Schulman IRB and Chesapeake IRB Merger and Integration: What You Need to Know
On November 7, 2017, we announced that Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra....
Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know
On October 1, 2017, NIH’s policy for certificates of confidentiality (CoCs) changed so that CoCs are now automatically issued for...
“Significant Risk” and “Nonsignificant Risk” Determinations for Medical Devices
In medical device research, the determination of “significant risk” or “nonsignificant risk” can sometimes be confusing, especially for those new...
IBC vs. IRB: What’s the Difference?
Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring...
Legally Authorized Representatives (LARs): Support for Decisionally Impaired Research Subjects
A potential research subject must provide his or her informed consent before enrolling in a clinical trial. But for adult...
Informed Consent and Individuals with Diminished Decision-Making Capacity
Researchers continue to chip away at the challenging field of neurological disease, seeking new treatments and potential cures for these...
If I’d Known You Were Coming, I’d Have Translated the Consent: Short Form Consents and the Unexpected Non-English Speaking Participant
For research sites in communities with large populations of non-English speakers, it may be standard operating procedure to obtain a...
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. Sec. 907...
Evaluating eConsent: Some Considerations from an IRB Perspective
At Advarra we’ve been seeing more and more eConsent studies recently, which is great—eConsent technology can often better inform participants...
Does This Study Require IBC Review?
One of the fastest growing areas in clinical research is clinical trials involving recombinant DNA, or gene therapy research. It’s...