In medicine, there are four core ethical tenets:
-Beneficence
-Nonmaleficence
-Autonomy
-Justice
Nonmaleficence
The obligation to avoid treatments or interventions in which the potential for harm outweighs the potential for benefit
Autonomy
The responsibility to respect patients’ decisions and choices about their own healthcare
Justice
The responsibility to treat similar patients with similar care, and to distribute healthcare resources fairly.
The Belmont Report delineates the three necessary pillars of research ethics:
-Respect for persons
-Justice
-Beneficence
Respect for persons requires ...
-requires honesty between the subject and the researcher
-generally prohibits deception
-requires informed consent
-requires respect of vulnerable persons
-generally ensures confidentiality
-prohibits coercion
Informed consent
Respect for persons also includes the process of informed consent, in which a patient must be adequately counseled on the procedures, risks and benefits, and goals of a study to make a knowledgeable decision about whether or not to participate in the study. Further, the investigator cannot exert a coercive influence over the subjects, or they will not be acting autonomously. The subject may withdraw consent that was previously granted at any time.
In an ethical study, consent can be _____.
withdrawn at any time
Many older studies ...
... did not abide by respect for persons.
Institutional review boards
A committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans.
Vulnerable persons (with examples)
Vulnerable persons, which include children, pregnant women, and prisoners, require special protections above and beyond those taken with the general population.
Confidentiality
Confidentiality involves a set of rules or a promise usually executed through confidentiality agreements that limits the access or places restrictions on certain types of information.
Tuskegee syphilis experiment
The Tuskegee syphilis experiment (formally known as the Tuskegee Study of Untreated Syphilis in the Negro Male) was a notorious forty-year study (1932–1972) by the United States Public Health Service that was fraught with extreme violations of the ethical principle of respect for persons. In this study, poor African-American men were enrolled into a study on the natural progression of syphilis. These men were given sham treatments, barred from accessing appropriate healthcare, and repeatedly deceived by investigators—including the fact that they were never told they had syphilis! This study was so significant in bioethical history that it is actually considered the primary impetus for the writing of the Belmont Report.
What was the main experiment leading to the Belmont Report?
Tuskegee syphilis experiment
Morally relevant differences
Morally relevant differences are defined as those differences between individuals that are considered an appropriate reason to treat them differently.
What are generally not considered morally relevant differences?
Race, ethnicity, sexual orientation, and financial status are generally not considered morally relevant differences.
It should be noted that religion may or may not be a valid moral criterion, depending on the context; for example, certain interventions that are prohibited by a given religion are grounds to avoid that treatment in an individual of that religion—this is in keeping with patient autonomy.
Justice in research applies to both the _____ and the _____.
selection of a research topic
execution of the research
What are generally considered morally relevant differences?
-Age is a significant moral difference in ethical deliberations: all else being equal, a transplant that is as likely to benefit a young child or an elderly adult might be given to the child because of a longer life expectancy.
-Population size is often morally relevant in study design because a study that impacts a large population will generally have more potential to do good than one that impacts a small population.
When there is risk associated with a study, it must be _____.
fairly distributed
Sometimes, the population that is most likely to benefit from the study may be required to _____.
bear a greater proportion of the risk
In studies in which there is no perceived difference in the likelihood of benefit between individuals, ...
... all individuals should assume equal risk.
In those studies for which a particular population is most likely to benefit, ...
... that population should assume a higher proportion of risk.
in some cases, such as drug trials, it may necessary to test the intervention in ...
... healthy individuals unaffected by the illness for which the drug has been designed.
This is permissible as long as the potential risks and benefits for the subjects have been addressed through informed consent and respect for persons has been maintained.
Beneficence definition
Beneficence is our intent to cause a net positive change for both the study population and general population, and we must do our best to minimize any potential harms.
Research should be conducted in the least _____.
least invasive, painful, or traumatic way possible
Equipoise
In short, clinical equipoise means that there is genuine uncertainty in the expert medical community over whether a treatment will be beneficial. If it becomes evident that one treatment option is clearly superior before a study is scheduled to finish, the trial must be stopped because providing an inferior treatment is a net harm.