Interested in doing research at the FMC?
The Department of Family Medicine values the importance of research. As both a primary care clinic and a research and teaching institution, we understand the vital role studies can play in generating and furthering our knowledge of health and health practices. That said, this pursuit of knowledge must be balanced with considerations for our patients, our staff, and the clinic itself. The Department is obliged to follow University, state, and federal rules and laws in conducting research. For these reasons, the Department requires all investigators proposing to undertake studies in the Family Medicine Center to follow the review process outlined below. Some studies may not require review-- efforts that are solely exercises in quality assurance or utilization review do not require review, unless findings may be published or otherwise presented as “research.” However, if your study involves patients, records, staff, or the facilities of Family Medicine, review is required.
- All studies proposing active recruitment of FMC patients must involve a member of the Department’s faculty as a co-investigator. This individual will help assure the study’s applicability to family medicine and smooth execution within the practice. We have learned through years of experience that studies lacking a Family Medicine co-investigator are rarely successful in meeting recruitment goals. A list of Department research faculty members can be found here.
- Generally, full monetary compensation is expected by the Department for the staff and clinician time and other costs required in study participation. Studies that are small and unobtrusive and those initiated by students or residents may not require compensation.
- Before the study may begin, a letter of approval or exemption must be provided from the School of Medicine’s Committee on the Protection of the Rights of Human Subjects (IRB).
- Whenever possible, Department physicians should be informed when their patients are approached for inclusion in a study. Physicians should be provided with information on the nature of the study and terms of participation. Physicians also should be apprised of their patients’ progress in the study and informed of study-derived information which might be relevant to ongoing care.
- Studies approved for the FMC may acknowledge to participants and others that it has been reviewed and approved by the UNC Department of Family Medicine, but it may not make claims of endorsement by the department.
Steps in Applying for Approval
Written applications must contain the following elements:
- A brief (one page) general description of the study, including its goals, methods, and a list of personnel.
- A statement of the study’s ethical issues and how patient rights will be safeguarded.
- If applicable, a description of the flow of the proposed project’s work in the FMC, including who will do what with whom, when and where. For example, for studies involving patients it should be clear who will recruit patients into the study, when this will occur (e.g., before or after their visit), what space is needed for this activity, how this might affect patient flow in the practice, and how data will be stored securely. Many of these details can be worked out through the Department’s faculty liaison to the study. Be sure to name the Family Medicine co-investigator in your application.
- When relevant, an indication of how the study will follow the clinic’s policies and procedure, e.g., aseptic techniques in drawing blood and monitoring for adverse outcomes following pharmaceutical injections.
- A project calendar timeline.
- Plans for reimbursing patients and the FMC for the time and effort assisting the study.
- Plans for notifying patients’ primary provider in the Department that their patient will be asked to participate in a study. Submit application to the Director of FMC Studies, Gary Asher MD, MPH firstname.lastname@example.org, and Heather Wilson, the research section administrative assistant email@example.com,
Studies proposed for the FMC will be evaluated in terms of their perceived importance, likelihood of answering their research questions, ethical soundness, compliance with the policies of the Department of Family Medicine, School of Medicine, UNC, state and federal laws, and the anticipated impact and costs for the FMC, its patients and staff. Applications will be reviewed by a committee that includes the Director of FMC Studies, the Director of the FMC, the Department’s Director of Operations, and the Department’s Financial Administrator. Review typically takes about four weeks, but may take longer. Appeals of unfavorable decisions may be made to the Director of FMC Studies. Further appeals may be made to the Chair of the Department.