Tam metin için tıklayınız

Abstract
Background
It behoves every national society of clinical laboratory medicine to have a well formulated and publicly accessible policy concerning the morally acceptable way in which its members should practise their profession; such a policy is published as a Code of Ethics.

This Code assists its members in the performance of their duties in relation to the patients they share with other clinicians, within their own particular professional environment and, at large, to the rest of their national society.

Methods and result
The International Federation of Clinical Chemistry and Laboratory Medicine’s (IFCC) Task Force on Ethics here examines a curated selection of extant Codes and provides guidance at the level of definition, structure and procedures to assist national societies and their clinical chemistry and laboratory medicine professionals in the task of crafting their own Ethics Code.

Key words: clinical laboratory, ethics code

Office of the Secretary

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Tam metin için tıklayınız

AGENCY: Department of Health, Education, and Welfare.

ACTION: Notice of Report for Public Comment.

SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution’s Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department’s policy. The Department requests public comment on this recommendation.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Members of the Commission

Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women.
Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University.
Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
Dorothy I. Height, President, National Council of Negro Women, Inc.
Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco.
Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.
Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
*** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
***Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of Pennsylvania.
*** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C.
*** Deceased.
Table of Contents
Ethical Principles and Guidelines for Research Involving Human Subjects
A. Boundaries Between Practice and Research
B. Basic Ethical Principles
Respect for Persons
Beneficence
Justice
C. Applications
Informed Consent
Assessment of Risk and Benefits
Selection of Subjects

Biospecimen research is a prominent investigative strategy that aims to
provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials,
and develop effective, life-saving treatments. However, COVID-19 biospecimen research
raises accompanying ethical concerns and practical challenges for investigators and
participants. In this special article, we discuss the ethical issues that are associated with
autonomy, beneficence, and justice in COVID-19 biospecimen research and describe
strategies to manage the practical challenges, with an emphasis on protecting the rights
and welfare of human research participants during a pandemic response. Appropriate
institutional review board oversight and bioethics guidance for COVID-19 biospecimen
research must maintain their focus on protecting the rights and welfare of research
participants, despite the urgent need for more knowledge about the virus and the threat it
poses to communities and nations.