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 Be aware of the definition of Human Subject Research.
 Consult the IRB where there is uncertainty about whether an activity is
Human Subject Research.
 Not conduct Human Subject Research or allow Human Subject Research to be conducted without review and approval by an IRB designated by the Institutional Official.
 Report allegations of undue influence regarding the oversight of the Human Research Protections Program or concerns about the Human Research Protections Program to the Institutional Official.
 Report allegations or funding of non-compliance with the requirements of the Human Research Protection to the IRB
Individuals who are responsible for business development are prohibited from carrying out day-to-day operations of the review process.
10.8.5 Relationship between Components:
The MHC IRB functions independently of, but in coordination with, other institutional regulatory committees. The IRB, however, makes its independent determination whether to approve or disapprove a protocol based upon whether or not human subjects are adequately protected. The IRB has review jurisdiction over all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that has adopted the human subjects regulations.
Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution(s). However, those officials may NOT approve research if it has not been approved by the IRB.
10.8.6 Protocol-specific coordination:
The Initial IRB Application form, which must be submitted with every protocol, requires Principal Investigators (PIs) to indicate institutional support that may be required for the research, including, but not limited to:
 Nursing
 Medical Records
 Lab
 Pathology
 Surgery
 Finance
 Pharmacy
 Radiation Oncology
Human Research Protections Program Manual
Revised 12/1/16
McLaren Health Care
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