Overview of Normative Frameworks Applicable to Health Research Involving Humans
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The regulation of research involving humans has evolved over the past century. Within the last half century, it has taken the form of rules, guidelines and even state regulations. There is no single instrument that applies to all research involving humans worldwide. However, there are various instruments — some more and some less specific to research — that establish safeguards to oversee the conduct of research involving humans. This section will focus on instruments that are relevant to biomedical or health research.
2. International Instruments
1. World Medical Association (WMA), Declaration of Helsinki
The WMA was founded in 1947. It showed concern over the state of medical ethics in general and took up the responsibility for setting ethical guidelines for the world’s doctors. The WMA hoped that developing guidelines ‘would help to impress on newly qualified doctors the fundamental ethics of medicine and would assist in raising the general standards of professional conduct.’
One of the early guidelines developed by the WMA is the Declaration of Helsinki, which provides recommendations to guide doctors from all over the world in biomedical research involving human participants. The original 1964 text of the Declaration of Helsinki has been revised several times over the years. It has had ‘great impact on human experimentation and has served as a starter for establishing ethical committees in various countries to scrutinise research projects on human beings’.
It is referenced in many other international and national documents that address biomedical and other types of research. As such, the Declaration of Helsinki sets the core values that guide biomedical research.
2. World Health Organisation (WHO)
The WHO is involved in many ways in supporting improved ethical standards and review processes for research with human participants. Guidance documents in this field have been developed directly by the WHO and cooperatively with other groups, particularly the Council for International Organisations of Medical Sciences (CIOMS).
Significant documents for researchers and RECs include:
- Operational Guidelines For Ethics Committees That Review Biomedical Research (2000).
- International Clinical Trials Registry Platform (ICTRP).
The CIOMS is an international, non-governmental, non-profit organisation. It was established jointly by the WHO and the United Nations Educational, Scientific and Cultural Organisation (UNESCO) in 1949. It represents the biomedical scientific community, for example Medical Research Councils.
The CIOMS has issued international guidelines, particularly used in low-resource countries, for the application of ethical principles in various key areas, including:
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002).
- International Ethical Guidelines for Epidemiological Studies (2009).
4. International Conference on Harmonisation - Good Clinical Practice guidelines (ICH-GCP)
Clinical trials should be carried out according to the GCP guidelines developed by the ICH. Regulatory authorities in a number of countries require adherence to these guidelines. Thus, any country that adopts the ICH-GCP guideline technically follows the same standards when conducting clinical trials. The ICH-GCP is relevant for ethics since they refer to the principles of the Declaration of Helsinki and include guidance on various ethics-related processes and procedures. This includes ethics evaluation, investigator qualification, consent and confidentiality.
In addition to the texts described above, there are a number of other international instruments relevant to research involving humans that are broader in scope.
For example, UNESCO has adopted several declarations, including:
- Universal Declaration on Bioethics and Human Rights.
- Universal Declaration on the Human Genome and Human Rights.
In the EU, the key standards are set by commission directive 2001/20/EC (the so called ‘Clinical Trials Directive’) which has been replaced in June 2014 by the new Clinical Trials Regulation 536/2014, effective in 2016.
All of these documents should be considered within the broad framework of human rights protections in research.
3. National Instruments
Regulations or guidelines specific to research involving humans
In most countries, there are regulations or guidelines that apply to any type of research involving humans. Typically, such regulations or guidelines will cover requirements for:
- Ethics review and positive opinion before the research starts.
- Appropriate risk to potential benefit assessments.
- Respect for autonomy - through consent and protection of confidentiality.
In many countries, however, there are no research specific regulations or guidelines. This does not in any way mean that there is a gap in legal requirements. Indeed, broader based legal frameworks will provide guidance and minimal standards that must be met. Some examples are:
- In many countries with a civil code or a constitution, there will be broader provisions protecting individuals’ physical integrity as well as requiring respect for autonomy.
- There may be provisions that require consent to treatment or regulations around privacy.
- Criminal law prohibitions could be invoked in the absence of other more specific provisions.
- When researchers are also healthcare professionals (such as doctors, nurses, etc.) professional codes of conduct must be respected.
4. Institutional Requirements
Institutions where biomedical research is conducted (for example, hospitals, research institutions and universities) also bear responsibility for the ethical conduct of research involving humans. When researchers conduct their research abroad in other countries, their home institution maintains responsibility.
Governmental agencies that fund research, as well as many private and not-for-profit organisations, will often adopt research ethics guidelines that must be respected as a condition for funding. Well known examples, of such guidelines include:
- US National Institutes of Health (NIH): NIH Grants Policy Statement.
- UK Wellcome Trust: Research involving people living in developing countries: Position statement and guidance notes for applicants.
- EDCTP: EDCTP Guidelines on Ethics.