Estrategias de aprovechamiento de la madera

In the United States of America, the role of ethics committees is seen as a more statutory and legalistic construct compared to the directive and statement based committees of the United Kingdom and Australia. This is primarily due to the fact that much of the ethics legislation in the United States has its basis of requirement in statutory law, as opposed to the suggestions and recommendations of both United Kingdom and Australian law.

While there are examples in the United States of informed consent and ethical discussions on research prior to the Belmont report, it is this report that is seen as the stepping stone to regulations [227, 282].

The basis from which the ethical regulations in the United States are derived is the Belmont Report. This report – published in 1979, and prompted by the Tuskegee Syphilis Study as well as others, was the fulfilment of the second mandate of the 1974 Public Law 93-348, which established a National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research [227]. This mandate asked the Commission to

distinguish between medical research and practice and to develop the basic ethical principles to govern research with human subjects. The Belmont Report distinguishes between three basic ethical principles – Respect for Persons, Beneficence and Justice. These three

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principles are the basis on which most American research ethics is based. The Belmont Report also looked at how these principles could be applied to general research and what sort of consideration should be given to items such as informed consent, risk/benefit assessment and the selection of subjects for research.

The Belmont Report led to federal regulations regarding the Protection of Human Subjects of Research, which is formally known as ―Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46).‖[228].

These regulations were published in the Federal Register in 1991 and are the official policies concerning research on humans in the United States[283].The US Federal regulations are divided in parts. Sub-part A is the basic Human Health Services (HHS) policy for protection of human research subjects. This is the area which outlines to whom the regulations apply, what they apply to and how they need to be applied [283].

The regulations can be perceived to apply to all research that is funded wholly or in part by the Department of Health and Human Services (DHHS), and anything the DHHS itself may undertake in the research arena at a Federal level. It encompasses all research, which involves human research subjects. There are, however, exceptions. The exception is non- invasive viewing of normative practices in educational settings, educational testing, publicly available data and non-identifiable surveys, interviews and observations. This can be summed up as meaning that investigations undertaken to improve government agencies or programs are not considered to be research on human subjects even if interviews or interactions with human subjects occurs. The final exception is DHHS research – which in the opening paragraph of subsection A specifically includes: (emphasis added).

―Except as provided in paragraph (b) of this section, this subpart applies to all research involving human subjects conducted by the Department of Health and Human Services or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship.‖

Paragraph (b) part 6, stated that

―Unless specifically required by statute (and except to the extent specified in paragraph (i), research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluated or otherwise examine: (i) programs under

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the Social security Act, or other public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.‖

This statement appears to preclude most DHHS research from undergoing ethical

consideration if taken literally. It is interesting to note that within this there is provision for vulnerable populations to be covered by a certificate of confidentiality. This certificate protects vulnerable participants in studies by preventing compelled disclosure of identifying information [284].

Separate to this Federal Regulation, but related, are Institutional Review Boards. These were established by National Institute of Health (NIH) policies in 1966 and 1977. They were included in the considerations by the committee which produced the Belmont Report. This same committee also made recommendations for the improvement of the process of ethical review. Institutional Review Board review is legally required for any research which is conducted with Federal Funds [285]. However McNeill [30] does note that Curran mentioned ―the American System is far, far more elaborate, far more sophisticated, much more detailed than any other system around the world‖.

The process of applying for ethical approval for research in the United States is similar in many ways to both the United Kingdom and Australia, however as with these countries, while the law/regulations may guide the researcher, the implementation between and within states and counties, and even between different institutions is varied. This is particularly true with non-funded research. As the law stands, in all three countries if the researcher can fund his or her own research, and if it takes place at a non-academic institution, they are not legally obligated to present to an ethics committee.