The Combine and the Common Rule: Future NFL Players as Unknowing Research Participants.

This Article analyzes the application of federal regulations governing human subjects research to the National Football League (NFL). More specifically, this Article examines research conducted via the NFL Scouting Combine. The NFL Combine is an annual event in which approximately 300 of the best college football players undergo medical examinations, intelligence tests, interviews, and multiple football and other athletic drills in the hopes of demonstrating their prowess and landing a spot in the NFL. Combine participants are under intense pressure to impress NFL clubs. Indeed, the Combine is routinely called the "biggest job interview of their lives." The examinations, tests and drills provide a plethora of data for NFL clubs to analyze in considering which players to select in the NFL Draft. NFL club medical personnel scour the data on behalf of the clubs, looking for medical conditions that might affect a player's short-term or long-term usefulness to the club. Many of these medical personnel have then also published studies utilizing the medical data from the NFL Combine. Such studies can provide a better understanding of the medical conditions faced by elite football players. At the same time, these studies help clubs predict how a Combine participant's medical condition or history might affect his performance on an NFL field. Against this backdrop is the field of human subjects research regulation. Born out of some horrific historical incidents, bioethicists, doctors, lawyers and related experts constructed a paradigm setting forth the requirements for research--particularly medical research--involving humans as subjects. Included in this paradigm are federal regulations, known as the "Common Rule," which typically require that research be reviewed and approved by an Institutional Review Board (IRB) and that the researchers obtain the participants' informed consent before proceeding. Moreover, the Common Rule requires that additional protections be implemented where the population being researched is considered "vulnerable." This Article examines whether 42 medical studies published using the medical records and data of NFL Combine participants comply with the Common Rule and other human subjects research guidelines. Given the intense pressure to please NFL clubs, and the precariousness of a career in the NFL, NFL Combine participants have significantly constrained choices about whether to participate in the research being conducted. Consequently, it is highly questionable whether informed consent--as required by the spirit and letter of the Common Rule--is being obtained. Additionally, given most players' limited financial resources and the inequitable power relationship between players and NFL clubs, there is a strong argument that NFL Combine participants should be considered a vulnerable research population. This argument is bolstered by similarities between the workplaces of NFL players and military personnel-a population regularly recognized as vulnerable. The Article concludes with five recommendations for better protecting NFL Combine participants in the context of human subjects research: (1) requiring researchers and/or the Combine participants to read the consent form aloud and audio record the process; (2) requiring all research to be approved by the National Football League Players Association; (3) requiring consent forms to be provided to the Combine participants' agents; (4) having IRBs engage the perspective of a player when evaluating research; and (5) requiring that Combine participants' decision whether or not to participate in the research remain confidential. By requiring such protections, IRBs have the potential to ensure that NFL Combine participants are being subjected to research in the dignified and respectful matter required by the Common Rule. [ABSTRACT FROM AUTHOR]