DOCSLIB.ORG

Free PDF Download

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Free PDF Download Eur opean Rev iew for Med ical and Pharmacol ogical Sci ences 2015; 19: 4182-4186 Ethical governance in biobanks linked to electronic health records L. CAENAZZO 1, P. TOZZO 1, A. BOROVECKI 2 Department of Molecular Medicine, Clinical Bioethics Laboratory, University of Padova, Padova, Italy Department of Social Medicine and Organisation of Health Care, University of Zagreb, Zagreb, Croatia Abstract. – In the last years an alternative to legally binding instruments or by general regula - traditional research projects conducted with pa - tory texts. Over the years, new questions, diffi - tients has emerged: it is represented by the pair - culties and solutions have appeared. The result is ing of different type of disease biobanks speci - mens with Electronic Health Records (EHRs). that there is lack of clarity and uniformity in Even if informed consent remains one of the biobank regulation and consideration of this con - most contested issues of biobank policy, other fusing literature and procedures may be difficult ethical challenges still require careful attention, to understand . given that additional issues are related to the Nonetheless, it is reductive, on first view, to use of EHRs. try to capture in a single term a reality so varied: In this new way of doing research harmoniza - small and vast collections, managed by private tion of governance is essential in practice, with the aim to make the most use of resources at entities and public bodies, containing tumors, tis - our disposal, and sharing of samples and data sue, blood, plasma and other forms of DNA. In among researchers under common policies reg - fact, the term biobank is not yet entirely univer - ulating the distribution and the use. sal. A biobank-specific Ethics Committee could be Some prefer to talk about “biolibraries ”, oth - seen as a new and type of Ethics Committee, ers, such as the French legislature, of “biological that we suggest to be applied to each biobank, with possible different functions. sample collections ”, others still prefer to talk In particular, considering the possible use of about “biological resource centers ” (BRCs) or electronic health record data linked to biological “specimen banks ”. Other designations include specimens in biobanking research, this specific “genetic databases ” or “human genetic research Ethics Committee could draft best practice and databases ” (used by the OECD), “virtual ethical guidelines for the utilisation of the EHRs biobanks ” (the Human Genome Organisation and as a tool for genetic research, addressing con - the Institute for Genomic Research), “bioreposi - cerns on accessibility, return of results and pri - vacy and help to educate patients and health - tories ” (OECD, International Society for Biologi - care providers. cal and Environmental Repositories), “tissue banks ”, “ gene banks ”, and “registries ”. These ex - Key Words: amples show just how varied the terminology is Ethics Committee, Biobanks, Clinical research gov - and how unbridled the semantic imagination of ernance, HERs. those involved 1. However in general terms, a biobank has the following characteristics and elements: an infra - Introduction structure (that is, a place and equipment) man - aged by a public or private body, the accumula - Biobanking, the organised collection of bio - tion in an organized fashion and over a period of logical samples and associated data, ranges from time of biological samples (cells, tissue, urine, small collections of samples in academic or hos - genes, or DNA or RNA fragments) and data pital settings to large-scale national repositories. (clinical information about patients and their Different approaches to regulations of families, or even populations, genealogical or bi - biobanks have appeared both at the national and ological data, lifestyle information, etc.), for the international levels, sometimes through specific purpose of medical research. 4182 Corresponding Author: Luciana Caenazzo, MD; e-mail: [email protected] Ethical governance in biobanks linked to electronic health records A biobank is composed of biological speci - tions, new research in both public and private mens and of the information related to the speci - contexts, and new ethical challenges in biobank - mens and their sources. Individual or patient in - ing 7,8 . formation is part of the biobank and has the same Even if informed consent remains one of the relevance as the tissue sample and for this reason most contested issues of biobank policy 9, other eth - collection of information should be accurate and ical challenges still require careful attention, given complete. that additional issues are related to the use of In the last years an alternative to traditional re - EHRs: these include the protection of vulnerable search projects conducted with patients has subjects, the safeguarding of privacy, the commu - emerged: it is represented by the pairing of dif - nication of research results to donors, the conflicts ferent type of disease biobanks specimens with over patenting, the access, the need for open sci - electronic medical/health records (EMRs/EHRs), ence, the rights of donors to retain a property claim for example the Electronic Medical Records and or control over their samples and data. In particular Genomics (eMERGE) network 2, the Vanderbilt it is necessary to pay attention to the management Electronic Systems for Pharmacogeomic Assess - of healthcare information collected from patients in ment (VESPA) Project 3 and the Estonian different research projects 10,11 that can overwhelm Biobank, that was the first country to implement the original purpose of the research and the related a nationwide electronic health records system for informed consent . Furthermore, the ethical policy all citizens 4,5 . In these models of research , a has to take in consideration the fact that some pa - healthcare facility collects biological samples of tient’s EHR data are collected for healthcare pur - patients (as indicated above) for research and poses, without specific informed consent. stores them in a biobank, maintaining a linkage Biobanking enables a new way of doing re - between the sample and the patient’s EHR data, search: research projects are now frequently that constitute the primary source of phenotypic global, involving international teams, cross-bor - information. der networks of expertise, members of interna - Incorporating health information from partici - tional scientific societies belonging to different pant in Biobanking research aids in correlating institutions around the world, which pool and phenotypic information with genetic data and en - share samples and data ; this is crucial in order to vironmental data. make investigations more robust, more targeted, The advantages of collecting EHRs related to and more economical . The use of EHRs related genomic information stored in biobanks are cost- to biobanks may enable this new way of doing effctiveness and the potential to reuse genetic research, and it could benefit from the creation of and phenotypic information collected during a teams for phenotyping and genetic data analysis, patient’s lifespan, beyond the original study. This facilitating communication and spread of exper - is particularly true for dense genetic data such as tise among research teams. thosegenerated through genome-wide association In this new way of doing research harmoniza - studies or large-scale sequencing data 6. tion of governance is essential in practice, with the aim to make the most use of resources at our Biobanking Governance disposal , and the sharing of samples and data Although biobanking is not new, what distin - among researchers under common policies regu - guishes the present from the past is that the gen - lating the distribution and the use. Furthermore eral scientific context has changed, and the scale governance harmonization among different of biobanking activities, both in terms of the biobanks in different countries could ensure an quantity of samples and data, as well as the range equal protection of autonomy, dignity and funda - of disease areas and institutions now involved in mental rights of patients and research partici - biobanking have increased considerably, espe - pants, helping researchers in their activity and cially with the emergence of EHRs-linked ensuring a flexible framework that should not be biobanks . The other significant change is that an obstacle for the technical progress of the these collections are being configured so that biobank, and offering to all communities the op - they can be used as a resource for the whole sci - portunity to benefit from the results obtained. entific community. Governance harmonization could guarantee ac - In these last years the importance of biobanks cess controls and security measures in order to is testified by the great increase, in the scientific avoid breach of partecipants’ privacy and the risk literature, of papers that consider new applica - of stigmatization of specific groups. 4183 L. Caenazzo, P. Tozzo, A. Borovecki For these reasons biobank harmonization has development of a fair and equitable system of ac - become a key issue in the field of biobanking, cess for researchers wishing to use the biobanks both in terms of regulation and governance, with and the benefits of shared results 7. respect to peculiar challenges of EHRs-related In this context, the development of ethical biobank . guidelines and a systematic involvement of Ethics In response to biobanks challenges, different Committees
Load more

Recommended publications
  • Review of Scientific Self-Experimentation: Ethics History, Regulation, Scenarios, and Views Among Ethics Committees and Prominent Scientists
    Rejuvenation Research Page 1 of 41 © Mary Ann Liebert, Inc. DOI: 10.1089/rej.2018.2059 1 Review of Scientific Self-experimentation: ethics history, regulation, scenarios, and views among ethics committees and prominent scientists. Brian Hanley, Butterfly Sciences, POBox 2363, Davis, CA 95616, USA. [email protected] William Bains, Rufus Scientific Ltd. 37 The Moor, Melbourn, Royston, Hertsfordshire, SG8 nt scientists. (DOI: 10.1089/rej.2018.2059) 10.1089/rej.2018.2059) scientists. nt (DOI: 6ED, UK. [email protected] nal published version may fromdiffer this proof. George Church, Department of Genetics, Harvard Medical School, Boston, MA 02115, USA. Word count: 5,969 Address for correspondence and reprints: [email protected] Keywords: ethics, research history, human research, medical ethics; self-experimentation, n-of-1 Abbreviated title: Review of Scientific Self-experimentation Rejuvenation Research lation, scenarios, and views among ethics committees and promine Downloaded by UNIVERSITY OF FLORIDA from www.liebertpub.com at 06/25/18. For personal use only. Review of Scientific Self-experimentation: regu ethics history, This paper has been peer-reviewed and accepted publication,for but has yet to copyediting undergo correction. and proof The fi Page 2 of 41 2 Abstract We examine self-experimentation ethics history and practice, related law, use scenarios in universities and industry, and attitudes. We show through analysis of the historical development of medical ethics and regulation, from Hippocrates through Good Clinical Practice that there are no ethical barriers to self-experimentation. When the self- experimenter is a true investigator, there is no other party to be protected from unethical behavior.
    [Show full text]
  • Informed Consent and Refusal
    CHAPTER 3 Informed Consent and Refusal Evolution of the doctrine of informed consent Elements of informed consent and refusal The nature of informed consent Exceptions to the consent requirement Mrs. Stack is a 67- year- old woman admitted with rectal bleeding, chronic renal in- sufficiency, diabetes, and blindness. On admission, she was alert and capacitated. Two weeks later, she suffered a cardiopulmonary arrest, was resuscitated and intu- bated, and was transferred to the medical intensive care unit (MICU) in an unrespon- sive and unstable state. Consent for emergency dialysis was obtained from her son, who is also her health care agent. Dialysis was repeated two days later. During the past several years, Mrs. Stack has consistently stated to her family and her primary care doctor that she would never want to be on chronic dialysis and she has refused it numerous times when it was recommended. The physician, who has known and treated Mrs. Stack for many years, also treated her daughter who had been on chronic dialysis for some time and had died after suffering a heart attack. According to the physician and the patient’s family, Mrs. Stack’s refusal of dialysis has been based on her conviction that her daughter died as a result of the dialysis treatments. Mrs. Stack’s mental status has cleared considerably and, despite the ventilator, she is able to communicate nonverbally. Although she appears to understand the benefits of dialysis and the consequences of refusing it, including deterioration and eventual death, she has consistently and vehemently refused further treatments. Her capacity to make this decision is not now in question.
    [Show full text]
  • Ethics for Researchers
    Ethics for researchers Facilitating Research Excellence in FP7 Research and Innovation EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B – European Research Area Unit B.6 – Ethics and gender Contact: Isidoros Karatzas European Commission B-1049 Brussels E-mail: [email protected] [email protected] EUROPEAN COMMISSION Ethics for researchers Facilitating Research Excellence in FP7 Directorate-General for Research and Innovation 2013 Science in society /Capacities FP7 EUROPE DIRECT is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. The views expressed in this publication are the sole responsibility of the author and do not necessarily reflect the views of the European Commission. More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found at the end of this publication. Luxembourg: Publications Office of the European Union, 2013 ISBN 978-92-79-28854-8 doi 10.2777/7491 © European Union, 2013 Reproduction is authorised provided the source is acknowledged. Cover Image © Sergey Nivens, #49108932, 2013. Source: Fotolia.com. Table of Contents Introduction .....................................................................................................................
    [Show full text]
  • (IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research Be Standardized?
    Washington University Global Studies Law Review Volume 15 Issue 2 2016 Research Ethics Committees (RECS)/Institutional Review Boards (IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research be Standardized? Andrea S. Nichols Follow this and additional works at: https://openscholarship.wustl.edu/law_globalstudies Part of the Biochemistry, Biophysics, and Structural Biology Commons, Bioethics and Medical Ethics Commons, Health Law and Policy Commons, Laboratory and Basic Science Research Commons, Medical Jurisprudence Commons, and the Science and Technology Law Commons Recommended Citation Andrea S. Nichols, Research Ethics Committees (RECS)/Institutional Review Boards (IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research be Standardized?, 15 WASH. U. GLOBAL STUD. L. REV. 351 (2016), https://openscholarship.wustl.edu/law_globalstudies/vol15/iss2/8 This Note is brought to you for free and open access by the Law School at Washington University Open Scholarship. It has been accepted for inclusion in Washington University Global Studies Law Review by an authorized administrator of Washington University Open Scholarship. For more information, please contact [email protected]. RESEARCH ETHICS COMMITTEES (RECS)/INSTITUTIONAL REVIEW BOARDS (IRBS) AND THE GLOBALIZATION OF CLINICAL RESEARCH: CAN ETHICAL OVERSIGHT OF HUMAN SUBJECTS RESEARCH BE STANDARDIZED? INTRODUCTION Current United States’ policy requires federally funded research studies involving human subjects to be approved by an interdisciplinary committee called an institutional review board (IRB).1 IRBs exist to protect the safety and welfare of human subjects participating in research studies. Although oversight of human subjects research and, consequently, IRBs, is governed by federal regulations, the operation of IRBs remain largely mysterious to those other than IRB members themselves.
    [Show full text]
  • Protecting Human Research Participants NIH Office of Extramural Research Introduction
    Protecting Human Research Participants NIH Office of Extramural Research Introduction Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. Who? This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research. What? This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Why? As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000.
    [Show full text]
  • NACO Ethical Guidelines for Operational Research
    ETHICAL GUIDELINES FOR OPERATIONAL RESEARCH ON HIV/AIDS Version 2008 NATIONAL AIDS CONTROL ORGANISATION Ministry of Health & Family Welfare, Government of India CONTENTS 1. Introduction 1.1 Preamble 1.2 Basic Responsibility of the Ethics Committee 1.3 Composition of NACO Ethics Committee 1.4 Terms of Reference of Members 2. Principles for Ethical Issues 2.1 General Principles for Ethical Issues 2.2 Specific Principles 2.2.1 Informed consent of Participants 2.2.2 Essential Information for prospective research participants 2.2.3 Confidentiality for prospective research participants 2.2.4 Conflicts of Interest 2.2.5 International collaboration/assistance in Evaluation and Operational Research 2.2.6 Special Concerns 3. Researcher‟s relations with the media and publication practices 4. Ethical Issues in Epidemiological Research 5. Distinction between research and program evaluation 6. Community participation 7. Ethical Issues in Questionnaire based research 8. Ethical Issues in Focus Group Discussion 9. Ethical Issues in Internet Based Research 10. Procedure for Ethical Review of Proposals 11. Submission of Application 12. Decision making process 13. Review Process APPENDIX: Appendix A: Application Form 2 1. INTRODUCTION 1.1 Preamble NACO Ethics Committee for Research is constituted with responsibility to ensure that the ethical implications of any research undertaken are afforded serious consideration prior to the commencement of a project and that such research is consistent with legislative and statutory requirements. The rationale for ethical approval is to ensure that the process of research is conducted „ethically‟ and responsibly and ensures protection of privacy and not exploitative of participants. This mainly involves establishing procedures for the informed consent of those subjects involved in research, as well as appropriate handling of the research findings (e.g.
    [Show full text]
  • Biobank Regulation in Finland and the Nordic Countries
    Biobank Regulation in Finland and the Nordic Countries By Dr. Salla Silvola, University of Helsinki l 1 The biobank as a concept The term biobank, or biopankki, in Finnish, is not used in everyday life in Finland. Neither does the concept of the biobank appear in the existing legislation in Fin- land.2 The word itself refers to the storing of biological material. As it does not di- rectly refer to any research activities, the average layman could easily mistake its purposej guesses can range from collections of rare plants to human organ banks. However, the word is commonly used amongst Nordic biomedical researchers, and has been in use in the ethico-Iegal debate since the mid-1990S, although there is no Single universal definition for it even in this forum} Biobanks may be established not only for research, but also, for example, for patient safety, quality assurance, trans- plantation, assisted procreation, or for manufacturing medicinal products. Many biobanks have been set up for a combination of purposes.4 For present purposes, I will refer to a biobank as a collection of human biological samples combined with health and lifestyle information on the provider of the sam- ple.S The information mayor may not be linked to an identifiable person (personal data), and the information mayor may not contain genetic information. 1 Dr. Salla Silvola (fonnerly Salla L6tjonen) works as Senior Advisor in Legislative Affairs in the Ministry ofJustice, Finland. She is also a Docent in Medical and Bio Law and teaches part-time at the Faculty of Law at the University of Helsinki.
    [Show full text]
  • International Compilation of Human Research Standards 2017 Edition
    International Compilation of Human Research Standards 2017 Edition Compiled By: Office for Human Research Protections U.S. Department of Health and Human Services PURPOSE The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines that govern human subjects research in 126 countries, as well as standards from a number of international and regional organizations. This Compilation was developed for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research around the world. Content experts from around the world, listed at the back of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered in this Edition. Six new countries are featured in the 2017 Edition: Benin, Bermuda, Democratic Republic of the Congo, Dominican Republic, Guyana, and Senegal. The countries of the Middle East are now found in a separate section beginning on page 136. ORGANIZATION The Table of Contents is on pages 3-4. For each country, the standards are categorized by row as: 1. General, i.e., applicable to most or all types of human subjects research 2. Drugs and Devices 3. Clinical Trial Registries 4. Research Injury 5. Privacy/Data Protection (also see Privacy International reports: https://www.privacyinternational.org/reports) 6. Human Biological Materials 7. Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/) 8. Embryos, Stem Cells, and Cloning These eight categories often overlap, so it may be necessary to review the other standards to obtain an accurate understanding of the country’s requirements.
    [Show full text]
  • Case Study Guidelines
    CASE STUDIES Note to the Facilitator The Case Studies section provides 10 health-research case studies to prompt discussion about the material presented in the curriculum. Case Studies in the Curriculum Case Study 1: Principles of Research Ethics (slide 13) Case Study 2: Informed Consent (slide 46) Case Study 3: Research Ethics Committee Considerations (slide 57) Case Study 4: Community Participation (slide 77) Additional Case Studies Case Study 5: Inducement/Compensation Case Study 6: Social Risks Case Study 7: Respect for Persons Case Study 8: Beneficence and Justice Case Study 9: Individual versus Community Consent Case Study 10: Research Involving Minors The case studies are based on real-life research studies conducted throughout the world. They illustrate the complexity of human research and how cultural, social, and gender issues impact the ethics of a research study. The issues that are raised transcend any specific category of research and were selected to elicit a variety of reactions. This type of discussion will enrich the training group and should be pursued. The facilitator might find that discussion becomes so absorbing that he or she will need to curtail it in the interest of time. We believe that these case studies are applicable to most geographic settings, but discussions of characteristics that are unique to a particular country are encouraged. Discussing the Case Studies • The ideal way to discuss the case studies is to divide the participants into groups of eight and have them sit around group tables, round tables being preferred. Ask the groups to pretend to be formally established Research Ethics Committees.
    [Show full text]
  • Guiding Principles on Ethical Issues in HIV Surveillance
    UNAIDS/WHO Working Group UNAIDS/WHO Working on Global HIV/AIDS and STI Surveillance For more information, contact: World Health Organization Department of HIV/AIDS ISBN 978 92 4 150559 8 Avenue Appia 20 Guiding principles on Ethical 1211 Geneva 27 Switzerland issues in HIV surveillance E-mail: [email protected] www.who.int/hiv WHO Library Cataloguing-in-Publication Data Guiding principles on Ethical issues in HIV surveillance. UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance. I.World Health Organization. ISBN 978 92 4 150559 8 (NLM classification: WC 503.4) © World Health Organization 2013 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: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO web site (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
    [Show full text]
  • The Declaration of Helsinki on Medical Research Involving Human Subjects: a Review of Seventh Revision Badri Shrestha,1 Louese Dunn1
    J Nepal Health Res Counc 2019 Oct-Dec;17(45): 548-52 Medical Education DOI https://doi.org/10.33314/jnhrc.v17i4.1042 The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision Badri Shrestha,1 Louese Dunn1 1Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK. ABSTRACT The pinnacle of success achieved by the medical science and the benefits accrued to the patients have become possible through the medical research where human participants in the research are exposed to hazards inherent to the experiments. To protect the human subjects and to maintain high ethical standards, the World Medical Association has adopted “The Declaration of Helsinki” in 1964. After two years of consultation with the experts throughout the world, the seventh revision of the Declaration was adopted on 19th October 2013 in Brazil. The aim of this article is to review the seventh revision of the Declaration of Helsinki in relation to medical research involving human subjects and highlight the amendments made in the latest revision which are relevant to clinical research in human subjects. The latest revision has made four substantial changes on the existing Declaration, whch include dealing with the compensation of the trial-related injuries, approval of use of placebos in the clinical trials, protection of vulnerable groups and the post-trial provisions. The implications of these amendments in the clinical research are highlighted. Keywords: Consent; Declaration of Helsinki; ethics; experimental medicine; research; seventh revision. INTRODUCTION the latest revision has made four substantial changes, whch include dealing with the compensation of the Extensive medical research is being conducted trial-related injuries, approval of use of placebos in the throughout the world with an intention to understand clinical trials, protection of vulnerable groups and the the aetiology, natural history, diagnosis, prevention post-trial provisions.
    [Show full text]
  • Ethical Principles for Medical Research Involving Human Subjects
    Clinical Review & Education Special Communication World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects World Medical Association Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification added) 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59th WMA General Assembly, Seoul, Republic of Korea, October 2008 64th WMA General Assembly, Fortaleza, Brazil, October 2013 Preamble bestproveninterventionsmustbeevaluatedcontinuallythrough research for their safety, effectiveness, efficiency, accessibility 1. The World Medical Association (WMA) has developed the Dec- and quality. laration of Helsinki as a statement of ethical principles for medi- cal research involving human subjects, including research on 7. Medical research is subject to ethical standards that promote and identifiable human material and data. ensure respect for all human subjects and protect their health and rights. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consider- 8. Whiletheprimarypurposeofmedicalresearchistogeneratenew ation of all other relevant paragraphs. knowledge, this goal can never take precedence over the rights and interests of individual research subjects. 2. Consistent with the mandate of the WMA, the Declaration is ad- dressed primarily to physicians. The WMA encourages others 9. It is the duty of physicians who are involved in medical research who are involved in medical research involving human subjects to protect the life, health, dignity, integrity, right to self- to adopt these principles.
    [Show full text]