Informed Consent Regulations Today

Today in the United States, informed consent in experimental research is governed by the 1991 Federal Policy for the Protection of Human Subjects, otherwise known as the ``Common Rule''. Almost all of the departments and agencies in the United States government that take part in human research have adopted this policy. The policy requires that research institutions are compliant with regulation, that informed consent be obtained and documented under specific guidelines, and includes general administrative requirements such as documentation and record-keeping, membership to the Institutional Review Board, and specific additional protection for vulnerable subjects such as pregnant women, children, and prisoners. The Food and Drug Administration imposes further restrictions on research through various regulations that govern research involving test articles such as drugs, additives, electronic products, etc. It is interesting that there is little background philosophy as to why informed consent is needed in these policies, especially since they are laid out as a set of compliance rules and do not allow people to gain an appreciation of the reasons (and therefore spirit) underlying the requirements. The Belmont Report continues to provide this function to a large degree, although it is not up to date with current practices, such as those used in Europe and Australia (and which are discussed next).

European regulation on informed consent derives mainly from a 1997 treatise, the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, that builds on the Universal Declaration of Human Rights of 1948 and other subsequent documents such as the European Social Charter of 1961. It provides rules for obtaining informed consent for medical interventions and protection for minors, those unable to consent, and emergency situations, as well as ``previously expressed wishes'' of the subject. It makes particular reference to information privacy, and has specific clauses for genetic information, scientific research, and organ transplantation [Council of Europe, 1997]. European countries also have specific local laws, such as in France, where laws on patient rights and health care have built on a traditional understanding for the need for informed consent based on the philosophy of noli me tangere (do not touch) [Moumjid & Callu, 2003]. The European Union's Charter of Fundamental Rights of 2003 formalises this in the third article, where the ``right to the integrity of the person'' specifically mentions the right to respect for a person's physical and mental integrity, and in particular that gaining informed consent is the mechanism for fulfilling this requirement [European Union, 2000].

In Australia, the National Statement on Ethical Conduct in Human Research functions much like the European Charter in providing an ethical background and philosophy for carrying out research^1.1. It, too, identifies particular values, such as research merit and integrity, justice, beneficence, and respect. It specifically states in the guidelines that they ``are not simply a set of rules'' and that ``their application should not be mechanical'' (p. 13). There is an entire section devoted to outlining the procedures for informed consent for both the research involved and data collection for that research. It acknowledges that there is no one specific set of rules that ought to be followed, but that satisfying the conditions for the ``requirement for consent [...] depends on the nature of the project, and may be affected by the requirements of the codes, laws, ethics and cultural sensitivities of the community in which the research is to be conducted'' (p. 19). It also states specifically that gaining consent is a necessary but not always sufficient justification for the participation of a subject in research. There could be a few different reasons for this, one being due to concerns over choosing appropriate subjects, as candidates may well be unsuitable for the research despite having given consent: for example, they could be elderly with an unknown (to them) mental illness. Another reason could be that the project itself is ethically problematic for reasons independent of subject consent. Governance is based on relevant state/territory and federal law regarding rights for participants as well as responsibilities for researchers and institutions, consistent with international human rights legislation. It also requires monitoring from the research institution through to appropriate national research bodies [National Health and Medical Research Council et al., 2007].

The European and Australian approaches form an interesting contrast to the US regulation in which it is encouraged for practitioners interested in informed consent requirements to look initially to the legal system to provide the framework. In the US framework, informed consent is defined without any mention of the principles involved, rather than outlining the principles at stake and then encouraging researchers to develop their own approach keeping in mind fundamental legislation of international human rights law. In fact, apart from the Belmont Report, which was a response to a specific set of incidents, the US doesn't even have a broader ethical ``statement'' much like European or Australian law, relying instead on individual research groups to develop their own statements of philosophy to fit in with the law.

These differences between developed countries show the potential difficulties in an international effort to establishing regulatory guidelines and law in informed consent in other areas because of the differences in approach to the existing regulations for informed consent between countries. International efforts in information technology require not only alignment or recognition of international laws, but education and recognition of social customs and behaviour of other cultures. Cultural differences lead to different conceptions of values, such as privacy, so it is particularly hard to try to standardise in an environment like the Internet, which is an international platform that transcends physical boundaries.