-Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants -> https://www.ncbi.nlm.nih.gov/books/NBK310666/pdf/Bookshelf_NBK310666.pdf
´´In November 2016, the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization published the fourth revision of its ethical guidelines. The International Ethical Guidelines for Health-related Research Involving Humans (1) are the culmination of a four-year process.´´
´´In October 2013, a year after the CIOMS revisions commenced, the Declaration of Helsinki (DoH), another influential international ethics guidance, published its seventh revision (2). Since then, three important regulatory regimes have been under revision: the Common Rule of 1991 (applicable in the United States of America), was revised after 25 years and this revision published in January 2017 (CR 2017) (3); the European Union Directive 2001/20/EC (4), or Clinical Trials Directive (EU-CTD) was repealed by the European Parliament and replaced with the Clinical Trial Regulation (536/2014) (EU-CTR) (5) in April 2014, and will be implemented from 2019; and the Good Clinical Practice (GCP) (6) guidelines of the International Conference of Harmonization (ICH) are under revision.´´
´´Structurally, CIOMS 2016 maintains its format with each guideline supported by a substantive comment to develop and anchor ethics reasoning in various situations. Making available the bibliography used and the literature reviews undertaken towards the current revisions would be useful as a “ready reference” for the global peer community.´´
´´In closing, it is noteworthy that a number of countries draw on international ethics guidance such as CIOMS and DoH despite their known limitations. One reason seems to be the lack of resources to develop guidance documents sensitive to the local context. However, a few ethics codes developed locally by ethnic groups, such as the code developed by the San people of South Africa (15), question the dominance of international guidance.´´
´´Conflict of interest: Some members of the Working Group, CIOMS revisions are known to SVSB in various work-related associations.´´
´´1. Council of International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research involving Humans. Geneva: CIOMS; 2016 [cited 2017 June 21]. Available from: http://cioms.ch/ethical-guidelines-2016/WEB-CIOMS-EthicalGuidelines.pdf
2. World Medical Association Declaration of Helsinki – Ethical principles for medical research involving human subjects. WMA General Assembly, Fortaleza,
Brazil; October 2013. World Med J. 2013 Oct;59(5):199–202
3. Federal Policy for the Protection of Human Subjects. Federal Register. 2017 January 19;82 (12):7149-7274.
4. European Parliament, Council of the European Union. Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union. 2014 May 27;L158:1-76.
5. European Parliament and Council of the European Union. Directive 2001/20/EC 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 Union. 2001;L121:34-4.
6. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2) [cited 2017 June 20]. Available from: http://www.ich.org/products/
7. Friesen P., Kearns L., Redman B. & Caplan AL. Rethinking the Belmont Report? The American Journal of Bioethics. 2017;17(7):15-21, DOI:10.1080/1526516
8. Ehni H-J, Wiesing U. Research ethics for a globalised world: the revised CIOMS international guidelines. Indian J Med Ethics. 2017 Jul-Sep; 2(3) NS:165-8.
Epub 2017 Mar 7.
9. Schuklenk U.Revised CIOMS research ethics guidance: on the importance of process for credibility. Indian J Med Ethics. 2017 Jul-Sep;2(3) NS:169-72. Epub
2017 Mar 7.
10. Ho CWL. CIOMS Guidelines remain conservative on vulnerability and social justice. Indian J Med Ethics. 2017 Jul-Sep;2(3) NS:175-9. Epub 2017 Jun 20.
11. Macklin R. Schuklenk’s critique of the CIOMS guidelines: All procedure, no substance. Indian J Med Ethics. 2017 Jul-Sep;2(3) NS:173-5. Epub 2017 Mar 29.
12. Ravinetto R. The revision of the ICH Good Clinical Practice guidelines: a missed opportunity? Indian J Med Ethics. Published on May 23, 2017. Available from: http://ijme.in/wp-content/uploads/2017/05/20170523_the_revision.pdf Accessed on June 27, 2017.
13. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human
Subjects. Geneva: CIOMS 2002 [cited June 1, 2017]. Available from: https://cioms.ch/wp-content/uploads/2016/08/International_Ethical_Guidelines_ for_Biomedical_Research_Involving_Human_Subjects.pdf
14. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Epidemiological Studies. Geneva: CIOMS, 2009.
[cited June 1, 2017]. Available from: https://cioms.ch/wp-content/uploads/2017/01/International_Ethical_Guidelines_LR.pdf
15. Callaway E. San people issue research code. Nature. 2017 March 23; 543: 475-6.´´
-Council For International Organizations Of Medical Sciences
-APPENDIX 1. Ethical guidelines for epidemiological investigations
–Ethics in epidemiological research – A ética na pesquisa epidemiológica http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1413-81232008000200020
-New guidelines on ethical treatment of humans in health-related research
-A ética da pesquisa em seres humanos e a publicação de artigos científicos ´-> http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-35861999000200001
-International Ethical Guidelines on Epidemiological Studies
-What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486592/
-International Ethical Guidelines for Epidemiological Studies https://cioms.ch/shop/product/international-ethical-guidelines-for-epidemiological-studies/
´´Na década de 80, o Council for International Organizations of Medical Sciences (CIOMS), juntamente com a Organização Mundial da Saúde (OMS), elaboraram um documento mais detalhado sobre o assunto estipulando as “Diretrizes internacionais para a pesquisa biomédica em seres humanos”, traduzida para a língua portuguesa pelo Ministério da Saúde. O documento foi reavalizado e publicado em nova versão em 1993, traduzido e publicado pela revista Bioética, do Conselho Federal de Medicina (CFM).´´
´´Na década de 90, o CIOMS lança o primeiro documento especificamente voltado para a pesquisa em estudos de coletividade (estudos epidemiológicos): International Guidelines for Ethical Review of Epidemiological Studies.´´
-International Ethical Guidelines for Epidemiological Studies: By the Council for International Organizations of Medical Sciences (CIOMS) https://www.researchgate.net/publication/246085570_International_Ethical_Guidelines_for_Epidemiological_Studies_By_the_Council_for_International_Organizations_of_Medical_Sciences_CIOMS
-Diretrizes internacionais propostas para a pesquisa biomédica em seres humanos
-International Ethical Guidelines on Epidemiological Studies (A CIOMS Publication) 1st Edition
-Annex 1 Guidelines and codes of best practice and statutes and regulations
-International Ethical Guidelines for Biomedical Research Involving Human Subjects
WHO/CIOMS, Geneva, 1993