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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


15.2. Scientific integrity and ethical conduct


Principles of scientific integrity and ethical conduct are paramount in any medical research. The Declaration of Helsinki (2013) provides ethical principles addressed primarily to physicians participating in medical research involving human subjects, including research on identifiable human material and data and is the main document on human research ethics. The ENCePP Code of Conduct (Revision 4, 2018) offers standards for scientific independence and transparency of research in pharmacoepidemiology and pharmacovigilance and promotes best practice for the interactions between investigators and study funders in critical areas such as planning, conduct and reporting of studies. As a core transparency measure, it recommends that the protocols of all pharmacoepidemiology and pharmacovigilance studies should be registered in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register), ideally before they start. The Code also recommends that study findings should be published irrespective of positive or negative results.


Guided by three core values (best science, strengthening public health and transparency), the ADVANCE Code of Conduct for Collaborative Vaccine Studies (Vaccine 2017;35(15):1844-55) includes  recommendations about 10 topics: Scientific integrity, Scientific independence, Transparency, Conflicts of interest, Study protocol, Study report, Publication, Subject privacy, Sharing of study data, Research contract, and be used for research on any type of medicinal product. Each topic includes a definition, a set of recommendations and a list of additional reading. The concept of the study team is introduced as a key component of the ADVANCE Code of Conduct with a core set of roles and responsibilities. It also provides direct access to a comprehensive list of relevant guidelines.


The Good Pharmacoepidemiology Practices (GPP) (2015) of the International Society for Pharmacoepidemiology (ISPE) proposes practices and procedures that should be considered to help ensure the quality and integrity of pharmacoepidemiological research, including detailed guidance for protocol development, roles and responsibilities, study conduct, communication, reporting of adverse events and archiving. The Good Epidemiology Practice (GEP) (2007) of the International Epidemiological Association addresses four general ethical principles for research (Autonomy, Beneficence, Non-maleficence and Justice) and proposes rules for good research behaviour in relation to working with personal data, data documentation, publication, the exercise of judgment and scientific misconduct.


The CIOMS International Ethical Guidelines for Health-related Research Involving Humans (Geneva: 2016) provides detailed commentary on how universal ethical principles should be applied, with particular attention to conducting research in low-resource settings. It includes 25 guidelines addressing different topics, settings and population groups concerned by health-related research.

The Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals (2021) by the International Committee of Medical Journal Editors (ICJME) include clear statements on ethical principles related to publication in biomedical journals. Authorship and contributorship, editorship, peer review, conflicts of interest, privacy and confidentiality and protection of human subjects and animals in research are addressed.


The Agency for Healthcare Research and Quality (AHRQ) published Registries to Evaluate Patient Outcomes: a User’s guide, 4th Edition, 2020, which is a reference for establishing, maintaining and evaluating the success of registries created to collect data about patient outcomes. Section II: ‘Legal and Ethical Considerations for Registries’ is a specific chapter dedicated to ethics, data ownership, and privacy. The concepts within are focused on US law.

More specifically on data used for the purpose of pharmacoepidemiology and pharmacovigilance studies, the HMA-EMA Joint Big Data Taskforce Phase II report: ‘Evolving Data-Driven Regulation’ (2019) acknowledges (in section 5.7) that data sharing and secondary use of data for research raise ethical issues which require identification, examination and guidance. The report uses Floridi and Taddeo’s definition of data ethics: a new branch of ethics which “studies and evaluates moral problems related to data (including generation, recording, curation, processing, dissemination, sharing, and use), algorithms (including artificial intelligence, artificial agents, machine learning, and robots), and corresponding practices (including responsible innovation, programming, hacking, and professional codes), in order to formulate and support morally good solutions (e.g. right conducts or right values)”. The Task Force report provides a set of recommendations for secure and ethical use of data ensuring that personal data are protected and that ethical challenges are addressed.


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