Flexible continuing ed meets varied needs

Something for everyone’s skill level and schedule

It can be a challenge to design a training program in human subjects protection that can meet all the needs of varied researchers — from biomedical to social-behavioral disciplines, from introductory courses to advanced topics for experienced researchers.

Officials at Case Western Reserve University in Cleveland have taken up the challenge, designing a flexible program that mixes established basic courses with guest speakers, seminars, and on-line offerings to give researchers the ability to take courses when and how they want.

Christian LaMantia, assistant vice president in the Office of Research Compliance at the university, says the Continuing Research Education Credit (CREC) program was developed in response to requirements that the university provide documented training in a variety of research areas. She says her group started with human subjects protection, launching the program in 1999 and setting September 2000 as the first deadline for training.

Case Western began by requiring all investigators and key personnel to study Dunn & Chadwick’s manual Protecting Study Volunteers in Research, which includes a multiple choice test. They then began looking at options to meet NIH’s requirements for continuing education.

"Our group started thinking, ’OK, we did this, it doesn’t seem to make sense [review the manual] again,’" she says.

Meeting social-behavioral needs

At the same time, LaMantia was hearing from researchers outside of biomedical disciplines who felt that the manual wasn’t specific enough to their areas of study.

"We cover people who do anthropologic observations, Psych 101, and the feedback we got from our faculty and our researchers was that although the [test] was easy to take, a lot of people were upset that things didn’t actually apply to them. For example, there were FDA sections where a lot of people don’t do FDA-regulated research.

"Thinking through a continuing program, we wanted to make sure it would be meaningful," LaMantia says. "And to do that, it had to have options for people who do hundreds, if not thousands, of specific types of research. They’re all each in their own worlds."

The team asked, "How could we make this meaningful?" The answer, as it developed, was CREC, a continuing medical education program that requires key human subjects protection personnel to earn a set number of credits every three years.

The credits could be earned by attending one of a few dozen seminars offered at Case Western each year, or by taking on-line courses offered by different institutions, or by attending other programs such as a seminar at a professional association conference.

The CREC program is administered on-line, with links to outside tutorials and other programs, and with units of credit assigned to a participant’s CREC account when the activities are completed.

LaMantia says Case Western next turned its attention to another group of researchers seeking more specialized instruction — experienced researchers, who wanted meatier fare than the standard human subjects protection training available to everyone.

"They’d already been through the Belmont Report, the Helsinki, all the basics of informed consent," she says. "They wanted to talk about institutional conflicts of interest, what you do when you have an investigator-initiated study, what are your responsibilities as a sponsor. How do you know that your informed consent process was effective?"

Using an NIH human subjects research enhancement grant, Case Western set out to meet the needs of the experts in the field, creating an on-line program of advanced seminars on cutting-edge human protections issues.

Because such events can be hard to schedule, they created digitally recorded seminars by nationally recognized experts that CREC participants could access via the web.

"We digitally record them and then create an associated quiz or learning tool that goes with the videos," she says. "Right now, we have three sets of series, one on adolescents and children, one on investigator-initiated research, and the other on ethical dilemmas in international research.

"People can watch the series, they can print out the handouts on their own time, and to earn credit within our documented program, they can take these quizzes, which can automatically connect them to our system and credit their account," LaMantia says. "In a sense, the goal of the project is to take this expert-level training home to our investigators and allow it to be accessible to everyone."

Because the program received NIH funding, Case Western has designed it to be accessible publicly to anyone with a media player, although no one can receive CREC credit without an open account. To view Case Western Reserve University’s on-line Continuing Research Education Credit program, visit http://ora.ra.cwru.edu/research/orc/crec/orc_education_crec_video.php.

LaMantia says the program is a tool not only to improve education locally at Case Western, but to share with other institutions that might not have the same resources.

Through a second NIH grant, Case Western is developing relationships with other smaller institutions, such as unaffiliated hospitals or social science institutions, to share its human subjects protection education tools.

Through those relationships, they could become CREC members, with program content customized for their own institutions, "so they don’t have to start out from scratch like we did," LaMantia says.

Technology challenges

She says that creating the content was a "huge, huge challenge," primarily because of start-up problems associated with the new digital media technology they were using. Partly because of that, she’s always looking for other sources of new seminars and on-line information to provide new content for the CREC program.

"I go through sister institutions’ web sites, do Google searches for a lot of the on-line things," she says. She says institutions such as the Office for Research Integrity web site also can be a source of good content.

In many cases, such as Case Western’s program, other on-line programs created with NIH money are offered free to other institutions.

Unfortunately, much of that content is still focused in the area of biomedical research, with social-behavioral content being harder to come by.

"But I think there is a push toward getting more behavioral science tools out there to train people," she says. For example, LaMantia says Case Western wants to host a segment on Internet research, including such topics as how to recruit subjects and how to ethically be involved in chat room discussions.

One of the technical challenges of creating the CREC program has been maintaining individualized accounts for the 3,000 to 4,000 researchers and others who use it. LaMantia says that because of privacy concerns, accounts are not linked to Social Security numbers but to another unique identifier so that the proper person is credited for taking the on-line courses.

In offering courses on-line to those inside and outside the university, LaMantia says her department also now finds itself running a data management program in addition to all its other duties. A lot of other institutions have firewalls in the computer systems that make it difficult to offer the technology across institutional boundaries.

LaMantia says she’s considered the idea of burning digital seminars onto DVDs in order to distribute them more easily.

The CREC program has evolved, retooling its web site and moving to use the Collaborative IRB Training Initiative (CITI) on-line education program created by the University of Miami for the basic training component.

The seminar program continues, with recent topics including confidentiality and privacy of electronic records in human subjects research and informed consent in research involving children.

LaMantia says response to the program has been enthusiastic. "The feedback we get from people who participate fully is they love it," she says. "They love that they can take something that’s meaningful. They love that the content is current, which is a struggle that we have with HIPAA and with everything else changing."

In fact, the complaints they do get are now from people who say there are almost too many choices for their continuing education training.

"The same people who were saying one size doesn’t fit all now are saying they have too much to choose from, that they want to go back to the 50-point multiple choice test, because it was defined. Meaningful’ takes more work on their part."