ln the current issue of Mayo Clinic Proceedings, Tweet et al (1) describe a novel solution to a perpetual problem that clinical researchers must address: How can researchers effectively and ethically identify and recruit adequate numbers of research participants, particularly if the research protocol involves participants having a rare condition? Absent such recruitment, a study will fail.
In their report, Tweet et al describe how a social networking site used by a disease-specific support group provided participants for a research registry of spontaneous coronary artery dissection. The social network reached beyond national boundaries to form a patient-initiated group, potentially of a size necessary to support research in this rare condition. Patients voluntarily became participants in the registry and provided their medical histories and disease-specific pathologic data to the registry. Key to the initiation of this project was the fact that members of the social network contacted the investigators. As such, Tweet et al avoided "cold calling" patients or other undesirable recruitment techniques to gain access to the valuable clinical data.
Federal regulations (2) governing protection of human research participants have been widely interpreted to prohibit "cold calling" of potential study participants. As an example of this interpretation, a researcher cannot develop a set of inclusion/exclusion criteria and then contact, to request consent for study participation, every patient who meets those criteria by randomly sampling from a geographic area or any other defined domain. However, there are different conditions under which clinical research may progress.
Study of a public health issue affecting many people might use deidentified data obtained from hospital discharge databases collected by each state in the United States or data reported to a federal organization such as the Centers for...