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.
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.
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.
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.
> 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.
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! :-)