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Informed Consent in Research and Individuals with Impaired Decision-Making Capacity
This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.
Non-English Speaking Research Subjects: What’s in the Regs?
Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies.
Evaluating eConsent: Some Considerations from an IRB Perspective
eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective.
Planning Gene Therapy Research? Plan for IBC Review
The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer
Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections
A major element of any IRB review is the examination of potential benefits and risks to study participants.
IRB Review of Adaptive Design Studies
Learn why the popularity of adaptive design in clinical research is continuing to grow!
6 Ways Sponsors Can Improve Feasibility Questionnaires
Learn how sponsors can alleviate frustrations when it comes to clinical trial feasibility questionnaires to get the best information from sites.
“Single IRB” vs “Central IRB” – What’s the Difference?
Is there a difference between the terms sIRB and cIRB?
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