Ethics (W1/L2)
FDA's definition of a human subject (Protection of Human Subjects 2014)
"An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient."
According to the Common Rule (Protection of Human Subjects 2009) Research means ...
"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
The Uniform Requirements consists of 9 sections, only the ... of which is relevant for this discussion.
2
uIt is the first time in the history of bioethics that Member States committed themselves and the international community to respect and apply such fundamental principles.
2005, the Universal Declaration on Bioethics and Human Rights
The definitions of human subjects and research are provided within
Common Rule
Physicians from the WMA were appalled at the atrocities revealed at the Nuremberg Trial and, in 1949, issued a code of medical ethics to condemn what Nazi doctors had done. This code came to be known as ...
Declaration of Geneva
Ethical Principles for Medical Research Involving Human Subjects, was approved in 1964 is known as
Declaration of Helsinki.
the Belmont Report in 1979 is entitled
Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
... are established in scientific research groups and hospitals to review study protocols and protect patient interests, to ensure that participants are fully informed
Institutional review boards (IRBs)
The current ethical and legal framework for conducting human subjects research evolved from the...
Nuremberg Code
Declaration of Helsinki (Paragraph 29 and 30 : outlines)
Paragraph 29 asserts that new treatments should be tested against standard treatment; thus proscribing the use of placebo-controlled studies when a known treatment exists. This statement was clarified to allow exceptions in cases where a placebo is "scientifically" necessary to evaluate a treatment or when the condition being investigated is "minor" and a placebo does not entail additional risks to the subject. Paragraph 30 states that, at study conclusion, all participants should be assured access to the "best" treatment as identified in the study.
Nuremberg Code
a set of guidelines developed after the Second World War in response to the atrocities committed by Nazi researchers.
Conducted by Public Health Service
Tuskegee Study of Untreated Syphilis in the Negro Male (1932-1972
the National Research Act was done because of
Tuskegee Study of Untreated Syphilis in the Negro Male (1932-1972
In 2003, official statements of the Vancouver Group were incorporated into the .... , resulting in the current, 2004, edition.
Uniform Requirements
the International Committee of Medical Journal Editors known as
Vancouver Group
the Universal Declaration on Bioethics and Human Rights
addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions, and states fundamental principles that are relevant from a global perspective.
The Beecher Paper
as U.S. courts reject evidence obtained unconstitutionally—even if it is useful justice—journal editors should reject papers with information obtained unethicall
The second section of The Uniform Requirements, entitled "Ethical Considerations in the Conduct and Reporting of Research," is broken into 6 subsections:
authorship, editorial obligations, peer review, conflicts of interest, privacy and confidentiality, and human/animal protections.
Respect for persons refers to
autonomy of subject and Informed consent. It also involves allowing subjects to leave the research at any point if they decide to do so.
Declaration of Helsinki (1964) was adopted to ...
clarify a physician's duties as an investigator
Declaration of Helsinki (Section B: outlines).
discusses basic principles for medical research and reaffirms points of the Nuremberg Code—such as the need for basing a human trial rationally on available evidence. u It states that potential subjects should only give consent after being fully informed of the study's setup, goals, and sources of funding; potential conflicts of interest; researcher affiliation(s); risks and benefits; and their right to withdraw. u Only populations likely to benefit from the research should be targeted for recruitment, and vulnerable populations should not be used when other populations are available and appropriate. u Furthermore, populations requiring a third party to give informed consent (because they are unable) should give assent instead (thereby agreeing to participate even if not able to be fully informed).
Declaration of Helsinki (Section C: outlines).
discusses research combined with medical care and states that research can only be combined with clinical care if it has the potential to prophylax, diagnose, or treat. In these cases, subjects must be made aware what aspects of their care are experimental. Experimental care may be offered to individuals outside a formal research study if standard care has been ineffective for their condition. This section also contains the 2 most controversial statements in the document: Paragraphs 29 and 30.
the Universal Declaration on Bioethics and Human Rights has furthermore inspired Member States to
establish national bioethics committees and to take legislative measures to give effect to the principles included in the Declaration.
Declaration of Geneva's (1948) main uniqueness is
general principles to which physicians should hold themselves. For example, "the health of my patients will be my first consideration
Regarding privacy and confidentiality, participants in studies should not be ... in the resulting article.
identifiable
The Belmont Report emphasizes three ethical principles, which are ...
respect for persons, beneficence, and justice
Declaration of Helsinki (Section A: outlines)
sets the stage of what human research is and why it is necessary and stresses the obligation of the physician to prioritize participant health. This section reminds physicians that special populations involved in research must be closely monitored.
If there is a potential for identification—through a photo or pedigree and so on—the individual should be ...
shown the article and asked for consent to publish.
The National Research Act led to the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which drafted ... . The report is entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
the Belmont Report in 1979
The Belmont Report also provided the conceptual foundation for ... , which governs how federally funded human subjects research must be conducted and reviewed
the Common Rule
The idea that medical journal editors are a final common pathway in the evaluation of a study's ethics was later adopted by
the International Committee of Medical Journal Editors
The National Research Act led to the formation of ... , which drafted the Belmont Report in 1979. The report is entitled 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
Because of concerns that American citizens were being mistreated in research, the U.S. government in 1974 ratified ...
the National Research Act
... .... are the basis for the Code of Federal Regulations Title 45 Part 46, which are the regulations issued by the United States Department of Health and Human Services governing federally funded human subjects research in the United States.
the Nuremberg Code and the related Declaration of Helsinki
in 1974 Within the US Department of Health and Human Services, ... was established to oversee clinical trials.
the Office for Human Research Protections (OHRP)
The Vancouver Group publishes
the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, which was completely revised in 1997 and updated in 1999, 2000, and 2001
In October 2005, the General Conference of UNESCO adopted by acclamation ...
the Universal Declaration on Bioethics and Human Rights
Justice requires that
the benefits and burdens of research be distributed fairly. For example, although it may be relatively easy to recruit a particular subset of the population for a study, such as homeless people, taking advantage of that group or excluding other potential groups of subjects might violate the principle of justice.
The Common Rule (45 CFR 46)
the regulation to which numerous U.S. federal agencies are signatory, including the Department of Defense, the Department of Energy, the Department of Health and Human Services, and the National Science Foundation (NSF).
Conflict of interest
they may indicate a potential for biased results
Beneficence obligates researchers
to "maximize possible benefits and minimize possible harms."
The Association's foremost goal for the Declaration of Helsinki was ...
to address ethical complexities associated with conducting human subjects research internationally.