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Anchor your training program with Ethics 101
Start with ethics, peers advise
When selecting educational topics for your clinical research staff and investigational review board (IRB) members, where do you start?
Begin with the ethics of clinical research, advises Lynette M. Schenkel, administrative director of research and academic affairs at Beth Israel Deaconess Medical Center in Boston. For example, explain "why it is so vital to engage in the sometimes seemingly redundant processes in order to protect human participants," she says.
For the clinical research staff, Beth Israel Deaconess is implementing weekly training, Schenkel reports. The first meeting of the month will be mandatory and will last one hour and 15 minutes. It will provide some food and possibly continuing education credit and risk management credit, Schenkel says.
"Even if they are mandatory, you have to provide incentives," she says.
The meeting will focus on administrative aspects of clinical research, dealing with the IRB, and dealing with the Clinical Research Office in areas such as contracts, budgeting, and case report forms.
"The rest of the weekly meetings will be more informal, brown-bag sessions related to the first-of-the-month topic," Schenkel explains.
The facility already has been offering these types of sessions to administrative staff, she says.
"There’s much better discussions and exchange of ideas and questions at the information sessions," Schenkel says. "People aren’t afraid to speak up."
For the clinical staff, discuss good clinical practices, including their relationship with the principal investigator, other research staff, the IRB staff, and most importantly, the patient, Schenkel says.
Discuss the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines for the Standards of Good Clinical Practice, suggests Selika Gutierrez, RN, BSN, CNS, ACNPc, program director at Rush-Presbyterian St. Luke’s Medical Center in Chicago.
Consider these suggestions for other topics from Gutierrez: explanation of a clinical trial and what it entails, IRB standards for conducting a clinical trial, new Health Insurance Portability and Accountability Act policy and privacy acts, roles of team members such as principal investigator and research coordinators; and for administrators, information on how to conduct interrater reliability training for all staff.
While education of staff is ongoing, Beth Israel Deaconess has designated training for IRB staff at least bimonthly. According to Schenkel, that training covers:
Although the development of training and education programs can be time- and resource-intensive, they are critical elements of your program, experts advise.
"There is nothing that substitutes for having your own in-house training program," Schenkel emphasizes.