The Institutional Review Board for Human Research (IRB) has elected to implement a formalized quality assurance system to improve the IRB for Human Research process. The policy and commitment is to protect human subjects. The objective of implementing the quality system is to continue protection of human subjects, while improving the process to better serve all the participants, including researchers submitting projects, proposal reviewers and the IRB staff. The purpose of adopting

ISO 9002 is to develop and implement a quality assessment and improvement program to ensure the university and IRB performance in regards to compliance with the MUSC Multiple Project Assurance and other human research issues is of the highest quality. ISO 9002 is a quality system standard recognized throughout the world. ISO 9002 is issued by the international organization for standardization, which also issues standards for such widely varying products as computer languages and photographic film. ISO 9002 is used by many different industries and is therefore widely recognized in corporate America. In fact, the Joint Commission for Hospital Accreditation is using ISO 9002 as a basis for their accreditation systems.

ISO 9002 has been described as “Say what you do, and do what you say.” This is a simplification, but does describe the essence of the standard. This standard, which requires you to determine what is essential to your operation and then ensure that it is done, streamlines processes and results in consistency. ISO 9002 fits very well with the function of the IRB for Human Subject Research. It is critical that all Human Subject Research receives consistent review to protect human subjects. It is also important for the review to happen as efficiently and quickly as possible to allow MUSC to compete for research grants and attract industry sponsored clinical trials.

Quicker IRB Turnaround

Many investigators at MUSC could benefit from faster review and approval of their protocols. In the past, incomplete or incorrect submissions often delayed turnaround time for everyone. New deadlines for application and protocol submissions will be implemented. Compliance with procedures will be measured and required. Applications and protocols that are incomplete, or do not comply with the procedures, will be returned. Individuals not following procedures may be required to attend training. Details and specific procedures are in the quality manual which can be found on the MUSC home page.

Training

The IRB will implement changes to the existing system. These changes include:

• Availability of IRB procedures and forms via the MUSC home page
• Clarification of responsibilities for each step of the process
• Implementing the internal audit system
• Monitoring and reporting compliance with IRB procedures
• On-going training programs

Training will be available on all of the changes to the IRB process. Attendance at the formal classroom training sessions will be voluntary. However, everyone who participates in the IRB process is responsible for following all of the procedures. There is the option of independently reviewing the procedures to ensure understanding or attending a training session. Once the system is implemented, everyone is expected to comply with the procedures.

Training will take place in the University Diagnostic Center, room 506. Call 792-4148 to reserve a place as class size will be limited to 8 participants.

The schedule for September is: Sept. 9, 8:30 to 11 a.m.; Sept. 10, 8:30 to 11 a.m.; Sept. 14, 1:30 to 4 p.m.; Sept. 16, 8:30 to 11 a.m.; Sept. 17, 8:30 to 11 a.m.; Sept. 21, 1:30 to 4 p.m.; Sept. 23, 8:30 to 11 a.m.; Sept. 24, 8:30 to 11 a.m.; Sept. 28, 1:30 to 4 p.m.; Sept. 30, 8:30 to 11 a.m.

The training schedule for October will be published in an upcoming issue of The Catalyst.

Implementation Team

Volunteers were asked to participate on the team implementing ISO 9002 for the IRB. The team was made up of members representing investigators, IRB reviewers, IRB staff members, study coordinators, and investigator staff members. Some of the accomplishments of this team include:

• Updated IRB procedures to be in compliance with ISO 9002
• Completed a survey of IRB participants to identify areas for improvement and to get input for upgrading the process
• Reviewed the deadlines and turnaround time for IRB review and approval
• Initiated an internal audit system to measure effectiveness and implementation

Team members form the departments of College of Nursing, Medicine, Clinical Pharmacology, Dental Medicine, Transplant Surgery, Psychiatry, Pediatrics, Community IRB member, Bild Associates and ORI, made a significant time commitment to improve the IRB process for everyone.

Survey

This survey was conducted to meet one of the ISO 9002 quality system requirements of identifying opportunities for corrective and preventive action. The IRB will periodically administer surveys to measure whether or not the process has improved and to identify other elements for continuous improvement. Overall there was a high level of satisfaction with the IRB process. Areas with the lowest levels of satisfaction have been identified and targeted for improvement. The results of the survey helped develop a system to monitor the process for the protection of human subjects and help understand problems researchers face.

If researchers have questions regarding the new system, they are encouraged to contact the ORI staff at 792-4148.

IRB's website

The web site can be accessed at <http://www.musc.edu/research/ori/> A copy of the survey results can be found on The Catalyst online website at <http://www.musc.edu/catalyst>