Developing solid standard operating procedure (SOP) documents is a “vital starting point” in order to successfully conduct a clinical trial with the involvement of an institutional review board (IRB), says Challace Pahlevan-Ibrekic, director of clinical research with Northwell Health/Feinstein Institutes for Medical Research.
As someone who has experience working both with IRBs and now on the research side, she says that “addressing behind-the-scenes minutiae is the key to a smooth” working relationship. Further, she has developed a “launchpad” document outlining policies to help manage every event stage of the IRB-approved study protocol, including:
- Initial submission
- Continuing review or annual report (as applicable)
- Unanticipated problems or another reportable event
SOPs should be used to outline consistent procedures to be followed for virtual research. Done properly, it “ensures transparency and consistency, and creates an efficient and effective process” between researchers and IRB personnel, Pahlevan-Ibrekic notes. It is also important for researchers and IRBs to work collaboratively to refine the SOP, she says.
Those conducting the research need to understand the IRB’s goals and point of view regarding trial conduct, she adds. An IRB’s focus generally includes seeking assurances and evidence that:
- risks to subjects are minimized;
- risks are reasonable in relation to anticipated benefits;
- selection of subjects is equitable;
- informed consent is sought; and
- informed consent is appropriately documented.
In addition, in some situations, IRBs will focus on:
- how data collection is monitored to ensure safety;
- whether patient privacy and confidentiality are sufficiently protected; and
- proof that additional safeguards are included to protect vulnerable populations.
Pahlevan-Ibrekic uses SOPs to promote “opportunities for collaboration” between research sites and IRBs. It’s all about smart study design, explaining the use of technology, agreeing on documentation standards and practices, and “defining the space” covered by the trial’s conduct, she adds.
Author: Michael Causey