Table 3.
Exemplar Quotes: Reflections on Lessons Learned1
| Be Persistent |
| • “And as circumstances change, you know, reconsider or have others reconsider their previous decisions.” (Site W; Protocol Approved; Implementing) |
|
Strive for Collaborative Relationships with IRB Members |
| • “Rather than just putting it in and making the IRB go through the motions, I think I would try again to ... query the [IRB] administrator and try to maybe speak to the lawyer and see, behind the scenes, if there's a way to word certain segments of the submission or ... try to strategize a way to submit it that could be acceptable.” (Site K; No Formal Protocol Disposition; Non-Implementing) |
|
Engage Experts Early and Often |
| • “What I should have done initially was get lawyers involved, which I didn't. The IRB initially got the lawyer involved. So, in the future, if I'm doing something that there's a question ... how law may impact a consent process, then I'll get lawyers involved from the beginning because we went back and forth, I believe it was four times, and that takes a lot of time.” (Site L; No Formal Protocol Disposition; Non-Implementing) |
1
Data sources are informant interviews. Study site, IRB decision, and protocol status are noted in parentheses after each text segment.