Guidelines for Conducting Research

These guidelines have been developed to assist investigators with the process review and approval of research studies conducted within Affinity Health System.

  1. To request permission to conduct a research study within Affinity Health System, the following items must be submitted at least two weeks prior to the review date:
    1. A completed "Request to Conduct Research" application form.
    2. A copyof the entire research proposal.
    3. A copy of the approval letter from the Human Subjects Review Committee, if the investigator is affiliated with a university.
    4. A brief synopsis of the investigator’s credentials or curriculum vitae.
  2. Limit research proposal to five-10 pages.
  3. Return the completed material to the Coordinator of the AHS IRB, 1570 Midway Place, Menasha, WI 54952.
  4. A signature from the manager/director of the service area(s) involved in data collection must accompany the proposal, if appropriate.
  5.  The principle investigator will be asked to attend the AHS IRB, meeting to explain or respond to the research proposal and will be notified of the date, time and place of the meeting at least one week in advance.
  6. The Chair of the AHS IRB will send written notification to the investigator(s) indicating approval, denial or deferral of the research study within two weeks after the proposal is reviewed.
  7. The chair will notify the director of the appropriate service area(s) involved of final approval to conduct research, if applicable.
  8. It is the responsibility of the investigator(s) to provide documentation of consent to participate in the study, if applicable.
  9. Upon completion of the research study, the investigator(s) agree(s) to provide a written report or abstract of the completed study to the AHS IRB.
  10. Any subsequent publication of the research study will contain no names nor identifying data about Affinity Health System unless such identification has been specifically approved.
  11. The investigator will report to the AHS IRB the status of the study (nationally and locally) at least annually, or as requested. Annual status report to include:
    • Status of study nationally (adverse event reports)
    • Status of study locally (number enrolled, risks, side effects)
    • In such case where mortality is thought to be related to study, the IRB chairperson is to be notified within 24-48 hours.
    • Investigator shall notify the IRB chairperson of any adverse reaction that may reasonably be regarded as caused by or probably caused by the investigational product and that was not previously anticipated in the written information concerning the product submitted to the investigator by the sponsor. Such adverse reaction notification shall be made as soon as possible, but in no event later than five (5) working days after discovery by the investigator. A full report of the adverse reaction must be contained in the next full committee meeting minutes.

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