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Dear Patients,
As chair of the Stevens IRB (Institutional Review Board) Committee, I am frequently asked about the role of the IRB at Stevens and within our community. Those who choose to read further will learn more about this valuable group of professional and community members who volunteer to address medical research as it affects those within and around our neighborhood.
Our primary mission is to safeguard the rights and welfare of human research subjects. The committee has the obligation to assess the risks and benefits of any patient's participation before and during the proposed research to ensure that the risks are both minimized and appropriately disclosed. We do this with particular attention to the process of informed consent when testing involves drugs, vaccines or medical devices.
IRBs have the authority to approve, require modification to or disprove any proposed study protocols and consent forms. We typically meet directly with investigators to hear about the proposed research and to address our concerns or requests for revisions in an open format. We believe that bringing together members of our medical and lay community with researchers from our immediate community plus regional and national communities improves the opportunity to advance medical information and science for everyone while having a positive effect here in our own neighborhood.
The Stevens IRB team includes medical staff members appointed by the president of the medical staff, the medical director, representatives from the hospital staff (including pharmacy and nursing), our hospital chaplain and community members who are required to have no direct affiliation with Stevens Hospital. All members complete an educational tool—the human participants protection education for research reams—sponsored by the Nation Institutes of Health (NIH).
The Stevens IRB reviews approximately 12 studies a year. Currently we have 18 open studies. Some of these studies are initiated at regional research centers, including the University of Washington and Fred Hutchinson Cancer Research Center. Some studies are initiated by our medical staff here at Stevens Hospital. It is our intent that any medical staff member be permitted the opportunity to explore research in the office or hospital setting and that Stevens IRB facilitates the review process while ensuring the protection of patients.
I hope this gives the reader a better idea of who we are and how we function. Please feel free to contact me or Rhoda Ovalles, the IRB Project Manager, at 425.640.4397, if you would like additional information.
Eileen Johnston, M.D.
IRB Chairperson
