Outpatient psychiatrists, a couple questions for you

[loveoforganic]

1) If you were approached by someone seeking to do a research study needing access to your patients' files, would you be (very open/reserved/opposed) to relaying this information to your patients?

If reserved, what would sway you toward open or toward opposed?

2) Would any reasonable number of your patients be open to releasing their files? Would any tiny monetary compensation ($5-$15) appreciably change this number?

Thanks for your time.

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[Regnvejr]

1) If you were approached by someone seeking to do a research study needing access to your patients' files, would you be (very open/reserved/opposed) to relaying this information to your patients?

Opposed, for a bunch of reasons, not the least that of privacy.

If reserved, what would sway you toward open or toward opposed?

2) Would any reasonable number of your patients be open to releasing their files? Would any tiny monetary compensation ($5-$15) appreciably change this number?

Thanks for your time.

Patients really have no concept of what it means to be in a research study, the hassle, work, and risks involved. Even if it is just a chart review. At least, if it was a medication trial, then the patients for which nothing has worked may have another chance for relief, but even then I would hesitate to recommend it.

And the risks of privacy problems from a chart review, where names may or may not leak simply are not acceptable to me.

 

[loveoforganic]

Thanks for your reply.

Are the "hassles and work" directed at chart review research, in addition to the risks? I definitely see the risk present (although I feel the research can be conducted in a manner that makes that risk comparable to day-to-day risk), but I'm not sure I see what hassles/work you're talking about, unless that wasn't directed at chart review work.

Thanks again.

 

[Regnvejr]

Thanks for your reply.

Are the "hassles and work" directed at chart review research, in addition to the risks?

More general research. But chart reviews are a problem as well. Certainly, as every psychiatric patient is unique, there are risks.

And chart reviews sometimes lead to secondary studies, where the original participants are sought for clarification (And, of course, my hassle in having to explain anything).

 

[sunlioness]

Opposed, personally. Privacy issues as mentioned about and just really not wanting to be bothered navigating all the legal ins and outs when I am busy doing other things.

 

[Sneezing]

An Internal Review Board (IRB) would need to be consulted first. If they approved of the research design, ALL the patients in the chart review would have to be sent a letter requesting their written permission. My understanding is research firms will often supply the costs for these letters, and even the people who will do the chart reviews. However, you will still have administrative things to do and sign and who knows what else that will require your time, taking you away from your practice. This is frequently during business hours, because the research folk don't want to work off hours. They will sometimes pay you for your lost clinical time, but that rate must be negotiated. I have seen this overall process in a different specialty physician's office.

I personally wouldn't do it nor want to deal with patients calling in about the letters. "Dr. Sneezing, so you are showing THEM my records? You know THEM?" I would rather collaborate with a study that requires recruitment up front, which I could do in person as opposed to a retrospective study.

However, I believe it may be possible for an IRB to approve a study if ALL identifying information is removed from the copied records to be reviewed. The IRB still might require a letter to be sent stating their records may be looked at, but identifying information removed. Of course this means someone on your staff would then have to prepare these non-sensitive records. Quite a labourius process.

* I am not an expert on this, so I may be saying some things that are blatantly wrong. *

 

[loveoforganic]

Thank you all for the replies.

http://www.feinsteininstitute.org/Feinstein/IRB+Chart+Reviews

I'm definitely aware of the IRB Chart reviews don't always need patient consent, as far as I'm aware, but I think they very well may in the case I'm considering unfortunately.

For you two that already voiced opposed, would not needing consent from patients change anything?

The researcher would also need to undergo HIPAA and Human Subject Protection certification, FWIW.

Thank you all again. I definitely see how this type of thing could be a major headache for you.

 

[Therapist4Chnge]

Thank you all for the replies.

http://www.feinsteininstitute.org/Feinstein/IRB+Chart+Reviews

I'm definitely aware of the IRB Chart reviews don't always need patient consent, as far as I'm aware, but I think they very well may in the case I'm considering unfortunately.

For you two that already voiced opposed, would not needing consent from patients change anything?

The researcher would also need to undergo HIPAA and Human Subject Protection certification, FWIW.

Thank you all again. I definitely see how this type of thing could be a major headache for you.

The standards for human subject research can be stringent, so i'd strongly recommend anyone looking in this area secure mentorship. As for chart review not requiring consent...it is dicey at best, but most likely some type of informed consent would be needed. Good luck selling this to a practitioner.

 

[loveoforganic]

Thanks, I'm being supervised by the clinical pscyh prof I work with and have correspondence with someone from the medical IRB. I definitely don't have high hopes of being able to get participation (lower hopes after this thread ), but I'm going to try to carry the project out regardless and see what happens. I think it'll be a worthwhile experience either way.

 

[Sneezing]

Yup. We have kind of swong from the extreme of Tuskgeegee and nazi experimentation to now not being able to do a dang thing without offering your first born child to the bureaucratic gods.

 

[loveoforganic]

So I'm going to have to go get some chick preggers to get through the IRB eh? Sounds like... fun.

 

[michaelrack]

When I was a sleep medicine fellow (2002-2003), it was still possible to do chart review studies- you just filled out a simple 2 page form and the IRB approved it. Now it requires a 20+ page form and all kind of hassles to protect the patients.
It used to be possible for an academic doc getting started to do some simple research not costing a lot of $. Now it's hard to do even the simplest of research without a $50,000 grant. It's one of the reasons why I got out of academics.

Is it any wonder that much of psychiatric research is now biased drug-company funded studies??

 

[235750]

Chart reviews don't always need patient consent, as far as I'm aware, but I think they very well may in the case I'm considering unfortunately.

I did I couple of retrospective cohort studies by reviewing deidentified chart data last year and I think it can go pretty smoothly depending on what you're measuring, and who you're looking at.

IRBs are a lot of busy work, nothing that requires too much thinking, a bit like doing taxes. The most frustrating thing for me was that the city IRB only met during full moons, or something equally as ridiculous. Hospital IRBs are great as they want you to do research for their institution, at least that's my experience. Also, for chart reviews I've never had to seek pt approval/consent as they were deidentified. This includes a study about minors seen in the ED

Worst case, they give you ways to improve your proposal and you come back to them

good luck to you!

 

[Therapist4Chnge]

De-identification can still be tricky, particularly w special populations.

The VA system has changed a lot of their protocols for research, which has negatively impacted the type, speed, and volume of research.

 

[loveoforganic]

I was wondering about this, maybe you can provide an answer T4C.

I was initially under the impression that all mentally ill were a protected population, but after some searching, it seems like only the institutionalized are (assuming we're talking adults at any rate). Do you know which it is? Or is there not a clear yes/no answer here?

And thanks ilove