Internal Review Boards
RSSArticles
-
Researchers Are Revamping Processes to Gather Community Input
Input from community members can help researchers make the study more effective by providing participants with regular updates on the results and proactively translating research consent forms into preferred languages. Investigators also could hire a staff representative of the community who can navigate cultural nuances and speak the preferred languages.
-
Decision-Making Capacity Is Concern for Older Study Participants
It likely is an accident if investigators enroll participants lacking decision-making capacity in trials. Since capacity to consent is not a mandated area to report for most journals publishing research, it may be left out for space or other reasons. Nevertheless, some researchers are seeking to start a conversation about this.
-
IRBs Must Review Study Protocols Rapidly and Ethically During Public Health Emergency
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination. The entire process hinges on excellent communication among everyone involved.
-
New Tools to Facilitate Single IRB Process
The intent of the revised Common Rule requiring institutions to rely on a single IRB for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
-
The Trouble with Electronically Tracking Study Medications
Digital pills allow data to be recorded automatically about patients’ medication adherence, but patients and providers have expressed significant ethical concerns.
-
Updated Guidance Provides Sense of Urgency to Improve Clinical Trial Diversity
Organizations must invest in research infrastructure to support investigators in enrolling and retaining diverse study populations.
-
Few People with Limited English Proficiency Participate in Stroke Studies
Rather than making the IRB processes more difficult for researchers who wish to include underrepresented populations in their study, IRBs should work with researchers to overcome obstacles.
-
New Guidance on Incorporating Patient-Reported Outcomes in Clinical Research
Patient-reported outcomes can be used to develop healthcare policy and regulatory decisions, and also to monitor symptoms to provide timely care tailored to the patient’s needs.
-
Parents, IRBs Hold Different Views on Phase I Pediatric Oncology Trials
IRB members are more likely than the public to think the risks outweigh the potential medical benefits. Parents think about the possibility of caring for a child with severe cancer and no treatment alternatives. IRBs ensure trials are ethical and that pediatric subjects are not exposed to excessive risk.
-
Pain Researchers Are Engaging Patients as Partners
Pain researchers would benefit by enacting a comprehensive approach to patient engagement, perhaps engaging people with lived experience of chronic pain in developing study recruitment materials.