Ethics

The International Governance and Ethics Committee — IGEC — has a major responsibility to expedite the appropriate ethical review of all research proposals involving iPRI.

All studies iPRI is performing are based on scientific excellence and undergo strict ethical review. The ethical review is performed by IGEC and IRB.

The iPRI International Governance and Ethics Committee has a statutory face-to-face meeting each July and can also meet electronically (through medium such as skype) whenever need arises.

External Guidelines

The IGEC follows all established international ethics recommendations including:

• International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS 2002
• International Ethical Guidelines for Epidemiological Studies, CIOMS 2009
• Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Council of Europe 1997
• Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
• The Nuremberg Code, 1949
• UNESCO Universal Declaration on the Human Genome and Human Rights, 1997
• UNESCO International Declaration on Human Genetic Data, 2003
• World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, 1964 in its last version from 2008
• UNESCO Universal Declaration on Bioethics and Human Rights, 2005

All scientific findings are sent for publication in peer-reviewed journals. Specific provisions are made for avoiding any role of public and private sponsors in reporting of scientific findings.

iPRI recognizes the following documents as additional guidelines:

• European Commission Recommendation of 11 March 2005 on the European Charter for Researchers and on a Code of Conduct for the Recruitment of Researchers
• Council of Science Editors’ White Paper on Promoting Integrity in Scientific Journal Publications
• International Committee of Medical Journal Editors’ Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, February 2006
• the ENCePP Code of Conduct, for scientific independence and transparency in the conduct of pharmacoepidemiological and pharmacovigilance studies, May 2010
• the Moose Statement, April 2000
• the Prisma Statement, July 2009 

Declaration of Helsinki

The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. These articles are of particular relevance to iPRI studies:

(1) The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

(6) The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

(16) Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

(21) Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

(24) Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

(26) In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.

(27) Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available.