4

If you get the written IRB approval of the school/site for research and you conduct the research with all participants' written agreement, can the school revoke agreement to research after you are done with the research?

An IRB was signed. Research for dissertation. can the research site revoke the agreement after the research was conducted?

Research was approved through signed IRBs. Research was completed and results were done. How can a school revoke approval if the research was completed?

In essence, I am asking if IRB can withdraw approval from all schools involved after the fact.

13
  • 6
    Can you add more details, such as your academic rank, what the agreement was, etc? Nov 25, 2023 at 20:34
  • 3
    Has this happened or is it just a worry? Do you mean an ethical review (IRB) such as is required in the US and elsewhere was signed off on?
    – Buffy
    Nov 25, 2023 at 20:45
  • 1
    @Mary - this is a very interesting question. Please edit your post to add the details requested above.
    – cag51
    Nov 26, 2023 at 19:19
  • 1
    I voted to reopen. The question as asked is clear and can be answered without additional details, even if it would be interesting to read them. Nov 27, 2023 at 8:03
  • 4
    Ugh. I don't think this question should have been reopened until clarified and I don't think the edits understand the question. I do not think OP is asking about IRB approval being withdrawn. They have a study site, for example a school, that agreed to participate in research. This is a consent process a lot like the consent for an individual. It is not an IRB approval, IRB approval would be with OP's institution. The "research site" is distinct from OP's academic institution. The new question is a good question but it is not OP's question unless they phrased the original wrong.
    – Bryan Krause
    Nov 27, 2023 at 14:48

2 Answers 2

4

There's perhaps a disconnect in expectations here - you say 'agreement' to do research, which implies you're thinking of the discussion with the IRB as a contract or similar. However, IRB reviews are generally framed in terms of approval - that is, they say that based on current information, you may conduct the research you describe. Because this is a unilateral decision by the IRB, it can also terminate these approvals for any given study at any time. Most commonly this is because the researcher is not following the agreed plans or other new information comes to light which affects the approval, but there are probably numerous other reasons.

Typically, they have to be able to justify this decision, but nothing you mention in your post would seem to prevent them from terminating an approval (even primary data gathering being completed).

As others mention in the comments, you will probably get better answers by providing more detail, but the general answer to your headline question at the moment is 'yes'.

7
  • Yes. I think that "Most commonly this is because the researcher is not following the agreed plans" is the key here.
    – Buffy
    Nov 27, 2023 at 14:00
  • 1
    To support your answer, drug trials are often halted part way through based upon preliminary results. Here is an example from a recent news reuters.com/business/healthcare-pharmaceuticals/…. Nov 27, 2023 at 14:33
  • 1
    See my comment on the OP and compare to the original question. I think edits have messed up OP's intended question. The agreement for research is likely a consent process with e.g. a school for children, not an IRB approval with a higher ed institution. They would first get IRB approval, and then seek agreements with their study sites to do research there with the students or teachers.
    – Bryan Krause
    Nov 27, 2023 at 14:52
  • @BryanKrause That's a good point - looking back at the original version of the question it's unclear if an IRB approval was meant at all. I think in almost all cases the answer of if an ethical approval for research can be terminated will still be 'yes', but the details will definitely depend a lot on what exactly is being asked. Nov 27, 2023 at 15:54
  • @BryanKrause, it was the OP that added the IRB in the text. I added the tag and changed the title. But it was the OP that indicates IRB approval. And, like you, I'd have preferred more information, which is why I haven't tried to answer.
    – Buffy
    Nov 27, 2023 at 16:15
0

Absolutely, at least in the US. There are legal requirements for re-reviews after a certain amount of years. The study approval will lapse if you don't keep up on the paperwork.

If you expect to re-contact participants years after they sign a consent, you need to work to keep the study open.

Also, there are reporting requirements to the IRB (and sometimes the funding institutes) for certain types of events during a study. Some of these types of events may force the IRB's hand, calling for a change in protocol, or even a suspension of approval.

If the question involves a the institution that owns the research site and a separate IRB, the mechanism may be a bit different, but yes, the approval can be withdrawn. The site can simply mandate what can go on at the site. If the site is shut down for purposes of the investigator's research, then that would be reported to the IRB, which will probably yank approval (because there is no site for the research) unless acceptable substitution can be made.

You must log in to answer this question.

Not the answer you're looking for? Browse other questions tagged .