Alexis Baughman

With research becoming increasingly participant-centric, there has been a push to return individual results, as is standard practice in clinical laboratories. Not only does this value the contributions of the individual, but it also promotes transparency, trust, and engagement in the research enterprise. However, research laboratories are not held to the same quality assurance requirements as clinical laboratories, creating a potential for testing and reporting errors that risk misleading or harming participants. Given that the ability to confidently and reliably return results to research participants could further the success of the Translational Genomics Research Institute (TGen), this project is intended to be a basis for further deliberations by analyzing the differences in regulations for clinical and nonclinical laboratories. In particular, a computer-assisted qualitative analysis software, MaxQDA, is utilized to elucidate the degree to which quality standards — intended to promote accuracy and reproducibility of results — are mandated in these opposing spaces. The analysis doubly confirms that guidance for nonclinical laboratories has significantly less coverage of quality standards, representing only 6.6% of the observed total. More importantly, it highlights systems used in the clinical setting to minimize uncertainty and therefore may curtail some cited concerns of research laboratories returning results. For this discussion to progress, the subsequent step is determining whether TGen can reasonably institute such quality metrics to increase confidence in research results that may be returned. Thoroughly answering this question is no easy feat, given that it requires the input of numerous stakeholders, including researchers, study participants, bioethicists, legal, regulatory, and compliance professionals. Luckily, the challenge is not unfamiliar to the research enterprise, and this one, in particular, deserves consideration beyond this project.