Fill often overlooked site education gap
Fill often overlooked site education gap
Focus on training research coordinators
Research institutions and clinical trial sites often pay close attention to investigator training, particularly to what’s required through regulations and institutional policies. But an important educational opportunity often is overlooked, and that involves the training of research coordinators.
"Research coordinators are often the first line of contact with subjects," says Monika Markowitz, MSN, RN, MA, director of the Office of Education and Compliance Oversight in the Office of the Vice President for Research at Virginia Commonwealth University in Richmond. Markowitz spoke about education for research coordinators at the 2005 annual HRPP conference on ethics and trust across boundaries, sponsored by Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA), held Dec. 3-6, 2005, in Boston.
"It’s not that research coordinators are not acknowledged, but much of the regulatory language and institutional language is aimed toward the investigator," Markowitz says. "Even though the investigator is in charge and responsible for conduct of the research, often he or she doesn’t conduct all of the research."
Virginia Commonwealth University began to provide specific education for research coordinators in the fall of 2004, Markowitz notes.
The educational program now includes monthly programs about topics of interest to research coordinators, including lectures on the IRB process.
Here is how the education program was developed:
• Hold a meet and greet:’ The institution invited experienced research coordinators to attend a casual educational session in which they would meet some of the chief research people they contact through their work.
"We met with some key research coordinators who are very experienced and have worked in research for a long time," Markowitz says.
The seasoned research coordinators were asked to describe their roles, their departments, and to say whether they would be interested in serving as mentors, she explains.
"Also, at this meet and greet function, we had representatives from many of the areas with whom research coordinators need to interact, including from sponsored programs, from the HIPAA privacy board, and from investigational pharmacy, radiology, pathology, and the IRB," Markowitz says. "The face-to-face contact was very important."
More than 40 research coordinators attended the afternoon meeting.
"The feedback we received was they were glad to meet many of the people they had spoken with over the phone or had e-mailed, and they were glad to meet other research coordinators," Markowitz says.
• Provide monthly educational sessions: Each month the institution has a research coordinator host a fourth Friday lunch and learn in which different topics are presented as research coordinators take a lunch break.
"The ideas for the sessions come from the research coordinators themselves," Markowitz says. "We have a steering committee consisting of experienced research coordinators, and some of the ideas come from the committee."
The one-hour program typically has between 10 and 30 attendees, and the monthly programs have included these topics:
— the IRB process at Virginia Commonwealth University;
— informed consent conundrums about the language and misrepresentation of important language that often is put into an informed consent;
— using the investigational drug pharmacy;
— the responsible conduct of research;
— the sponsor contract.
Speakers have included research coordinators who have worked on complicated and interesting studies and who discussed their roles with this type of research, Markowitz says.
"They are experts in what they do, and I think it’s empowering and a great use of a wonderful resource to have them share some of the progress and trials and tribulations they experience," Markowitz says.
There are no quizzes, and the educational sessions are entirely voluntary, she adds.
• Provide networking opportunities: Another aspect of the research coordinator education focus has been to provide informal opportunities for research coordinators to network with each other, Markowitz says.
The research department regularly updates a list of research coordinators and their contact information, including departments, e-mail addresses, and telephone numbers, she says.
"So they can contact each other if need be, or they can meet each other within these lunch and learn programs," Markowitz explains.
Since research coordinators have a variety of job titles and often change jobs and departments, maintaining such a contact list can be a little time consuming, she notes.
"Research coordinators often come into a health science setting with different job titles, and those titles rarely are research coordinator,’" Markowitz says. "They can be nurses and have other titles, so finding out who they are and who the new people are can be challenging," Markowitz says. "What we’ve been trying to do is find people through word-of-mouth and by looking at IRB protocols and getting names off of those."
The distribution list also is how the department informs research coordinators about education sessions and updates, she adds.
As the research coordinator educational programs evolve, the institution might develop a certification program and live educational programs, along with sessions that could earn coordinators continuing educational units, but the important thing is to address this missing link in institutions’ research education programs, Markowitz says.
"The major reason for our talk about this topic at the PRIM&R conference was to share ideas and concerns among all institutions that are struggling with how to provide education to this group on the research team that is actively involved in the conduct of research," Markowitz says.
Research institutions and clinical trial sites often pay close attention to investigator training, particularly to whats required through regulations and institutional policies. But an important educational opportunity often is overlooked, and that involves the training of research coordinators.Subscribe Now for Access
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