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Research Process Details

A. When reviewing study protocols, the research committee (RC) shall consider federal, state and hospital policy.

  1. The RC shall consider the “Common Rule” 45 Code of Federal Regulations (CFR) part 46 (DHHS), Oregon Department of Human Services (DHS) Policy AS-100-06, and National Bioethics Advisory Commission reports and recommendations. Final approval for research, and the consideration of the protection of human subjects, shall reside with the Institutional Review Board (IRB).
  2. The RC shall consider the proposed benefit to OSH and OSH patients. This consideration will not be the deciding factor when determining whether to guide a proposal through the OSH system, but shall be considered in relation to other factors – such as the burden on the hospital or infrastructure.
  3. The patient committee member shall review all proposed research surveys for content and appropriateness for OSH patients. In addition, the committee or the patient member can convene a patient review panel to review surveys directed at patients, specifically.
     

B. Prior to Submission:

  1. The researcher shall consult with the appropriate OSH stakeholders relevant to the project and show evidence in their protocol that this input was sought, barriers and risk have been addressed, and the stakeholder has acknowledged the capacity to support or accommodate the study.
  2. The RC shall be available to consult with researchers regarding contacting potential stakeholders.
     

C. Submission: The researcher shall submit the Research Submission Form and study protocol.

  1. The submission form shall include the IRB to be authorized for this project.
  2. The RC shall review the IRB listed against OSH’s current list of IRBs with signed authorizations on file.
    1. If the IRB has a signed authorization on file, the review process shall continue.
    2. If the IRB does not have a signed authorization on file, or the authorization is out of date, the researcher is responsible for providing the RC with the documentation needed to complete the authorization process.
  3. The RC shall formally review a proposal once the Research Submission Form and completed study protocol has been submitted to the committee.
  4. The RC review shall culminate in one of three outcomes:
    1. Provisional Approval, to submit to the authorized IRB;
    2. Not Approved, revisions recommended;
    3. Not Approved, protocol is not appropriate for OSH at this time.
  5. Once a provisional approval has been granted, the RC:
    1. Shall provide the researcher with a letter of approval, and
    2. Shall submit the project to Clinical Executive for ratification.
  6. Once a provisional approval has been received, the researcher shall submit the study to the authorized IRB.
  7. Once the researcher receives approval from the authorized IRB, they shall submit the approval letter and approved study documentation to the RC.
  8. The RC shall review the IRB approval and final study documentation, and provide one of three outcomes:
    1. Approval for implementation;
    2. Not Approved, revisions recommended ;
    3. Not Approved, protocol is not appropriate for OSH at this time.
       

D. Post-Approval:

  1. The researcher shall forward all documentation between themselves and the authorized IRB, including but not limited to:
    1. Continuing review,
    2. Protocol deviations,
    3. Protocol amendments,
    4. Unanticipated problems involving risks to subjects or others,
    5. Serious adverse events,
    6. Serious or continuing noncompliance with the applicable U.S. federal regulations or the requirements or determinations of the IRB,
    7. Suspension, termination or closure.
  2. The research shall forward a summary of study findings or all publications resulting from the approved research.
  3. The RC shall be available for consultation and problem-solving efforts at all times.