Mentoring can improve human subject protection
Training geared toward students, residents
Physicians often are engaged in a research study at some point in their careers, but if they're working in the community primarily as clinicians they might not receive optimal mentoring and training in protecting human research subjects.
Problems occur when new student researchers start their first research project without having full knowledge of the human research subject protection and other regulations, says Barbara Frentzen, ARNP, MSN, coordinator of clinical programs, department of neurosurgery, University of Florida in Gainesville. Frentzen is the principal author of a study about the department's mentoring and educational program for new researchers.
"They can become frustrated and start to hate the difficult process of research if they don't have people who help them through it initially," Frentzen says.
The solution is to develop a program that provides medical residents with specific training through the IRB and through faculty mentoring. The University of Florida's department of neurosurgery began to implement a more formal training process five years ago with a research ethics educational series.
"The chairman of the IRB speaks about the role of the IRB," Frentzen says.
Also, a medical ethicist spoke with residents about research ethics, and the head of the IRB office provided a nuts-and-bolts educational session on the IRB submission process, she adds.
Among the topics presented in the series were:
— the history of research ethics;
— the institutional review board;
— federal regulations;
— informed consent;
— the Health Insurance Portability & Accountability Act (HIPAA);
— the ethics of writing for publication.
"I talked about the best strategies for interacting with patients to obtain informed consent," Frentzen says. "Our general counsel talked about what to do when a patient cannot consent for himself."
Since all residents are required to conduct one research project per year, educational lectures and sessions are important to their development as researchers. Fledgling researchers also need an opportunity to obtain expert feedback on their research proposals.
"Residents understood they could not start a project or collect data without IRB approval," Frentzen said. "For the next step, we created a research review committee."
The departmental research committee, consisting of the departmental chair, a younger faculty member, a statistician, and the resident who won the previous year's research award, reviews written proposals and provides feedback.
"We send comments back to each of the residents about the strengths and weaknesses of each proposal," Frentzen says.
Residents amend their projects and present the revised proposals to faculty and fellow residents for additional comments and feedback.
"Proposals are reviewed twice, and we think that will help improve the quality," Frentzen said.
Frentzen created a written research proposal template that residents can use. It includes at the top the date the written proposal is due and the date of the oral presentation to neurosurgery faculty, as well as the researcher's name, project title, and mentor's name.
Other features of the template are as follows:
- abstract: a summary of the proposed study in 250 words or less;
- hypothesis and specific aims;
- background and significance;
- preliminary results;
- research plan and methods.
The template advises researchers to have their mentors approve it before they send it to the department research committee and that they then should begin preparing their IRB and HIPAA submissions.
The final page of the template includes a timeline of activities that should be done with columns for putting dates at the targeted date of completion and the actual date of completion.
This process has led to a much more efficient and faster IRB review process for resident researchers, Frentzen notes.
Since the IRB review is faster, residents have more time to collect and analyze data. As a result, the number of published studies among residents has increased in recent years, Frentzen adds.
"The number of times residents were first authors on their first publications went up significantly, as well," she says. "They were owning what they did much more than in previous years, and it was very exciting."
The mentoring program has been another way to ensure resident researchers are complying with research regulations and maintaining high ethical and professional standards.
"Each student picks a faculty mentor," Frentzen says. "Prior to sending the proposal to the research committee, they meet with their mentor."
They discuss their research idea with the mentor and determine ways to improve the proposal. Mentors can help new researchers with design and analysis of the study.
"They need mentoring both in terms of how to design a study, clarify a question, and determine what is really relevant in terms of their professional development, and they need people who help them get through the nuts and bolts of the regulatory process," Frentzen says.
Once a new researcher is prepared to start the trial, he or she submits an application to the IRB, which Frentzen reviews.
"We go through the IRB process, which involves a review by their office staff to make sure everything is complete, and then the IRB chair reviews everything," she explains. "I sit with the chair to answer any questions he might have."
All of the additional training, mentoring, and reviews have improved the research process, making it less frustrating for new investigators, Frentzen says.
"Making the process smoother for them will contribute to making them more willing to be involved in research," she says.
Physicians often are engaged in a research study at some point in their careers, but if they're working in the community primarily as clinicians they might not receive optimal mentoring and training in protecting human research subjects.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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