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. In most countries, DA campaigns fall outside of the laws and regulations that apply to promotion of medicines. Currently, guidance for industry is limited and only exists at national level. This article provides an overview of existing guidance on DA campaigns, discusses benefits and risks, and proposes recommendations for industry-sponsored vaccination awareness campaigns.

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. MAIN TEXT: Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context "specification" substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity. CONCLUSION: Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society.

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. The model uniquely supports practical prospective decision-making: employees are engaged as moral agents applying values and principles to guide their decision in a specific situation. We illustrate, by way of case studies, how the model is being used in practice. The consistent application of company values during decision-making calls upon employees to use their judgment, therefore reducing the need for the organization to systematically generate written instructions. Finally, we report on preliminary results of model adoption by teams within our organization, discuss its limitations and likely future contribution. We applied our model within a vaccines R&D context and believe its use can be extended to other areas where business-related decisions impact patients.

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. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

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. The Voice of the Patient ("VoP"), begun in 2014, is an educational programme directed at the 16,000 employees of a global vaccine company. It engages employees through an understanding that they are all "vaccine patients", and that they can make a difference by considering the impact of decisions made in their day to day work. The initiative includes presentations about vaccine-preventable diseases, global live webcasts with experts and patients, employee visits to healthcare facilities in developing countries, and the production of patient-focused sections in research publications. In a 2017 employee survey, 90% of respondents said they know how their daily work impacts patients and they demonstrate focus on patients. We believe this is preliminary evidence that, by supporting employee awareness of the impact of their individual roles, VoP could be a model for a type of initiative that will contribute to industry's continuing evolution towards more patient-centred healthcare.

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. Investigators and researchers (n = 1,273) who had authored at least one publication reporting on GSK Vaccines-sponsored human research since 2007, were invited to participate. Responses to 37 closed questions are presented. The remaining 13 questions were open-ended or did not concern publication practices. RESULTS: A total of 415 external authors (32.6%) responded. International Committee of Medical Journal Editors (ICMJE) authorship criteria were clear to most respondents (78.1%); 7.7% found they were unclear. The majority of participants (86.8%) found GSK Vaccines' authorship questionnaire a suitable tool to assess eligibility for authorship as per the ICMJE criteria. However, only 68.5% felt that the outcome of the questionnaire is communicated appropriately and 58.3% felt well informed on changes in authorship. Nearly two-thirds (62.9%) of respondents felt that having a pharmaceutical company employee as lead author makes manuscript acceptance less likely. Access to relevant data was regarded as sufficient by 78.5% of respondents. Briefing meetings before publication start, publication steering committees and core writing teams were recognized as valuable publication practices. Professional medical writing support was seen as adding value to publication development by 87.7% of participants. Most respondents agreed that manuscript discussions should start early, with 81.7% stating that they were in favor of introducing a formalized 'author agreement' at the publication start. CONCLUSIONS: GSK Vaccines made changes to its publication practices to ensure improved transparency and better involvement of external authors. The results of this survey suggest that these changes have been effective to a large extent. They confirm the need for effective and timely communication, as well as transparent processes for authorship and decision-making during publication development. The identified gaps in GPP will help to guide further improvements to the company's policies on publication practices.