Volume 9 Research
Chapter 0402 Policy for Use of External Institutional Review Board
Responsible Office: Office of Human Research Protection
Originally issued: 7/1/2005
All research using human subjects or human-derived materials conducted by Medical College of Georgia (MCG) faculty, staff, or students must obtain Institutional Review Board (IRB) approval prior to the initiation of any research activity that involves human subjects or human-derived materials. Certain types of human research studies at the Medical College of Georgia, as described in this policy, may obtain IRB approval from an external IRB that is approved by the Medical College of Georgia. Currently, that external IRB is Chesapeake Research Review, Inc. (CRRI). CRRI is the only external IRB that is approved by MCG and that may be used by MCG researchers. Protocols that may be submitted to CRRI must be industry-sponsored, industry-initiated, and multi-center clinical trials and in addition, they cannot be conducted at the Charlie Norwood Veterans Affairs Medical Center.
Reason For Policy
The Medical College of Georgia has contracted with an external IRB to help manage the oversight of human research protocols at the institution, especially with respect to clinical trials with short deadlines. However, to maintain the highest standards of human research oversight, only an MCG-approved external review board may be utilized by MCG investigators and only selected types of studies may be submitted to the external review board. This policy is intended to meet Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations, Good Clinical Practice (GCP) guidelines, state regulations, and Medical College of Georgia Health System regulations regarding IRB submissions by Medical College of Georgia faculty.
Entities Affected By This Policy
Medical College of Georgia faculty, staff and students who conduct clinical research as noted above are affected by this policy.
Who Should Read This Policy
All Medical College of Georgia faculty, staff and students who conduct clinical research should know this policy.
|Director, Office of Human Research Protectionemail@example.com
Printable Version of This Policy
Chesapeake Research Review, Incorporated Web site:
Standard Operating Procedure 6.0 Using Chesapeake Research Review:
MCG IRB Institutional Charter:
CRRI Contact Flow Chart:
These definitions apply to these terms as they are used in this policy:
|Chesapeake Research Review, Inc. (CRRI)||An independent IRB available for studies that meet all the following criteria: industry-sponsored, industry-initiated, multi-center clinical trials that are not conducted at the Charlie Norwood Veterans Affairs Medical Center|
All research using human subjects or human-derived materials conducted by Medical College of Georgia (MCG) faculty, staff, or students must obtain Institutional Review Board (IRB) approval prior to the initiation of any research activity that involves human subjects or human-derived materials. The internal IRB at MCG is the Human Assurance Committee. In order to manage the oversight of human subjects research at MCG in a timely way, the Office of Human Research Protection has contracted with an external, commercial IRB to review certain types of human subjects research, namely, clinical trials that are industry-sponsored, industry-initiated, multi-centered, and are not conducted at the Charlie Norwood Veterans Affairs Medical Center. Procedures for submitting research to CRRI are outlined below.
- Once CRRI has been chosen as the IRB of record for a protocol, the protocol may not be switched to the HAC for review. If one IRB (either CRRI or HAC) disapproves a study, the other IRB is notified of the disapproval as per federal regulations.
- If the study sponsor chooses to use CRRI as the central IRB for the study, MCG sites should submit the study and all appropriate forms according to the procedures described herein.
- The investigator must use the CRRI- MCG customized forms available on the MCG Office of Human Research Protection (OHRP) Web site.
- The investigator must copy OHRP and the Division of Sponsored Program Administration (DSPA) on the initial submission correspondence to CRRI.
- The investigator should be aware of and committed to ensuring that all applicable fees are paid.
- All applicable institutional approvals must be obtained.
- The study cannot begin until the principal investigator receives a release letter from OHRP.
Reporting Study Activities to CCRI
To report unanticipated problems that may include adverse events, serious adverse events, protocol deviations/violations or others:
- CRRI’s policy for prompt reporting must be followed (not the procedures sued by MCG’s HAC). Investigators must be compliant with CRRI’s policies when they are the IRB of record.
To reporting study amendments:
- All study amendments should be submitted to CRRI for approval according to their guidelines.
- DSPA should receive notification regarding all CRRI-approved amendments.
- OHRP will receive notification of study amendments from CRRI.
To request a change in study status, continuation, or expiration:
- The above-listed study reports should be reported to CRRI according to their reporting requirements.
- OHRP will receive notification regarding these reports from CRRI.
- The CRRI fee schedule is posted on their Web site. These fees should be included in the study budget. 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. This fee should be included in the study budget.
The responsibilities each party has in connection with Academic, Research, and Student Affairs Policy 9.0402, Policy for Use of External Institutional Review Board, are:
|Principal Investigators||Must use either the Human Assurance Committee or Chesapeake Research Review, Inc as the IRB of record.Comply with policies of CRRI review board.|
|CRRI||Will promptly review all submissions and return to the institution any that are not eligible for review as noted above.|
CCRI Research templates: http://www.mcg.edu/research/ohrp/irb/crri/templates.html