IRB Advisor – September 1, 2017
September 1, 2017
View Issues
-
Newest Oncology Studies Raise Ethical, Other Questions for IRBs
Clinical research — especially involving oncology trials — is evolving with the introduction of new therapies and therapeutic mechanisms. These raise new and sometimes challenging questions for IRBs reviewing the study protocols.
-
Finding the Best Role for Community Members: A Look at Two Strategies
IRB questions sometimes arise about the role and responsibility of community members/nonscientists on review boards. Should their — and other nonaffiliated members’ — contributions be limited? Do they have enough training to be primary or secondary reviewers?
-
Community Research Training Helps Subjects Become Investigators
A new social-behavioral research model IRBs might encounter is one in which researchers include people who also could be participants, or their guardians, for the same studies.
-
The Single IRB: One Board to Rule Them All
The National Institutes of Health recently delayed the effective date of its requirement to designate a single IRB in research involving multiple boards, but NIH officials have lost none of their enthusiasm for the idea.
-
Gene Expert: IRBs Should Prepare for Somatic Cell Trials
With somatic gene cell editing already underway in some trials, IRBs should prepare to deal with protocols involving noninheritable genetic changes.
-
Pregnant Pause: Time to Push ‘Play’ on Trials With Expectant Mothers
There are many obstacles to including pregnant women in research, and IRBs may understandably err on the side of caution when it comes to expectant mothers in clinical trials.
-
Medical Marijuana Inc. Moves Forward With Proof of Concept Study
Medical Marijuana Inc. announced it is working with an Israel-based contract research organization to begin a clinical proof of concept study with its cannabidiol and gabapentin chewing gum product to treat restless leg syndrome in patients.