Critical Care Nurse Researchers Must Know IRB Process
Many critical care nurses are involved in study recruitment. Lack of basic knowledge on how IRBs work can hinder this process.
“Critical care nurses are focused on caring for the patient, yet they have an important role in identifying patients who may meet inclusion criteria to participate in a study,” says Mike Aldridge, PhD, RN, CNE, co-chair of the IRB at the University of Northern Colorado School of Nursing.
Aldridge has interacted with IRBs as a researcher, as an IRB member, and as a co-chair. “A lot of what IRBs do is in a ‘black box’ to researchers,” Aldridge says.
To help critical care nurses facilitate study enrollment, Aldridge created a guide to explain the role of the IRB and its review process.1 Just knowing the research studies with which the site is participating is important. Nurses also must understand that research studies are driven by protocols. “Timing of laboratory tests, diagnostic tests, and interventions is very important,” Aldridge says.
Understanding the consent process for study participation, and the role of legally authorized representatives in giving consent, is especially important in the critical care setting. “Many people hesitate to participate in research due to our well-known history of unethical research in the United States,” Aldridge notes.
Nurses can alleviate those concerns by explaining ethical standards of research and the IRB review process. However, critical care nurse researchers can be reluctant to ask questions of IRB staff. “If a researcher isn’t sure which form to use or how to classify a protocol, it saves so much time to ask before submitting something,” Aldridge says.
If the study protocol is submitted incorrectly, the IRB will return it for corrections, adding time to the process. Aldridge suggests that nurses ask IRBs these questions: What is the typical approval timeline for submissions? What is the background of IRB members who will be reading the study protocol? How does the IRB want the informed consent document written? “IRBs tend to spend a lot of time reviewing this document,” Aldridge explains.
If researchers ensure the consent document is in the correct format, that templates provided by the IRB are used, and that all the necessary elements of consent are included, it prevents too much back-and-forth. “I have seen investigators and IRBs argue over phrasing and verbiage of sentences in the consent document. This adds time to the approval process,” Aldridge says.
Most IRBs use templates with preferred phrasing. If researchers adhere to those, then the IRB will see language with which members are familiar. In one oncology study, a researcher thought it was important to describe how the investigational drug worked on a physiological level. It took nearly a paragraph to explain. The IRB edited it to a single sentence that laypeople could understand, but the investigator thought the consent was incomplete.
When there is an issue like that, Aldridge says “the path of least resistance is to allow the IRB to make edits to the consent.” As long as the IRB isn’t changing the meaning of the consent, nitpicking over the exact wording used is not a good use of the investigator’s time. “If the investigator wants to explain how the study drug works in detail, that can be done verbally — if the participant wants to know that level of information,” Aldridge says.
REFERENCE
- Aldridge MD. Maneuvering the institutional review board process: A guide for critical care nurses and researchers. Dimens Crit Care Nurs 2022;41:24-28.
Many critical care nurses are involved in study recruitment. Lack of basic knowledge on how IRBs work can hinder this process.
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