In response to new regulations from the National Institutes of Health (NIH), the Office for Sponsored Research (OSR), in conjunction with the Institutional Review Board (IRB) offices of the Faculty of Arts and Sciences (FAS), Medical School (HMS), and School of Public Health (SPH), recently launched a Web site to provide training to grantees responsible for the design and conduct of research involving human subjects.
The new NIH requirement, which went into effect Oct. 1, calls for training not only for principal investigators, but also for all key personnel with human-subject responsibilities. The training Web site and general information on the NIH policy can be accessed via the OSR home page (http://vpf-web.harvard.edu/OSR/RA/) or via the HMS, SPH, or FAS IRB Web sites.
Announcement of the new policy was made in early June, which meant that universities across the country were scrambling to develop and offer training in time for the October deadline.
“While we were anticipating that the NIH would issue human-subject training requirements at some point during the summer, we were surprised at the short period of time between announcement and effective date,” said Beppie Huidekoper, vice president for finance. “When one considers that the University was also preparing for an NIH site visit this summer, the pressure on our sponsored research community to comply with the new NIH requirement on a timely basis was enormous.”
A team of faculty and administrators from OSR, FAS, HMS, and SPH was quickly assembled to review existing programs at other universities to determine whether any would meet Harvard’s needs. According to those who served on the team, it soon became evident that none of the programs included the right mix of clinical and social science necessary for the diverse human-subject protocols in place at Harvard.
The team’s goal was to develop and deliver a program that would meet the University’s research needs, while meeting the NIH requirements with minimal disruption to the faculty’s teaching and research programs — hence, the decision to develop a Web-based program that could be accessed at any time from any place. Within six weeks the University’s team wrote the curriculum and developed the Web site.
The result is an interactive program whose only technical requirement is a Netscape browser (version 4.6 and above) configured for e-mail. The program takes approximately one hour to complete online and includes sections focused on historical examples, ethical principles, University and federal rules, Harvard’s IRBs, roles and responsibilities, informed consent, and use of tissues, genetic samples, survey research, deception, and students.
As an alternative to the University’s Web site, the Medical School made arrangements to offer a half-day seminar covering substantially the same topics in greater detail.
As the NIH regulations are currently written, regardless of the number of human-subject research projects in which an investigator is participating, he or she is required to complete the training program only once. A project’s principal investigator and the University must certify that key personnel have completed the training. With the limited lead time to get a functional program in place for Oct. 1 application and proposal submissions, the Web site’s technical developers crafted an e-mail-based certification system that notifies the appropriate IRB and sponsored research offices that an investigator has completed training. This information is then kept on file until the time comes to provide certification to the NIH.
It is critical that principal investigators and key personnel complete training as soon as possible during the application and award process. The NIH will not award funds without the requisite training certification.
While initial reaction to the training program’s content has been favorable, the curriculum developers are planning to return to the drawing board to make the program more interactive and add case studies and graphics. In addition, the technical team will focus on creating a more robust database as a substitute for the e-mail certification system, in addition to creating a more streamlined “look and feel” for the program.
Given the recent attention the Department of Health and Human Services has directed at training researchers at all levels on the responsible conduct of science and the discussion this has generated throughout the national research community, Huidekoper anticipates the University may be called upon to develop additional training programs.