Background: Healthcare institutions may often prohibit “cold-calling,” or direct contact with a potential research participant when the person initiating contact is unknown to the patient. This policy aims to maintain patient privacy, but may lead to unintended consequences such as physician gatekeeping or increase concerns for coercion if treating physicians are the sole contact allowed. Patients may also be denied full knowledge and benefit of research opportunities, and clinical studies may suffer from selection bias and under enrollment. Differences in cold call policies across institutions have yet to be explored.
Objectives: To review the current landscape of cold call policies among top academic institutions in order to inform guidance about future policy change.
Methods: Sixteen institutions with the highest NIH grant funding were classified as providing guidance about cold-calling, prohibiting cold-calling, and/or allowing exceptions to the cold call policy, based on publically available data.
Results: Among the top 16 research intensive institutions, 5 institutions have no cold-call policy. There are 7 institutions that prohibit cold-calling with exceptions, including when provider contact is impractical. There are 2 that do not have a cold call policy, but provide guidance such as taking extra care to respect patient privacy and inform patients of how they were identified. Finally, 2 prohibit cold-calling without exceptions. For patients not receiving care within the hospital’s health system, some institutions require that the PCP make first contact (Table).
Conclusion: The approach to engaging patients in large, research intensive health systems varies significantly. As healthcare has evolved with more virtual visits, team-based care or system-based care, the engagement of potential research participants should similarly evolve while preserving patient privacy and autonomy. Potential solutions include opt-in or opt-out approaches for future contact, replacement of cold call policies with best practices, or a team based collaborative approach between physicians and researchers to guide recruitment decisions.