DOCSLIB.ORG

What Makes Clinical Research Ethical?

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
What Makes Clinical Research Ethical? SPECIAL COMMUNICATION What Makes Clinical Research Ethical? Ezekiel J. Emanuel, MD, PhD Many believe that informed consent makes clinical research ethical. How- David Wendler, PhD ever, informed consent is neither necessary nor sufficient for ethical clinical Christine Grady, PhD research. Drawing on the basic philosophies underlying major codes, dec- larations, and other documents relevant to research with human subjects, HAT MAKES RESEARCH IN- we propose 7 requirements that systematically elucidate a coherent frame- volving human subjects work for evaluating the ethics of clinical research studies: (1) value— ethical? Informed con- enhancements of health or knowledge must be derived from the research; sent is the answer most (2) scientific validity—the research must be methodologically rigorous; (3) WUS researchers, bioethicists, and insti- fair subject selection—scientific objectives, not vulnerability or privilege, and tutional review board (IRB) members the potential for and distribution of risks and benefits, should determine com- would probably offer. This response re- munities selected as study sites and the inclusion criteria for individual sub- flects the preponderance of existing jects; (4) favorable risk-benefit ratio—within the context of standard clini- guidance on the ethical conduct of cal practice and the research protocol, risks must be minimized, potential research and the near obsession with benefits enhanced, and the potential benefits to individuals and knowledge autonomy in US bioethics.1-4 While gained for society must outweigh the risks; (5) independent review— informed consent is necessary in most unaffiliated individuals must review the research and approve, amend, or but not all cases, in no case is it suffi- terminate it; (6) informed consent—individuals should be informed about cient for ethical clinical research.5-8 In- the research and provide their voluntary consent; and (7) respect for en- deed, some of the most contentious con- rolled subjects—subjects should have their privacy protected, the opportu- temporary ethical controversies in nity to withdraw, and their well-being monitored. Fulfilling all 7 require- clinical research, such as clinical ments is necessary and sufficient to make clinical research ethical. These research in developing countries,9-13 requirements are universal, although they must be adapted to the health, the use of placebos,14-16 phase 1 re- economic, cultural, and technological conditions in which clinical research search,17-19 protection for communi- is conducted. ties,20-24 and involvement of chil- JAMA. 2000;283:2701-2711 www.jama.com dren,25-29 raise questions not of informed consent, but of the ethics of subject se- THE 7 ETHICAL For the past 50 years, the main sources lection, appropriate risk-benefit ratios, REQUIREMENTS of guidance on the ethical conduct of and the value of research to society. Since The overarching objective of clinical re- clinical research have been the Nurem- obtaining informed consent does not en- search is to develop generalizable berg Code,35 Declaration of Helsinki,36 sure ethical research, it is imperative to knowledge to improve health and/or in- Belmont Report,37 International Ethical have a systematic and coherent frame- crease understanding of human biol- Guidelines for Biomedical Research In- work for evaluating clinical studies that ogy30,31; subjects who participate are the volving Human Subjects,38 and similar incorporates all relevant ethical consid- means to securing such knowledge.32 documents (TABLE 1). However, many erations. By placing some people at risk of harm of these documents were written in re- In this article, we delineate 7 require- for the good of others, clinical re- sponse to specific events and to avoid fu- ments that provide such a framework by search has the potential for exploita- ture scandals.50,51 By focusing on the in- synthesizing traditional codes, declara- tion of human subjects.33,34 Ethical re- stigating issues, these guidelines tend to tions, and relevant literature on the eth- quirements for clinical research aim to ics of research with human subjects. This minimize the possibility of exploita- Author Affiliations: Department of Clinical Bioeth- ics, Warren G. Magnuson Clinical Center, National In- framework should help guide the ethi- tion by ensuring that research sub- stitutes of Health, Bethesda, Md. cal development and evaluation of clini- jects are not merely used but are treated Corresponding Author and Reprints: Christine Grady, PhD, Warren G. Magnuson Clinical Center, Bldg 10, cal studies by investigators, IRB mem- with respect while they contribute to Room 1C118, National Institutes of Health, Bethesda, bers, funders, and others. the social good.30 MD 20892-1156 (e-mail: [email protected]). ©2000 American Medical Association. All rights reserved. (Reprinted) JAMA, May 24/31, 2000—Vol 283, No. 20 2701 Downloaded from www.jama.com at Dartmouth College, on September 19, 2006 ETHICAL REQUIREMENTS FOR CLINICAL RESEARCH emphasize certain ethical requirements peutic and nontherapeutic research that large-scale trials of vaccines and drugs.” while eliding others. For instance, the is rejected or not noted by other docu- The CIOMS guidelines lack a separate Nuremberg Code35 was part of the judi- ments.30,52 The Belmont Report37 was section devoted to risk-benefit ratios, al- cial decision condemning the atrocities meant to provide broad principles that though the council considers this issue of the Nazi physicians and so focused on could be used to generate specific rules in commentary on other guidelines. It the need for consent and a favorable risk- and regulations in response to US re- also includes a section on compensa- benefit ratio but makes no mention of fair search scandals such as Tuskegee53 and tion for research injuries not found in subject selection or independent re- Willowbrook.54,55 It focuses on in- other documents. Because the Advisory view. The Declaration of Helsinki36 was formed consent, favorable risk-benefit ra- Committee on Human Radiation Experi- developed to remedy perceived lacunae tio, and the need to ensure that vulner- ments was responding to covert radia- in the Nuremberg Code, especially as re- able populations are not targeted for risky tion experiments, avoiding deception was lated to physicians conducting research research. The Council for International among its 6 ethical standards and rules; with patients, and so focuses on favor- Organizations of Medical Sciences most other major documents do not able risk-benefit ratio and independent (CIOMS) guidelines38 were intended to highlight this.56 This advisory commit- review; the Declaration of Helsinki also apply the Declaration of Helsinki “in de- tee claims that its ethical standards are emphasizes a distinction between thera- veloping countries...[particularly for] general, but acknowledges that its choices were related to the specific cir- cumstances that occasioned the re- Table 1. Selected Guidelines on the Ethics of Biomedical Research With Human Subjects* port.56 Finally some tensions, if not Guideline Source Year and Revisions outright contradictions, exist among Fundamental the provisions of the various guide- Nuremberg Code35 Nuremberg Military Tribunal 1947 lines.5,19,30,51,52,57,58 Absent a universally ap- decision in United States v Brandt plicable ethical framework, investiga- Declaration of Helsinki36 World Medical Association 1964, 1975, 1983, tors, IRB members, funders, and others 1989, 1996 lack coherent guidance on determining Belmont Report37 National Commission for the 1979 whether specific clinical research pro- Protection of Human Subjects of Biomedical and Behavioral tocols are ethical. Research There are 7 requirements that pro- International Ethical Guidelines for Council for International Proposed in 1982; vide a systematic and coherent frame- Biomedical Research Involving Organizations of Medical revised, 1993 work for determining whether clinical re- Human Subjects38 Sciences in collaboration with World Health Organization search is ethical (TABLE 2). These Other requirements are listed in chronologi- 45 CFR 46, Common Rule8 US Department of Health and DHHS guidelines in cal order from the conception of the re- Human Services (DHHS) and 1981; Common search to its formulation and implemen- other US federal agencies Rule, 1991 tation. They are meant to guide the Guidelines for Good Clinical World Health Organization 1995 Practice for Trials on ethical development, implementation, Pharmaceutical Products42 and review of individual clinical proto- Good Clinical Practice: International Conference on 1996 cols. These 7 requirements are in- Consolidated Guidance44 Harmonisation of Technical Requirements for Registration of tended to elucidate the ethical stan- Pharmaceuticals for Human Use dards specific for clinical research and Convention on Human Rights and Council of Europe 1997 assume general ethical obligations, such Biomedicine43 as intellectual honesty and responsibil- Guidelines and Recommendations European Forum for Good 1997 ity. While none of the traditional ethi- for European Ethics Clinical Practice Committees45 cal guidelines on clinical research ex- Medical Research Council Medical Research Council, 1998 plicitly includes all 7 requirements, these Guidelines for Good Clinical United Kingdom requirements systematically elucidate the Practice in Clinical Trials46 fundamental protections embedded in Guidelines for the Conduct of Uganda National Council for 1998 Health
Load more

Recommended publications
  • Occupational Therapy Code of Ethics and Ethics Standards (2010)
    Occupational Therapy Code of Ethics and Ethics Standards (2010) PREAMBLE The American Occupational Therapy Association (AOTA) Occupational Therapy Code of Ethics and Ethics Standards (2010) ("Code and Ethics Standards") is a public statement of principles used to promote and maintain high standards of conduct within the profession. Members of AOTA are committed to promoting inclusion, diversity, independence, and safety for all recipients in various stages of life, health, and illness and to empower all beneficiaries of occupational therapy. This commitment extends beyond service recipients to include professional colleagues, students, educators, businesses, and the community. Fundamental to the mission of the occupational therapy profession is the therapeutic use of everyday life activities (occupations) with individuals or groups for the purpose of participation in roles and situations in home, school, workplace, community, and other settings. "Occupational therapy addresses the physical, cognitive, psychosocial, sensory, and other aspects of performance in a variety of contexts to support engagement in everyday life activities that affect health, well being, and quality of life" AOTA, 2004). Occupational therapy personnel have an ethical responsibility primarily to recipients of service and secondarily to society. The Occupational Therapy Code of Ethics and Ethics Standards (2010) was tailored to address the most prevalent ethical concerns of the profession in education, research, and practice. The concerns of stakeholders including the public, consumers, students, colleagues, employers, research participants, researchers, educators, and practitioners were addressed in the creation of this document. A review of issues raised in ethics cases, member questions related to ethics, and content of other professional codes of ethics were utilized to ensure that the revised document is applicable to occupational therapists, occupational therapy assistants, and students in all roles.
    [Show full text]
  • Biobanks for Europe
    KI-NA-25-302-EN-C This expert group report on the ethical and regulatory challenges of international biobank research has been authored by an interdisciplinary group with experts from science, law, governance and ethics. Biobanks for Biobank research is rapidly evolving, and in close interaction with developments in informatics and genomics. The size and breath of the collections of biological samples and associated data that can be Europe assembled has increased exponentially. This opens up a vast range of new options for research and diagnosis, but at the same time also holds an important challenge for the governance of these activities. In this report, the expert group makes speci c recommendations for good A Challenge for Governance governance of Biobanks Research and Innovation policy Research and Innovation ed205134cover_BAT.indd 1-3 11/06/12 09:14 How to obtain EU publications Free publications: • via EU Bookshop (http://bookshop.europa.eu); • at the European Union’s representations or delegations. You can obtain their contact details on the Internet (http://ec.europa.eu) or by sending a fax to +352 2929-42758. Priced publications: • via EU Bookshop (http://bookshop.europa.eu). Priced subscriptions (e.g. annual series of the O cial Journal of the European Union and reports of cases before the Court of Justice of the European Union): • via one of the sales agents of the Publications O ce of the European Union (http://publications.europa.eu/others/agents/index_en.htm). EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B — European Research Area Unit B6 — Ethics and gender Contact: Lino PAULA European Commission B-1049 Brussels E-mail: [email protected] ed205134cover_BAT.indd 4-6 11/06/12 09:14 EUROPEAN COMMISSION Biobanks for Europe A challenge for governance Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research Chair: Herbert Gottweis Rapporteur: Jane Kaye Members: Fabrizia Bignami, Emmanuelle Rial-Sebbag, Roberto Lattanzi, Milan Macek Jr.
    [Show full text]
  • A Comparison of Two Bioethical Theories
    A Comparison of Two Bioethical Theories A thesis presented to the faculty of the College of Arts and Sciences of Ohio University In partial fulfillment of the requirements for the degree Master of Arts Gavin G. Enck June 2009 © 2009 Gavin G. Enck. All Rights Reserved. 2 This thesis titled A Comparison of Two Bioethical Theories by GAVIN G. ENCK has been approved for the Department of Philosophy and the College of Arts and Sciences by Arthur Zucker Associate Professor of Philosophy Benjamin M. Ogles Dean, College of Arts and Sciences 3 ABSTRACT ENCK, GAVIN G., M.A., June 2009, Philosophy A Comparison of Two Bioethical Theories (81 pp.) Director of Thesis: Arthur Zucker This thesis compares two bioethical theories in order to determine which theory is better for use by medical professionals. The two theories are Tom L. Beauchamp and James Childress’s “Principlism” and Bernard Gert, K. Danner Clouser, and Charles M. Culver’s “Moral Rules.” The structure of the paper is as follows: an explication of both theories, an examination of the similarities and differences between the theories, an evaluation of criticisms of both theories, and identification of the three advantages the Moral Rules theory has over Principlism. In the conclusion, I claim the Moral Rules is the better bioethical theory for the medical profession. Approved: _____________________________________________________________ Arthur Zucker Associate Professor of Philosophy 4 TABLE OF CONTENTS Page Abstract ..............................................................................................................................
    [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]
  • Revised Ethical Guidelines in Indian Biobanking
    Revised Ethical Guidelines In Indian Biobanking: Do We Need To Downregulate the Proposed Frameworks? Juhi Tayal1, Anurag Mehta2 and Alok Kumar1 1 Biorepository, Department of Research, Rajiv Gandhi Cancer Institute and Research Centre, India 2 Department of Laboratory Sciences and Molecular Diagnostics, RGCI&RC, India 1,2 Sec-5,Rohini, New Delhi, India-110085 Email: [email protected]/ [email protected] BACKGROUND Guideline for Indian Biobanks ABSTRACT • Clinical biobanks are gaining popularity in India and are also revolutionizing research. Indian • Biomedical research in India has revolutionized with the changing times. This Council for Medical Research(ICMR),Council for Scientific and Industrial Research (CSIR) and paradigm shift has not only bought greater complexities but also greater Department of Biotechnology (DBT) are the major agencies supporting research in India. The ICMR responsibilities for policy makers ,researchers and stakeholders. The is the national organization and also the apex body for developing ethical frameworks and guidelines advancement is not limited to basic research or clinical research ,it has now and also enforcing them. The ICMR issued the Policy Statement on Ethical Considerations Involved taken a foothold into Digital imaging and Artificial intelligence platforms as in Research on Human Subjects in 1980. Due to rapid advancement in biomedical sciences new well. ethical dimensions have emerged and nesseciated the updation of these guidelines time and again in • The aim of policy makers worldover was to safeguard four basic ethical 2000,2003, 2013 and very recently in 2017. The revision has introduced many new sections and principles for research involving human subjects: respect for persons, also revamped the existing sections .A new Section 11 was dedicated to Biological materials, beneficence, non-maleficence and justice.
    [Show full text]
  • Medical Ethical Aspects
    MEDICAL ETHICAL ASPECTS Eric van Roon – September 30 2017 – EAHP Academy Seminar CONFLICT OF INTEREST THERE ARE NO CONFLICTS OF INTEREST TO DECLARE QUESTIONS - Yes or no: respect for autonomy, non-maleficence, beneficence and justice are the four principles for bioethics? - Yes or no: the framework of biomedical ethics is defined sharply - Yes or no: methodological issues may be grounds for non-accceptance of a study protocol for a research ethics committee ETHICAL DILEMMA - For a birthday you give a friend a ticket for the national lottery - You bought a ticket for yourself also - The next day you see that your friend forgot to take the ticket home - You won’t see your friend for the next two weeks - Before you can hand over the given ticket, the ticket of your friend receives a price of 150,000 EURO in the lottery; your ticket does not receive a price - Your friend doesn’t know the lottery results nor the number of the ticket you gave - What do you do? ETHICS Ethics: the discipline dealing with what is good and bad and with moral duty and obligation 1 1. https://www.merriam-webster.com/dictionary/ethic (Visited July 3 2017 BIOETHICS - Application of ethics to the field of medicine, healthcare, biotechnology and ecology - No absolute standards - Standards are developed in time BIOETHICAL PRINCIPLES A.k.a. Georgetown mantra - Respect for autonomy - Non-maleficence - Beneficence - Justice http://medanth.wikispaces.com/Bioethics (visited July 3 2017) RESPECT FOR AUTONOMY - Right tot self-rule - Free from both ­ controlling interference by others and ­ from limitations, such as inadequate understanding, that prevent meaningful choice.
    [Show full text]
  • Principles — Respect, Justice, Nonmaleficence, Beneficence
    Principles — Respect, Justice, Nonmaleficence, Beneficence The focus of this perspective is on the four PRINCIPLES supported by or compromised by the question or issue at hand. Philosophers Tom Beauchamp and Jim Childress identify four principles that form a commonly held set of pillars for moral life. Respect for Persons/Autonomy Acknowledge a person’s right to make choices, to hold views, and to take actions based on personal values and beliefs Justice Treat others equitably, distribute benefits/burdens fairly. Nonmaleficence (do no harm) Obligation not to inflict harm intentionally; In medical ethics, the physician’s guiding maxim is “First, do no harm.” Beneficence (do good) Provide benefits to persons and contribute to their welfare. Refers to an action done for the benefit of others. • Draws on principles or pillars that are a part of American life – familiar to most people, although not by their philosophical term • Compatible with both outcome-based and duty-based theories (respect for persons and justice are duty-based, while nonmaleficence and beneficence are outcome-based). • Provides useful and fairly specific action guidelines • Offers an approach that is appropriate for general bioethics and clinical ethics • Requires weighing and balancing – flexible, responsive to particular situations • Lacks a unifying moral theory that ties the principles together to provide guidelines • Principles can conflict and the theory provides no decision-making procedure to resolve these conflicts • Difficult to weigh and balance various principles • Autonomy in some cultures refers to individual autonomy, while in others refers to group/family/community autonomy Adapted with permission from Laura Bishop, Ph.D., Kennedy Institute of Ethics, Georgetown University 21.
    [Show full text]
  • EXAM QUESTIONS & ANSWERS LEGAL MEDICINE & MEDICAL Ethics Prepared by Prof. Ahmed Ammar
    EXAM QUESTIONS & ANSWERS LEGAL MEDICINE & MEDICAL ETHICs Prepared by Prof. Ahmed Ammar Arab Board, Bio-Ethics (medical Ethics questions) First part. Bioethics (general medical ethics) 1. The full version of the ‘Ought Implies ‘Can’ principle is ... a. Ought implies can, only when you can b. Ought implies can, and can not* c. Ought implies can (that’s it; what more do you want!) d. Ought implies can, and can implies ought e. Ought implies ought, and can implies can 2. Autonomy is one of the main principles of bioethics , which mean: a. Selfishness b. The right to be selfish c. Self-awareness d. Self-promotion e. Self-governance * 3. The four medical ethics principles which shared between Values Based Medicine and the principles of ethics, explained by Beauchamp and Childress are: a. Autonomy, privacy, respect, and confidentiality b. Veracity, privacy, beneficence, and nonmaleficence c. Autonomy, nonmaleficence, beneficence, and justice * d. Veracity, privacy, confidentiality, and fidelity e. Autonomy, veracity, nonmaleficence, and beneficence 4. Which of the following ethical issues form the foremost part of Hippocratic Oath? a. Confidentiality * b. Sexual boundaries c. Advertising d. Bribery e. Doctor’s rights 1 5. Paternalism among doctors is not an ethical attitude because it conflicts with a. Patient’s medical care b. Doctors’ tasks and duties c. Patient’s autonomy* d. Doctor’s autonomy e. Patient’s family rights 6. The concept of justice in ethics is: a. an obligation of the patient to the society. b. that the health resources must be distributed according to the principals of equity.* c. taken as patients right to choose or refuse treatment.
    [Show full text]
  • Overview of Ethics of Clinical Research, Ethical Principles & Requirements
    Overview of Ethics of Clinical Research, Ethical Principles & Requirements MREC 1 Protecting Human Research Subjects Four Presentations on Clinical Research Ethics # Presentation titles 1 Overview of research ethics • Historical origin & development • Three fundamental ethical principles • What makes clinical research ethical? 2 Procedure for protecting human research subjects: IRB/IEC review 3 Procedure for protecting human research subjects: Informed consent 4 Some ethical problems in clinical research & Research misconduct MREC Protecting Human Research Subjects What is a Human Subject? a living individual about whom an investigator conducting research obtains 1. Data through intervention or interaction with the individual, or 2. Identifiable private information MREC Protecting Human Research Subjects Definition of a Clinical Trial? WHO any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes NIH A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes. GCP MREC Protecting Human Research Subjects What is Intervention? NIH manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioural processes and/or endpoints. MREC Protecting Human Research Subjects What
    [Show full text]
  • Establishing an Institutional Review Board (IRB): Procedures and Resources
    JUSTICE RESEARCH AND STATISTICS ASSOCIATION Establishing an Institutional Review Board (IRB): Procedures and Resources Stan Orchowsky, Ph.D. February 2007 (rev. May 2014) A. IRB Overview 1. All Federally-funded research must comply with regulations designed to protect human subjects and ensure confidentiality of data. These regulations are set forth in Title 45, Part 46 (“Protection of Human Subjects”) of the Code of Federal Regulations (abbreviated as 45 CFR 46). The regulations are promulgated by the Department of Health and Human Services (DHHS), and overseen by DHHS’s Office for Human Research Protections (OHRP). 2. 45 CFR 46 spells out: (1) definitions of “research” and “human subjects;” policy exemptions; requirements for Institutional Review Boards (IRBs); and requirements for informed consent (this is all contained in Subpart A). The regulations in Subpart A are also known as “The Common Rule” because they have been adopted by a number of Federal agencies; the Department of Justice’s version is found in 28 CFR 46. The DHHS regulation also provides additional protections for three special groups involved in research: (1) pregnant women, human fetuses and neonates (Subpart B); (2) biomedical and behavior research involving prisoners (Subpart C); and (3) children (Subpart D). Also relevant are the Justice Department’s requirements for confidentiality of identifiable research and statistical information, contained in 28 CFR 22. B. What Does the IRB Review? 1. Any research involving human subjects must be reviewed by an IRB. The exemptions are research in educational settings, research involving educational tests, surveys or interviews with elected or appointed public officials, provided the information is kept confidential; research involving the collection or study of existing data or records if the data are publicly available or if the information does not include subject identifiers.
    [Show full text]
  • The Ethical and Legal Regulation of Human Tissue and Biobank Research Across the 27 European Member States Plus Switzerland
    uman tissue and biobank research is of increasing importance for Katharina Beier, Hunderstanding the causes of widespread diseases and developing Silvia Schnorrer, effective therapies. However, while the success of biobank research depends Nils Hoppe, on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective Christian Lenk (eds.) of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across The Ethical and different countries. Moreover, the lack of comprehensive supranational Legal Regulation of regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was Human Tissue and one of the aims of the EU-funded Tiss.EU project (“Evaluation of Legislation Biobank Research and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis”) in Europe to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The Proceedings of the results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of Tiss.EU Project ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project’s results.
    [Show full text]
  • Ethical Issue in Biobanking
    Pearls of Laboratory Medicine Title Pearls of Laboratory Medicine www.traineecouncil.org TITLE: Ethical Issue in Biobanking PRESENTER: Ann M. Gronowski Slide 1: Hello, my name is Ann Gronowski. I am a Professor of Pathology & Immunology and Obstetrics & Gynecology at Washington University School of Medicine. Welcome to this Pearl of Laboratory Medicine on “Ethical Issues in Biobanking.” This Pearl was developed with Gwen Clrake and in collaboration with the IFCC Task Force on Ethics. Slide 2: In order to discuss ethics in biobanking, let’s start first with some basics on biobanking. Biobanks have also been referred to as: biolibraries, biorepository, tissue repositories, biological resource center, genetic databases, or DNA banks. A biobank can be defined as: An entity that receives, stores, processes and/or distributes specimens, as needed. It encompasses the physical location as well as the full range of activities associated with its operation. There are many definitions for biobanks and this one was chosen because it is consistent with a 2016 Pearl on biobanking by Dr. Christina Ellervik. Certainly in medicine there are other banks for instance image banks. These also would need to apply similar sets of principals as outlined here. There are many types of biobanks. There are some that are established for general medical & academic research for instance by a University and the specimens may be available to many researchers. Some may be for specific clinical studies and not generally available to other researchers. Clinical laboratories often have a collection of specimens sent to the laboratory for physician ordered pathology or laboratory testing. These specimens may be retained for long periods.
    [Show full text]