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Glossary of Nursing Research - Ch. 5 (Reviewing the Ethical Aspects of a Nursing Study)

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Created by daisy497

Historical Background
Examples of research VIOLATIONS of moral principles:


1. Nazi medical experiments in the 1930s and 1940s tested human reactions to diseases and untested drugs without consent; many subjects died or were injured
2. Tuskegee Syphilis Study (1932-1972) - low income African-American males with syphilis were monitored for 40 years to study the disease, were not told about their disease, and not given effective treatment. Many subjects died of syphilis during the study.
3. Thalidomide 1950s - unapproved and investigational drug resulted in deformities to the fetus.
4. Brooklyn (1960s) - injection of live cancer cells in elderly patients without their consent.
5. New Zealand (1980s) - women with cervical cancer were not given treatment so that the natural progression of their disease could be studied.



Codes of Ethics and Guiding Principles:
1. NUREMBERG CODE (1949) - moral, ethical, and legal requirements that must be established for protection of participants
2. DECLARATION OF HELSINKI (1964) - principles for ethical medical research
3. ETHICAL GUIDELINES FOR NURSES IN RESEARCH INVOLVING HUMAN PARTICIPANTS (1983)
4. GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINES (1997) - clinical trial research
5. TRI-COUNCIL POLICY STATEMENT (TCPS) ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS (1998, 2010) - guiding ethical principles



ETHICAL DILEMMAS:
- full disclosure of purpose of a study (people who know they are being studied may alter their behaviour)
- "Can full disclosure undermine a study?"
*Bias from inaccurate data; bias from an inadequate sample
*Concealment and deception
- Potential for psychological upset
- Denial of a potentially beneficial treatment
- Exposure to privileged, private, or incriminating information





Should research participants be paid for participating in a study?
No, they should not be paid because there should be no rewards or coercion
RESPECT FOR HUMAN DIGNITY (Ethical Principle)
RESPECT FOR HUMAN DIGNITY:
- protection of participants' physical, psychological, and cultural integrity
*the right to self-determination: voluntary participation; freedom from coercion by threats or rewards or a position of authority
*the right to full disclosure: a full description of the nature of the study, participants rights, researcher responsibilities, risks and benefits


Ethical Principles
1. Respect for HUMAN DIGNITY
2. Respect for FREE and INFORMED CONSENT
3. Respect for VULNERABLE persons
4. Respect for PRIVACY and CONFIDENTIALITY
5. Respect for JUSTICE and INCLUSIVENESS
6. Balancing HARMS and BENEFITS




RESPECT FOR FREE AND INFORMED CONSENT (Ethical Principle)
RESPECT FOR FREE AND INFORMED CONSENT:
- complete and understandable information on which to base a decision and with free choice
*concealment and deception interfere with informed choice
* should be voluntary and understandable
*free to withdraw at any time



RESPECT FOR VULNERABLE PERSONS (Ethical Principle)
RESPECT FOR VULNERABLE PERSONS
- diminished competence or autonomy or at-risk
1. CHILDREN
2. PREGNANT & BREASTFEEDING WOMEN
3. MENTALLY OR EMOTIONALLY DISABLED PEOPLE
4. PHYSICALLY DISABLED PEOPLE
5. TERMINALLY ILL PEOPLE
6. INSTITUTIONALIZED PEOPLE






RESPECT FOR VULNERABLE PERSONS
(Children)
CHILDREN:
- cannot give consent (legal age for consent is 19 years)
- require informed consent of parents or legal guardian
- if at least 7 years old, offer an opportunity to assent to the research (if the child doesn't assent, then he doesn't have to participate even if his parents want to give consent)
- if at least 13 years old, obtain consent from child as well as parents/guardian



RESPECT FOR VULNERABLE PERSONS
(Pregnant and Breastfeeding Women)
- take into account potential harms and benefits to the embryo, fetus, or child
RESPECT FOR VULNERABLE PERSONS
(Mentally or emotionally disabled people)
- people whose cognitive impairment or mental illness make them incompetent to give consent
- obtain written consent from the person's legal guardian
- obtain informed consent from participant as a supplement as possible

RESPECT FOR VULNERABLE PERSONS
(Physically disabled people)
- special procedures may be required
- hearing impaired: written consent only
- illiterate: verbal consent, audio recorded and witness

RESPECT FOR VULNERABLE PERSONS
(Terminally ill people)
- may not personally benefit
- need to pay careful attention to risk/benefit
- ensure that care and comfort are not compromised

RESPECT FOR VULNERABLE PERSONS
(Institutionalized people - ex. prisoners, residents of long-term care facilities)
- may feel obligated to participate
- may believe care would be compromised if failed to cooperate
- ensure that voluntary nature of participation is emphasized. Assure that personal care or situation will not be compromised by failure to participate

Respect for privacy and confidentiality
- personal information kept private and confidential
Respect for justice and inclusiveness
- equal distribution of benefits and risks associated with research
- equal opportunity
- selected on the basis of the research requirements, not vulnerability or disadvantage
- not discriminatory


Balancing harms and benefits
foreseeable harm must not outweigh expected benefits
BENEFICENCE
- Maximize potential benefits
- Must benefit the individual or society
NONMALEFICENCE
- minimize harm and discomfort
- ideally none
- avoid exploitation

Potential benefits to participants
1. Intervention that otherwise would not be available
2. Opportunity to discuss a problem, provide information about one's situation, etc.
3. Opportunity to learn more about one's situation, condition
4. Satisfaction in being helpful
5. Monetary or other material gain



Potential RISKS to participants:
1. Physical harm - ex. side effects of treatment, injury from treatment
2. Physical discomfort, fatigue
3. Inconvenience, loss of time
4. Psychological or emotional discomfort or distress (ex. about disclosure, embarrassment, fear, etc.)
5. Social risks (ex. stigma - personal or cultural, loss of status
6. Loss of privacy
7. Financial costs - ex. travel, child care (need to be subsidized for travel, child care and other costs)





Respect for the unique needs of Aboriginal people
- respectful partnerships, unique needs, historical context, mutual benefit, community consent, role of elders
Procedures to protect the rights of study participants:
1. Risk/benefit assessment - is the research about an important topic that has the potential of benefiting the participant or society?
2. Informed consent - written and understandable (grade 8 level or less); must be ONGOING
3. Confidentiality procedures - anonymity, oath of confidentiality for all who have access to study records, ID numbers, aggregate data, disguise identity in research reports, not divulging setting
4. Debriefing (who participated in the study? what were the results?)
5. Sensitive and tactful interaction (be respectful)
6. Make appropriate referrals, obtain any necessary help




Research Misconduct
1. Fabrication
2. Falsification
3. Plagiarism
4. Conflict of Interest
5. Failure to comply with government regulations
6. Claiming improper authorship
7. Using confidential information without permission





Fabrication
Making up study results and reporting or publishing them
Falsification
Distorting research procedures, changing or omitting data
Plagiarism
using someone else's ideas without giving them credit
Conflict of interest
Personal vested interest in the findings
Role of Research Ethics Boards
1. Review research plans (proposal and protocol) using ethics guidelines by the TCPS
2. Can reject a research proposal, request modifications, and terminate a study on the basis of non-compliance with ethic standards
3. Provide templates and required wording for consent forms
4. Review research projects annually for continued compliance with ethics standards

Note: no study can begin without ethics approval
*Memorial University has 2 REBs





Composition of Health Research Ethics Board
1. Usually 10-12 people
2. Persons who have EXPERIENCE in the conduct of the human health research
3. Someone with knowledge in ETHICS
4. Someone with knowledge in the LAW related to health research involving human subjects
5. A person representing the GENERAL PUBLIC
6. A person in a NON-SCIENTIFIC discipline




Critiquing research ethics:
1. Usually not possible to identify research ethics transgressions
2. Could be caught in the peer review process
3. Often reference only to research ethics board review and informed consent
4. What were the risks and benefits?
5. Were privacy and confidentiality breached?
6. Were there coercion or deception?
7. Were vulnerable participants involved?
8. Were groups unjustifiably omitted?

Note: no one can bypass the ethics board








Which ethical principle is being applied when research participants are given the right to withdraw from a study if they change their mind about participating?

a. Self-determination
b. Respect for privacy
c. Informed consent
d. Respect for




A. Self-determination
Deliberately withholding information about the study or providing participants with false information is an example of:

a. deception
b. coercion
c. process content
d. beneficence




a. Deception

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