Research education and training need commitment
Research education and training need commitment
Here are five organizing concepts
Top officials at research institutions need to give systematic and comprehensive thought to what educational programs might involve, an expert advises.
There are plenty of training programs available, and federal regulators provide ample rules to learn, but the question institutional executives should be asking themselves is "Why worry about whether or not they work?" says Judith A. Nowack, MA, an associate vice president for research in the Office of the Vice President for Research at the University of Michigan in Ann Arbor, MI. Nowack spoke about research education and training programs at the 2006 annual Human Research Protection Program Conference of the Public Responsibility In Medicine & Research (PRIM&R), held Nov. 15-18, 2006, in Washington, DC.
An answer to the rhetorical question is: "Why spend time and resources on programs that don't work?" Nowack says.
"All our programs and institutions are exercises in taking limited resources and putting them in the places where they do the most good," Nowack explains.
When Nowack spoke to research institution executive and managers, one question that arose was why they shouldn't just export the whole education business.
"The answer I gave them was repeated by other people, and that is 'You can't export this part of it; you can go to a central IRB or a commercial IRB or have institutional agreements, but you're left with the community,'" Nowack explains. "If there are researchers that are part of your operation or part of what you do, then the university has a responsibility and liability and moral obligation to be training very good people."
Nowack identifies five organizing concepts for an institutional research education program. They are as follows:
1. Performance standards: "You really need to know what the system needs to achieve or guarantee," Nowack says. "Education and training programs add a high level of abstraction, and are what get you to a state where everybody in the system knows exactly what they need to know so your system can perform."
Here are some of the ways that an institution's leader receives feedback about research education and training success:
• What were the post-approval monitoring outcomes, audit outcomes?
• How many IRB applications are sent back as inadequate?
• What are common mistakes and inadequacies and who makes those mistakes?
"Mistakes are evidence that somebody in the system doesn't know what they need to know or that the process isn't presenting information in a way that is useful as a teaching tool," Nowack says.
Also, when an institution experiences post-approval monitoring problems, there frequently are IRB determination mistakes or misunderstandings, Nowack says.
Institutional officials ought to attend to qualitative measures of an educational program, and there could be sessions where qualitative information reflects back on the educational and training programs, Nowack says.
"Trends in any of those qualitative or quantitative indicators are ways in which you are making progress towards this goal," she says.
What Nowack advocates is an active management system in which top institutional officials think about creating information and collecting and monitoring outcomes measures.
"The more you look, the more you find, but that's a positive indicator because at least you're looking," Nowack says.
2. Diversity/heterogeneous: Human research protection programs are comprised of many individuals who have different roles and responsibilities, as well as baseline knowledge and needs, Nowack says.
"So a smart system understands what different people and different subsystems know and what they need to know," she says. "That harkens back to the performance standard."
For example, consider these questions:
• What does an IRB need to know?
• What do clinical monitors need to know?
• What does the population of research administrators and school of education need to know?
"A sophisticated system knows that people need to know different things, and the system has ways of finding out what each of the subpopulations need to know and how far off the mark they are," Nowack explains. "This knowledge helps to guide limited resources in a comprehensive system."
The notion behind acknowledging a system's diversity is to recognize that certain populations are more important than others, with regard to educational and training needs, Nowack says.
"The population of clinical trial monitors, for example, is an extraordinarily important community to attend to and know what they need to learn because they serve your system in an important way," she says.
On the other hand, it may be overkill to train someone in the school of education about FDA regulations, Nowack adds.
"But a sophisticated system knows this," she says.
Sophisticated systems also acknowledge the different ways people learn, and there are a variety of educational venues, including the use of visual and audio media, attention to timing of training programs, electronic educational programs, and other methods. Examples of diverse training methods include brown-bag lunches, department visits, Web-based instructions, etc.
"In universities, we hear a lot from people that they need to have a way of finding out what they need to know when they need to know it," Nowack says.
"Having good functions on electronic applications is one example we recognize as an important opportunity at the University of Michigan," she says. "We're not at the position we want to be in, but it's one of our highest priorities because system monitoring has told us that it is something people really want in a way that we're not giving to them."
In other words, it's a high priority for the education and training program to provide the surgical precision sort of assistance the research professionals desire, she adds.
Mentoring is another training method that should be utilized and valued in an educational and training system, Nowack says.
"Mentoring is the workhorse of an educational system over time," Nowack says. "Also, think about the cultural conscience and baseline knowledge that people don't have to be trained to learn because they already know it."
3. Embedding: "Well-developed educational and training programs typically include one or all of those kinds of things, but they're really more than that," Nowack says. "Embedding is a concept that implies cultural acceptance and integration into a normal institution."
For example, cultural acceptance research could be included in research methods coursework, and there could be apprenticeships for IRB members, Nowack says.
"Some people wouldn't normally think about health functions being part of an educational program," Nowack says.
But when education and training programs are considered from the perspective of time, meaning that knowledge increases among individuals over time, then it can be seen that health functions really are a part of that conceptual menu or tool, Nowack explains.
Ongoing compliance efforts, including monitoring and post-approval feedback monitoring, also are part of embedding in an educational and training system, she notes.
"I haven't seen post-approval monitoring reports that didn't include some kind of assessment of what people knew," Nowack says. "If there is any kind of finding, major or minor, an outcome generally is getting effective information to people who didn't have the necessary information."
4. Exemplars: "By exemplars I mean the acceptance of knowledge standards by the most accepted members of the community," Nowack says. "One way of doing this is to have the individuals who are high prestige people in the system and in a research university display acceptance of the knowledge standards."
These high prestige investigators and others can do this by participating on the IRB, talking about the value of standards, and not denigrating standards to others in the institution, she explains.
"In many of the standard educational and training mechanisms, people bring in speakers," Nowack notes. "Bringing in the highest caliber speaker you can is also a way to piggyback on the notion."
The academic, medical, and research communities pay a great deal of attention to the prestige and reputation of people within their group, so if those who have the prestige and valued reputations show respect for knowledge standards, so will others.
It's also important that an institution demonstrates that human subject protection is a core institution value, Nowack says.
"Just knowing it's important is a good contribution," she says. "Another important feature is for institutional officials to model institutional remediation of problems and concerns based on values."
Just as children watch their parents to learn values, so do an institution's staff watch their managers and top officials.
"There are a lot of ways a community, like a university, looks at how the person in charge of the system resolves problems," Nowack says. "It really speaks volumes."
5. System intelligence: What's needed is a self-aware, self-monitoring, self-correcting system that evolves over time, Nowack says.
"The system you have today will be outgrown," Nowack says. "Your training program protects and informs, shapes to your needs."
Too often institutions treat educational programs in a knee-jerk fashion of offering whatever is new or most convenient, such as Web-based training, which can be offered and be done with, she says.
"Training for an institution is tailored to that institution, and you need to know what the system is doing," Nowack says. "You need an inventory of strategies and you need knowledge by role, by investigator, or by support community segment."
Poorly designed systems with programs that are not geared to what the system needs are wasteful with time and resources, she says.
"It breads cynicism," Nowack says. "If you have cynicism, it's human subjects protection that suffers."
Top officials at research institutions need to give systematic and comprehensive thought to what educational programs might involve, an expert advises.Subscribe Now for Access
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