Dean’s Message

Dean Donald E. Wilson, MD, MACP, The John Z. and Akiko K. Bowers Distinguished Professor and Dean

It is an exciting time at our medical school due to the dynamic growth of our research programs. Nowhere is that excitement more evident than in the area of clinical research. I previously wrote about our Center for Clinical Trials (CCT), which brings together university investigators and sponsor organizations to initiate, conduct, and complete the highest quality clinical studies as efficiently and safely as possible. Our faculty have eagerly embraced the CCT, and it is now processing agreements for more than ten new trials a month.

In March, our new General Clinical Research Center (GCRC) successfully competed for NIH funding and will receive at least $12.5 million over the next five years. The goal of the GCRC is to provide medical investigators with a state-of-the-art facility for clinical research that will enhance the quality of clinical and translation research studies.

We could not carry out this vital research without the willing cooperation of the people who volunteer to participate in these studies. Conducting ethical and safe research provides a safety net that is woven out of the fabric of knowledge, integrity, and institutional safeguards. At the core of this fabric is the integrity of the individual investigator, whose high ethical, scientific, and medical standards and knowledge of research principles are essential.

Supporting this capacity is the Institutional Review Board (IRB). In order to strengthen this safety net and meet federal requirements, we have invested considerable effort and resources over the past two years to provide additional safe guards, which include:
• Implementing mandatory training programs, one for employees involved in research protocols, and a more rigorous program for principal investigators in high-risk protocols.
• Expanding the number of IRB committees from two to four, involving nearly 80 members and alternates, broadening their expertise, and recruiting additional support staff.
• Establishing a quality assurance program which conducts internal audits and provides outreach and education to research staff and principal investigators.
• Launching a Website which provides extensive “one stop shopping” for forms and information.
• Using electronic mail to speed IRB approval letters and approved consent forms to investigators.

Now we are looking toward the future and even further enhancements of the safety net. We just submitted a grant application to the NIH for funds to license and adapt the Baylor Research and Assurances Information Network (BRAIN). BRAIN is an online system for creating, routing, approving, and archiving IRB documents. It will greatly enhance our capacity to evaluate new IRB protocols, to oversee active protocols, and to document responsibilities and accountability of all individuals conducting research involving human subjects. Unlike traditional IRB documentation methods, BRAIN provides data verification, tracks adherence to IRB procedures, and permits an infinite number of reports to be generated for management and compliance needs.

In addition, BRAIN streamlines administrative processes, enabling us to free-up staff time that will be deployed toward more intensive education initiatives, more individualized support for principal investigators and research personnel, and more compliance oversight activities.

The Department of Health and Human Services Office for Human Research Protections (OHRP) has responsibility for the oversight of human subjects research supported by the federal government. This fall we will participate in a new OHRP Voluntary Quality Improvement (QI) Program intended to help institutions evaluate and improve the quality of their human research protection program. The primary purpose of the QI Program is “to increase the quality, performance, and efficiency of an institution’s human subjects protection program. Secondarily, the QI Program is designed to help institutions ensure compliance with federal regulations for the protection of human subjects in research.”

OHRP notes that the program may “help institutions prepare to achieve accreditation of their human research protection programs by private-sector accrediting entities. HHS believes that such accreditation is an important complementary process for strengthening and improving the performance of the national system for protection of human subjects in research.”

We will also seek accreditation from the non-profit Association for the Accreditation of Human Research Protection Programs, offering accreditation to selected institutions engaged in research involving human participants. This program uses a voluntary, peer-driven educational model, seeking not only to ensure compliance, but also to raise the bar in human research protection.

The protection of the people who volunteer to participate in our clinical research is a sacred trust. We are committed to doing it right.