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NUR 80A/B Study Guide - Midterm Guide: Informed Consent, Eth, Grounded Theory

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Leo Michelis
Study Guide

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NSE 80A Week 3 1
NSE 80A Week 3
Nursing Research: Ch. 5 & 6
Tri-Council Policy Statement 2
Chapter 5 Reviewing the Ethical Aspects of a Nursing Study
The Researcher’s Responsibility
To ensure the study is conducted in an ethical manner; that no harm comes to the participants
Researchers must prepare an ethics application and submit to research ethics committees for approval before the
study starts
The Nurse Researcher’s Role
The nurse in a researcher role demonstrates ethical practice (ethics standard) by:
Ensuring client has all information necessary to make informed decisions
Advocating for nursing involvement on ethical review boards
Participating in ethical review of research
Ensuring ethical guidelines are followed to protect research participants
Because research has not always been conducted ethically, and because of the ethical dilemmas researchers
often face in designing studies that are both eth- ical and methodologically rigorous, codes of ethics have been
developed to guide researchers.
In Canada, the Tri-Council Policy Statement on ethical conduct for research with humans set forth eight key
ethical principles: respect for human dignity, respect for free and informed consent, respect for vulnerable
persons, respect for privacy and confidentiality, respect of justice and inclusiveness, balancing harms and
benefits, minimizing harm, and maximizing benefit.
Ethical Principles for Protecting Study Participants
1) Respect for Human Dignity
Self determination
o the prospective participant has the right to decide voluntarily whether to participate in a study (with
the associated risks)
o Includes Coercion involved explicit or implicit threats of penalty for failing to participate in a study
or excessive rewards for agreeing to participate
2) Respect for Free and Informed Consent
Informed consent is intended to provide prospective participants with information needed to make a
reasoned and voluntary decision about participation in a study.
Full disclosure means researchers have fully described the study, including risks and benefits, to
prospective participants.
When full disclosure poses the risk of biased results, researchers sometimes use covert data
collection or concealment (the collection of data without the participants’ knowledge or con-
sent) or deception (withholding information from participants or providing false information).
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NSE 80A Week 3 2
3) Respect for Vulnerable Persons
Vulnerable subjects require additional protection as participants.
They may be vulnerable because they are not able to make a truly informed decision about study
participation (e.g., children); because of diminished autonomy (e.g., prisoners); or because their
circumstances heighten the risk of physical or psychological harm (e.g., pregnant women)
Vulnerable Groups:
Mentally or emotionally disabled people
Physically disabled people
Terminally ill people
Institutionalized people
Pregnant and breastfeeding women
4) Respect for Justice and Inclusiveness
The principle of justice includes the right to fair and equitable treatment and to an inclusionary approach
to recruitment of participants.
Balancing Harms and Benefits
Beneficence involves the performance of some good, and the protection of participants from harm and
exploitation (nonmaleficence).
Various procedures have been developed to safeguard study participants’ rights, including the performance of a
risk/benefit assessment, implementation of informed consent procedures, and efforts to safeguard participants’
Risk/Benefit Assessments
In a risk/benefit assessment, the individual benefits of participation in a study (and societal benefits of the
research) are weighed against the costs to individuals.
Informed Consent
Informed consent normally involves the signing of a consent form to document voluntary and informed
participation. In qualitative studies, consent may need to be continually renegotiated with participants as the
study evolves, through process consent procedures.
Confidentiality Procedures
Privacy can be maintained through anonymity (wherein not even researchers know the participants’ identity) or
through formal confidentiality procedures that safeguard the information participants provide.
Debriefings and Referrals
Researchers sometimes offer debriefing sessions after data collection to pro- vide participants with more
information or an opportunity to air complaints.
Research Ethics Boards and External Reviews
External review of the ethical aspects of a study by a Research Ethics Board (REB) or other human subjects
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