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PNUR 129 Week 8 Slides

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16 views18 pages

PNUR 129 Week 8 Slides

Uploaded by

Ashvin Chawla
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Week 8

PNUR 129
Foundations of Research
and Evidence-Based
Practice for Practical
Nurses
Week 8 objectives
1. Identify and discuss the historical events influencing the
development of ethical codes and regulations for research.
2. Identify the Canadian core principles that are important in
conducting research on human subjects.
3. Describe and discuss the importance of research and
research ethics.
4. Review and discuss the general principles of TCPS2’s consent
process. Tri-Council Policy Statement 2 (TCPS2)
5. Describe the role of research ethics boards in Canada.
6. Review and discuss protecting the rights of human subjects in
healthcare research including first nation populations.
7. Discuss the ethical responsibilities of research and related
risks of misconduct
The Tuskegee Syphilis Experiment

https://www.youtube.com/watch?v=R9a
y3RJhavI
Human experiments on prisoners

https://www.youtube.com/watch?
v=70I4emLo390 4:47
Protecting the rights of human subjects
• It is necessary to provide protection of
participants while serving the legitimate
requirements of research
• It is an obligation to avoid, prevent, or minimize
harm to others beyond everyday situations.
Possible risks of physical, emotional, legal,
financial and social harms must be considered.
• It is also a duty of research to maximize benefits.
• One must receive ethical approval prior to
conducting research
Canadian core principles: conducting
research on human subjects
Respect for human dignity is an underlying value of the Tri-Council Policy
Statement: Ethical Conduct for Research Involving Humans (TCPS or the
Policy) since its inception. Despite clear recognition of its centrality in
research ethics, the term lends itself to a variety of definitions and
interpretations that make it challenging to apply.
Respect for human dignity requires that research involving humans be
conducted in a manner that is sensitive to the inherent worth of all human
beings and the respect and consideration that they are due. In this Policy,
respect for human dignity is expressed through three
core principles –
Respect for Persons, Concern for Welfare, and Justice.
These core principles transcend disciplinary boundaries and, therefore, are
relevant to the full range of research covered by the Policy.
Respect for human dignity

Researchers are obligated to protect


the physical, psychological, social and
cultural interests of the person in
Respect for free and informed consent
• Consent is informed and voluntary
• Oral and written consent is needed
(Note oral consent alone must be
witnessed)
• Legally authorized or a parent / guardian
must sign if a minor or incapable
• Withdrawal or refusal to participate
cannot jeopardize the quality of nursing
care delivered
Essential information for consent
• Introduction of research activities
• Statement of the research purpose
• Selection of research subjects
• Explanation of procedures
• Description of risks and discomforts
• Description of benefits
• Disclosure of alternatives
• Assurance of anonymity and confidentiality
• Offering to answer questions
• Voluntary participation
• Option to withdraw
• Consent to incomplete disclosure the participant must be aware
if all information cannot be disclosed
Excerpt from Genetic Research
F. Genetic Material Banks
Article 13.7 (a) Researchers who propose research involving the collection
and banking of genetic material shall indicate in their research proposal, and
in the information they provide to prospective participants, how they plan to
address the associated ethical issues, including confidentiality, privacy,
storage, use of the data and results, possibility of commercialization of
research findings and withdrawal by participants as well as future contact of
participants, families, communities and groups.

(b) Researchers who propose research involving the secondary use of


previously collected and banked genetic material shall, likewise, indicate in
their research proposal how they plan to address associated ethical issues.
Application Collection of human biological materials including genetic
materials, and their retention in biobanks provides an increasingly important
research resource. Guidance for research involving human biological
materials applies to banking of genetic material. Researchers who intend to
bank genetic material shall inform participants of the potential for secondary
use.
http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
Henrietta Lacks

https://www.youtube.com/watch?
v=fd9NITWpcp0 3:17
Respect for vulnerable persons
Researchers have greater ethical
obligations toward vulnerable people.
Respect for privacy and confidentiality
• Fundamental to human dignity

• Protect personal information

• Anonymity of a study participant ensures no


links to the specific subject’s information

• Researchers must disclose the measure


used to provide the privacy and confidentiality
rights
Respect for justice and inclusiveness

Ensure individuals and groups are not


unfairly burdened or neglected /
discriminated against with respect to
inclusion in research studies
Protecting the rights of Aboriginal People

Canadian Institute for Health Research


states: A researcher should understand
and respect Aboriginal world views,
including responsibilities to the people
and culture that flow from being granted
access to traditional or sacred
knowledge. These should be
incorporated into research agreements,
to the extent possible.
Right to full disclosure

Basic right that means that deception


via withholding information or giving
false / misleading information will not
occur.
Right to self-determination

Participants must feel free to decide to


take part or not in the study. Cannot
feel obligated or coerced.
Research misconduct
Research misconduct occurs when a
researcher fabricates or falsifies data,
or plagiarizes information or ideas
within a research report.

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