Chapter 5 - Ethical concerns in research. This chapter includes contents: Historical perspective on ethics, ethical standards for the protection of research participants, basic principles of belmont report, informed consent, protecting vulnerable subjects,...
Trang 1Ethical Concerns in
Research
Trang 2 Nazi Experimentation in WWII
research involving human subjects
Tuskegee Syphilis Study
Human radiation experiments
Trang 3Research Participants
Nuremberg Code (1947) – first set of guidelines
Helsinki Declaration (1964) – medical research
Belmont Report (1979) – fundamental document for current federal regulations in US
Common Rule (1991) – 45 C.F.R. 46
participants in the US
Institutional Review Boards (IRB)
Trang 4 Respect for persons
thus voluntary consent is essential
Beneficence
and minimize possible harm
Justice
fairly distributed
Trang 5 Arguably the most important ethical standard
Refers to telling research participants about all
aspects of the research that might reasonably influence their decision to participate
Four important elements
research project
researcher
Trang 6 Particular precautions must be taken to protect the welfare of subjects that might be considered especially vulnerable or at risk for some reason
The following types of subjects might be
considered to be vulnerable: children,
handicapped, cardiac rehab patients, welfare
recipients, prisoners, pregnant women, patients
in a mental hospital, etc
Trang 7 Privacy – refers to the capacity of individuals to control when and under what conditions others have access to their behaviors, beliefs, and
values
Confidentiality – refers to treating subject
information or responses in a manner so that it is not linked to any specific individual who
participated in a study
Normally addressed through informed consent
Trang 8 IRBs established by federal mandate to assure compliance with governmental regulations
IRBs have authority to approve, require
modifications, or disapprove research
IRB approval required before any aspect of the research involving human subjects may
commence
Trang 9 Exempt from review
Expedited review
Full review
Dependent upon amount of risk present
Trang 10 Risks to subjects are minimized
Risks to subjects are reasonable in relation to
anticipated benefits
Selection of subjects is equitable in relation to the
purpose of the research and its setting
Informed consent will be sought from each prospective
subject or their legal representative
Informed consent will be appropriately documented
Provisions for monitoring data collected to ensure
safety of subjects
Trang 11 Research investigations normally result in some disclosure of the results of the study (e.g.,
paper, published article, presentation)
The preeminent ethical obligation in this regard
is not to disclose inaccurate, deceptive, or
fraudulent research results
To do so undermines the very nature of the
scientific process!
Proper establishment of authorship
Trang 12 According to the U.S. Public Health Service . .
plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research
Trang 13 Researcher is responsible for his/her subjects
Researcher is responsible for his/her own actions and those of any research aides
Subjects must provide informed consent
Researcher protects subjects from harm, danger, and discomfort
Maintain anonymity and confidentiality
Subjects should not be coerced
Researcher has responsibility after the investigation is complete to safeguard subject data
Honest disclosure of results