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Titolo:
Ethical research issues: Going beyond the declaration of Helsinki
Autore:
Striefel, S;
Indirizzi:
Utah State Univ, Logan, UT 84322 USA Utah State Univ Logan UT USA 84322Utah State Univ, Logan, UT 84322 USA
Titolo Testata:
APPLIED PSYCHOPHYSIOLOGY AND BIOFEEDBACK
fascicolo: 1, volume: 26, anno: 2001,
pagine: 39 - 59
SICI:
1090-0586(200103)26:1<39:ERIGBT>2.0.ZU;2-F
Fonte:
ISI
Lingua:
ENG
Soggetto:
CLINICAL-TRIALS;
Keywords:
declaration of Helsinki; the Belmont Report; placebo treatment controls; ethical principles; ethic; risks and benefits; human subject research;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Social & Behavioral Sciences
Citazioni:
32
Recensione:
Indirizzi per estratti:
Indirizzo: Striefel, S 1564 E 1260 N, Logan, UT 84341 USA 1564 E 1260 N Logan UT USA84341 1260 N, Logan, UT 84341 USA
Citazione:
S. Striefel, "Ethical research issues: Going beyond the declaration of Helsinki", APPL PSY BI, 26(1), 2001, pp. 39-59

Abstract

La Vaque and Rossiter made a strong, supported argument that it is unethical to use a "no treatment" control group in a research study ifa known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in thispaper: The World Medical Association developed the Declaration of Helsinkias one of their official policies. The Declaration of Helsinki, however isnot accepted as the world ethical standard, as demonstrated by its lack ofadoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter: Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vague and Rossiter paper The Belmont Report is the basis for the ethical protection of human research subjects for atleast 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. Ar least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vague and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 06/04/20 alle ore 08:40:50