Attachment 13 POLICY AND PROCEDURES OF THE PACIFIC NORTHWEST RESEARCH FOUNDATION WITH REGARD TO INVESTIGATIONS INVOLVING HUMAN SUBJECTS I. Ethical Policy. Since 1958 the investigators of this Foundation have conducted all research under the ethical provisions of the Nuramburg Code, modified to permit consent by parents or legal guardians. II. Administrative Review. All applications for funds must be reviewed by the Director; this review is chiefly concerned with completeness, budget accuracy and conformance with granting agency policy. The Director is also required to ascertain that projects involving human subjects have been referred to the proper committees for scientific and ethical review. All proposals are initially submitted to the Medical Research Board for review of their scientific merit. All applications for support of research training or general research support projects, including those of fellows and trainees, which involve the use of human subjects must be approved by the Medical Research Board and the Review Committee for Research Involving Human Subjects before approval by the Director and submission to the granting agency. Specially selected consultants are called upon to comment on any scientific or ethical questions for the information of the Medical Research Board and the Review Committee for Research Involving Human Subjects. See also Attachment A - "Institutional Assurance on Research Involving Human Subjects". III. Membership of Review Committee for Research Involving Human Subjects. This Review Committee bears the primary responsibility for review and approval of methods used to deal with the use of human subjects at the Pacific Northwest Research Foundation. It is made up of mature, competent individuals in the fields of surgery, internal medicine, ophthalmology and microbiology, the Director of The Swedish hospital Medical Canterm the Head of the Department of Pathology of The Swedish hospital Medical Center, the Director of the Tumor Institute of The Swedish Hospital Medical Center, the Chaplain of The Swedish Hospital Medical Center, an attorney, a nationally respected business man, a Registered Nurse and the President of the Board of Trustees of the Pacific Northwest Research Foundation. See Attachment 3 - Membership of the Review Committee for Investigations Involving Human Subjects of the Pacific Northwest Research Foundation. IV. Initial Review by Committee. All applications are considered by the Medical Research Board in the exact form to be used in submission to the granting agency. Subsequently, all proposals involving human subjects are submitted to the Review Committee for Research Involving Human Subjects and the investigators must discuss and be prepared to defend in person the following points: 1. A detailed discussion of the possible risks to the rights and welfare of human subjects, including the right of privacy and freedom from undue harassment, and a description of the provisions made to minimize these risks 2. Methods used to acquire informed consent, with special emphasis on their appropriateness to the individual study situation. 3. The relative risks involved as compared to the probable benefits to the subject and to society. Members of the Committee who are in any way directly involved in the work covered by any project being considered will be excused during pertinent discussion. For each application, the Committee will either certify that these points have been properly dealt with and declare that the project may be submitted to the agency, or recommend to the Director that submission be delayed until specific deficiencies (spelled out in writing) are adequately dealt with. The Committee's finding will be transmitted in writing to the Director and the investigators. V. Continuing Review by Committee. The Review Committee meets quarterly. The Committee, the membership of which is available at all times, will be convened by the Director for emergent problems. Investigators in charge of projects involving human subjects are required to submit status reports to the Committee, at appropriate intervals. Any unusual circumstances or procedural changes will be reported immediately to the Committee Chairman. The Chairman will maintain a project log summarizing all Committee actions, including discussions on these reports. If a report is delinquent, the Chairman will contact the investigator to ascertain the status of the study protocol. If at any time the Committee is dissatisfied with the conduct of the project or with the cooperation of the investigator, they shall recommend that financial support of the project be withheld immediately until the deficiencies are corrected. If any investigator plans a change in study protocol, he will submit the proposed changes to the Committee for their approval, before putting them in to practice. VI. Provisions to protect the health and safety of human subjects. Any research conducted involving possible risk to human subjects will be done at The Swedish Hospital Medical Center where complete patient care is available in a 500-bed facility. The Pacific Northwest Research Foundation is situated on the campus of The Swedish Hospital Medical Center. VII. Applicability of this assurance. This assurance applies to the Pacific Northwest Research Foundation. ATTACHMENT A INSTITUTIONAL ASSURANCE ON RESEARCH INVOLVING HUMAN SUBJECTS The Pacific Northwest Research Foundation will comply with the principles of the Public Health Service policy with regard to research involving human subjects which requires a review independent of the investigator or director to safeguard the rights and welfare of those subjects. It assures the Public Health Service that it will establish and maintain advisory groups competent to review research plans involving human subjects, prior to the initiation of this research, in order to insure adequate safeguards. Group reviews and decisions will be carried out in reference to (1) the rights and welfare of the individuals involved, (2) the appropriateness of the methods used to obtain informed consent, and (3) the risks and potential benefits of the proposed research. The Pacific Northwest Research Foundation agrees to a continuing exchange of information and advice between the review group and the investigator or director, particularly to deal with proposed changes in research design, and with emergent problems which may alter the investigational situation with regard to the criteria cited above. The Pacific Northwest Research Foundation will assure itself that its policies and the advice of its review groups are followed. It will also provide whatever professional attention or facilities are required to safeguard the rights and welfare of human subjects involved in research. Records of group review and decision on the use of human subjects and of informed consent will be developed and kept by this institution. William G. Hutchinson, M.D. President and Director Pacific Northwest Research Foundation Date: ATTACHMENT B LIST OF MEMBERS OF THE REVIEW COMMITTEE FOR INVESTIGATIONS INVOLVING HUMAN SUBJECTS OF THE PACIFIC NORTHWEST RESEARCH FOUNDATION Mr. C. Spencer Clark Chairman of the Board Cascade Natural Gas Company, Seattle, Washington William B. Hamlin, M.D. Certified by the American Board of Anatomical and Clinical Pathology Head of the Department of Pathology The Swedish Hospital Medical Center, Seattle, Washington Carl G. Heller, M.D., Ph.D. Head of the Division of Reproductive Physiology Pacific Northwest Research Foundation, Seattle, Washington William B. Hutchinson, M.D., F.A.C.S. Certified by the American Board of Surgery President and Director Pacific Northwest Research Foundation, Seattle, Washington Miss Olive Ihmels, R.N. Head Nurse The Swedish Hospital Medical Center, Seattle, Washington Carl D.F. Jensen, M.D. Certified by the American Board of Ophthalmology Chairman, Medical Research Board Pacific Northwest Research Foundation, Seattle, Washington Reverend Richard E. Johnson, B.D. Professional Hospital Chaplain The Swedish Hospital Medical Center, Seattle, Washington Allan W. Lobb, M.D., F.A.C.S. Certified by the American Board of Surgery Medical Director The Swedish Hospital Medical Center, Seattle, Washington Mr. David C. Lycette, L.L.D. Attorney at Law Seattle, Washington ATTACHMENT B (Continued) Vernon T. Riley, D.So. Chairman, Department of Microbiology Pacific Northwest Research Foundation, Seattle, Washington Orliss Wildermuth, M.D., A.B.R.(T) Certified American Board of Radiology Director, The Tumor Institute of The Swedish Hospital Medical Center, Seattle, Washington This list may be subject to change periodically