NURS 2031H Chapter Notes - Chapter 5: Syphilis, United States Public Health Service, Diminished Responsibility
26 Jun 2018
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CH 5: Applied Ethics in Health Sciences Research
Health Research Methods
Ethics and 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 across geographic groups and eras and are thus considered to be relative to
cultures, time, and place.
- 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)
oThis is challenging: the challenge is to develop an ethics of research that can be
applied with consideration of morally relevant contextual factors without
reverting to moral relativism.
oEthics differs from the law, guidelines, and regulation, although law, guidelines
and regulation of conduct should ideally be based on ethical considerations.
oThe challenge for ethics is to formulate justifiable arguments for human conduct
generally for research specifically.
- 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 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)
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- 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.
Requirements for Ethical Research
- 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 in the course of
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.
- In order 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
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