Parent DTF: Methods and Processes Domain Task Force
- As large multi-center clinical trials emerge from cross-CTSA collaborations, investigators are encountering a variety of institutional policies and practices regarding the recruitment of potentially eligible participants identified through electronic medical record (EMR) databases. Many IRBs only allow contact of potentially eligible participants with the permission of their PCP or other treating provider, or even mandate a preliminary solicitation of patient interest by their clinicians, to respect the treating physician’s role as the custodian of confidential patient information. Others allow direct contact in certain cases, but require that clinicians be notified that their patients are being contacted directly by researchers, to reduce surprises that might disrupt their care plans and disturb therapeutic relationships. At the other extreme, a few institutions permit IRB-approved studies to contact potential participants directly whenever they can, on the grounds that involving treating physicians in research recruitment can create conflicts of professional commitment, encourage the therapeutic misconception, and may ultimately undermine doctor/patient relationships.
- At UNC, the Carolina Data Warehouse for Health (CDW-H) serves as a gatekeeper to providing research teams with EMR data on patients who meet eligibility for recruitment purposes. The CDW-H is a central data repository containing clinical, research, and administrative data sourced from the UNC Health Care System. The CDW-H is managed by a Governance Board and various committees, which review and approve requests for EMR data due to the sensitive nature of the protected health information it contains. The CDW-H works closely with the UNC IRB to ensure proper approvals and appropriate recruitment materials (telephone scripts, recruitment letters) are in place prior to the provisioning of EMR data to a study team for recruitment purposes.
- When the recruitment of patients into research is conducted largely in-house within a health care institution, or from a network of institutionally-affiliated providers, policies requiring the involvement of treating physicians promotes research recruitment by encouraging respectful collaborations between professional colleagues. The traditional exception in such policies has been for situations in which an IRB determines that involving treating clinicians “is impracticable” due to the large number of clinical sites involved, and the researchers’ access to identified patient records is authorized in other ways, like a research registry or EMR such as the CDW-H. Increasingly, however, this exceptional case is becoming the norm, as multiple clinics, institutions, and provider networks begin to pool their EMR data for research purposes. For initiatives like the CTSA Consortium that aspire to cross-institutional data-sharing, local insistence on PCP-mediated recruitment can complicate and slow high-impact research. On the other hand, as EMR data cross boundaries between institutions, lack of parity between our intra-and inter-institutional practices can also discourage collaboration and inhibit research. Practice guidelines are needed that can both facilitate direct transparent research recruitment via the EMR and accommodate the fiduciary interests of clinicians in how the patient information they collect and record is used by others for research purposes.
- Develop best practices / recommendations regarding the use of EMR’s to recruit potential research participants
- Develop educational materials targeting IRBs, PCP/treating providers and patients regarding the recruitment process using EMR (PowerPoint, draft letters, newsletter inserts, online tools)
- Develop a white paper for dissemination to the CTSA network
This group is sunsetted.