Recommendations for the ethical conduct of vaccination awareness campaigns by biopharmaceutical companies.

Health awareness campaigns educate and inform the public about particular health conditions with the aim of either changing behavior or enhancing uptake of appropriate healthcare, such as vaccination or screening. The campaigns may be run by governments and public health bodies but are also deployed by biopharmaceutical companies. Industry-sponsored disease awareness (DA) campaigns intend to provide information about diseases and their prevention or treatment, without mentioning specific products.

Considerations for applying bioethics norms to a biopharmaceutical industry setting.

Background: The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.

Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model.

"Values-based decision-making" frameworks and models are widely described in the literature in various disciplines, including healthcare settings. However, there is a paucity of literature on the application of systematic methods or models in the biopharmaceutical research and development (R&D) field of drugs, vaccines, and immunotherapeutics. In this report, we describe our model that uses company values along with framing questions in a five-step process to guide ethical decisions in the vaccines R&D context.

Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial.

Outside in - inside out. Creating focus on the patient - a vaccine company perspective.

Involving patients in the development of medicines and vaccines should result in benefits to patients. The vaccine recipient is usually a healthy person. We describe the rationale and implementation of a vaccine company's initiative to encourage employees to identify with patients of the conditions prevented by the vaccines they help to produce.

Publication practices and standards: recommendations from GSK Vaccines' author survey.

Background: Evolving standards of good publication practice (GPP) and a survey conducted in 2009 of authors, who were investigators and researchers not employed by the company prompted changes to GSK Vaccines' publication practices. We conducted a follow-up survey in 2012 to assess the company's revised practices and to evaluate understanding of GPP among investigators and researchers who had previously authored at least one publication in collaboration with GSK Vaccines.

Methods: The 50-question web-based survey addressed authoring practices and transparency of decision-making.