Workshop series gives research coordinators professional updates
Topics range from budgeting to HIPAA
Research coordinators come from such a wide variety of backgrounds and experience that it can challenge institutions to meet everyone's educational needs.
Weill Cornell Medical College in New York, NY, has solved this dilemma with its workshop series called the Research Coordinators Network.
The network originated from an annual IRB submissions orientation program for research coordinators, says Jonathan M. Cohen, research integrity coordinator of Weill Cornell Medical College's division of research integrity.
This annual event included speakers from the IRB, pharmaceutical industry, and others, Cohen says.
The sessions, which began a few years ago, quickly drew in more attendees than anticipated, and these included investigators, post-doctorate students, graduate students, administrators, and others, he says.
Due to their popularity, the institution started the monthly workshop series in 2007. A National Institutes of Health (NIH) grant helped the institution start the new research training program to target research coordinators, as well as administrators, new principal investigators, and research staff at other local institutions with whom Weill Cornell has cooperative research agreements, Cohen explains.
Each workshop lasts 2.5 hours and includes PowerPoint presentations and handouts. There's a pizza lunch, and the typical attendance is 60-80 people, Cohen says.
After each workshop, attendees receive an evaluation form that asks for requests for future workshops. This way the attendees help to direct the topics selected for workshops, he adds.
"There's a lot of turnover in the research community, which is one reason why the ongoing education is so important," Cohen says. "It's a job a lot of people have for only a couple of years and then, maybe, they'll go into graduate school or to work for industry."
One recent session was on the pathology review process, a topic that drew attendees from both the research side and from the pathology department.
"We had a lot of people from the pathology department because they wanted to know what they could expect research coordinators to know about pathology," Cohen says.
Here are some of the workshop topics:
• Pathology review process. This workshop covered the study of disease tissues and a very detailed and intensive examination of the disease process, Cohen explains.
"Investigators from many different clinical specialties will rely on pathology services within their trials," Cohen says. "So there's a separate pathology review component of the protocol review process, and pathology has to sign off that they have the facilities to do the microscopic studies that the investigator is calling for."
The pathology department has to make certain the study won't interfere with any pathology obligations the hospital has for patient care and that the department will be paid for its work, he adds.
"It used to be the pathology review was part of the IRB review process, but it was changed to go through pathology as a separate process," Cohen says. "People submitting a protocol to pathology need to know what goes on in pathology and what the department handles so that their forms aren't rejected."
• Budget process. This workshop covers grant submissions, contracts related to clinical trials, billing compliance, and budgeting.
"A big part of a grant proposal is budget justification," Cohen says. "You have to account for how the money is spent in terms of personnel and equipment, and various granting agencies have very strict requirements in terms of what are acceptable expenditures."
Once an investigator receives a grant, he or she is accountable to the institution for the money.
"In clinical trials, because you often have medical procedures being done in the hospital and the hospital has to get paid for that, there's a form that describes exactly which procedures the research subject is going to be required to pay for as part of normal care," Cohen explains.
The workshop session also covers budgeting and how budget justification is a part of the grant submission process.
"The investigator describes how the money is spent, including salaries and time," Cohen says.
• Study organization and compliance. "Research coordinators need to keep their study organized and ready in case of an audit," Cohen says. "I think the biggest issues with audits tend to be you have to keep clear records of the consenting process."
Study volunteers sometimes say they expected something different than what occurred during the study, he notes.
"To prepare for that possibility, which might be unfounded, you need to show what they consented to, what you did, and how you kept records for the entire informed consent process," Cohen says.
"Since the consenting process is reviewed by the IRB, if you deviate from the consenting process that was reviewed then you're operating an unapproved consenting process," he adds.
Also, researchers need to list all key personnel on the study, including the PI, co-investigators, clinic nurses, research coordinators, and others.
There should be documentation of oral informed consent, and someone needs to keep track of who administered the consent form and make sure that if the IRB-approved protocol says the physician will give informed consent that the physician indeed handle the informed consent, Cohen adds.
• Data security and HIPAA. "This office reviews HIPAA compliance for every protocol that will collect protected information," Cohen says.
Investigators have to complete forms listing how the data will be kept, which data will be kept, and how the data will be made secure.
For instance, if there's a paper file, is the filing cabinet located in an area where patients have access, and is the cabinet locked?
"And if it's on a computer, it better not be on a public computer," Cohen says. "Or if it's on a personal computer, is it password protected?"
• Workplace conflict resolutions. A previous educational outreach officer had a background in conflict resolution and had worked for the New York City Public Schools for many years, doing conflict resolution workshops, Cohen says.
"So this is a conflict resolution workshop that discusses interpersonal problems and how to work around them," he explains. "The workshop covers strategies for dealing with a difficult boss and what to do when administrators in other departments don't do what you asked them to do."
The workshop had 52 attendees, he adds.
Some future workshops will cover the topics of hematology/oncology, departmental compliance issues, and research ethics.
"We work on these two months in advance," he says. "This office is working more closely with the department of medical ethics, and the ethics department said when we met with them that they would like to present what they do to the research community network."
In this way, the workshops help to facilitate communication between researchers and study coordinators with various college departments and administrators, Cohen says.
"They want to disseminate what goes on in their department, and they want research coordinators to know what is going on," Cohen adds.
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