PhD/PsyD Getting IRB Approval Without an IRB

[bcliff]

I work at a private practice, and one of the clinicians asked me to work on a paper with her using data from our patients. I was taken aback and asked her how we would get IRB approval, but she seemed rather confident that getting IRB approval without an in-house IRB would be pretty straight forward and would not be cost prohibitive. I've looked into this in the past, and I was always under the impression that it is difficult to get IRB approval without an in-house or affiliated review board. Has anyone here had any experience getting IRB approval for research done in a private practice?

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[Marissa4usa]

I work at a private practice, and one of the clinicians asked me to work on a paper with her using data from our patients. I was taken aback and asked her how we would get IRB approval, but she seemed rather confident that getting IRB approval without an in-house IRB would be pretty straight forward and would not be cost prohibitive. I've looked into this in the past, and I was always under the impression that it is difficult to get IRB approval without an in-house or affiliated review board. Has anyone here had any experience getting IRB approval for research done in a private practice?

I'm confused. If there is no IRB, what IRB would grant approval? Any IRB that I've ever heard of only approves studies that are conducted by researchers affiliated with the institution where the IRB is housed.

 

[CheetahGirl]

I work at a private practice, and one of the clinicians asked me to work on a paper with her using data from our patients. I was taken aback and asked her how we would get IRB approval, but she seemed rather confident that getting IRB approval without an in-house IRB would be pretty straight forward and would not be cost prohibitive. I've looked into this in the past, and I was always under the impression that it is difficult to get IRB approval without an in-house or affiliated review board. Has anyone here had any experience getting IRB approval for research done in a private practice?

I feel like you should be able to contact APA, but I have doubts now b/c of other SDNers opinions. There are certain patient rights that an IRB commands in approved studies, such as informed consent, HIPPA authorization, NIH research w/ human subjects acknowledgment. It seems counterproductive for your PI to get retrospective approval. Seems like you'll first have to worry about tracking down all the patients to approve use of their data for scientific analysis. I would help your PI discover the necessary steps w/o making that person seem like a total idiot for not thinking of these things first. If you have these things, then perhaps you could contact the PI's affiliate hospital (usually doctors in private practice have privileges at a group of facilities that their patients can go to if they need to be hospitalized).

Good luck and please report back what you found out! This seems like an interesting problem to encounter.

 

[Therapist4Chnge]

Would it be with de-identified archival data that was collected during the normal clinical treatment? There may be some wiggle room, depending on what kind of information, how it was collected, the purpose of the research, etc. I know we'd still have to go through an IRB process, though it'd be 'fast-tracked' bc of the minimal impact on test subjects (assuming it is archival, de-identified, etc). I'm not sure what that would look like in a PP setting. Interesting question.

 

[bcliff]

I apologize, I meant that the clinician (PhD) would like to work on a study with patients of our practice in the future, so no pre-existing data would be used. All participants would be given informed consent prior to any data collection.

I've seen third party IRB's that allow you to pay a fee for their services but the ones that I have heard of have been prohibitively expensive given that they need to do site visits, handle all of the paperwork, and the liability of signing off on an independent study. I explained a lot of this to the clinician who seemed unaware of the extensive role the IRB needs to play in the process (this would be the clinician's first paper), so I'm now pitching the idea of a lit review or something publishable and a little more feasible that doesn't require an IRB.

For my own benefit, if a PhD in private practice would like to collect data from his patients as part of a study, how would he secure IRB approval without having one in-house? If he was an adjunct at a research university would it be possible for him to use his university's IRB? Would he need to create his own IRB?

 

[bcliff]

It seems like this person has a deficit in their research knowledge. If the person wants to conduct a study, it might behoove them to connect with a faculty member at a local university who may have complimentary interests and invite them to be a Co-Investigator. The project could then be submitted to this person's institution's IRB for review. Having a collaborator who is skilled in research would likely be a big help in making sure the research is carried out appropriately - it sounds like this person may not know what they don't know. It is not possible to "create" one's own IRB.

Yes, I agree. Going from 0 publications to PI is a pretty big leap, and when I asked in the previous post if a PhD in private practice would need to create his own IRB, I meant if his practice as an institution would need to form its own review board.

 

[voyeurofthemind]

I am pretty sure that there are IRB's that exists as commercial entities. I think CRO's use them all the time. See the link...

http://www.irbservices.com/irbservices/Home.html

 

[Ollie123]

There are definitely private IRBs. Even some major university-affiliated hospitals are switching to them since depending on how things are structured the university may still charge fees to the hospital. This will likely be the best option, but I imagine the cost will not be insignificant.

And to answer the obvious question...yes, it is incredibly ironic/sketchy that the folks who manage/obsess over financial conflicts of interests have enormously glaring ones themselves.

 

[eowyne]

There are definitely private IRBs. Even some major university-affiliated hospitals are switching to them since depending on how things are structured the university may still charge fees to the hospital. This will likely be the best option, but I imagine the cost will not be insignificant.

And to answer the obvious question...yes, it is incredibly ironic/sketchy that the folks who manage/obsess over financial conflicts of interests have enormously glaring ones themselves.

No kidding. I agree with psycscientist that collaborating with an academic would be a good way to go for the sake of research quality, cost of IRB approval, and ease of eventual publication. However, due to aforementioned conflicts of interest and specialization, a private IRB firm might get the job done faster than some academic IRBs I've experienced...

 

[Goobernut]

Sorry if this has been addressed and I missed it, but what kind of research? I'm confused as to the purpose? If its something s/he wants to publish later then yes, I'd suggest finding someone to work with at a local university.

If it's just focus group stuff, then why need an IRB? But I'm guessing it's not, and that's why you asked.

 

[bcliff]

Yes, she ideally wants to interview/assess pt's who are coming in to the practice for group services and use that data to get a publication out of it. I brought up my concerns about not having an IRB, and she didn't seem phased by it, but this thread seems to have reaffirmed my original belief that securing IRB approval without an in-house IRB is costly, time consuming, and probably not worth the trouble for a study this small.

 

[CheetahGirl]

Now I'm confused. Are you going to try to proceed w/o any IRB (free-standing or institutional)? No peer-reviewed journal will accept this work if you have not obtained the proper documentation for a legitimate study (which as we all know, is what an IRB requires). Peer-reviewed publications may not explicitly ask (I can't remember what questions submission paperwork asks), but it is subsumed in your research. And most studies have a one-liner that says where subjects were recruited and states that informed consent was obtained (those informed consent docs are among the materials reviewed by the IRBs). It is unethical to collect study data otherwise. If your PI wants to continue and it is not worth finding an IRB for such a small scale study, then don't plan on submitting anywhere reputable...target Psychology Today. Their standards are so low, they'll accept anything that mentions 'psychology.'

I'm not making jokes (well, I welcome any chance to bust on Psychology Today), just suggesting to begin your research experience with ethics and integrity in mind, it's the only way to conduct research...and don't be involved in shoddy research - it becomes garbage in, garbage out...and you will not want your name and future reputation attached to garbage research (not assuming you would anyway).

Go here: http://phrp.nihtraining.com/users/login.php Register for free, take the test, print the little certificate. Most IRBs require anyone conducting research to get this certificate as part of the process. Regardless, it's good to know these things if this is your field of study.

 

[bcliff]

Now I'm confused. Are you going to try to proceed w/o any IRB (free-standing or institutional)? No peer-reviewed journal will accept this work if you have not obtained the proper documentation for a legitimate study (which as we all know, is what an IRB requires). Peer-reviewed publications may not explicitly ask (I can't remember what questions submission paperwork asks), but it is subsumed in your research. And most studies have a one-liner that says where subjects were recruited and states that informed consent was obtained (those informed consent docs are among the materials reviewed by the IRBs). It is unethical to collect study data otherwise. If your PI wants to continue and it is not worth finding an IRB for such a small scale study, then don't plan on submitting anywhere reputable...target Psychology Today. Their standards are so low, they'll accept anything that mentions 'psychology.'

I'm not making jokes (well, I welcome any chance to bust on Psychology Today), just suggesting to begin your research experience with ethics and integrity in mind, it's the only way to conduct research...and don't be involved in shoddy research - it becomes garbage in, garbage out...and you will not want your name and future reputation attached to garbage research (not assuming you would anyway).

Go here: http://phrp.nihtraining.com/users/login.php Register for free, take the test, print the little certificate. Most IRBs require anyone conducting research to get this certificate as part of the process. Regardless, it's good to know these things if this is your field of study.

I'm sorry, I may not have been clear. I've talked the clinician out of conducting an actual study and have suggested a literature review instead, until we figure out a better way to get IRB approval.

 

[LisaLisa86]

I googled it and found a few university/hospital websites with some hints that it is possible to get IRB approval through other IRBs in the area:

""Q: How can independent investigators (i.e., investigators not associated with an Assurance-holding institution) who wish to engage in cooperative research in their private practices obtain local IRB approval for their research?


A: The proper approach is for the independent investigator to seek permission from OHRP (and the institution) to rely upon the IRB of a local institution with an OHRP-approved Assurance for the research in question. If no such local institution is available or permission is denied, the independent investigator must identify another IRB that holds an appropriate Assurance for reviewing the research. It will be important for the investigator to ensure that the IRB he or she selects can evaluate the research in accordance with the needs of the research setting (e.g., local laws, professional and community standards, and cultural differences due to different geographical or research settings)."

The FDA FAQ says: (http://www.fda.gov/regulatoryinformation/guidances/ucm126420.htm)

"An investigator [in private pratice] should be able to obtain IRB review by submitting the research proposal to a community hospital, a university/medical school, an independent IRB, a local or state government health agency or other organizations."

I'd start by calling local IRBs.