OAR 333-010-0055: Cancer Reporting Regulations: Research Studies

(1) Requirements for Research Studies. Before any confidential data may be disclosed to a researcher, OSCaR must: (a) Approve a submitted protocol for the proposed research, which describes how the research will be used to determine the sources of cancer among the residents of Oregon or to reduce the burden of cancer in Oregon, in accordance with ORS 432.510 and OAR 333-010-0010; (b) Agree that the data requested are necessary for the effective and efficient conduct of the study; (c) Approve the researcher's submitted protocol and procedures for: (A) Identifying patients to be contacted; (B) Protecting against inadvertent disclosure of confidential and privileged data; (C) Providing secure conditions to use and store the data; (D) Assuring that the data will only be used for the purposes of the study; and (E) Assuring that confidential and privileged data will be destroyed upon conclusion of the research; (d) Determine that the researcher has access to sufficient resources to carry out the proposed research before releasing any confidential data; (e) Confirm appropriate review of the research, including peer review for scientific merit, and review by the body used by the Authority as the Committee for the Protection of Human Research Subjects and established in accordance with 45 C.F.R. 46: (A) A researcher’s proposed study must comply with the requirements of the Federal Policy for the Protection of Human Subjects codified at 45 C.F.R. 46 as a condition of receiving confidential information from OSCaR. (B) The Committee must evaluate studies under 45 C.F.R. Part 46’s requirements for disclosure and must approve the study prior to OSCaR releasing any data. (f) Determine the need for and require the researcher to implement other safeguards which, in the judgment of OSCaR, may be necessary for protecting confidential and privileged data from inadvertent disclosure due to unique or special characteristics of the proposed research. (2) Contacting Patients for Research. As outlined in OAR 333-010-0035(2)(e) and (f), participation in research is voluntary and patients may choose whether or not they want to participate in research studies. (a) Before disclosing confidential patient information to a researcher, OSCaR must determine whether any of the patients meeting the criteria for the research study have previously informed OSCaR that they do not wish to participate in research. Such patients will be excluded from the list of patients provided to the researcher or contacted by OSCaR regarding research. (b) Patients may be contacted a maximum of one time per year. Patients who meet the criteria for the research study and have been contacted for any OSCaR-related research study within a year preceding the initiation of the patient contact process for the research study will be excluded from the list of patients provided to the researcher or contacted by OSCaR regarding research. (c) Unless OSCaR determines it to be impracticable, OSCaR or the researcher must contact the patient's current treating physician to inform them of the study prior to any contact with a patient. In situations where the treating physician of record is no longer the patient's physician, OSCaR or the researcher must make a good faith effort to find the patient's current physician. (d) When contacted, the patient’s physician must be informed of the study and the identity of the eligible patient. Within three weeks the physician must: (A) Agree that direct contact by the researcher would be appropriate; or (B) Indicate the presence of a medical, psychological or social situation in the patient's life that would make contact inappropriate at that time. The physician is under no obligation to disclose the specifics of the medical, psychological or social situation. (e) If a researcher does not receive a response from the physician within one month, the researcher may contact the patient directly. (f) When a researcher contacts a patient directly, the researcher must include information explaining the registry, why the patient’s contact information was disclosed, and the purpose of the disclosure. (g) Researchers are strictly prohibited from redisclosing patient names or other confidential information to other researchers, individuals, or institutions not specifically identified in the approved study protocol as outlined above.