|
|
|
|
|
|
|
Beginning on October 1, 2000, the National Institutes of Health (NIH) will require education on the protection of human research participants for all NIH projects in which human subjects are involved. This requirement for education extends not only to individuals who have face-to-face contact with humans as subjects, but also to anyone who uses blood, specimens, or data from human subjects.
NIH also will require a letter with the proposal from principal investigators who use humans as subjects describing the education that each person working on the project has received. The letter must be countersigned by the authorized institutional official. For non-competitive renewal applications that involve human research, investigators must include a description of such education in their annual progress reports.
The NIH requirement extends to subcontract personnel and consultants if they are involved with the design and conduct of research that utilizes human subjects. The details of the requirement are posted on the NIH Website at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
“This seems to be a response by the NIH to the gene therapy tragedy at Penn earlier this year,” Dr. David Litster, MIT’s vice president for Research, commented. “In addition, it’s important to note that the new regulations apply not only to research activities where there is direct contact with humans as subjects, but NIH also has explicitly included social science and behavioral research,” Dr. Litster said.
To implement the requirements of the NIH notice, MIT plans to develop a Web-based education and training program over the next several months, but in the interim, the Institute has adopted the training and education program developed by the University of Rochester.
According to Dr. Leigh Firn, chairman of MIT’s Committee on the Use of Humans as Experimental Subjects (COUHES), individuals may request a copy of the book on protecting research subjects directly from the MIT COUHES office (E23-230, phone 253-6787) and take the test in that book. Tests should be submitted to the COUHES office for scoring. Please note that this is a change from Provost Bob Brown’s 6/28/00 memo to NIH principal investigators, which indicated that the University of Rochester would do the scoring. Although there are wide differences between individuals, a reasonable estimate is that it would take 2-3 hours to read the text and complete the exam.
Dr. Litster also said, “The Public Health Service agencies have a great deal of power, and faculty and other principal investigators need to respond proactively to the education requirements. Submission of proposals to NIH may be delayed pending successful completion of the University of Rochester course. We are investigating other ways to comply with the education requirements in the future, but the Rochester course is the best way to comply on the short notice we have been given.”
Dr. Firn commented that it’s important to recognize that all individuals who work on NIH-funded research that uses humans as subjects or uses specimens or data from humans must pass the Rochester course in order to participate in such research activities. “We are confident that the MIT community will respond appropriately to these new requirements,” Dr. Firn said.
For further information, please contact the COUHES office at 253-6787.
|
|
|
|
|
|
|