Everyone agrees--IRB members, investigators, administrators: It is not satisfying to delay research. So why do we?
Investigators
Either lack of qualified research staff (high turnover or no money to hire/retain) or interest to learn what IRBs want and ask for. They can make significant life-saving scientific discoveries, but they do not know how to submit an IRB application, respond to questions from the IRB, or simply have a general irritation towards the IRB which is reflected in their effort. Sloppiness leads to delay.
IRB members
Like investigators, overworked and limited resources. High turnover, little training for members. Terrible questions. Poor reviews such that upon first or second review, significant issues aren't raised and after three years of approval, major questions are asked. The current IRB gets blamed for mistakes and sloppiness of the past IRB, which may now have different and/or better trained members.
Chief Executive
Despite the spin, money talks. Inadequate resources are allocated to administrative IRB infrastructure, including investigator support and training, IRB staffing, IRB member training, and technology. Listen to your advisers, investigators, IRB members! But instead they are ignored and the system suffers from lack of action and mismanagement. No recognition that an efficient IRB will result in improved recruitment of top faculty and increased research money into the institution.
Back to work!
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2 comments:
All good points. Especially with regards to IRB members. But there are IRBs with members who are engaged. At my first IRB, we didn't have much turnover, members volunteered to mentor new members; we had a contact with a person who taught a course and coordinated a program for non-scientist/community irb members; and most importantly, staff did not write up the issues before sending out the protocols for review. Members were expected to learn the regs and perform a thorough review, they were not spoonfed. It was sink or swim time. By and large, the review quality was quite high and both OHRP and FDA commented on the reviews. For your IRB, stop spoonfeeding your committee members and throw them into the water. Some will drown, you'll have a tumultous couple of months, but hopefully the situation will resolve itself and you will emerge with a recomposed IRB with more knowledgeable and capable reviewers.
There is also another player in the game - the leader of the IRB staff (generally known as the Director). If you have a visionary leader who is also involved and familiar with his/her staff's activities, and is objective, you can overcome a lot of the Chief Executive problems. This person is the key player linking the IRB staff to the Chief Executive.
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