Optimum Ethics Review Board (ERB) is an independent ethics review board (also called an IRB or REB) that is constituted and operates according to Division 5 of the Food and Drug Regulations,  ICH/GCP Guidelines, FDA 21 CFR Parts 50 & 56, DHHS Section 45 CFR 46, the Declaration of Helsinki, FDA Information Sheets: Guidance for IRBs and Clinical Investigators and the Tri-Council Policy Statement for Ethical Conduct of Research Involving Humans.

It was formed in September 1995, to respond to the needs of investigators and the pharmaceutical industry.  It is comprised of members with diverse and varying backgrounds in the medical, physical and social sciences.

Optimum Ethics Review Board Offers:

              
Quality Ethics Review...in a timely manner
Weekly Meetings/Flexible Scheduling  
Experienced Members and Staff
Prompt Responses/Turn around time
Proper Documentation
Single-centre or Multi-centre Review
Customized Documentation Forwarding
Site Assistance
Continuing Review
ICH-GCP Compliance

 

Please note: Some of the documents/instructions included on this website may not pertain to BA/BE Studies. Please email us with your contact information if you prefer to discuss by phone.