Revised Common Rule Compliance Now in Full Effect—and What That Means
The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.
Making Sense of the New HUD Guidance
Understand how the new HUD guidance clarifies responsibilites of the IRB and institutions, while widening the access of small communities to HUDs.
Compensating Clinical Trial Participants: The Basics
Participant compensation is often a complicated matter. This blog will shed light on what an IRB considers during its review.
What Is a Screening Consent?
Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.
After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.
Informed Consent Changes in the Revised Common Rule
If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements.
Do I Need to Comply With the Revised Common Rule?
While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.
ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.
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.