Human subject protections ed goes on-line at UM
Human subject protections ed goes on-line at UM
Consortium joins web-based training program
When members of the Human Subjects Forum at State University of New York (SUNY) campuses went looking for a better way to train investigators involved in human subjects research, they found the University of Miami’s Collaborative IRB Training Initiative (CITI).
Launched September 2000, CITI is a web-based course consisting of 14 modules covering all aspects of human research protections mandated by federal guidelines. The program was developed in response to the June 2000 U.S. Public Health Service (PHS) announcement that anyone engaged in PHS-funded research involving human subjects must have training in the protection of subjects by Oct. 1, 2000.
"When the federal training mandate came to pass, we crunched ideas about how best to satisfy the requirement," says Judy Matuk, MS, associate director of the Office of Research Compliance at Stony Brook (NY) University, a SUNY member school. "After a demonstration of the web site and review of the material contained within the modules, it was immediately clear that CITI would be an excellent method of training investigators in the protection of human subjects."
Content for the various modules comes from content experts at institutions from around the country, including Dartmouth College in Hanover, NH, the University of Nebraska Medical Center in Omaha, The Department of Veterans Affairs (VA) headquartered in Washington, DC, and Children’s Hospital of Boston.
"From the beginning, it was clear that the only cost effective approach to meet the Oct. 1 deadline was to organize a multi-institutional collaboration for content development," says Paul Braunschweiger, PhD, professor of radiation oncology at the University of Miami and director of the university’s office of research education.
Though housed and maintained at the University of Miami, CITI is a collaboration between the university and Fred Hutchinson Cancer Research Center in Seattle. In two years, CITI has grown from 10 participating institutions to more than 200 and designed an exclusive site for SUNY, and currently is developing a custom site for the Department of Energy.
Initially, Karen Hansen, director of the institutional review office at the Fred Hutchinson Cancer Research Center and co-founder with Braunschweiger of CITI, recruited the contributing content experts and their institutions, but now word of mouth or an Internet search is bringing in more participants.
"We heard about the program from doing a basic Internet search," says Ken Capps, PhD, CPT, MS, clinical research associate in the department of clinical investigation, Walter Reed Army Medical Center in Washington, DC. "Our department compared the CITI course to other web-based courses and found it by far to be the best. Most of the other web-based courses were too specific to the institution that it was created by."
The core CITI modules include:
- history and ethical principles;
- basic institutional review board regulations and review process;
- informed consent;
- social and behavioral research;
- research involving records;
- genetic research in human populations;
- research with protected populations;
- research involving prisoners;
- research involving minors;
- research involving pregnant women and fetuses in utero;
- population risks, group harms, community consultation, and IRB review — research with American Indian and Alaska Native, and other socially vulnerable populations;
- FDA-regulated research;
- research protections in the VA;
- hot topics.
Institutions are free to choose the appropriate modules for participants, and each user may complete the modules at his or her own pace. That’s one of the features that really drew SUNY, says Matuk. "CITI has done exactly what we hoped it would do in this regard — it serves as a valuable alternative to the lecture series, enabling investigators to cover required material in a manner that fits their schedule, at their own pace, in the privacy and comfort of their office or home," she explains.
"Another feature of the CITI program of which Stony Brook has taken advantage is the ability to require completion of a variable number of modules based on investigator type," she continues. "For example, someone who is only involved in analysis of data has to complete four modules. Alternatively, an investigator who is involved in research regulated by the FDA must complete 12 modules."
"The institutions pretty much determine what modules their people are going to view," echoes Braunschweiger. "Some are not affiliated with a VA facility, so they excuse their people from doing the VA module. Some institutions don’t conduct research with prisoners, so they excuse their people from that module."
CITI is subscriber-based. The cost for each institution is $1,000 per year. An unlimited number of learners can access the system for the one fee, and institutions may create institutional pages that contain policy and procedure documents, as well as forms or training materials and quizzes pertinent to that institution. Content for the custom pages is developed by the institution. CITI administrators will upload materials once they are ready.
"Miami provides templates for the institutional pages. [The institution] has to provide content, questions, if desired, and feedback regarding answers," says Braunschweiger.
The university does not assess participants’ scores. Instead, institutions are sent weekly reports on their learners’ test scores. "We send out reports on each learner so training coordinators can tell whether people have successfully passed the course. Each participating institution decides what a passing score will be," he says.
The CITI course has undergone three revisions since its launch, and user feedback has provided insight for improvements. "We rely on that quite heavily," says Braunschweiger. "One of the major comments was the course is too long,’ so we’ve been able to edit it and merge a couple of modules to make it shorter. Also, learners wanted more in the way of case studies, so we’ve endeavored to add more scenario-based quiz questions."
If you’d like more information on CITI, you may visit the web site at www.miami.edu/UMH/CDA/UMH_Main/1,1770,6460-3,00.html.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.