Quality Improvement Project Reveals Reasons for Long IRB Approval Process
A recent quality improvement project identified reasons for long delays in the IRB approval of clinical research. Project leaders offered some tactics to streamline the process.1
“It is very important that the conduct of research be safe and ethical, but also that the appropriate review of the protocols be as expeditious and timely as possible,” says Elaine Larson, PhD, RN, FAAN, CIC, one of the paper’s authors and professor emerita and special lecturer at the Columbia University School of Nursing.
Larson and colleagues analyzed minutes of IRB meetings for 33 protocols that were approved in 2019. All 33 protocols required at least two full board reviews before approval. They also evaluated 244 protocols that were reviewed faster.
“The majority of delays in IRB approval relate to the fact that researchers submit protocols that do not adequately describe the research,” Larson explains.
Some consent documents are incomprehensible to people without medical backgrounds. Safety risks, duration, and allocation of cost sometimes are unclear. All this requires feedback from the IRB, to which researchers need to respond.
“All of this could be prevented if researchers took the time to seriously review their own protocols before submitting them for IRB approval,” says Emily Rodriguez, MS, the paper’s lead author and an intern with Columbia University Irving Medical Center’s Human Research Protection Office.
These factors were linked to long delays in IRB review: researchers’ conflict of interest; the need for radiation safety evaluation; protocols that also were clinical trials; consent forms using too much technical jargon; inadequate description of data security; protocol design that insufficiently protected participants’ safety; and lack of clarity on either participant compensation, payment, or study duration.
Clinical trials and protocols with demonstrable conflicts of interest require additional review. It makes sense the review process will be extended somewhat for those studies.
Additionally, investigators found not all problems came from researchers. Correspondence from IRBs to researchers could be difficult to decipher. Some IRB reviewers identified issues in the second or third return of a protocol they did not catch the first time.
“Our paper doesn’t suggest a complete transformation of the review process,” Rodriguez notes. “It just identifies a number of small inefficiencies that can pile up.”
REFERENCE
- Rodriguez E, Pahlevan-lbrekic C, Larson EL. Facilitating timely institutional review board review: Common issues and recommendations. J Empir Res Hum Res Ethics 2021;16:255-262.
Researchers analyzed minutes of IRB meetings for 33 protocols that were approved in 2019. All 33 protocols required at least two full board reviews before approval. They also evaluated 244 protocols that were reviewed faster. Most delays were attributed to protocols that did not adequately describe the research. Some consent documents are incomprehensible to people without medical backgrounds. Safety risks, duration, and allocation of cost sometimes are unclear. All this requires feedback from the IRB, to which researchers must respond.
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