Guidelines and codes of best practice and statutes and regulations

Warning: The NCBI web site requires JavaScript to function. more...

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.

Show details

Contents

< Prev Next >

Annex 1Guidelines and codes of best practice and statutes and regulations

Guidelines and codes of best practice

1.: Nuremberg Code. [17 January 2009]. Available at: http://ohsr.od.nih.gov/guidelines/nuremberg.html.
2.: Declaration of Helsinki. [05 October 2011]. Available at http://www.wma.net/en/30publications/10policies/b3/index.html.
3.: CIOMS. International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002. [05 October 2011]. Available at http://www.cioms.ch/publications/layout_guide2002.pdf.
4.: CIOMS. International Ethical Guidelines for Epidemiological Research Involving Human Subjects. 2009. (For more information click http://www.cioms.ch/frame_ethical_guidelines_2009.htm)
5.: UNAIDS/WHO. Ethical Considerations in Biomedical HIV Prevention Trials. 2007. [05 October 2011]. Available at http://data.unaids.org/pub/Report/2007/JC1399_ethical_considerations_en.pdf.
6.: UNESCO. Universal Declaration on Bioethics and Human Rights. 2005. Available at http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html.
7.: Nuffield Council on Bioethics: the Ethics of Research related to Healthcare in Developing Countries. 2002. (Available at http://www.nuffieldbioethics.org/sites/default/files/Ethics%20of%20research%20related%20to%20healthcare%20in%20developing%20countries%20I.pdf)

Statutes and regulations

1.: The Universal Declaration of Human Rights. [05 October 2011]. Available at http://www.un.org/en/documents/udhr/
2.: ICH Good Clinical Practice Guidelines. 1996. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_Rl/Step4/E6_Rl_Guideline.pdf.
3.: ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials. 2000. [05 October 2011]. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_Guideline.pdf.
4.: Council of Europe. Convention on Human Rights and Biomedicine. 1997. [05 October 2011]. Available at http://conventions.coe.int/treaty/EN/Treaties/Html/164.htm.
5.: Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. 2005. [05 October 2011]. Available at http://conventions.coe.int/treaty/EN/Treaties/Html/195.htm.
6.: Directive of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities. 2001 [05 October 2011]; L121/34. (Available at http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf. [PubMed: 16276663]
7.: The Common Rule (45 CFR Part 46). [05 October 2011]. Available at http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.
8.: United States Food and Drug Administration regulations for the protection of humansubjectsCFR—CodeofFederalRegulations Title21, Part50. [15 August 2011]. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50.

All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob).

Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html).

Bookshelf ID: NBK310664

Contents

< Prev Next >

PubReader
Print View
Cite this Page
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011. Annex 1, Guidelines and codes of best practice and statutes and regulations.
PDF version of this title (1.2M)

Other titles in this collection

WHO Guidelines Approved by the Guidelines Review Committee

Related information

PubMed
Links to PubMed

Recent Activity

Clear Turn Off Turn On

Guidelines and codes of best practice and statutes and regulations - Standards a...
Guidelines and codes of best practice and statutes and regulations - Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
Standards and guidance for entities that establish research ethics committees - ...
Standards and guidance for entities that establish research ethics committees - Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
Standards and guidance for researchers - Standards and Operational Guidance for ...
Standards and guidance for researchers - Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

Bookshelf