CORRONA Ethics

CORRONA has established a comprehensive Ethics Program to assure that the organization and its executives, staff, board of directors, investigators, and scientists adhere to high ethical standards in our research and other activities. CORRONA’s mission and its unique research and business activities create a responsibility for all to respect these standards and to participate in our Ethics Program.

CORRONA’s mission and activities provide significant value to patients, science, the practice of medicine, and the life sciences industry. CORRONA maintains the largest rheumatic disease research registry in the United States, through which clinical information is collected from patients and their treating rheumatologists from throughout the country to support disease and therapeutics research. CORRONA also provides sponsoring pharmaceutical companies with therapeutics data derived from the registry population. Also, physicians affiliated in various ways with CORRONA have independent relationships with industry.

Business and professional ethics have become more important than ever before because of concerns about the possible effects of relationships among physicians, scientists, and industry on patient care, research integrity, and scientific publications. Some such relationships have been lacking in transparency. Recently a number of medical group practices and academic institutions have reviewed and restructured their guidance on ethical standards and the relationships of their professional and business staffs with industry. CORRONA has done the same.

Program Elements

• Ethics Policy: CORRONA has completed a formal ethics policy document with contributions from the executive committee, Board of Directors, and a medical ethicist of counsel to CORRONA.

• Ethics Committee: CORRONA has established an Ethics Committee to manage this program, review disclosures relating to relationships with industry, and advise the company on ethics issues.

• Research registry ethics: The CORRONA registry and its procedures have been reviewed for all research sites by either a central Institutional Review Board or local Institutional Review Boards. Patients who wish to consider participation in the registry are fully informed about the registry’s purposes, the possible uses of their clinical data, privacy procedures, the low risks associated with participating in the registry, and the lack of effect of registry participation on their usual care. Informed consent is obtained separately for sub-study protocols.

• Disclosure policy: CORRONA executives, staff, board of director members, and affiliated scientists are required to complete and update disclosure forms that permit review of individuals’ relationships with industry that might create or be perceived as conflicts of interest for CORRONA.

• Sponsor Rules: CORRONA’s relationships with its sponsors, the processes for responding to sponsors’ information queries, and the types of information that may be shared from the registry are all explicitly defined. These data provide real-world insights relating to therapeutic efficacy, practice choices, and drug safety. Registry data may not be used for direct marketing purposes.

• Communications regarding CORRONA’s Ethics Program: The Chief Operating Officer is authorized to manage all communications regarding the Ethics Program.

Please address any questions to James Cavan, Chief Operating Officer.