OHIO UNIVERSITY-COLLEGE OF OSTEOPATHIC MEDICINE
ScopeThe patient pool at UMA is considered a valuable resource and great efforts are made to provide for their respect, beneficence, and justice.
1. Patient charts: A) Medical Records will release no patient charts for research purposes without written approval for the study from the OU-COM Human Subjects Committee and the OU Institutional Review Board.
B) Principal Investigators will not request patient charts from Medical Records for research purposes without having received written approval from the OU-COM Human Subjects Committee and 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 Medical Records for more than 24 hours. Patient charts are not to leave the UMA facilities.
2. Principal Investigator Responsibilities: A) Principal Investigators (PI) will be given copies of the OU and OU-COM policies regarding protection of human subjects when Human Subjects Committee and Institutional Review board applications are made to the Office of Research & Grants.
B) The cover sheet of the Human Subjects Committee/ Institutional Review Board application will contain an acknowledgement that the PI will not begin research nor request patient charts prior to approval.
C) PI’s 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) The PI will inform the Office of Research & Grants of all personnel involved with each research project. All infractions of patient confidentiality and patient rights will be reported immediately to the Office of Research & Grants.
E)
Provide regular reminders to project staff regarding data
confidentiality and the protection of human subjects. 3. Project Staff and Student Responsibilities: A) At the time of starting work on a research project, staff and students will report to the Office of Research & Grants, receive information on the protection of human subjects and sign confidentiality statements. These statements will be kept on file in the Office of Research & Grants.
B) Report all infractions of patient confidentiality and patient rights immediately to the PI and the Office of Research & Grants.
4. Student Initiated Research Projects: A) All student-initiated projects must have an OU-COM faculty research member.
B) The OU-COM faculty research mentor will undertake all responsibilities of a Principal Investigator as designated under section 2 above.
5. Recruitment of University Medical Associates Patients (UMA): A) The Human Subjects Committee must approve all letters and other materials designed to recruit UMA patients to participate in clinical research projects.
B) Research staff (clinical research nurses) from the Office of Research & Grants will handle all patient interaction with regard to interest from the recruitment efforts.
C) Only these persons who would normally have the right to know of a person’s status as a UMA patient, i.e., the patient’s physician or his/her designee, may contact that person as a patient to solicit research participation.
D) The use of telephone calls to target specific patients without that patient’s prior consent is not acceptable.
E) Physicians can be asked to identify and approach specific patients.
6. Research Initiated from Outside of OU-COM A) All research initiated by investigators outside of OU-COM, and desiring to use UMA patients, must include an OU-COM faculty member as co-investigator.
B) The OU-COM co-investigator will be responsible for adherence to the Human Subjects Research Policy.
C) All investigators must adhere to the OU-COM Human Subjects Research Policy.
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