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Assignment: Salient Ethical Issues
Assignment: Salient Ethical Issues
- Analyze salient ethical issues in psychiatric mental health practice
- Compare ethical dilemmas with state health laws and regulations
- Analyze ethical decision-making processes
- Review literature for moral/ethical issues encountered by a PMHNP.
- Select one of the articles you found that was published within the last 5 years to use as a focus for this assignment
- Write a 2-page paper essay in which you do the following:
- Summarize the moral/ethical issue in the article (no more than 1 paragraph).
- Describe the moral and ethical dilemmas surrounding the issue.
- Analyze the ethical issue and compare them to the state health laws and regulations in your state.
- Outline the process of ethical decision making you would use to address this ethical dilemma..
Biomedical research is carried out with the goal of gathering and analyzing data in order to make generalizable findings that can help improve the care of currently unknown beneficiaries in the future.
The primary function of human participants in research is to provide needed data.
This is not the case in clinical medicine, when diagnostic or therapeutic measures are recommended or carried out purely for the benefit of the current patient.
As a result, while many ethical issues in research and clinical medicine overlap, ethical considerations in human subjects research are distinct from those that arise in diagnostic and therapeutic settings.
Beneficience (doing good), nonmaleficence (preventing or mitigating harm), fidelity and trust within the fiduciary investigator/participant relationship, personal dignity, and autonomy pertaining to both informed, voluntary, competent decision making and the privacy of personal information are the most salient ethical values implicated by the use of human participants in research.
An complex regulatory structure governing human subjects research addresses these (and other) ethical problems.
The historical and philosophical context that led to the current American system of governmental command and control regulation in this area has been well documented elsewhere.
Go to: Regulatory Oversight in the United States
The federal Department of Health and Human Services (DHHS) published regulations governing the conduct of biomedical research involving human participants in 1981, based largely on the recommendations of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (the Belmont Commission), which was established by the 1974 National Research Act (at that time, the Department of Health, Education and Welfare).
Most research-conducting health-care organizations in the United States have now committed to implement these federal rules to all of their research protocols, regardless of the study’s funding source.
DHHS regulations, as updated, have also been adopted as a Common Rule by a number of other federal agencies to protect human participants in any research program that those agencies support.
The federal Food and Drug Administration (FDA)7 regulates research involving the testing of experimental pharmaceuticals or medical devices at the same time as the Common Rule; the Common Rule and FDA standards are similar but not identical.
An institutional review board (IRB) recognized by the federal Office of Human Research Protections (OHRP) within the Office of the Secretary, DHHS, must assess and approve research that falls under the Common Rule or FDA rules, or both.
Following then, the research activity is subject to ongoing IRB scrutiny and, at the very least, annual reapproval.
The IRB must assess that each of the following requirements is met before it can approve (or renew) a protocol:
Subjects’ physical and psychological hazards are kept to a minimum.
Physical and psychological hazards to individuals are tolerable when weighed against the predicted benefits to those subjects and the value of the resulting general knowledge.
The subjects are chosen fairly.
The following items will be presented to potential participants or their authorized surrogates in order to acquire informed consent:
– the research’s objectives, projected duration, and nature of any treatments or experiments;
– expected hazards and advantages of involvement in the research protocol, as well as feasible alternatives to participation;
– provisions pertaining to the confidentiality of research records;
– any recompense and/or therapy provided for injuries resulting from research;
– the right to choose whether or not to participate, as well as the ability to stop participating at any moment without consequence.
Informed consent will be properly documented.
The regulatory provisions for informed consent in research are essentially a codification and expansion of the therapeutic informed consent doctrine8 created by the courts in the United States.
In addition to federal regulation, some states have established legislation that provides protections for human participants and requires some form of prior assessment and oversight.
The content of these state statutes varies.
In addition, an individual participant may file a private civil case against researchers and protocol sponsors for violations of common law tort standards of care (medical malpractice) in the conduct of research involving and affecting that person.
Visit Tissue Specimens for further information.
Applications in research
“Human biological specimens have been the foundation of pathological study ever since Rudolf Virchow propounded the cellular basis of disease in 1858,” Hakimian and Korn11 wrote.
Human tissue research now provides unique and increasingly sophisticated molecular and genomic insights that are gradually illuminating the detailed processes and pathways of human disease.”
Individuals who are either having non-experimental diagnostic or therapeutic interventions for a medical concern, or who are currently participating in a different research protocol, may be asked for tissue specimens expressly for use in a current study protocol.
In addition, patients or present research participants are increasingly being asked to donate biological tissue for preservation and possible use in the future as part of human genetic studies whose particular details are unknown or unknown.
It has been suggested that genetic examination of human tissue samples could yield extremely helpful information about the genetic causes of human disease.
“Both the number of known target genes and the methods for rapid and inexpensive genetic analysis are expanding, as is our knowledge of the intricacy of the genetic linkages of common diseases,” according to the Human Genome Project.
Complex disorders involving many different genes will necessitate the analysis of massive volumes of data on the genotypes and phenotypes of many people.
Researchers in the United States and throughout the world are excited about the prospect of building massive database systems to contain the human tissues collected to offer this potentially valuable genetic material.
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