Blog

Schulman IRB and Chesapeake IRB Merger and Integration: What You Need to Know

November 30, 2017

On November 7, 2017, we announced that Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra....

Blog

Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know

October 31, 2017

On October 1, 2017, NIH’s policy for certificates of confidentiality (CoCs) changed so that CoCs are now automatically issued for...

Blog

“Significant Risk” and “Nonsignificant Risk” Determinations for Medical Devices

October 31, 2017

In medical device research, the determination of “significant risk” or “nonsignificant risk” can sometimes be confusing, especially for those new...

Blog

IBC vs. IRB: What’s the Difference?

September 22, 2017

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring...

Blog

Legally Authorized Representatives (LARs): Support for Decisionally Impaired Research Subjects

September 22, 2017

A potential research subject must provide his or her informed consent before enrolling in a clinical trial. But for adult...

Blog

Informed Consent and Individuals with Diminished Decision-Making Capacity

August 30, 2017

Researchers continue to chip away at the challenging field of neurological disease, seeking new treatments and potential cures for these...

Blog

If I’d Known You Were Coming, I’d Have Translated the Consent: Short Form Consents and the Unexpected Non-English Speaking Participant

August 30, 2017

For research sites in communities with large populations of non-English speakers, it may be standard operating procedure to obtain a...

Blog

Non-English Speaking Research Subjects: What’s in the Regs?

July 27, 2017

Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies. Sec. 907...

Blog

Evaluating eConsent: Some Considerations from an IRB Perspective

July 27, 2017

At Advarra we’ve been seeing more and more eConsent studies recently, which is great—eConsent technology can often better inform participants...

Blog

Does This Study Require IBC Review?

June 29, 2017

One of the fastest growing areas in clinical research is clinical trials involving recombinant DNA, or gene therapy research. It’s...