The patients of the OU-COM free clinics, University Medical Associates, Inc. (OU-COM’s faculty practice plan), and affiliated faculty practices are considered a valuable resource and great efforts are made to provide for their respect, beneficence, and justice. 1. Patient charts: A) Medical Records areas from the OU-COM free clinics, University Medical Associates, Inc., and affiliated faculty practices will release no patient charts for research purposes without written approval for the study from the OU Institutional Review Board. Before issuing such approval, OU Institutional Review Board will expect a letter of agreement for the release of patient charts from either the Director of Community Health Services, the University Medical Associates, Inc. Board, or authorizing representative from an affiliated faculty practice plan.
B) Principal Investigators will not request patient charts from OU-COM free clinics, University Medical Associates, Inc., or affiliated faculty practices for research purposes without having received written approval from the OU Institutional Review Board. This requirement applies to all aspects of the research project including, but not limited to, the examination of data for project development ideas, pilot studies, retroactive chart review, and feasibility studies.
C) For research purposes, patient charts will not be removed from OU-COM free clinics, University Medical Associates, Inc., or affiliated faculty practice offices.
2. Principal Investigator Responsibilities: A) Principal Investigators (PIs) should refer to the OU policies and procedures regarding protection of human subjects prior to submitting applications to the OU Institutional Review Board. Policies and procedures can be found on the OU Institutional Review Board website at http://research.ohiou.edu/compliance/index.php?section=12.
B) The cover sheet of the OU Institutional Review Board application will contain an acknowledgement that PIs will not begin research nor request patient charts prior to approval.
C) PIs will be responsible for all aspects of the research project including the protection of human subjects. This responsibility extends to insuring that project personnel are aware of and maintain patient confidentiality.
D) PIs will provide regular reminders to project staff regarding data confidentiality and the protection of human subjects.
3. Project Staff and Student Responsibilities: A) All project staff and students working on projects should be familiar with information on protection of human subjects as described in the OU Institutional Review Board guidelines.
B) Project staff and students will report all infractions of patient confidentiality and patient rights immediately to PIs and the OU Institutional Review Board.
4. Student Initiated Research Projects: A) All student-initiated projects must have an OU-COM faculty research mentor.
B) The OU-COM faculty research mentor will assume all responsibilities of a Principal Investigator as designated under section 2 above.
5. Recruitment of Private Practice Patients: A) The OU Institutional Review Board must approve all letters and other materials designed to recruit patients to participate in clinical research projects.
B) Only the patient’s physician or the physician’s designee may contact patients to solicit research participation. For grant-funded projects, PIs are encouraged to contact granting agencies for proper patient contact protocols.
6. Research Initiated from Outside of OU-COM A) All research initiated by investigators outside of OU-COM, and desiring to use OU-COM free clinic, University Medical Associates, Inc., or affiliated faculty practice patients, must include an OU-COM faculty member as co-investigator.
B) The OU-COM co-investigator will be responsible for adherence to all OU Institutional Review Board policies and procedures. C) The cover sheet of the OU Institutional Review Board application will contain an acknowledgement that PIs will not begin research nor request patient charts prior to approval.
D) PIs will be responsible for all aspects of the research project including the protection of human subjects. This responsibility extends to insuring that project personnel are aware of and maintain patient confidentiality.
E) PIs will provide regular reminders to project staff regarding data confidentiality and the protection of human subjects.
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