only three articles used in the English language - a, an and the. Their purpose as adjectives is very specific - to delineate between definite or indefinite subjects. A definite article used in reference to a group refers to the entire group.
You might explain to yourself the use of a definite article in reference to an indefinite subject as casual hyperbole, but it can be read as a grandiose exaggeration of your role in "the" psychiatric community.
Posted by Dr. Bob on October 28, 2014, at 23:52:46
In reply to Re: privacy, posted by bryte on October 27, 2014, at 3:23:03
> you invited me to "get() to know the psychiatric community, or allow() the psychiatric community to get to know (me)." You represented yourself as the agent who would direct my introduction to "the psychiatric community."
I saw my role as including you on a panel. After which you could introduce yourself to others at the meeting. I hope that's more clear now. Even though it's moot if your priority is to preserve your privacy.
Bob
Posted by bryte on October 29, 2014, at 2:13:38
In reply to Re: privacy, posted by Dr. Bob on October 28, 2014, at 23:52:46
> I saw my role as including you on a panel.
> I hope that's more clear now.
> BobYou envisioned your role as placing me in front of a group where you could manipulate the environment. That's very clear now.
Posted by Dr. Bob on November 11, 2014, at 14:16:16
In reply to Re: privacy, posted by bryte on October 29, 2014, at 2:13:38
> > I saw my role as including you on a panel.
>
> You envisioned your role as placing me in front of a group where you could manipulate the environment. That's very clear now.Manipulate the environment in what way? You make it sound like you'd be a lab rat.
Bob
Posted by bryte on November 12, 2014, at 22:44:18
In reply to Re: privacy, posted by Dr. Bob on November 11, 2014, at 14:16:16
> Manipulate the environment in what way?In what way do you propose to manipulate this environment you propose to create? Setting the agenda? Controlling who speaks when and for how long? Why are you interested in drawing me into an environment you can control?
>You make it sound like you'd be a lab rat.
>
> BobTo be precise, "lab rat" was your term.
Do you know somebody with a history of abusing rats for professional reasons, including perhaps for the development of profitable compounds?
This is the end of the thread.
Psycho-Babble Administration | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.