George Gasparis came to Columbia as assistant vice president and senior assistant dean for research ethics in June. He oversees Columbia's four Institutional Review Boards (IRBs) and is also executive director of the human subjects protection program, which he is developing and implementing university-wide. Mr. Gasparis was most recently the director for the Division of Assurances and Quality Improvement at the Office for Human Research Protections (OHRP), a federal regulatory office that oversees IRBs nationally.

Describe your role.
I direct the office that is responsible for helping Columbia University ensure that all human subjects research is reviewed and approved in accordance with federal regulations for the protection of human subjects. We review all human subjects research conducted by faculty, students, and staff, regardless of the location of the research activity and source of funding. Our office directs the three IRBs here at Health Sciences and another at the Morningside campus. We are also developing and managing a human research protection program that will seek accreditation status.

What are human subjects protection programs?
A 2001 Institute of Medicine (IOM) report articulates that a human subjects protection program should extend beyond the IRB to include all components of the research enterprise at an institution involved with the conduct of research. The report also strongly recommends that all such programs be accredited.

As a consequence of the IOM report, all major universities and hospitals are working to become accredited and there is a national movement toward creating such programs. Accreditation likely will have important implications for human research as it has with animal research (animal research programs have had an accreditation procedure for about two decades.) It is anticipated that most funding organizations will award grants predominantly to accredited institutions.

To fulfill the IOM's suggested national guidelines, we are meeting with the Clinical Trials Office, the Irving Center for Clinical Research, the pharmacy, the research pharmacy, the Institutional Biosafety Committee, the Radioactive Drug Research Committee, the Conflicts of Interest Committee and all departments and investigators to form a truly comprehensive human subjects protection program. Many of the investigators we've met with have noted that things are moving in the right direction.

We also are developing a quality improvement program, important for receiving accreditation. I helped develop the quality improvement program for IRBs at OHRP. The program here will follow nationally accepted best practices to not only ensure compliance with federal regulations, but to maximize the quality of human subjects research.

How would you describe the direction of the IRB?
We want to develop a model IRB that is recognized as one of the best in the nation. We're striving to provide researchers with high quality reviews and excellent service. We will be user-friendly and have an open door communication policy. We know that researchers want an efficient, responsive IRB and that's our goal. The Health Sciences administration recognizes the importance of not only promoting and facilitating research but also ensuring that it is conducted ethically. The administration has provided significant financial support for the IRB to make sure this happens. Our staff has doubled over the past eight months, which goes a long way in achieving these goals.

The newly developed human subjects protection program will help us fulfill the university's research mission and goals.

One of your goals is to improve communication between the IRBs and researchers. How do you plan to do this?
We will work hard to provide a user-friendly, service-oriented office. We will have an open-door policy that will require a timely response for each inquiry. Our web site will be redesigned to provide the necessary information to interact efficiently with the IRB.

We will make every effort to respond to each call or e-mail in a timely manner. In order to achieve these goals, we have doubled the staff that will respond to inquiries. Incoming calls will be directed to administrative aides, who are now trained to respond to many of the common questions or issues that we receive. These operational changes will allow our professional staff to concentrate and close out more significant tasks.

Another one of your goals is to improve educational training for researchers. What are some plans in this area?
We want to create a paradigm shift in how educational training is offered. The flow of educational training has occurred in a one-way direction, with information flowing from the government to the IRBs and then to the researchers. We want to convert this flow into a two-way street, where faculty also provide educational training for IRBs who in turn work with the government for the development of new guidance. Researchers confront ethical issues day in and day out and sometimes are more creative on how to address solutions to these ethical issues than the IRBs.

We also plan to build a list of internal consultants comprised of senior researchers and clinicians at Columbia who will be able to supplement and improve the quality of IRB reviews of research by providing more expertise in specific areas. We will also provide a consultation service to address ethical issues during the design and development of human research studies.

We have a number of initiatives we have begun to launch, including an intensive educational training program for IRB staff, IRB members and investigators. For IRB staff and members, there is a significant allocation of financial resources for attending education conferences and seminars. We are also conducting in-house, biweekly training on regulatory requirements for IRB staff. In June, we held a day-long training session for IRB members and professional IRB staff. In November, we will begin to hold monthly meetings with investigators and research coordinators and plan to start a quarterly lecture series on hot issues in research ethics.

Other plans include creating a newsletter and revamping the IRB web site (www.cpmcirb.hs.columbia.edu) to be a stronger communication and educational resource for faculty. We're now providing a good deal of information through RASCAL (www.rascal.columbia.edu), Columbia's research administration system launched in April that provides for electronic submission of research protocols to the IRB.