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Tissue microarray construction and IRB information: All use of human tissue samples was conducted under IRB-approved protocols.
Additional pain points that are not shown include the transfer of (1) case report form (CRF) results to CTMS and later to ASMS; (2) primary study consent and IRB information to CTMS and later to ASMS; and (3) ancillary study consent and IRB approval to ASMS; and (4) assay results from laboratory machines to lab record systems.
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Given the requirements of the local IRBs, information on nonparticipants was not available, nor was the nonresponse rates across samples, which may limit the generalizability of the findings.
Respondents included IRB directors, information security officers, Office of Research representatives, privacy officers, and compliance officers.
IRB contact information: Bannatyne Research Ethics Board, P126 Pathology Building, 770 Bannatyne Avenue, University of Manitoba, Winnipeg, MB, R3E 0 W3.
After patients reviewed the IRB-approved information about the study and provided written informed consent, research coordinators completed forms to document each patient's eligibility and to capture information on clinical characteristics.
The patient surveys, which were anonymous, were accompanied by an IRB-approved "Information Sheet" which described the study and participants' rights as research subjects.
In addition the university has written institution-wide policies that describe the kinds of research activities that need approval from the IRB, and what information researchers should include when submitting research protocols to the IRB.
Anonymous data was mined from a research database containing SPECT data and corresponding clinical information (IRB #004).
The IRB-approved study information sheet was posted on the course website.
These investigations appear to be minimal risk and are typically considered exempt by IRBs when the information is low-risk, presented in aggregate and used by faculty members responsible for the specific curricular component.
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