Kate-Louise Gottfried
Director of Research Integrity for Tufts-NEMC and the Tufts Health Sciences Campus

May 2004, Issue 2

Kate-Louise Gottfried, JD, MSPH, came to Tufts / Tufts-New England Medical Center in June 2003 to fill a new position, director of research integrity. Her responsibilities include overseeing all aspects of research involving humans at the Tufts Health Sciences Campus and Tufts-NEMC. She is actively involved in creating new educational resources, establishing a new Scientific Review Committee, and streamlining the Health Sciences Institutional Review Board (IRB). Before coming to Tufts, Gottfried worked at the Office for Human Research Protection in the Department of Health and Human Services, where she developed, managed, and implemented the Secretary's National Human Research Protections Advisory Committee and worked in the compliance division.

"I came to Tufts because it was a unique opportunity to apply what I had learned in the federal context to an academic medical center and because it was a new position that I could help shape," Gottfried says. She has been constructing a strong foundation for research integrity at Tufts and Tufts-NEMC. Her priorities are (1) to create a sound educational program with access to information, courses and ongoing seminars; (2) to establish a Scientific Review Committee; (3) to convert the paper IRB system to an electronic system; and (4) to obtain accreditation for the IRB.

The education program for investigators conducting research involving humans is well under way. Educational requirements have been updated and are now more customized to the needs of the various members of a research group. (See the New IRB Education Requirements for Tufts Health Sciences and Tufts-NEMC for a full article on the new educational requirements, this issue of Research News @ Tufts.)

The Scientific Review Committee gives investigators feedback on the design and validity of their protocols prior to IRB submission. It ran as a pilot project from July 2003 until February 2004 and is now fully established. The committee usually meets weekly and has been reviewing one to two protocols each week.

BRAAN (pronounced "brain") is the new electronic IRB protocol system that Gottfried's office is implementing. BRAAN stands for Biomedical Research And Assurance Network. The system will help investigators get their human subjects protocols submitted and reviewed more efficiently. BRAAN is in the final stages of development and should be up and running by September. BRAAN training seminars are set to begin, however, this spring. Look for the article on BRAAN in the September 2004 issue of Research News @ Tufts for more information.

Besides these initiatives, Gottfried and her staff have been reworking policies in the IRB operations manual, focusing especially on HIPAA issues and conflicts of interest. HIPAA stands for Health Insurance Portability and Accountability Act, and involves regulations for researchers working with identifiable, living human research subjects' data that was gathered from an insurance-covered entity, such as Tufts-NEMC or one of the Dental School clinics.

Gottfried wants people to know that the Office for Research Integrity is there to assist them in getting the information they need and to ensure that they have a sound human research program in place. "I don't want people to be afraid to say, 'I don't know.' People should feel free to come in and ask how to do something. My mission is to inform," Gottfried says. She welcomes all those interested in learning more about the Office for Research Integrity to stop by. The office is on the 8th floor of 35 Kneeland Street in Boston.

For more information, go to: http://www.tufts.edu/central/research/IRB.htm


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