Good news: There’s more than one way to meet new education requirements
Teaching researchers is a continuous effort
IRBs may have rushed last year to meet the Bethesda, MD-based National Institutes of Health (NIH) requirements for educating investigators, but now is the time to fine-tune and improve those educational programs.
"Everybody did the best they could last year and now they are looking at the long term, setting new goals, and considering what our institution wants to do with this requirement," says Rebecca Flores Stella, research compliance education administrator with Cedars-Sinai Medical Center in Beverly Hills, CA. "Our institution has put a great emphasis on creating a research community that is really in tune with human subjects’ protection and respect for human subjects," Flores Stella notes. "A lot of our educational effort has been going out and meeting with individual investigators to discuss their specific needs."
The Cedars-Sinai IRB also has provided group education programs that detail IRB procedures and general training.
Education and training for investigators who work at the U.S. Army Institute of Surgical Research in Houston is a thorough and methodical process that includes a two-page checklist of educational requirements, says Denyse Pettersson, coordinator for human research compliance. Pettersson also is a contract employee of Professional Performance Development Group Inc. of San Antonio. "We have a checklist for the human-use committee members and one for principal investigators (PIs), and it’s part of their credentialing requirements to read all materials on a shared drive and then return the checklist signed that they have read everything," Pettersson says.
Pettersson, Flores Stella, and other education experts offer these strategies for how an IRB can improve education and training:
• Set goals, make checklist/outline for program.
The educational program created by Professional Performance Development Group includes a detailed list of all the required reading material that must be covered by either human use committee members or principal investigators, Pettersson says. For instance, the checklist includes all the command policies that involve human use, the ethical use of human cadavers, obtaining volunteer agreement affidavit for research protocols, eligibility requirements for volunteers for payment, and research protocols.
Other policies are:
- continuing review policy;
- amendment addendum request;
- standard operating procedures;
- assessing method feasibility requiring human subjects;
- anatomical substances;
- guidelines for reporting adverse events;
- use of a medical monitor.
Investigators also should be required to read a variety of background material, including the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, which was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Putting pieces together
A web-based educational program devised by Alfred S. Graziano Jr., USAF, BSC, chief of Biomedical Research Regulatory Division for the United States Air Force in Falls Church, VA, provides investigators, committee members, and staff with appropriate oversight to ensure federal requirements are met, including those of the Office of Human Research Protections (OHRP) in Rockville, MD, the Food and Drug Administration (FDA) also in Rockville, MD, and the Department of Defense in Washington, DC.
• Describe various resources to meet educational requirements.
Whether an IRB director is looking for material to incorporate into an educational program or looking for training and educational resources that would serve as the program, there is plenty of information available. The FDA has a tutorial that’s available, and the OHRP is expected to list training options on its web site, Pettersson says.
Also, there is an NIH training module that is very useful, Flores Stella says. "We’re looking into some web-based resources to address continuing education needs, so the new staff and investigators don’t have to wait for a single-group session," she explains. "We are considering various web modules that are out there, and in the interim, we are accepting certification from the NIH educational module if an investigator is unable to complete our institutional module." Investigators completing the NIH module also are required to review materials related to the assurance and local IRB program, Flores Stella adds.
Graziano’s program provides the basic information through an easy-to-use web program. A part of the program that is crucial to the successful integration of requirements with local policies and procedures is the block four of the training module in which there is face-to-face training at each individual site, Graziano says. A partial list of various training programs offered nationally is available at the web site www.afms.mil/moasgot/sgxcoct1.html#dear, and Graziano’s training program is located at www.afms.mil/moasgot/Training_Plan.htm.
"I believe IRBs are accepting any certification of educational training now," Graziano says. "I think that this training should be validated first, and approved by the IRB or by local policy, and then a short face-to-face training session at the local research facility should complete the course."
• Offer a variety of educational formats.
The training program created by Professional Performance Development Group includes in-person instruction, web-based training, individualized learning modules, and tests to assess what was learned, says Annette MacClinton, RN, MA, BSN, quality assurance unit for the company. Since formal training and education is new to investigators, IRBs may experience some resentment among individuals who previously only had to attend a conference of their choosing each year, she notes. "I think the more formalized the training you do, you’ll get a more consistent and better product at the end, so all investigators will be singing off the same sheet of music," MacClinton says. "Once we start this with new investigators, and once they realize it is a requirement just like any other federal requirement, I think it will become a way of life," she adds.
• Provide PIs with area-specific training as well as general training.
"Everything that’s there for them to read is really to help them conduct research much better and help keep them out of trouble," MacClinton says. She recommends that clinicians attend on an annual basis a good clinical practice guideline session regarding their specific area of human subject research. A variety of companies offer such sessions, including pharmaceutical companies that are involved in phase I research, MacClinton adds.
General training can be provided via the Internet, videos, software modules, inservices, teleconferences, regional courses, and other methods. Cedars-Sinai Medical Center provides research area specific training on a one-on-one basis when needed, Flores Stella says.
• Set educational/training policies.
Obviously, the training is a part of an investigator’s credentialing requirement, but there is a lot of room for flexibility in evaluating whether an individual has met an IRB’s training policies and requirements. "Everyone is going to have to show proof that they have continuing education," MacClinton says. "Each year they will need to be recredentialed and submit a new curriculum vitae with a progress report for studies."
But how often should investigators and others be required to take tests based on the educational material, and should tests be offered for every subject review? "I’m leaning more toward a review or refresher test; and therefore, it would just be in areas such as protocol addendums or continuing review questions or situations that involve informed consent with subjects — the major issues," MacClinton says.
Pettersson says she prefers that when tests are offered that all of the questions be given at one time rather than after each module or section. "They’re going to have to read all of the material to get an 80% on the test and it’s a better judge of what they’ve learned to ask them all of the questions at one time," Pettersson notes.
The test Pettersson and MacClinton have created includes 40 questions that are either multiple choice or true or false. "We took the required reading and made one to three questions for every major topic," MacClinton says. "The bulk of the questions deal with preparing to submit the protocol, protocol addendums, and a major area deals with informed consent." Then after writing the questions, Pettersson and MacClinton took the test themselves, documented that they had received passing grades, and then gave the test to the chair of the IRB.
"We might go ahead and test it on one of the seasoned investigators," MacClinton says.
Currently the educational material and test can be viewed on computers at the facility, but a likely future change will involve putting the material on a compact disc so that investigators could be mailed the materials for study and testing, Pettersson says.
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