How Long does it take to get irb approval and publication?

[bananasewq]

Hi all!

Happy New Year! I am starting to get involved in a clinical research opportunity at my school. The attending says that the project is still under IRB review. I have to do some CITI training for my hospital and school in order to to be added to the protocol of the project.

My questions is- how long does it take to get IRB approval? Also, how long does it take to publish in clinical research? - the attending said it's going to be retrospective chart reviews if that helps.

I have applied to several summer internships with clinical research, so if this current project extends into the summer, would I be able to continue the project while starting another one? I have only done bench research in the past, and I know a publication is not possible from here to the summer. What's the experience like for clinical research?

Thanks! Sorry if I sound naive about this. Happy studying!

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[ChrisMack390]

Is the project "still under IRB approval" as you said? If it is then....zero minutes....

If not it depends what were talking about. Some minimal risk data collection could take a few days, but an interventional clinical trial can take months. This also varies very widely between IRBs. I happen to work at an academic powerhouse that has a full staff of employees whose job it is to triage IRB submissions and ensure the fastest possible review. Some smaller private IRBs can take much longer. Some also have very rigid rules (submit on X, get an answer by Y) and some do not (they review as fast as they can based on current volume).

TBH I think the most likely thing is that your PI already has approval for this project, in which case you likely won't have to worry about seeking approval as long as what you are analyzing is already covered in the informed consent document that the patients signed.

 

[Goro]

Everything depends upon how often the committee meets.


My questions is- how long does it take to get IRB approval?


Totally dependent upon the quality of the paper, and the journal you send it to.

Also, how long does it take to publish in clinical research? - the attending said it's going to be retrospective chart reviews if that helps.

 

[FutureDoc1088]

IRB turn around is variable by institution and the type of research you're conducting. It also varies by when you submit (beginning of fall or spring might take longer than in the summer). It's good to form relationships with the IRB at your institution by calling or going in person to speak with people. Sometimes they will help expedite things because you're a nice, reasonable person when they're used to dealing with impatient people all day. Because your study is a retrospective chart review, informed consent is typically waived because asking patients to sign an informed consent for something that already happened would put that patient at increased risk of having a breach in privacy (i.e. The existence of a consent document with their name on it places them at higher risk of having someone find out their medical history). So your review should be speedy once the committee gets to it (depends on how many projects are ahead of you). I've done chart reviews where you do a telephone follow up and usually verbal consent is enough for that.

Chart reviews are definitely time consuming for the person pulling the data if you aren't from a research powerhouse with databases. It also requires you to know how to use the EMR to find all the information you're looking for. So I disagree that this takes "days"... most of the restrosoective chart reviews I have been a part of have taken a month or two depending on how much free time you have. Then you have to organize the data, do the stats, make the tables (I usually do this first), and then write the paper. If you've done your homework ahead of time, you should be able to write the introduction, methods, and most of the discussion before you even touch the data. Once you pull the data you can add results and then add some of the results to your discussion and conclusion. If you're organized and did your literature review first, you should be able to have a manuscript within a couple of months. Submitting and revising for a journal can take much longer. Sometimes it's rejected and you have to reformat the manuscript for a different journal (or go back and pull more data) and resubmit. So the entire process from IRB approval to accepted manuscript could take 6-12 months but it's very variable. I should note, however, that you could potentially have an abstract within days of having all your data. I have had podium presentations for abstracts I did in a day after getting my data. Podiums and posters count in your ERAS "pubs" category (but obviously papers mean more).

Hope this helps!

 

[ProfMD]

IRB approval for minimal risk retroespectice reviews have been quick at the places I have worked. Typically within a week. They can undergo expedited review by a member of the IRB and do not need full board approval. Prospective studies, particularly those that involve interventions, will take longer.

Publication times depend on the journal.

A lot depends on you PI as well.

Of note, case reports are typically exempted for IRB oversight.

 

[mvenus929]

It's going to be widely variable. I submitted my IRB application for a prospective simple study (short questionnaire, no direct examination of the patient), and from the time I submitted til the time I got approval from the IRB was 3 months. Part of that was getting my PI to actually sign off on stuff, part was due to not getting everything in and having to wait til the next meeting for review, and part was edits that the IRB asked that I make in my protocol.

Then I had another month waiting for my hospital to additionally approve the research.

Time to publication also depends on many factors--getting all the data collected, then analyzed, then writing the paper itself, submitting it for review, making any changes requested by the reviewers, and finally acceptance for publication. And you may have to submit it to multiple journals because the first one(s) don't want the paper. And once it's accepted, you have to wait for it to actually be published...

 

[HybridEarth]

Ballparking my experiences here:

Once you submit the clinical paper to a decent impact factor journal (3.0+), it's usually about 6 weeks before you get a decision. If rejected, the wise thing to do would be to incorporate the reviewers' suggestions before submitting to a new journal.

If you get revisions, it's probably going to take you a couple weeks to make all the necessary changes. Send out the revisions, then it takes usually another 4-8 weeks to hear back. At that point its a rejection, more revisions, or acceptance.

Once accepted, it takes usually a few weeks to get a set of "proofs" to basically fix any other typos and to make sure everything in the manuscript is exactly what you want it to be. Once the proofs are in, it will be sent to the publisher for inclusion in the journal. Usually the online version is made available a month or two before you actually see it in a paper copy of the journal, but you can still find it in pubmed beforehand in most cases.

I've only seen one paper get flat out accepted with minimal revisions at a solid journal, so don't bank on that unless you're doing something groundbreaking or if you get really lucky with easy reviewers.

Tl;dr it's really quite variable. IRB approval is usually fast for clinical stuff. Best case scenario, you can get a paper accepted and published probably within 3 months, but please don't bank on it. Realistically, it will be between 6 months to a year, if not longer, before you see it in PubMed. Good luck!