Challenges and questions remain as the one year anniversary of the implementation of the Revised Common Rule approaches
One year has passed since the implementation of the Revised Common Rule, and many challenges and questions remain. While IRBs wait for promised guidance to materialize, we are left to interpret various aspects of the rule ourselves. This has resulted in variability across IRBs in how the new requirements are interpreted and operationalized. Variability in […]
New CITI Program Courses and Webinar Help Researchers and Institutions Meet Regulatory Requirements
(Miami, FL) — The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, has announced new online courses and webinars designed to help research professionals understand and comply with regulatory requirements for clinical trials. The three courses and webinars address critical regulatory requirements: Transitioning research to the Revised Common Rule Protocol registration and disclosure […]
The Revised Common Rule and Informed Consent: Public Posting
Public Posting An important provision in the Revised Common Rule is the requirement to post, to a publicly-available federal Web site, a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency. The Office for Human Research […]
The Revised Common Rule and Informed Consent: Consent Waivers
The Revised Common Rule has a few important changes regarding consent waivers. Under the revised Common Rule, broad consent is provided as an alternative to the informed consent requirements for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. If an individual was asked and refused to provide broad consent, […]
The Revised Common Rule and Informed Consent: Broad Consent
While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of blog posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule. BLOG POST #2 — Broad Consent One […]
The Revised Common Rule and Informed Consent: Concise Summary
While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule. Concise Summary Consent forms must facilitate comprehension by […]