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Chapter 5

NURS 2031H Chapter Notes - Chapter 5: Global Health, Headon, Social Insurance Number


Department
Nursing
Course Code
NURS 2031H
Professor
Ellen Buck McFaden
Chapter
5

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CH 5: Applied Ethics in Health Sciences Research
Health Research Methods
What are Ethics in Health Research?
-Ethics (or moral philosophy): branch of philosophy that is concerned with systematic examination of, and
argumentation for, right and wrong conduct through theories and principles that can be applied universally.
-Morals: the observed ways in which individuals or groups behave.
oVary in different cultures, places and times
-When constructing frameworks and guidelines for ethics in research, the focus is on developing a universal
approach that applies to all research everywhere, rather than allowing different ethical standards in different
places and times.
oThis is important to avoid unethical research that has taken place in the past (i.e. Nazi Germany)
oEthics differs from the law, guidelines, and regulation, although law, guidelines and regulation of
conduct should ideally be based on ethical considerations.
-Two major theories of ethics: several ethical principles can be justified from both dominant theories***
1) Consequentialism (judges actions on the basis of whether they produce good or bad
consequences)
i.e. Utilitarianism: strives to reach a balance between benefits and risks to people in order
to maximize the best outcome for the greatest number of people (focuses on means to
ends).
2) Deontology (judges actions based on whether they are inherently right or wrong actions,
without emphasis on their consequence).
Acts themselves are inherently right or wrong, good or bad in a universal sense, and
requires that every person should be treated as having intrinsic moral value, and thus
treated as an end in themselves and never as the means of achieving good for others.
Lies at the heart of the idea of universal human rights and has greatly influenced ethical
deliberation in research.
-Researchers also need to develop both sensitivity and moral reasoning skills to resolve ethical dilemmas.
oThere is often no obvious single or “correct” answer to an ethical dilemma, it is important to
support whatever position is taken with sound arguments based on a clear knowledge of the facts
of the case and on how universal ethical principles can be justifiably applied.
-The Nuremberg Code: broadcasted in 1949 after the Nuremberg Trials, was the first international
endeavour to instill respect for research subjects and to guide human research. (Figure 5.1 p.83)
-Universal Declaration of Human Rights (1948): provides additional potential protection and extends
respect for human dignity beyond the realm of medical research.
-Prominence given in the 1960’s to ongoing unethical research on humans in prestigious medical schools in
the US and UK, and the public outcry in 1972 on exposure of the 40 yearlong US Public Health Service
Tuskegee study of the natural history of untreated syphilis in a cohort of African-American men, further
boosted interest in regulating human research.
-The World Medical Association’s Declaration of Helsinki in 1964 and many other national and
international guidelines have since facilitated universal approaches to the regulation of human research.
-In Canada, research is defined as “an undertaking that is intended to extend knowledge through a
disciplined inquiry or systematic investigation”.
oThe goals of research ethics are to systematically analyze ethical issues that may arise during
research, to ensure that study participants are protected, and that research is conducted in a way
that served the needs of participants and society at large while avoiding exploitation of vulnerable
persons.
What are the Requirements for Ethical Research?
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-Scientific design of the study and the methodology used should provide the means of answering the
research question, and the researcher should be sufficiently familiar with the design of a research project
and the methods to be used.
-Sample size, inclusion and exclusion criteria, measurable end points, consideration of potential adverse
effects and benefits, and informed consent obtained through an appropriate process –all need to be
considered.
-Need to sensitize researchers to the range of ethical issues that may arise during research on humans
oComplexities of obtaining informed consent in some contexts, maintain confidentiality,
appropriately balancing harms and benefits of research, and avoiding exploitation and conflicts of
interest.
-Guidelines for authorship need to be established to ensure fair treatment of all who contributed to the
generation of new knowledge and to preserve the freedom and integrity of scholarly work.
-For high scientific standards in research to be supplemented by high ethical standards, it is necessary for
researchers to receive some education about research ethics.
-Several procedural requirements also need to be met to ensure appropriate accountability.
-Clinical trials are categorized into four phases:
I. First-in-human trials that raise the most safety concerns because of little or no previous experience
with the intervention in humans.
Usually conducted on a small number of healthy humans to determine the rate at which
the drug is absorbed, excreted, and whether it has toxic effects
Provide early information about the safety of the potential use of the drug or intervention
II. Aim to explore therapeutic efficacy in target patients and to estimate proper dosage for future
studies
The intervention is tested for safety and efficacy on a larger number of individuals with
the disease or condition for whom the new treatment is intended.
III. Participants are randomly assigned to either an experimental or a control group, with the
experimental group receiving the new drug or intervention, while the control group receives either
a placebo or the currently standard treatment.
After a drug is shown to be reasonably effective it enters Phase III trials
Double blinding minimizes bias
The primary objective is to confirm a statistically significant therapeutic benefit of new
drugs and thus provide the scientifically justifiable basis for marketing approval.
IV. Assess long-term safety and effectiveness since earlier trials are of limited duration, and pre-
market clinical trials (phase I to III) normally detect only half of all serious adverse reactions that
eventually come to be associated.
Once an intervention is approved for distribution or marketing, phase IV trials (post-
marketing) may begin.
-What is the problem with clinical trials?
oTherapeutic Misconception: the difficulty in differentiating between clinical research and
clinical treatment.
Regulations Guiding Research in Humans in Canada
-In Canada, the guiding document for all research involving humans is the Tri-Council Policy Statement:
ethical conduct for research involving humans (TCPS).
-According to the document the core principles for conduct of research are:
oRespect for persons;
oConcern for welfare; and
oJustice
-What is respect for persons?
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