Table 1 Key characteristics of guideline and policy sample
From: The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines
Guideline/Policy | Date | Adopted | Abbreviation | Status | Intended Users | Guiding Ethical Framework/Principles |
|---|---|---|---|---|---|---|
Declaration of Helsinki | 2013 | Intl | Declaration of Helsinki | A statement of ethical principles proposing how physicians should act in research; not legally binding | Primarily physicians; others involved in medical research with human subjects are encouraged to adopt its principles | Articles of the Declaration itself are intended as guiding ethical principles for research |
Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects | 2002 | Intl | CIOMS | A guidance document intended to guide the effective application of the Declaration of Helsinki’s ethical principles in research, especially in low-resource countries; not legally binding | CIOMS member bodies, which include international and national biomedical organisations (e.g. World Medical Association) | Cites three guiding ethical principles: respect for persons, beneficence, and justice |
UNESCO Universal Declaration on Bioethics and Human Rights | 2005 | Intl | UNESCO Declaration | A universal framework of principles to guide States in formulating legislation and policies, as well as to guide the actions of individuals, groups, communities, institutions and corporations, public and private | Addressed to States, but also provides guidance for individuals, groups, communities and corporations, public and private | Articles of the UNESCO Declaration itself are intended as guiding bioethical principles |
Directive of 4 April 2001 N°2001/20/EC | 2001 | EU | EU Clinical Trials Directive | A legislative act that establishes specific provisions for good clinical practice in clinical trials; EU Member States must meet these provisions though the Directive does not legislate how | EU member states | Not explicitly provided; states that “[t]he accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being… as for instance reflected in the 1996 version of the Helsinki Declaration” [20] |
Regulation of 16 April 2014 N°536/2014 | 2014 | EU | EU Clinical Trials Regulation | A binding legislative act applying to all clinical trials conducted in the EU | EU member states | Not explicitly provided |
International Conference on Harmonisation, Good Clinical Practice | 1996 | US, EU, JP, AUS, CA | ICH GCP | An ethical and scientific quality standard for designing, conducting, recording, and reporting human subject research trials; serves as a unified standard for CA, the EU, JPN, and US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions | Targeted at those involved in the generation of clinical trial data intended to be submitted to regulatory authorities, especially in CA, the EU, JPN, and US; can also be used by others involved in clinical investigations “that may have an impact of the safety and well-being of human subjects” [22] | Not explicitly provided; states that “clinical trials should be conducted in according with the ethical principles that have their origin in the Declaration of Helsinki” ([22], Art. 2.1) |
National Statement on Ethical Conduct in Human Research | 2007 | AUS | Australian National Statement | Must be used to inform the design, ethical review, and conduct of human research funded by or taking place under the auspices of the bodies that have developed the Statement (i.e. National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors’ Committee) | Researchers, members of ethical review bodies, and those involved in research governance, as well as potential research participants | Describes four guiding values and principles: research merit and integrity, justice, beneficence, and respect |
Tri-Council Policy Statement, 2nd edition | 2014 | CA | TCPS2 | To be eligible to receive and administer research funds from the federal research agencies responsible for this policy (i.e. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council), institutions must agree to comply with it; while not required to do so, other organisations and entities are encouraged to adopt this Policy to guide the ethical aspects of the design, review and conduct of research involving humans | All those involved in the conduct and review of research funded by the federal research agencies, e.g. institutions, researchers, ethics review boards, etc. | Sets out three core principles: respect for persons, concern for welfare, and justice |
Research Governance Framework for Health and Social Care, 2nd edition | 2005 | UK | UK Research Governance Framework | Sets out a framework of principles, requirements, and standards for the governance of research in health and social care and applies to all research relating to the responsibilities of the Secretary of State for Health | Intended for all those who design research studies, participate in research, host research in their organisation, fund research proposals or infrastructure, manage research, and undertake research | Not explicitly provided |
The Belmont Report | 1979 | US | Belmont Report | A statement of basic ethical principles and guidelines intended to assist in resolving the ethical problems that surround the conduct of research created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research for the Department of Health, Education, and Welfare | Those involved in the review and conduct of research | Lays out three basic ethical principles: respect for persons, beneficence, and justice |
Title 45 Code of Federal Regulations, Part 46 | 1991 | US | Common Rule | Serves as a federal policy for human subjects research, and applies to all research conducted or supported by or affiliated with the federal agencies by which is has been adopted | Those involved in the review and conduct of research associated with the federal agencies by which the Common Rule has been adopted | Not explicitly provided, but the Regulations were created on the basis of the Belmont Report |