McGuire VA Medical Center; McGuire Research Institute, Richmond, VA
Submitted by: Franklin J. Zieve, M.D, Ph.D.

The following information was submitted by the applicant for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose. Institutions interested in adopting or adapting the practice would be well-advised to contact the person who submitted the application and to evaluate this and any additional information for their purposes.

Description: Institutional Review Board software designed from the inside out by IRB members to facilitate protection of human subjects. Records and retrieves information about protocols and IRB actions for IRB Continuing Review and Quality Assurance measurements. Records and retrieves information required by FDA, OHRP, and ORCA auditors and accreditation surveyors.

Genesis: Understanding the details of new submission items (ie. Amendments, Investigator Brochures, SAEs, etc.) for a given protocol is not enough. Details of previously reviewed items including the status of investigator responses need to be evaluated. Snapshot reviews are often incomplete- a complete systematic review of historical data is necessary. Review of paper files and minutes for historical data is impractical for a busy IRB. MIRB provides the required information electronically with the push of a button.

Experience: MIRB software development began in January 2000, the pilot version went live in July 2000, and there have been numerous upgrades since then to meet more stringent regulatory and accreditation requirements. IRB documentation and quality assurance requirements keep changing (weekly it seems), and so does MIRB.

Compliance: All IRBs must comply with federal requirements that govern human subject protection. Some IRBs are seeking accreditation and must adhere to even higher standards. MIRB functions currently enable sites to meet federal requirements. MIRB upgrades currently in process will enable sites to meet accreditation standards.

Protection of human subjects: MIRB and MIRB upgrades are designed by trained IRB members who understand subject risks and accreditation requirements.

Monitoring and evaluation/outcomes: Current upgrades are expanding the power of MIRB by developing different front ends for different users (IRB members, investigators, auditors etc.) and by incorporating quality improvement assessment reports of IRB activities that enable external review of IRB performance.

Innovation: MIRB is a nimble database that is quickly upgraded to meet rapidly changing requirements. The concept of professional IRB members (as opposed to computer programmers) designing their own system to manage risk and to exceed federal and accreditation requirements is a significant protection not generally associated with standard IRB databases.

Replicability: MIRB is adaptable to virtually any size program, and contains many customizable functions. As of September 26, 2002, 31 of 70 independent VA IRBs have installed MIRB.

Applicant’s justification for award: Development of MIRB has been recognized by the Department of Veterans Affairs, and, most importantly, by 31 individual sites who have evaluated competing products and have purchased MIRB.

For additional information:
Robert Dresch
Tel: 804-675-5151
Fax: 804-675-5139
Email: robert.dresch@med.va.gov