Psycho-Babble Administration Thread 315

Shown: posts 1 to 25 of 49. This is the beginning of the thread.

 

Institutional Review Board policies

Posted by Dr. Bob on January 25, 2001, at 3:33:27

Hi, everyone,

It's interesting, the question of whether this board should be considered a research project. The way I've looked at it is, as I mentioned before:

> [This board] is *not* an experiment in which I'm
manipulating anyone or anything...
>
> The IRB approves research, not publication...

However: my view may not be shared by my IRB. :-(

Their view (actually, that of the Department of Health and Human Services) is that research is "systematic investigation ... designed to develop or contribute to generalizable knowledge." Hmm...

http://ors.bsd.uchicago.edu/HS/bottom.html

OTOH, one type of research that can be exempt from full IRB review is "the collection or study of existing data ... if these sources are publicly available." However, only the IRB may determine whether research qualifies as exempt (from *full* review).

http://ors.bsd.uchicago.edu/HS/P&Pmanual.html#IX

So I'll submit this to them, and we'll see what they say. I apologize for not having been more aware of these policies, and I certainly do hope no one is harmed by the publication of this paper.

Hopefully, feedback from you (and my IRB) will lead to clarifications and improvements, which would of course be a good thing all around. Thanks for your understanding,

Bob

 

Re: Institutional Review Board policies

Posted by danf on January 25, 2001, at 5:19:05

In reply to Institutional Review Board policies, posted by Dr. Bob on January 25, 2001, at 3:33:27

There are 2 very different issues here.

The first: does an IRB need to decide if a support board is research, in & of itself ?

I think not. This board stands alone, on it's own merits & has public access. What many of the posters do not understand is that posting here is akin to writing a letter to a newspaper editor. If one does not want the whole world to have access, then do not post.

pseudo names ( screen names ) are available to protect the identity & privacy of all who post here. BUT, just like when your letter is published in a newspaper, all the information in posts is available for anyone to read....

The second question is: Does an IRB need to give consent when public information is used to write a paper that compiles information & draws conclusions.

Again, I think not. There is no doctor patient relationship here. There is no expectation of privacy. There is no copyrite ownership of a post by the poster, once it is made here...

& again the analogy/comparison of a letter to a newspaper editor holds. I can see no reason why an IRB would have any jurisdiction over evaluation of public published information.

The net medium of publication does not confer any special or unique rights to the posters here.

I could legally & ethically do a research paper based on information posted on this BB... It would not require the permission or even notification of Dr Bob or of any of the posters...

 

Re: Institutional Review Board policies

Posted by shar on January 25, 2001, at 9:40:33

In reply to Re: Institutional Review Board policies, posted by danf on January 25, 2001, at 5:19:05

I agree with Dan. I've thought of several projects that would be interesting to do with this information; a survey of meds and those that appear to be most successful, or those that seem to have the most side effects, or issues people bring up most often related to meds (will I be on them forever? I'm scared of starting.).

It would be interesting to compare PB with other like forums on the Internet. There would be many ways to go with that idea.

For the record, I would not feel constrained in any way from using the posts here. I would probably present more aggragated information which would make the use of screen names less likely, but I would use names or initials and not feel I was violating anyone's privacy since, as Dan said, posting here is akin to writing to a newspaper.

I'm not sure how many warnings people want you to have, Dr. Bob. Is there a magic number? Should the sign up screen have a warning in size 24 font? Should there be an additional screen whenever anyone signs on that makes them agree to terms of using the board, each and every time? Or maybe they should have 3 or 4 screens to go through, warning them over and over again that this is a public site.

It worries me when stuff like this happens, that often the tempest in the teapot ends up eliminating a good thing.

When I read the "I can do what I want" caveat, I knew immediately I wouldn't say anything that could identify me personally, plus I made my screen name something other than my real name. Recently, someone in my therapy group (where I have mentioned Psychobabble) asked me if I was Shar. (Hmmmm, I thought, have I copped to any criminal activity on that board?)

D--quit lurking and start posting!!

Shar


> There are 2 very different issues here.
>
> The first: does an IRB need to decide if a support board is research, in & of itself ?
>
> I think not. This board stands alone, on it's own merits & has public access. What many of the posters do not understand is that posting here is akin to writing a letter to a newspaper editor. If one does not want the whole world to have access, then do not post.
>
> pseudo names ( screen names ) are available to protect the identity & privacy of all who post here. BUT, just like when your letter is published in a newspaper, all the information in posts is available for anyone to read....
>
> The second question is: Does an IRB need to give consent when public information is used to write a paper that compiles information & draws conclusions.
>
> Again, I think not. There is no doctor patient relationship here. There is no expectation of privacy. There is no copyrite ownership of a post by the poster, once it is made here...
>
> & again the analogy/comparison of a letter to a newspaper editor holds. I can see no reason why an IRB would have any jurisdiction over evaluation of public published information.
>
> The net medium of publication does not confer any special or unique rights to the posters here.
>
> I could legally & ethically do a research paper based on information posted on this BB... It would not require the permission or even notification of Dr Bob or of any of the posters...

 

Re: Institutional Review Board policies

Posted by Noa on January 25, 2001, at 16:14:41

In reply to Re: Institutional Review Board policies, posted by shar on January 25, 2001, at 9:40:33

I definitely have attempted to guard my privacy/identity because of the nature of what I have disclosed here.

It does strike me that many posters here have been quite unguarded, using their own names, or something identifiable as a name, and, in the text of their messages, providing information that could help to identify them (some of which can seem benign by itself, but when combined with other personal info might give away more than is advisable)---personal info like location, name of workplace, affiliations/activities of various kinds, spouse name, kids' names, last names, etc.

Dr. Bob, one would think this isn't necessary, but perhaps when people register, you could offer a brief, very prominent warning message about the benefits of choosing a non-identifying screen name, and of being very judicious with personal, identifying info, on the web in general, but here especially, since the "intimacy" of the exchanges can sometimes create an illusion of being in a group with closer boundaries than are really there. What I am envisioning is a warning message that new registrants would have to go "through" to register their name here--I am thinking that this step could create a moment of thought about this that could really help.

What do you think?

 

Re: Institutional Review Board policies

Posted by name on January 25, 2001, at 16:16:40

In reply to Institutional Review Board policies, posted by Dr. Bob on January 25, 2001, at 3:33:27

After 2 1/2 years of using university resources for a project, it is reasonable to ask for input from an authoritative panel at the university.

The role of an IRB is not to comment on all research, but to review research conducted by employees of that institution. This "psycho-babble" project relies on the university for credibility and for financial support. The university has obligations to those who fund university projects and research. Federal grants are part of that funding, hence the role of the Department of Health and Human Services.

>does an IRB need to decide if a support board is research, in & of itself ? I think not

But the on-line discussion is obviously a “project” of a professor employed at the University of Chicago.

The IRB guideline says: "If you are planning to publish the results of a project, it is almost always regarded as 'research.'"

And Dr. Hsuing has said all along:

>I want to be able to use these posts elsewhere. For example, on my Books page or in an article or something.

>Does an IRB need to give consent when public information is used to write a paper?

In this case, the information was made public using equipment the university provided. The information was provided at Dr. Hsuing’s suggestion, and while he intended to publish papers based on the information.

Folks, I am not trying to impose a "brand of ‘white bread’, ‘moral majority’-like political correctness to this site." The reason I return to a site that "disgusts me the way this one seems to" is because there is the opportunity, to "take up … issues with … the U of Chicago" and perhaps develop here a more "scientifically, evidenced-based pharmacotherapy/psychotherapy form of treatment for those with mental illnesses."

Rebecca inventoried some possible weaknesses of the site in a post at:
http://www.dr-bob.org/babble/admin/20001124/msgs/321.html

And Snowie suggested methods used at other sites to reduce the stress to participants who otherwise might blindly attempt to navigate arbitrary rules of participation:
http://www.dr-bob.org/babble/admin/20001124/msgs/129.html

The reason I continue to advocate “in a cause against (for) the people (possibly) wronged via this site" or who might have suffered from some harm they encountered here, is because the involvement of more minds, and a diversity of viewpoints can improve collective activity. Even if, in a worst case scenario, it were "resonable to question Names' grip on reality," it is also reasonable to consider that in name's blathering psychosis, name might yet utter a meaningful statement that could contribute to better understanding of mental suffering and to more effective clinical practices.

 

Re: Institutional Review Board policies

Posted by name on January 25, 2001, at 18:12:39

In reply to Re: Institutional Review Board policies, posted by Noa on January 25, 2001, at 16:14:41

THE FOLLOWING ARE EXCERPTS FROM THE USDHHS OFFICE OF HUMAN RESEARCH PROTECTIONS IRB GUIDEBOOK
http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm


D. PRIVACY AND CONFIDENTIALITY
http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm#e4

INTRODUCTION


The possibility that research may invade the privacy of individuals or result in a breach of confidentiality sometimes arises in biomedical and behavioral research. Under certain circumstances, an invasion of privacy or breach of confidentiality may even present a risk of serious harm to subjects (e.g., as when the researcher obtains information about subjects that would, if disclosed by the researcher, jeopardize their jobs or lead to their prosecution for criminal behavior). Under less dramatic circumstances, an invasion of privacy or breach of confidentiality can be a moral wrong, or, at least in theory, provide cause for legal action against a researcher or institution.


Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.

...

Observational Studies. Of all the methods used to locate suitable subjects and obtain data, covert observation and participant observation are especially likely to raise concerns about privacy. Covert observation includes the use of concealed devices to record information for later analysis (e.g., tape recording conversations or videotaping personal interactions) and concealment of the researcher (e.g., behind a one-way mirror) as the behavior of subjects is observed and recorded. In participant observation, the researcher assumes a role in the setting or group being studied. When the purpose of these methods is to gain access to information not ordinarily available to "outsiders," questions of privacy arise. (Similar issues about obtaining information not intended to be disclosed can be raised about many other forms of research that involve deception.)


Several factors may be relevant to an IRB's evaluation of such privacy questions. One is the extent to which the behavior in question is public. Covert observation of public behavior (e.g., observing pedestrians on the street) raises little if any concern about privacy; concealed observation of people in their homes would be quite another matter. Some behavior that occurs in public places may not really be public behavior C the individuals involved have a reasonable expectation of privacy. Research involving covert recording of conversations in public parks or filming of activities in public rest rooms clearly raises invasion of privacy questions. Observational studies in quasi-public places (e.g., hospital emergency rooms or state mental hospital wards) may also raise such concerns.


A question sometimes raised about the use of covert observation in research is whether an ethical issue exists if the subjects never become aware of the invasion of privacy. That is, if subjects are never aware that their behavior has been observed or recorded for research purposes, they can hardly feel embarrassed, guilty, or that their rights have been violated. On the other hand, it can be argued that an invasion of privacy is wrong, whether or not the subjects are ever aware of it. In some cases, subjects may inadvertently learn of their involvement in the research, perhaps when the study is published, and feel that they have been harmed.


Most observational research, except that involving children and minors, is exempt from federal regulations. For studies involving adults, current regulations require IRB review only for the most risky observational investigations C those in which two conditions exist: (1) the observations are recorded in a manner that allows the subjects to be identified, directly or through identifiers linked to them; and (2) the observations recorded, if they became known outside the research, could reasonably place the subject either at risk of criminal or civil liability or cause damage to the subject's financial standing, employability, or reputation [Federal Policy §___.101(b)(2)]. Clearly, in such studies one of the IRB's major concerns should be to determine if it is necessary to record information in a way that entails such risk, and, if so, whether the provisions for maintaining confidentiality of the data are adequate. Observational research involving children and minors must be reviewed by the IRB unless the research involves observations of public behavior when the investigator(s) do not participate in the activities being observed; IRB review is also required where the two conditions described above obtain (i.e., identifiers will be recorded and the observations could place the subjects at risk).


Confidentiality of Research Data. A major set of concerns about confidentiality pertains to the methods used to ensure that information obtained by researchers about their subjects is not improperly divulged. Perhaps because the creation and handling of confidential records is routine in medical institutions, discussions of confidentiality as a special ethical responsibility of researchers have been more prominent in the social sciences than in the biomedical sciences. Nevertheless, the need for confidentiality exists in virtually all studies in which data are collected about identified subjects. It is in the interest of researchers C and essential to the conduct of research on sensitive topics C that researchers be able to offer subjects some assurance of confidentiality. These assurances should be given honestly, which sometimes requires the researcher and the IRB to make explicit provisions for preventing breaches of confidentiality.


In most research, assuring confidentiality is only a matter of following some routine practices: substituting codes for identifiers, removing face sheets (containing such items as names and addresses) from survey instruments containing data, properly disposing of computer sheets and other papers, limiting access to identified data, impressing on the research staff the importance of confidentiality, and storing research records in locked cabinets. Most researchers are familiar with the routine precautions that should be taken to maintain the confidentiality of data. More elaborate procedures may be needed in some studies, either to give subjects the confidence they need to participate and answer questions honestly, or to enable researchers to offer strong, truthful assurances of confidentiality. Such elaborate procedures may be particularly necessary for studies in which data are collected on sensitive matters such as sexual behavior or criminal activities.


In studies where subjects are selected because of a sensitive, stigmatizing, or illegal characteristic (e.g., persons who have sexually abused children, sought treatment in a drug abuse program, or who have tested positive for HIV), keeping the identity of participants confidential may be as or more important than keeping the data obtained about the participants confidential. In such instances, any written record linking subjects to the study can create a threat to confidentiality. Having the subjects of these studies sign consent forms may increase the risk of a breach of confidentiality, because the consent form itself constitutes a record, complete with signature, that identifies particular individuals of the group studied. The Federal Policy allows IRBs to waive the requirement for the investigator to obtain a signed consent form where it will be the only record linking subjects to the research, and where a breach of confidentiality presents the principal risk of harm that might result from the research [Federal Policy §___.117(c)]. FDA regulations allow IRBs to waive the signed consent form requirement only when the research presents no more than minimal risk and involves procedures that do not normally require consent when performed outside the research context [21 CFR 56.109(c)]. If both FDA regulations and the Federal Policy apply to a protocol, the IRB must meet the requirements of both. In this instance, documentation of informed consent can be waived only if the consent form is the sole record linking subjects to the research, the research involves minimal risk, breach of confidentiality is the principal risk of harm and the procedure involved in the research is one that does not normally require consent when performed outside the research context. (Note that the foregoing waiver provisions apply to documentation of informed consent and not waiver of the requirement to obtain informed consent.)


Where data are being collected about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences) protection of confidentiality consists of more than preventing accidental disclosures. There have been instances where the identities of subjects or research data about particular subjects have been sought by law enforcement agencies, sometimes under subpoena, and with the threat of incarceration of the uncooperative researcher. Under federal law (and some state laws), researchers can obtain an advance grant of confidentiality that will provide protection even against a subpoena for research data [Public Health Service Act §301(d)]. Although regulations implementing §301(d) are not in place as of this writing, the PHS has issued an Interim Policy Statement [also called the "Interim Guidance" (May 22, 1989)] that sets forth PHS policy exercising the its authority to grant certificates of confidentiality. Section 301(d) extends to "biomedical, behavioral, clinical, or other research" an earlier authority (in '303 of the Public Health Service Act) that was available only for "research on mental health, including research on the use and effect of alcohol and other psychoactive drugs."


To take advantage of §301(d), the investigator must request a grant of confidentiality from the appropriate official. Protection for research on mental disorders or the use and effects of alcohol and other psychoactive drugs can be obtained from the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), or the National Institute of Mental Health (NIMH), which, in 1991, became components of NIH. Certificates of confidentiality for biomedical, behavioral, clinical, or other research that does not fall into these categories are issued by the Assistant Secretary for Health. Protection is available for: (1) direct federal activities (i.e., intramural research); (2) federally-funded activities; and (3) research in the United States that has no federal funding. Under the Interim Policy, protection will be granted "sparingly," and only "when the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives." The Policy defines "sensitive" research as involving the collection of information falling into any of the following categories:

(a) Information relating to sexual attitudes, preferences, or practices;

(b) Information relating to the use of alcohol, drugs, or other addictive products;

(c) Information pertaining to illegal conduct;

(d) Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;

(e) Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;

(f) Information pertaining to an individual's psychological well-being or mental health.

Information in other categories, not listed here, might also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.


For studies in which the data to be obtained concern illegal or stigmatizing activities but which are not eligible for these statutory shields against subpoena, careful attention should be given to a series of decisions related to confidentiality: (1) whether the researcher will record subject identifiers at all (including on consent forms); (2) if identifiers are to be collected, whether they will be retained after the data are coded; (3) if identifiers are not destroyed, how are they to be maintained; and (4) what subjects should be told about these matters as part of the informed consent process. Some researchers enlist a third party (sometimes in another country) to act as a custodian of keys to coded identifiers or lists of participants. This approach may provide some protection for the data, but may expose the researcher to legal risks. Where such steps are contemplated, investigators should seek competent legal advice regarding the advisability of such arrangements.


Clearly, different types of studies entail different confidentiality problems. A variety of methods for protecting confidentiality are available for different situations, including situations in which there is a danger of deductive identification of otherwise anonymous subjects on the basis of separate elements of data (e.g., birthdate, occupation, and zip code). A substantial and highly specialized literature has developed on methods for safeguarding confidentiality. Among the available methods for assuring confidentiality are statistical techniques and physical or computerized methods for maintaining the security of stored data. The more sensitive the data being collected, the more important it is for the researcher and the IRB to be familiar with the state of the art in protecting confidentiality.


 

Re: Institutional Review Board policies

Posted by Dr. Bob on January 27, 2001, at 0:36:09

In reply to Re: Institutional Review Board policies, posted by danf on January 25, 2001, at 5:19:05

> There are 2 very different issues here.
>
> The first: does an IRB need to decide if a support board is research, in & of itself ?
>
> The second question is: Does an IRB need to give consent when public information is used to write a paper that compiles information & draws conclusions.

I was thinking something like that myself. I don't think I need their approval to make this board available, but I may need (should ask for) it to write about it.


> It would be interesting to compare PB with other like forums on the Internet. There would be many ways to go with that idea.

I agree! What other boards would be good "guinea pigs"? Maybe Tapir is mentioned the most often?


> Dr. Bob, one would think this isn't necessary, but perhaps when people register, you could offer a brief, very prominent warning message about the benefits of choosing a non-identifying screen name

Currently, under where you enter your "name", it says: "Does not have to be your real name; consider your privacy." "Not" is in bold, and "privacy" is a link to "How private are things here?" in the FAQ. This does fall short of *recommending* something other than your real name, however...

> the "intimacy" of the exchanges can sometimes create an illusion of being in a group with closer boundaries than are really there.

That's an excellent point. Some people refer to "disinhibition" online, but that makes me think of being drunk, whereas I think the key is a feeling of safety, so lately I've been thinking of it as "cybersecurity"...


> the involvement of more minds, and a diversity of viewpoints can improve collective activity.

It pains me a little to admit it :-) but this reminds me of something I added to my home page after the big crash:

Now, how are we to recognize Nature's most excellent web sites? ... whatever does not kill them makes them stronger. --Ecce Homo (adapted), Friedrich Nietzsche, 1889

Bob

 

Re: Institutional Review Board policies

Posted by name on January 27, 2001, at 1:48:47

In reply to Re: Institutional Review Board policies, posted by Dr. Bob on January 27, 2001, at 0:36:09

> I don't think I need their approval to make this board available, but I may need (should ask for) it to write about it.

The IRB could agree, but one must accept some exceptional authority to enjoy the intellectual fraternity of a respected and endowed academy. Because of the public nature of the medium, to publish the discussion board on the Internet is also “to write about it.” The board speaks publicly of itself.

“Is the project being undertaken with the notion that … a poster … may be presented at a … community gathering?” (IRB Guidelines)

The board does tend to be investigative and intended to contribute to generalizable knowledge. Whether or not systematic review is required by university or federal authorities, the Office of Human Protections informed consent guidelines might still be helpful:

http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm

Even if the board is not, in and of itself, research, it is a major innovation. The seminal 1979 Belmont report suggests “it is the responsibility of medical practice committees … to insist that a major innovation be incorporated into a formal research project.”

Rzip suggests a hypothetico-deductive approach, and of course "The Article" sites a need for further study.

> Now, how are we to recognize Nature's most excellent web sites? ... whatever does not kill them makes them stronger. --Ecce Homo (adapted), Friedrich Nietzsche, 1889

A recent Medscape article that suggested a need for rigorous assessment of claims that energy transfer can lead to accurate clinical diagnoses offered the advise of a Chinese proverb: "Real gold does not fear even the hottest fire."

 

Re: Institutional Review Board policies

Posted by phillybob on February 3, 2001, at 8:38:17

In reply to Re: Institutional Review Board policies, posted by name on January 27, 2001, at 1:48:47

Very interesting discussion. I agree strongly with danf's crystallization of the issues and I think Noa's idea really needs to be taken the necessary steps further: "What I am envisioning is a warning message that new registrants would have to go 'through' to register their name here--I am thinking that this step could create a moment of thought about this that could really help."

[I personally do not care of my own privacy and am very comfortable in my own being and with the words that emanate from me in the hopes that they will help others ... which ultimately is what I believe this board is all about.]

 

Re: New informed consent procedure

Posted by Dr. Bob on October 25, 2001, at 8:25:39

In reply to Re: Institutional Review Board policies, posted by phillybob on February 3, 2001, at 8:38:17

> [The] view ... of the Department of Health and Human Services ... is that research is "systematic investigation ... designed to develop or contribute to generalizable knowledge."

> I'll submit this to [my IRB], and we'll see what they say.

They have in fact deemed this research -- the "generalizable knowledge" is how online communities work and affect the mental health of their members -- and have approved it.


> What I am envisioning is a warning message that new registrants would have to go "through" to register their name here--I am thinking that this step could create a moment of thought about this that could really help.
>
> What do you think?

It's now considered research, so explicit informed consent -- just such a "moment of thought" -- is now required. As Noa suggested, I've incorporated this into the registration process. To be consistent, everyone, and not just new registrants, will need to consent.

I'd be interested in feedback. If you don't want to consent to post something, just email me directly: dr-bob@uchicago.edu

Bob

 

Re: New informed consent procedure

Posted by wendy b. on October 26, 2001, at 8:26:39

In reply to Re: New informed consent procedure, posted by Dr. Bob on October 25, 2001, at 8:25:39

> > [The] view ... of the Department of Health and Human Services ... is that research is "systematic investigation ... designed to develop or contribute to generalizable knowledge."
>
> > I'll submit this to [my IRB], and we'll see what they say.
>
> They have in fact deemed this research -- the "generalizable knowledge" is how online communities work and affect the mental health of their members -- and have approved it.
>
>
> > What I am envisioning is a warning message that new registrants would have to go "through" to register their name here--I am thinking that this step could create a moment of thought about this that could really help.
> >
> > What do you think?
>
> It's now considered research, so explicit informed consent -- just such a "moment of thought" -- is now required. As Noa suggested, I've incorporated this into the registration process. To be consistent, everyone, and not just new registrants, will need to consent.
>
> I'd be interested in feedback. If you don't want to consent to post something, just email me directly: dr-bob@uchicago.edu
>
> Bob


Dear Bob,

The only thing I'd like to *Register*, after having gone through the entire process last night - including taking the little 'test' - is that it's cumbersome. Of course, you can't help it if your IRB changed what you have to do in order to keep the site going. Whether or not PsychoBabble is 'research' proper is their call, obviously. You're just a member of the faculty, who cares about what you think, right? :-]

Also, I'm getting paranoid about my screen name now! But as Phillybob says more eloquently in the post above from February, I have nothing to hide, my comments and contributions are real and from the heart... oh well, let's just quote him:

"[I personally do not care of my own privacy and am very comfortable in my own being and with the words
that emanate from me in the hopes that they will help others ... which ultimately is what I believe this board
is all about.]"

Hope there ensues a good discussion about the re-registration process... Is there any way to tell how many people have done this since you posted it yesterday? I'd be interested.

Thanks, as always, for maintaining and monitoring the site as conscientiously as you do,

Wendy

 

Re: New informed consent procedure

Posted by Dr. Bob on October 26, 2001, at 11:52:37

In reply to Re: New informed consent procedure, posted by wendy b. on October 26, 2001, at 8:26:39

> The only thing I'd like to *Register*, after having gone through the entire process last night - including taking the little 'test' - is that it's cumbersome.

I know. :-( If you have any ideas as to how it could be streamlined, I'm all ears (or eyes, as may be the case here)...

> Of course, you can't help it if your IRB changed what you have to do in order to keep the site going. Whether or not PsychoBabble is 'research' proper is their call, obviously. You're just a member of the faculty, who cares about what you think, right? :-]

I could gripe, but to be fair, informed consent is important even if something isn't considered research (whether it needs to be so explicit is another matter), and it may be something new for them to approve a process that (1) is completely electronic and (2) allows people to be anonymous.

> Also, I'm getting paranoid about my screen name now! But as Phillybob says more eloquently in the post above from February, I have nothing to hide, my comments and contributions are real and from the heart...

This board wouldn't be anything without you contributors! Still, I do want your decision to participate to be an informed one.

If people decide not to continue contributing because they learn something they weren't aware of before, that's too bad for the board, but OK with me. What I don't want is to lose people just because it's cumbersome!

> "[I personally do not care of my own privacy and am very comfortable in my own being and with the words
> that emanate from me in the hopes that they will help others ... which ultimately is what I believe this board
> is all about.]"

That is in fact what this board is all about. But I don't think it requires people not to care about their privacy...

> Is there any way to tell how many people have done this since you posted it yesterday?

So far, about 60...

Bob

 

Re: Newer informed consent procedure

Posted by Dr. Bob on October 26, 2001, at 17:17:50

In reply to Re: New informed consent procedure, posted by Dr. Bob on October 26, 2001, at 11:52:37

> If you have any ideas as to how it could be streamlined, I'm all ears...

Hmm, after passing the quiz, at least a couple people reset their passwords by mistake, so instead of taking you back to the main registration page, the quiz now takes you to a simplified page with just the two relevant options, "register for the first time" and "update your registration". I hope that helps. Thanks again for your patience,

Bob

 

Oy, what a procedure! » Dr. Bob

Posted by Shar on October 26, 2001, at 19:12:36

In reply to Re: Newer informed consent procedure, posted by Dr. Bob on October 26, 2001, at 17:17:50

Dr. Bob-
I'm guessing you don't just want babblers, you want dedicated, tenacious babblers! It is a cruel twist of fate that people befuddled by multiple medications are required to read a long consent form and then take a test and then REMEMBER their password and then CONFIRM it all, just to be able to post.

I'm kidding, and not kidding. Is it necessary to ask 10 questions? Could you possibly have, at the end of the consent form, just the "I agree with the terms of this etc etc" so people can just agree and go on. I have to say, I missed two questions--on different tries--on that quiz! Don't you just really want to be sure that people know (1) this is a site for support etc (2) info may not be accurate (3) your mileage may vary (4) this could be published and/or used against you. Do you really think it is necessary to ensure that each potential poster knows that you have to give your real email addy to Dr. Bob (that is a moot point upon registration), or that PB is for support and research, etc.

If you could have checkboxes indicating "I read this" and have the statements that posters really need to understand to give a valid informed consent, then they could just check/click on the box which is easier than taking the multiple choice test especially if I am making mistakes and keep getting myself back to the test page while trying to register.

Shar

 

Re: Oy, what a procedure!

Posted by Dr. Bob on October 27, 2001, at 0:05:28

In reply to Oy, what a procedure! » Dr. Bob, posted by Shar on October 26, 2001, at 19:12:36

> I'm guessing you don't just want babblers, you want dedicated, tenacious babblers!

That's right, elite babblers! :-)

> I'm kidding, and not kidding. Is it necessary to ask 10 questions? Could you possibly have, at the end of the consent form, just the "I agree with the terms of this etc etc" so people can just agree and go on. I have to say, I missed two questions--on different tries--on that quiz! Don't you just really want to be sure that people know (1) this is a site for support etc (2) info may not be accurate (3) your mileage may vary (4) this could be published and/or used against you.

Are you saying there should be fewer questions or no questions at all? The idea of the quiz is to try to make sure people understand what they're being asked. Since, after all, it's supposed to be *informed* consent.

Bob

 

Re: Oy, what a procedure!

Posted by Shar on October 27, 2001, at 20:00:56

In reply to Re: Oy, what a procedure!, posted by Dr. Bob on October 27, 2001, at 0:05:28


> Are you saying there should be fewer questions or no questions at all?

Different, and fewer, items to acknowledge.


>Since, after all, it's supposed to be *informed* consent.

I understand very well the concept of informed consent. The ques is what do YOU want them to be informed about? That they have to give you their real email addy? Or, anyone can read the posts? Or do you want them to understand the purpose of the board, the fact that it is an ongoing research project, and what to expect (such as caveats about ymmv, get help the old-fasioned way, etc). If it is the last option, I don't think the 10 questions do the trick.

...on the other hand, in the larger scope of things, it's fine the way it is. Guess this is my Saturday night rant.

Shar
>
> Bob

 

Re: New informed consent procedure

Posted by akc on October 27, 2001, at 22:23:50

In reply to Re: New informed consent procedure, posted by Dr. Bob on October 25, 2001, at 8:25:39

I just want to throw my two cents in. This new procedure just doesn't seem right. While this might be "research," it is in a new forum and it is far from typical. And this new procedure is daunting.

On one level, I understand the need as a researcher for you to get "informed consent" -- hence, the quiz. But I can just imagine that in person, there must be the ability to "skim" to get through the process.

And more important is the fact that the people that until now who have wandered to PB, have come not for the "research" but for the support -- you might get the research benefit, but that is not their focus. I'm not saying this well.

My concern really is this. I can remember how hurting I was when I stumbled upon this site. I am pretty intelligent -- but emotionally, I don't think I could have handled a quiz that I had to get 100% to then participate in a forum that when I peaked, did look like it was about support. It would have been too daunting -- and I probably would have just read a few of the posts on topamax (what led me here) and gone on my way. And never have had this experience.

I just don't get the quiz. Why is it not sufficient to have the written statement? I did not realize that to have informed consent, you had to give a quiz? Is that a departmental requirement? A requirement within your particular field? From my legal way of thinking, I would think it sufficient to have a statement that then you would have a signature (and of course, an electronic signature is more than sufficient). Sure, some won't read it -- but that happens all the time -- with medical treatment, legal representation, buying a house -- people make all sorts of major decisions, decisions they know better than to make without reading the fine print, but they do it anyway.

Instead, there is this quiz. And I just see it as a huge roadblock for some people who could really benefit from PB. I think this goes back to what is this site really about -- is it research or is it support? If it is support, do you want to put a procedure in place that is going to be a roadblock?

I don't think I am making a big deal out of nothing. Just the little bit of response out of us who have been here a bit tells me this. I think this quiz thing is a really big deal. Especially for someone who is in a lot of mental and emotional pain -- usually those who are first stumbling upon PB. One of the hard things to do when your meds are messed up or you life is in shambles, is to think linear -- but yet, you ask those people to take this quiz. That doesn't mean they aren't together enough to give informed consent -- but it is one thing to give consent, another to take a quiz.

I guess my thought is that there has to be some other way to do this without the quiz. I sure hope this is not being forced upon you, so you can revisit this procedure.

akc

 

Re: New informed consent procedure

Posted by mair on October 28, 2001, at 11:44:42

In reply to Re: New informed consent procedure, posted by akc on October 27, 2001, at 22:23:50

> Bob - I think I weigh in here a bit with Shar. On the one hand, I'm very relieved actually that you're doing something like this. I've frankly been concerned in the past that you did too little to protect yourself. Also this might cut down on some of the types of remarks that were made in that sometimes tedious discussion that ensued after you published that article.
On the flip side - my this is intimidating, even to the initiated! Physicians, schools, camps, travel groups and just about everyone else out there ask people to give "informed consent" all the time, but I've never been quizzed on my understanding of what I've consented to. The quiz may not be a bad idea, but it does go on. As with akc, I'm not sure I'd go through all this if I weren't already pretty attached to this site. What if you did this: What if you broke your consent down important point by important point with questions starting out like "Do you understand that your post may be quoted in a research paper?" to give an example. And then people would answer something like "I understand and agree to this term" as to each of your questions. I'm not sure I'm explaining this very well but the idea would be to remove some of the intimidation of the quiz format and yet get people to focus on and address each important concept.

Mair

 

Re: New informed consent procedure

Posted by Dr. Bob on October 28, 2001, at 13:53:34

In reply to Re: New informed consent procedure, posted by mair on October 28, 2001, at 11:44:42

> > Are you saying there should be fewer questions or no questions at all?
>
> Different, and fewer, items to acknowledge.
>
> Shar

Hmm, in retrospect, maybe I should've just asked you all to suggest questions in the first place... Sometimes I do just get an idea and go with it...

Any suggestions for better questions?


> I just don't get the quiz. Why is it not sufficient to have the written statement? I did not realize that to have informed consent, you had to give a quiz? Is that a departmental requirement? A requirement within your particular field?

I hesitate to admit it now... but the quiz was my idea. I thought it would help reassure the IRB. One aspect of informed consent is that the person needs to be competent to make the decision. In person, you can assess how much someone understands as you explain something. But here I can't do that. But passing a quiz is pretty good evidence of competence.

A more general point could be that in some cases communication online may need to be more explicit than in person. Like with tone of voice. Sometimes in person that's how you know what someone means. But sometimes online I think you have to ask.

> From my legal way of thinking, I would think it sufficient to have a statement... Sure, some won't read it -- but that happens all the time -- with medical treatment, legal representation, buying a house -- people make all sorts of major decisions, decisions they know better than to make without reading the fine print, but they do it anyway.

Well, just because something happens all the time doesn't necessarily make it OK... Maybe it wouldn't be such a bad thing if people had to pass a quiz before buying a house? Also, I thought the quiz was more about basics than fine print -- and wouldn't have expected regulars to have a very hard time with it. Were there aspects that really weren't so clear before?

> I think this goes back to what is this site really about -- is it research or is it support?

The thing is, it's both. Mainly support (and education), but partly research, too.

> I think this quiz thing is a really big deal. Especially for someone who is in a lot of mental and emotional pain -- usually those who are first stumbling upon PB. One of the hard things to do when your meds are messed up or you life is in shambles, is to think linear -- but yet, you ask those people to take this quiz. That doesn't mean they aren't together enough to give informed consent -- but it is one thing to give consent, another to take a quiz.

That's actually a concern sometimes, that people who are in a crisis might not "think linear". I have some problems with "first, do no harm", but that might be one way to look at this.

Someone might be together enough to give informed consent, but not enough to take the quiz? Because it's too many extra steps?

> I guess my thought is that there has to be some other way to do this without the quiz. I sure hope this is not being forced upon you, so you can revisit this procedure.
>
> akc

I'm open to suggestions, and yes, I think I can work with the IRB...


> I found your new registration process considerably more trouble than consenting to major surgery and slightly less time-consuming than buying a new house.

(sigh) And I'm to assume you were happy with the surgery and the house? :-)

> However, had I had to deal with this obstacle course 2 years ago, I wouldn't have been one of the participants. I'd have "bailed" before I even *got* to the quiz--too many steps for something I wasn't sure I could, or wanted, to do in the first place.

This isn't to say that it isn't great to have you :-) but is it such a bad thing for people to be more sure that this is in fact what they want? There have always been people who've "lurked" a long time before posting. And of course those who still haven't posted...

> My concern is that this quiz may be a "straw that breaks" for too many potential participants. Of course, *any* quiz may have that effect. But this one has an academic-qualifying flavor that, if you find it difficult, is inhibiting--and, if you don't, is just very annoying.

The quiz itself has that flavor, or the information before and after? If there's some way to make the quiz more palatable, I'd love to do that, but some of the language before and after is required as is by the IRB.

> If some sort of quiz is a research sine qua non, a more user-friendly one would (IMHO) feature no more than 5 Qs, reiterate important points in some of the Qs, be mostly fill-in-the-blank, supply or approve answers Q by Q, and end with a consent option. The focus of this feature would then shift from proving competence to reinforcing information, but I think that the comprehension end point wouldn't be much different.

Hmm. I'm not sure what you mean by "reiterate important points". Fill-in-the-blank would be better than multiple-choice? It would be hard for the server to "grade" fill-in-the-blank... One question at a time would be better than all at once? I myself like being able to get an overview and to decide myself in what order to take the questions...

The idea really is more to prove competence than to reinforce information. If I reinforce and reinforce and reinforce, but still someone doesn't understand, is their consent be valid?

> I hope that this is "much ado about nothing." A counter on the first registration page to compare "hits" against registrations might be interesting, tho.
>
> medlib

I hope so, too, I do still want people to benefit from this -- although I realize fewer people may this way... The counter would be a measure of how much of a deterrent the new procedure is? Interesting idea...


> On the one hand, I'm very relieved actually that you're doing something like this. I've frankly been concerned in the past that you did too little to protect yourself. Also this might cut down on some of the types of remarks that were made in that sometimes tedious discussion that ensued after you published that article.

Thanks...

> What if you broke your consent down important point by important point with questions starting out like "Do you understand that your post may be quoted in a research paper?" to give an example. And then people would answer something like "I understand and agree to this term" as to each of your questions.
>
> Mair

Hmm, another vote for one at a time...

My concern with a system like that is that people might just zip through the whole thing, answering "yes, I understand" or "yes, I agree" every time, just to be done with it. Which really wouldn't accomplish anything. I know this isn't major surgery, but what if I were proposing to do major surgery and the patient said, "sure, sure, just give me the form and let me sign it so we can get on with things"?


Thanks for the input, which I understand comes from wanting the best for the board. I'll try to do what I can. And thanks for not jumping ship! :-)

Bob

 

Re: New informed consent procedure

Posted by KB on October 28, 2001, at 19:40:02

In reply to Re: New informed consent procedure, posted by Dr. Bob on October 28, 2001, at 13:53:34

I didn't really have difficulty with the quiz, though I was mildly annoyed by the disruption in my logging-on routine, but when I got to the part where I had to remember my password, I was stumped!!! I got it eventually, but . . .

 

Re: New informed consent procedure

Posted by tina on October 29, 2001, at 10:36:36

In reply to Re: New informed consent procedure, posted by Dr. Bob on October 28, 2001, at 13:53:34

>
> My concern with a system like that is that people might just zip through the whole thing, answering "yes, I understand" or "yes, I agree" every time, just to be done with it. Which really wouldn't accomplish anything. I know this isn't major surgery, but what if I were proposing to do major surgery and the patient said, "sure, sure, just give me the form and let me sign it so we can get on with things"?
>
THis is the reason for your quiz, yes? So this doesn't happen.

I liked the quiz idea. It's good to double check myself and this quiz helped me to understand the point of psychobabble which I think sometimes gets lost in the conversation.
Perhaps the ones who have such a problem with the quiz are the ones that should be monitored and checked?
I really don't see the big deal here. It's only 10 questions and if you read the information, the questions are easy. Plus, you can go back and back and back again to get it right. What is the problem here people?? Why is this such a tempest in a teacup??
Maybe I'm just too canadian.....but I say Well done Doc! Good idea. Leave it the way it is. You can't please all the people all the time and if you keep trying, you'll end up on the "poster" side of this board, not the doctor side. :)

 

Re: had to remember my password

Posted by Dr. Bob on October 29, 2001, at 12:00:14

In reply to Re: New informed consent procedure, posted by KB on October 28, 2001, at 19:40:02

> when I got to the part where I had to remember my password, I was stumped!!!

Hmm, that's come up before... I might be able to get it "automatically remembered" for you, let me look into that...

Bob

 

Re: New informed consent procedure

Posted by Dr. Bob on October 29, 2001, at 12:16:26

In reply to Re: New informed consent procedure, posted by tina on October 29, 2001, at 10:36:36

> I say Well done Doc! Good idea. Leave it the way it is. You can't please all the people all the time

Thanks! I learned early on that I couldn't please everyone all the time, but still I want to try to be open to feedback -- and please at least some people some of the time. :-)

Bob

 

Re: New informed consent procedure » tina

Posted by akc on October 29, 2001, at 13:02:32

In reply to Re: New informed consent procedure, posted by tina on October 29, 2001, at 10:36:36

> What is the problem here people?? Why is this such a tempest in a teacup??

I guess my point (and problem) is that some of the people in the biggest emotional crisis might have the biggest trouble with this. It seems like no big deal at all when I am happy go lucky. However, there have been days that such a quiz would have been virtually impossible. Yet, I would not have been incompetent -- just overwhelmed. And I think there is a big difference. Just because I am having a really bad time does not mean I am incapable of giving informed consent.

Dr. Bob speaks above about being able to judge in person whether a person is able to give informed consent. There is a lot of things a person can do "in person" that is impossible on-line. Ask different questions, read body-language, give additional information, ask for questions, etc. Dr. Bob is using the quiz to take the place of a lot of that stuff. My opinion is that it is a poor substitute. Hence, some people who could really benefit from this site may only get limited use (just reading the posts) or none at all (not feeling "welcome," they quickly move on).

Now here comes the big problem -- I don't have a better idea. Dr. Bob is right that my just let them read it and sign it (when we know they won't read it) is not informed consent. Even if that happens in a lot of contexts in the real world (both on line and off), doesn't make it "right." Unless Dr. Bob begins to interview each person who wants to join Psycho-Babble, there has to be a process that he can use to judge whether a person has some concept of what's going on. I hate the quiz idea -- I still think there has to be a better way. But I am still racking my brain to come up with that idea.

akc

 

Re: New informed consent procedure

Posted by stjames on October 29, 2001, at 18:27:00

In reply to Re: New informed consent procedure » tina, posted by akc on October 29, 2001, at 13:02:32

> > What is the problem here people?? Why is this such a tempest in a teacup??
> Now here comes the big problem -- I don't have a better idea. Dr. Bob is right that my just let them read it and sign it (when we know they won't read it) is not informed consent. Even if that happens in a lot of contexts in the real world (both on line and off), doesn't make it "right." Unless Dr. Bob begins to interview each person who wants to join Psycho-Babble, there has to be a process that he can use to judge whether a person has some concept of what's going on. I hate the quiz idea -- I still think there has to be a better way. But I am still racking my brain to come up with that idea.
>
> akc

James here....

Perhaps if people are unable to read a short para and answer some questions correctly, they may not benefit from this forum. It is in written form and requires the same skills.

james


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