OHSU eIRB#: _____
Protocol Approval Date: _____
LEGACY HEALTH SYSTEM and OHSU
CONSENT AND AUTHORIZATION FORM FOR INSTITUTIONAL REVIEW BOARD APPROVED RESEARCH
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
As many as 4,500 subjects will take part in this study, which will be conducted at Legacy Health System [and please list other OHSU affiliated sites] by Pacific Oncology and Legacy researchers [as relevant, add:, and at other hospitals and universities nationally/internationally]. The Pacific Oncology researchers are faculty of OHSU. About 30 subjects will be enrolled at Legacy Health.
WILL MY MEDICAL INFORMATION BE KEPT PRIVATE?
Efforts will be made to keep your personal information in your medical record confidential. We cannot guarantee total privacy. Your personal information may be disclosed if required by law. Organizations that may inspect and copy your research records include groups such as: Legacy Health System, the OHSU Institutional Review Board, the OHSU Knight Cancer Institute, the National Cancer Institute, the Food and Drug Administration, the Southwest Oncology Group, and the Office for Human Research Protections.
WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS STUDY?
You have not waived your legal rights by signing this form. If you believe you have been injured or harmed while participating in this research and require immediate treatment, contact Dr. [NAME] or one of the other study team investigators at (503) 413-8199.
If you become sick or injured by participation in this research study, medical treatment will be provided including first aid, emergency treatment and follow-up care as needed. Legacy Health System will bill your health insurance for the cost of such care. If your insurance does not pay for care, or pays only a portion of the cost of such care, Legacy Health System may bill you for any unpaid amounts. By providing or making available medical treatment for injuries or illness, Legacy Health System and persons conducting this research study are not admitting fault for injury or illness. Neither Legacy Health System nor Oregon Health & Science University offer to pay for the cost of the treatment. Any claim you make against Oregon Health & Science University may be limited by the Oregon Tort Claims Act (ORS 30.260 through 30.300).
This research is subject to the Oregon Genetic Privacy law (ORS 192.531 through ORS 192.549) and its requirements concerning confidentiality and the legal remedies provided by that law for breach of its requirements.
It is not the policy of the federal funding agencies to compensate or provide medical treatment for human subjects in federally funded studies.
If you have questions on this subject, please call the OHSU Research Integrity Office at (503) 494-7887.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
You are free to refuse to participate or to withdraw from participation at any time and it will in no way affect your relationship with, or treatment at, Legacy Health System or OHSU.
WHO CAN ANSWER MY QUESTIONS ABOUT THIS STUDY?
If at any time during this research study you feel that you have not been adequately informed as to the risks, benefits, alternative procedures, or your rights as a research subject, or feel under duress to participate against your wishes, you can contact Legacy Health System’s research regulatory specialist who will be available to speak with you during normal working hours (8:30 a.m. to 5:00 p.m.) at (503) 413-2474. Additionally, the study principal investigator, Dr. [NAME] or one of the other study team investigators may be contacted at (503) 413-8199.