title: A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.
abstract: Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey.Methods: Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007.Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive.Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues.
authors.affiliation: Eli Lilly and Company.
authors.forename: Luann E
authors.initials: LE
authors.lastname: Van Campen
authors.affiliation: Eli Lilly and Company.
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Allen
authors.affiliation: Eli Lilly and Company.
authors.forename: Susan B
authors.initials: SB
authors.lastname: Watson
authors.affiliation: Eli Lilly and Company (Retired).
authors.forename: Donald G
authors.initials: DG
authors.lastname: Therasse
keywords: descriptive research; ethics consultation; pharmaceutical bioethics; research ethics; survey research