Download Chapter 5: Ethics and Responsible Conduct in Research and

Chapter 5
Ethics and Responsible Conduct
in Research and Clinical Practice
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Chapter Overview
• Reinforcement of evidence-based practice’s (EBP)
interconnectedness with ethical codes of conduct in
research and clinical practice.
• Role of culture in the advancement of medical care.
• Belmont Report support of client/patient right to know the
procedures that they will be exposed to or the extent to
which they will be involved as participants.
• Ethical procedures transcend the boundaries of the United
States via international agreements on health, medicine,
and medical research.
• The federal government can intercede to make ethical
guidelines clear and to aid in the advancement of medical
practices.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Two Basic Tenets of Ethical Research
• The majority of ethical and moral considerations in
research and clinical practice have evolved from
two basic tenets:
1. The first obligation is to protect the participant
from physical and psychological injury
(Hippocratic Oath).
2. The benefit (to the participant) of participation
in the research must outweigh any potential
risk (to the participant) associated with
participation.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
General Background: Review
• Research results can offer evidence to support and
validate clinical decisions as well as provide a stimulus
for federal regulatory requirements and institutional
policies made in attempt to provide ethical guidelines
for patient care.
• Ethical codes in the health care profession are
developed and established to protect the patient and
provide a procedural conduct approach for the
practitioner.
• Many ethical standards are legislated into federal or
state law; but the origin, practice, and interpretation of
them are left to those in the specified profession.
• The only way the standard or paradigm of clinical
practice is changed is through the advances of
legitimized research.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Model of Interpretative Practice
• EBP perspective: consideration of experience of the clinician,
the most current research/literature available, and the patient
to determine best clinical practice available
• Clinician
– There is a parity of knowledge that exists within the
diagnosis and treatment of injuries in the medical
community.
• Research/Literature of the Field
– Clinicians must (1) keep up with the current literature and
advances in procedures/techniques and (2) be able to
interpret the literature presented in the journals.
• The Patient
– Should be viewed as an individual with a variety of
emotions, skills, education, religious beliefs, and personal
history/background.
–
Should be educated on the various types of treatments
available and be involved in his or her treatment process.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Ethical Principles and Human
Participation Protections
Informed Consent:
• The researcher needs to lay out the protocol of the
experiment to the participant; inform them on the
benefits, obligations, and any potential risks
• Consent forms have to be extremely explicit in their
language, and must clearly state the roles in the
study.
• Participants must to be informed of confidentiality
issues.
• The informed consent form is in fact a contract
between the participant and the researcher.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
National and International Practices
The Belmont Report
• Originated from the Department of Health, Education,
and Welfare [HEW]; lays down the guidelines for the
protection of human subjects used in research
• Covers three areas of ethical principles and conduct of
behavior in research:
1. Boundaries between practice and research
2. Basic ethical principles
3. Application of these principles in doing research
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Boundaries Between Practice and Research
1. Boundaries between practice and research:
• The Belmont Report necessitates the separation and
differentiation of the definitions of practice and
research.
– Practice—Refers to a practitioner adjusting or
slightly deviating from the standard protocol of
treatment to help an individual client or patient.
– Research—Refers to a rigidly designed protocol
that needs to be tested or is being tested. The
goal is to develop a hypothesis and to contribute
to the body of knowledge in the field.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Basic Ethical Principles
and Application to Research
2. Basic ethical principles:
– Outlines the justifications for applying codes of
conduct while proceeding forward with research on
human subjects.
3. Application of these principles in doing research:
Respect for persons
– Recognizes that individuals should not be
pressured into doing something that they feel
uncomfortable doing or that violates their own
personal belief system.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Application of These Principles to Do
Research
Beneficence:
– Refers to the ability of the practitioner to secure and
stabilize the well-being of the client while that client is
receiving treatments or involved in a research project.
– The client should receive the maximum benefit from
participation in the study while simultaneously
minimizing his or her exposure to threat or harm.
Justice:
– Who should benefit from the findings of the research
produced.
– If benefactors of medical research are coming from a
better social class; ideal health, age, or weight; and
financial standing, then an injustice has occurred.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Applications and Informed Consent
Under the Belmont Report
• The client has the choice to accept or reject
participation.
• Under the Belmont Report guidelines of informed
consent, researchers must disclose to the client what
the research entails and possibly the results.
• The client needs to be fully aware of what is being
asked of him or her. A simulation or practice may be
run prior to experiment.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
World Medical Association (WMA)
• The World Medical Association (WMA) is an
institutional body that has set procedures, policies,
and codes of conduct for doctors and medical
researchers to follow on a global level.
• WMA aids in furthering medical knowledge in
developed nations.
– This helps maintain a high standard of ethical
treatment of research subjects while not
impeding the progress of research in the field of
medicine on a global level.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Purpose of the World Medical Association
1. “The health of my patient will be my first
consideration.”
2. “A physician shall act only in the patient’s
interest when providing medical care that
might have the effect of weakening the
physical and mental condition of the
patient.”
(World Medical Association, 2008)
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Principles for All Medical Research
• WMA extends beyond the Belmont Report:
– The WMA requires that any medical
research involving human subjects be
research based
• In agreement with the Belmont Report, the
WMA:
– Is clear on any inherent risks to human
subjects, providing the subjects are
healthy.
– States that conducting medical research
should proceed only if the importance of
the medical objectives outweighs the
risks and hazards to the subject.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Medical Research Combined with
Medical Care
• In cases where research studies and medical
care share the same environment and relate
to the health status of the individual under
the care of a doctor, the two must be
warranted by the value of the research to aid
in the physical well-being of the client.
• When a patient/client refuses to take part in a
study, even if their participation may help
them and improve their health, there should
be no retribution to the patient or change in
the professional relationship between doctor
and patient.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Military and Other Special
Interest Research
• The funding of research at the university level can
come from a number of different sources:
– Universities in the form of internal grants
– The private sector
– The state government
– The federal government (military)
• The ethical issue with military funding tends to
center around the concept of “intention,” or
how will what is produced by the research be
used? Will the research findings be used
towards peaceful means (versus as a tool for
destruction)?
• The question becomes: How will the researcher’s
work be used once is out of his or her control?
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
The Bayh-Dole Act
• The Bayh-Dole Act put in place a series of ethical
checks and balances for proper disbursement of
inventions, along with a greater attention to the
details to monitor that proper protocols and
procedures are being followed by agencies receiving
grants.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Chapter Summary and Key Points
• The role of ethical treatment of clients is a product of
protection for the client.
• Ethical guidelines for client treatment go through a series
of checks and balances to insure proper treatment of the
client.
• Institutions, medical or otherwise, must establish and
uphold guidelines of ethical practice for uniform treatment
of clients.
• Ethical treatment includes, but is not limited to, the
methods of selection of clients for research or aiding them
in regaining their health status.
• Legislation has helped reduce the problems of who has the
rights to medical developments and other products that
would benefit clients.
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins