Frequently Asked Questions:

Basic information about these two IRBs can be found on the IRB Overview page. The following questions come up frequently in our office. Please contact us if you have any additional questions:

• Why add a second IRB?
• Why CRRI?
• When can we use CRRI?
• Can CRRI review all studies?
• What about the HAC?
• Are electronic submissions possible?
• What about paper submissions?
• Who pays for this service?
• Will OHRP audit studies submitted to CRRI?
• What about advertisements reviewed by CRRI?
• Who are our contacts at CRRI?

 

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• Why add a second IRB? 

  • We want to support and facilitate industry-sponsored clinical trials with tight deadlines by offering our investigators an opportunity to submit to either the commercial IRB known as CRRI or to the MCG HAC.

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• Why CRRI?

• They were the first commercial IRB accredited by both the National Committee on Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protections Programs (AAHRPP). They have a strong ethical background and a commitment to customer service.

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• When can we use CRRI?

• Protocols may be submitted as of July 1, 2005 to CRRI for review. We are finalizing the MCG/CRRI informed consent document template and the workflow document between the OHRP and CRRI. [

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• Can CRRI review all studies?

• NO. Only those studies that meet all four of the following criteria are eligible for review by CCRI:
  1. Industry Sponsored
  2. Industry Initiated
  3. Multi-Center Clinical Trials
  4. Cannot be conducted at the Augusta VAMC as the VA regulations prohibit the use of a commercial IRB
     

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• What about the HAC?

• Investigators who meet the criteria listed above, have a choice to use either the MCG HAC or CRRI for those specified studies. However, they must use one or the other. If all of the above criteria are not satisfied, the protocol must be submitted to the HAC. The use of any other IRB is are not allowed. Please note that a protocol may not be switched between the two IRBs. If one disapproves a study, we notify each other of that disapproval as per federal regulations.

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• Are electronic submissions possible?

• CRRI does accept electronic submissions. Please visit CRRI's submission page for details. Institutional routing still applies and the principal investigator must copy the Office of Human Research Protection OHRP(OHRP@mcg.edu) and the Division of Sponsored Programs Administration DSPA (DSPA@mcg.edu).
   
• HAC does not currently accept electronic submissions, but it has purchased a software system (eProtocol) to allow them to do so. It will be implemented in the fall of 2006.
   
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• What about paper submissions?

• Hard copy submissions can be made directly to HAC.
• Hard copy submissions to CRRI can be forwarded to OHRP. 

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• Who pays for this service?

• CRRI will bill the sponsor directly for the submission and review fees. OHRP will bill the sponsor directly for the one-time $750 compliance fee. 

 

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• Will OHRP audit studies submitted to CRRI?

• Yes, as the institution is still responsible for these studies. 

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• What about advertisements reviewed by CRRI?

• Please forward to OHRP, we will forward them to graphics for institutional approval.

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• Who are our contacts at CRRI?

• Katie Quinlan, CCRP
  Associate Director
  Institutional, Social & Behavioral Division
  Chesapeake Research Review, Inc.
  Columbia, MD 21046
  Phone: 443-283-1507
  Fax:  410-884-9190
  kquinlan@irbinfo.com

  Jeffrey Stockton, BSPharm
  Project Coordinator
  Chesapeake Research Review, Inc.
  Columbia, MD  21046
  Phone: 443-283-1554
  Fax: 410-884-9190
  jstockton@irbinfo.com

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