References Edit

U. S. National Institutes of Health - "Declaration of Helsinki", Human Participant Protections Education for Research Teams Shamoo, Adil E. and Irving, Dianne N. "Accountability in Research." 1993 in press - Public Responsibility in Medicine and Research, Boston, Oct. 21 - 22, 1993 Brennan, TA. "Proposed Revisions to the Declaration of Helsinki — Will They Weaken the Ethical Principles Underlying Human Research?" N Engl J Med. 1999 Dec 9;341(24):1852-3. Merson MH. "Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World." N Engl J Med. 1997 Sep 18;337(12):853-6.

Future

The controversies and national divisions over the text have continued. The US FDA rejected the 2000 and subsequent revisions, only recognizing the third (1989) revision (Wolinsky 2006), and in 2006 announced it would eliminate all reference to the Declaration. The European Commission refers to the fourth (1996) revision. The next round of revisions will be considered at the Seoul meeting in October 2008, following a consultation for submissions, closing in August 2007. [22]

While the Declaration has been a central document guiding research practice, its future has been called into question. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents. Another is whether it should concentrate on basic principles as opposed to being more prescriptive, and hence controversial. It has continually grown and faced more frequent revisions (Carlson 2004). The recent controversies undermine the authority of the document, as does the apparent desertion by major bodies, and any rewording must embrace deeply and widely held values, since continual shifts in the text do not imply authority.

Carlson raises the question as to whether the document's utility should be more formally evaluated, rather than just relying on tradition.

Principles

Basic principles

The fundamental principle is respect for the individual (Article 8), their right to self determination and the right to make informed decisions (informed consent ) (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9).

The recognition of the increased vulnerability of individuals and groups calls for special vigilance (Article 8). It is recognised that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor (Articles 23, 24), then allowance should be considered for surrogate consent by an individual acting in the subject's best interest. In which case their assent should still be obtained if it all possible (Article 25).

Operational principles

Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ethical review and oversight by a properly convened committee (Article 13). The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Information regarding the study should be publicly available (Article 16). Ethical publications extend to publication of the results and consideration of any potential conflict of interest(Article 27). Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilised (Article 29). The interests of the subject after the study is completed should be part of the the overall ethical assessment, including assuring their access to the best proven care (Article 30). Wherever possible unproven methods should be tested in the context of research where there is reasonable belief of possible benefit (Article 32).

Additional guidelines or regulations

Investigators often find themselves in the position of having to follow several different codes or guidelines, and are therefore required to understand the differences between them. One of these is Good Clinical Practice (GCP), an international guide, while each country may also have local regulations such as the Common Rule in the US, in addition to the requirements of the FDA and Office for Human Research Protections (OHRP) in that country. There are a number of available tools which compare these. [21] Other countries have guides with similar roles, such as the Tri-council Policy Statement in Canada.

Declaration of Helsinki

For the political accords, see Helsinki Accords.

There is also another Declaration of Helsinki, dealing with the Information Society. [1]