Badania kliniczne
WYTYCZNE, STANDARDY, STANOWISKA
DOKUMENTY MIĘDZYNARODOWE
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC; 1979.
https://www.ncbi.nlm.nih.gov/pubmed/25951677
dostęp: 27.02.2019
- World Medical Association, 1964, World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
dostęp: 27.02.2019
- Council for International Organizations of Medical Sciences (CIOMS), with the World Health Organization (WHO), 2002, International Ethical Guidelines for Biomedical Research Involving Human Subjects
https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
dostęp: 27.02.2019
- Council of Europe, 1997, The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98
dostęp: 27.02.2019
- UNESCO, 2005, Universal Declaration on Bioethics and Human Rights
https://unesdoc.unesco.org/ark:/48223/pf0000146180
dostęp: 27.02.2019
- Nuffield Council on Bioethics, 2014, The Ethics of Research related to Healthcare in Developing Countries
http://nuffieldbioethics.org/wp-content/uploads/2014/07/Ethics-of-research-related-to-healthcare-in-developing-countries-I.pdf
dostęp: 27.02.2019
Inne:
- European Commission, European Textbook on Ethics in Research
https://ec.europa.eu/research/science-society/document_library/pdf_06/textbook-on-ethics-report_en.pdf
dostęp: 27.02.2019
DOKUMENTY KRAJOWE
Kanada
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, 2014, Tri-Council Policy Statement: Ethical Conduct for Research Involving Human Subjects,
http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
dostęp: 27.02.2019
Australia
- National Health and Medical Research Council, 2018, National Statement on Ethical Conduct in Human Research
https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__1354
dostęp: 27.02.2019
Holandia
- The Central Committee onResearch Involving Human Subjects, 1991, Medical Research Involving Human Subjects Act
https://wetten.overheid.nl/BWBR0009408/2018-08-01
dostęp: 27.02.2019
- z udziałem dzieci
WYTYCZNE, STANDARDY, STANOWISKA
- DOKUMENTY MIĘDZYNARODOWE
UNICEF: Graham, A., Powell, M., Taylor, N., Anderson, D. & Fitzgerald, R. (2013). Ethical Research Involving Children. Florence: UNICEF Office of Research – Innocenti; [adres www: https://www.unicef-irc.org/publications/pdf/eric-compendium-approved-digital-web.pdf] [dostęp: 21.01.2019].
European Union (EU): European Union Commission ad hoc group. (2006) Ethical Considerations for clinical trials performed in children – Recommendations of the Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use [adres www: https://ec.europa.eu/health//sites/health/files/files/paediatrics/docs/paeds_ethics_consultation20060929_en.pdf] [dostęp: 23.02.2019].
Dokument ma status roboczy.
European Society for Opinion and Marketing Research (ESOMAR): ESOMAR (2009) Interviewing children and young people, Amsterdam: ESOMAR, [adres www: https://www.esomar.org/uploads/public/knowledge-and-standards/codes-and-guidelines/ESOMAR_Codes-and-Guidelines_Interviewing-Children-and-Young-People.pdf] [dostęp: 23.02.2019].
Dokument dotyczy badań opinii publicznej.
Society for Research in Child Development (SRCD): SRCD (2007): Ethical Standards in Research, [strona www] [adres www: https://www.srcd.org/about-us/ethical-standards-research] [dostęp: 23.02.2019].
- DOKUMENTY KRAJOWE
Irlandia
Department of Children and Youth Affairs (DCYA): DCYA (2012) Guidance for developing ethical research projects involving children, Dublin: DCYA; [adres www: https://www.dcya.gov.ie/documents/Publications/Ethics_Guidance.pdf] [dostęp: 23.02.2019].
Polska
Ministerstwo Zdrowia RP: Minister Zdrowia RP (2004) Rozporządzenie Ministra Zdrowia z dnia 30 kwietnia 2004 r.w sprawie sposobu prowadzenia badań klinicznych z udziałem małoletnich [w:] Dziennik ustaw r. 2004, nr 104, poz. 1108 [adres www: http://prawo.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20041041108] [dostęp: 23.02.2019].
Sejm RP: Kancelaria Sejmu RP (2017) Pokrewieństwo i powinowactwo (Tytuł II), [w:] Ustawa z dnia 25 lutego 1964 r. - Kodeks rodzinny i opiekuńczy z późniejszymi zmianami, s.21-54, [w:] Dziennik ustaw r. 2017, poz. 682. [adres www: http://prawo.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU19640090059] [dostęp: 23.02.2019].
Dokument regulujący ogólne ramy prawne instytucji rodzicielstwa w Polsce.
Wielka Brytania
National Children’s Bureau: Shaw, C., Brady L., & Davey C. (2011) Guidelines for Research with Children and Young People, London: NCB Research Centre; [adres www: https://www.ncb.org.uk/sites/default/files/field/attachment/NCB%20guidelines%20CYP.pdf] [dostęp: 21.01.2019].
British Educational Research Association (BERA): BERA (2018) Ethical Guidelines for Educational Research, London: BERA [adres www: https://www.bera.ac.uk/wp-content/uploads/2018/06/BERA-Ethical-Guidelines-for-Educational-Research_4thEdn_2018.pdf?noredirect=1] [dostęp: 23.02.2019]. Dokument dotyczy badań w dziedzinie edukacji.
Nuffield Council on Bioethics: Nuffield Council on Bioethics (2015) Children and clinical research: ethical issues, London: Nuffield Council on Bioethics [adres www: http://nuffieldbioethics.org/wp-content/uploads/Children-and-clinical-research-full-report.pdf] [dostęp: 23.02.2019].
- TEKSTY PRZEGLĄDOWE DOTYCZĄCE WYTYCZNYCH
European Union Agency for Fundamental Rights (FRA) Child participation in research [adres www: https://fra.europa.eu/en/theme/rights-child/child-participation-in-research] [dostęp: 23.02.2019].
- z udziałem osób o zaburzonych zdolnościach poznawczych
WYTYCZNE, STANDARDY, STANOWISKA
- DOKUMENTY MIĘDZYNARODOWE
- Alzheimer Europe, 2011, Ethics of dementia research
https://www.alzheimer-europe.org/Ethics/Ethical-issues-in-practice/2011-Ethics-of-dementia-research dostęp: 27.02.2019
- DOKUMENTY KRAJOWE
Wielka Brytania
dostęp: 27.02.2019
- Medical Research Council, 2007, Medical research involving adults who cannot consent
https://mrc.ukri.org/documents/pdf/medical-research-involving-adults-who-cannot-consent/dostęp: 27.02.2019
- The British Psychological Society, 2008, Conducting research with people not having the capacity to consent to their participation
https://www.ed.ac.uk/files/atoms/files/bps_guidelines_for_conducting_research_with_people_not_having_capacity_to_consent.pdf
dostęp: 27.02.2019
- Nuffield Council on Bioethics, 2009, Dementia: Ethical issues (Chapter 8: Research)
http://nuffieldbioethics.org/wp-content/uploads/2014/07/Dementia-report-Oct-09.pdf
dostęp: 27.02.2019
Irlandia
dostęp: 27.02.2019
Stany Zjednoczone
- University of California Los Angeles, Human Research Protection Program, 2010, Guidance and Procedure: Research Involving Persons with Cognitive Impairments
http://ora.research.ucla.edu/OHRPP/Documents/Policy/9/Cognitive_Impairments.pdf
dostęp: 27.02.2019
- Alzheimer's Association, 2004, Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators
https://www.ncbi.nlm.nih.gov/pubmed/15494623
dostęp: 27.02.2019
Australia
- National Health and Medical Research Council, 2018, National Statement on Ethical Conduct in Human Research (Chapter 4.5)
https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__1354
dostęp: 27.02.2019
Kanada
- Canadian Institutes of Health Research, National Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, 2014, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Chapter: 3 C)
http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
dostęp: 27.02.2019
- z udziałem osób psychicznie chorych
WYTYCZNE, STANDARDY, STANOWISKA
- DOKUMENTY MIĘDZYNARODOWE
- United Nations, Inter-Agency Standing Committee (IASC), 2014, Recommendations for Conducting Ethical Mental Health and Psychosocial Research in Emergency Settings
https://interagencystandingcommittee.org/system/files/1._iasc_recommendations_for_ethical_mhpss_research_in_emergency_settings_0.pdf
dostęp: 27.02.2019
- DOKUMENTY KRAJOWE
Wielka Brytania
- Royal College of Psychiatrists, 2000, Guidelines for Researchers and for Research Ethics Committees on Psychiatric Research Involving Human Participants
http://www.leedsth.nhs.uk/fileadmin/Documents/Academic/Research/Documents/ RESEARCH_PROPOSAL/cr82i.pdf
dostęp: 27.02.2019
dostęp: 27.02.2019
Stany Zjednoczone
- American Psychiatric Association, 2006, Ethical Principles and Practices for Research Involving Human Participants With Mental Illness,
https://ps.psychiatryonline.org/doi/full/10.1176/ps.2006.57.4.552?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
dostęp: 27.02.2019
- National Bioethics Advisory Commission, 1998, Research involving persons with mental disorders that may affect decision making capacity
https://bioethicsarchive.georgetown.edu/nbac/briefings/nov98/capacity.pdf
dostęp: 27.02.2019
Australia
- National Health and Medical Research Council, 2018, National Statement on Ethical Conduct in Human Research (Chapter 4.5)
https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__1354
dostęp: 27.02.2019
Genetyka kliniczna
Dokumenty międzynarodowe (dostęp do wszystkich 24.02.2019)
UNESCO
- International Declaration on Human Genetic Data
https://unesdoc.unesco.org/ark:/48223/pf0000136112
UE
- Genetic testing and common disorders in a public health framework
Recommendations of the European Society of Human Genetics
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.nature.com%2Farticles%2Fejhg2010176.pdf
2.Genetic testing in asymptomatic minors
Recommendations of the European Society of Human Genetics
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.nature.com%2Farticles%2Fejhg200926.pdf
- Whole-genome sequencing in health care
Recommendations of the European Society of Human Genetics
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.nature.com%2Farticles%2Fejhg201346.pdf
4.Letter to Members of the European Parliament from the European Society of Human Genetics
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.eshg.org%2Ffileadmin%2Fwww.eshg.org%2FESHGlettertoMEPs.pdf
WHO
1. Guidelines on ethical issues in medical genetics and the provision of genetics services
https://apps.who.int/iris/bitstream/handle/10665/62048/WHO_HDP_GL_ETH_95.1_%28part1%29.pdf?sequence=1&isAllowed=y część 1.
https://apps.who.int/iris/bitstream/handle/10665/62048/WHO_HDP_GL_ETH_95.1_%28part2%29.pdf?sequence=2&isAllowed=y część 2.
2. Summary statement on ethical issues in medical genetics: report of WHO temporary advisers
https://apps.who.int/iris/bitstream/handle/10665/61111/WHO_HDP_GL_ETH.SUM_95.2.pdf?sequence=1&isAllowed=y
3. Proposed international guidelines on ethical issues in medical genetics and genetic services: report of WHO meeting on Ethical Issues in Medical Genetics
https://apps.who.int/iris/bitstream/handle/10665/63910/WHO_HGN_GL_ETH_98.1.pdf?sequence=1&isAllowed=y
4. Statement of WHO Expert Advisory Group on Ethical Issues in Medical Genetics
https://apps.who.int/iris/bitstream/handle/10665/63873/WHO_HGN_ETH_98.2.pdf?sequence=1&isAllowed=y
- Review of ethical issues in medical genetics
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.who.int%2Fgenomics%2Fpublications%2Fen%2Fethical_issuesin_medgenetics%2520report.pdf
Dokumenty krajowe
Wielka Brytania
- Consent and confidentiality in clinical genetic practice: guidance on genetic testing and sharing genetic information
https://www.bsgm.org.uk/media/678746/consent_and_confidentiality_2011.pdf
Australia
- Clinical Genetics Services Standards Framework
https://www.hgsa.org.au/documents/item/5909
USA
- Ethical and Policy Issues in Genetic Testing and Screening of Children
https://docs.google.com/viewer?url=http%3A%2F%2Fpediatrics.aappublications.org%2Fcontent%2Fpediatrics%2F131%2F3%2F620.full-text.pdf
2. National Academies of Sciences, Engineering, and Medicine. Human genome editing. Science, ethics and governance https://www.nap.edu/read/24623/chapter/10
- Enhancing the Oversight of Genetic Tests. Recommendations of the SACGT
https://docs.google.com/viewer?url=https%3A%2F%2Fosp.od.nih.gov%2Fwp-content%2Fuploads%2F2013%2F11%2Foversight_report.pdf
appendix
https://docs.google.com/viewer?url=https%3A%2F%2Fosp.od.nih.gov%2Fwp-content%2Fuploads%2F2014%2F01%2FappendixA_0.pdf
- Ethical and Practical Guidelines for Reporting Genetic Research. Results To Study Participants: Updated Guidelines from an NHLBI Working Group
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC3090664%2Fpdf%2Fnihms272954.pdf
- Clinical utility of genetic and genomic services: a position statement of the American College of Medical Genetics and Genomics
https://www.nature.com/articles/gim201541.pdf
Japonia
- Guidelines for Genetic Tests and Diagnoses in Medical Practice . The Japanese Association of Medical Sciences
http://jams.med.or.jp/guideline/genetics-diagnosis_e.pdf
- Guidelines for genetic testing
http://jshg.jp/wp-content/uploads/2017/08/10academies_e.pdf
- Fundamental principles of research of human genome. Council for Science and Technology, Bioethics Committee
http://www.mext.go.jp/b_menu/shingi/kagaku/rinri/pri00614.htm
Kanada
- Joint Statement on the Process of Informed Consent for Genetic Research
https://docs.google.com/viewer?url=https%3A%2F%2Fwww.cagc-accg.ca%2Fdoc%2Fcagc-ccmg%2520joint%2520staement%2520on%2520the%2520process%2520of%2520informed%2520consent%2520for%2520research%2520final%2520nove%252027%25202009%2520vers%25201_0.pdf
Inne
- Research Ethics Recommendations for Whole-Genome Research: Consensus Statement
https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.0060073
- Genetic testing and genetic research. A report by bioethics advisory committee Singapore
http://www.bioethics-singapore.org/images/uploadfile/55211%20PMGT%20Research.pdf
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