IRB Services
A Dependable Resource for the ethical conduct of research

We support all phases of drug, device, and biologics development; as well as behavioral science research through:

• Multiple weekly review meetings insure timely review and response.
• Priority review meetings when needed - at additional cost.
• Certified non-English translations of approved material.
• Preparation and production of initial informed consent documents following IRB approval at no additional fee.
• Recruitment guidance for all media strategies and materials.
• On-call consultation on all aspects of study submission and review.

Preparation and production of approved consent forms (using CRRI's Informed Consent Form (ICF) template) is part of our fee structure, insuring subject protection and assuring appropriate use of approved documents, while minimizing administrative burdens on sponsors, sponsor representatives, and investigators. Using the CRRI ICF template, when submitting an Informed Consent Form to the IRB for review, will provide you with a quicker IRB review turnaround time and generation of a written response documenting the IRB's review.

On-call consultation and support to Project Managers, individual investigators, or sponsoring organizations is an important part of our work. Directly related advisory services are included at no additional fee.

Other information you may find helpful regarding our IRB:

• Organized and operates in compliance with FDA regulations as described in 21 CFR Parts 50 and 56, DHHS regulations as described in 45 CFR 46, guidelines resulting from the International Conference on Harmonization (ICH) and potentially The Common Rule as appropriate.
• Operates in compliance with the portions of the Health Insurance of Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164. · Audited by FDA ("no findings"determinations), sponsors, CROs, SMOs, and individual research sites.
• One of the first independent IRBs to receive authorization to support NIH studies.
• Our IRB Registration with the Office for Human Research Protection is number IRB00000790.
  http://www.hhs.gov/ohrp/
• Experience of IRB members includes service on institutional, community healthcare, academic, as well as independent Institutional Review Boards.
• Reviews sites in all 50 U.S. states, including Massachusetts.

We offer preferred provider agreements in order to incorporate cost-effective measures to help our clients maintain budget controls.