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 (Cancer and tumor registry system) 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 (Cancer Reporting Regulations: Patient Notification Requirement)(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.

Source: Rule 333-010-0055 — Cancer Reporting Regulations: Research Studies, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-010-0055.

333‑010‑0000
Cancer Reporting Regulations: Definitions 333‑010‑0020
Cancer Reporting Regulations: Reporting Requirements for Health Care Facilities 333‑010‑0030
Cancer Reporting Regulations: Reporting Requirements for Practitioners 333‑010‑0032
Cancer Reporting Regulations: Reporting Requirements for Clinical Laboratories 333‑010‑0035
Cancer Reporting Regulations: Patient Notification Requirement 333‑010‑0040
Cancer Reporting Regulations: Quality Standards 333‑010‑0050
Cancer Reporting Regulations: Confidentiality and Access to Data 333‑010‑0055
Cancer Reporting Regulations: Research Studies 333‑010‑0060
Cancer Reporting Regulations: Special Studies 333‑010‑0070
Cancer Reporting Regulations: Advisory Committee 333‑010‑0080
Cancer Reporting Regulations: Training and Consultation 333‑010‑0090
Cancer Reporting Regulations: Fees 333‑010‑0100
ScreenWise Breast and Cervical Cancer Program: Description of the ScreenWise Breast and Cervical Cancer Program 333‑010‑0105
Definitions 333‑010‑0110
Client Eligibility 333‑010‑0115
Client Enrollment 333‑010‑0120
Covered Services 333‑010‑0125
Excluded Services 333‑010‑0130
Standards of Care for Breast and Cervical Cancer Screening and Diagnostic Services 333‑010‑0135
Provider Enrollment 333‑010‑0140
Billing 333‑010‑0145
Claims and Data Submission 333‑010‑0150
Timely Submission of Claims and Data 333‑010‑0155
Payment 333‑010‑0160
Requirements for Financial, Clinical and Other Records 333‑010‑0165
Compliance with Federal and State Statutes 333‑010‑0170
Denial or Recovery of Reimbursement Resulting from Review or Audit 333‑010‑0175
Recovery of Overpayments to Providers Resulting from Review or Audit 333‑010‑0180
Provider Sanctions 333‑010‑0185
Provider Appeals 333‑010‑0190
Provider Appeals (Level 1) — Claims Reconsideration 333‑010‑0195
Provider Appeals (Level 2) — Contested Case Hearing 333‑010‑0197
Presumptive Eligibility for BCCTP 333‑010‑0200
ScreenWise WISEWOMAN Program: Description of the WISEWOMAN Program 333‑010‑0205
Definitions 333‑010‑0210
Client Eligibility 333‑010‑0215
Client Enrollment 333‑010‑0220
Provider Enrollment 333‑010‑0225
Standards of Care for WISEWOMAN Program Screening and Services 333‑010‑0230
Submission of Information by Ancillary Providers 333‑010‑0235
Covered Services 333‑010‑0240
Excluded Services 333‑010‑0245
Claims and Billing 333‑010‑0250
Payment 333‑010‑0255
Denial or Recovery of Reimbursement Resulting from Review or Audit 333‑010‑0260
Recovery of Overpayments to Providers Resulting from Review or Audit 333‑010‑0265
Client Data Submission 333‑010‑0270
Requirements for Financial, Clinical and Other Records 333‑010‑0275
Compliance with Federal and State Statutes 333‑010‑0280
Provider Sanctions 333‑010‑0285
Provider Appeals (Level 1) — Claims Reconsideration 333‑010‑0290
Provider Appeals (Level 2) — Contested Case Hearing 333‑010‑0300
Tobacco Prevention and Education Program: Definitions 333‑010‑0310
Tobacco Prevention and Education Program: Purpose and Intent 333‑010‑0320
Tobacco Prevention and Education Program: Framework for Grant Awards 333‑010‑0330
Tobacco Prevention and Education Program: Local Coalitions and Community-Based Programs 333‑010‑0350
Tobacco Prevention and Education Program: Statewide Public Awareness and Education Programs 333‑010‑0360
Tobacco Prevention and Education Program: Statewide and Regional Projects Programs 333‑010‑0370
Tobacco Prevention and Education Program: Reporting 333‑010‑0600
Childhood Diabetes Database: Definitions 333‑010‑0610
Childhood Diabetes Database: General Authority and Purpose 333‑010‑0620
Childhood Diabetes Database: Reporting Requirements for Schools 333‑010‑0630
Childhood Diabetes Database: Reporting Requirements for Practitioners 333‑010‑0640
Childhood Diabetes Database: Confidentiality and Access to Data 333‑010‑0650
Childhood Diabetes Database: Research Studies 333‑010‑0660
Childhood Diabetes Database: Advisory Committee 333‑010‑0700
Dental Pilot Projects: Purpose 333‑010‑0710
Dental Pilot Projects: Definitions 333‑010‑0720
Dental Pilot Projects: Application Procedure 333‑010‑0730
Dental Pilot Projects: Application Review Process 333‑010‑0740
Dental Pilot Projects: Project Application Provisional Approval or Denial 333‑010‑0750
Dental Pilot Projects: Provisional Approval 333‑010‑0760
Dental Pilot Projects: Minimum Standards 333‑010‑0770
Dental Pilot Projects: Informed Consent 333‑010‑0780
Dental Pilot Projects: Pilot Project Evaluation and Monitoring by Sponsor 333‑010‑0790
Dental Pilot Projects: Authority Responsibilities 333‑010‑0800
Dental Pilot Projects: Project Modifications 333‑010‑0810
Dental Pilot Projects: Discontinuation or Completion of Project 333‑010‑0820
Dental Pilot Projects: Suspension, Denial or Termination of Project
Last Updated

Jun. 8, 2021

Rule 333-010-0055’s source at or​.us