This assessment requires you to visit the The Research Clinic:
https://ori.hhs.gov/TheResearchClinicVideo/
You will click to play Jan Klein, RN. Work your way through the brief videos, choosing the best response as the RN assisting in research.
Upon completing the videos, you will submit a Word file that summarizes the essential elements of informed consent, special populations that require special legal and ethical research considerations, and the nurse’s role in advocating for the patient in research situations.
Objectives
Understand the history behind the development of Human Subjects Protection guidelines
To identify and describe the three principles of ethical human subjects research identified in the Belmont Report
To identify risks associated with participation in research and appropriate protections against risks, vulnerable populations that need specific protections, and situations in which research involving humans is exempt from regulatory requirements
Identify the essential elements of an informed consent form
Describe the nurse’s role as patient advocate in research situations
Instruuctor material
TitleNursing ResearchAuthorGeri LoBiondo-Wood; Judith HaberISBN978-0-323-43131-6PublisherElsevier – Health Sciences DivisionPublication DateJuly 26, 2017BindingTrade PaperTypePrintPrice
RequiredChapter 13
Legal and Ethical Issues
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an
imprint of Elsevier Inc.
Ethics
The theory or discipline dealing with principles of moral
values and moral conduct
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
2
Past Ethical Dilemmas in Research
Nazi experiments
Nuremberg Code and its definitions of the terms
“voluntary,” “legal capacity,” “sufficient
understanding,” and “enlightened decision”
Declaration of Helsinki, 1964
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
3
U.S. Federal Guidelines
In 1973, the Department of Health, Education, and Welfare
published the first set of proposed regulations on the
protection of human subjects, identifying basic ethical
principles that underlie the conduct of human research
National Research Act, passed in 1974 (Public Law 93-348),
created the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research
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4
Belmont Report Principles
Respect for persons
Beneficence
Justice
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5
Respect
Treat individuals as autonomous agents.
Do not use a person as a means to an end.
Allow people to choose for themselves.
Give extra protection to those with limited
autonomy.
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6
Beneficence
Acts of kindness or charity that go beyond duty
Obligations derived from beneficence:
➢ Do no harm
➢ Prevent harm
➢ Prevent evil
➢ Promote good
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7
Justice
Treat people fairly.
Share burdens and benefits of research fairly.
Distinguish procedural justice from distributive
(society as a whole) justice.
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
8
Principles Applied
Beneficence: sound research design, competent
investigators, favorable risk-benefit ratio
Respect: informed consent, respect for privacy
Justice: equitable selection of subjects
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9
DHHS Recommendations 1981
General requirements for informed consent
➢ Documentation of informed consent
➢ IRB review of research proposals
➢ Exempt and expedited review procedures for certain kinds
of research
➢ Criteria for IRB approval of research
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
10
Protection of Human Rights
Right to self-determination
Right to privacy and dignity
Right to anonymity and confidentiality
Right to fair treatment
Right to protection from discomfort and harm
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11
Informed Consent
What it is:
➢ Ongoing process of communications and mutual
understanding
➢ Shared responsibility for protection
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12
Informed Consent
What it is not:
➢ Piece of paper
➢ One moment in time
➢ Legal contract
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13
Elements of the Informed Consent
Form
If the study involves research:
➢ Purpose of research
➢ Expected duration for subject
➢ Description of procedures
➢ Identification of experimental procedures
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14
Elements of the Informed Consent
Form
Reasonably foreseeable risks or discomforts
➢ How can risks be minimized?
Reasonably foreseeable benefits for subjects or
others
➢ How can benefits be maximized?
What alternative procedures or treatments are
available?
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Elements of the Informed Consent
Form
Payment: total or prorated
Who has access to records
Probability of random assignment
Special qualifications for investigator
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16
Institutional Review Boards (IRBs)
Review research projects and ensure that ethical standards are
met in relation to the protection of the rights of subjects
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17
Elements of the
Informed Consent Form
Consents that involve an intervention:
May involve unforeseeable risks
Situations where researcher can terminate subject’s
participation
Any additional costs
Consequences and procedures for subject’s early
withdrawal
Revelation of new findings
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18
Elements of the Informed Consent
Form
Confidentiality
Compensation for research-related injury
Who can answer questions
➢ About study and research-related injuries
➢ About subject’s rights
Participation is always voluntary
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IRB Role
Assess for “fair” recruitment
Evaluate inclusion and exclusion criteria
Determine investigator-subject relationship
Establish role of IRB in study
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Definition of Human Subject
A living individual about whom an investigator
conducting research obtains:
➢ Data through intervention or interaction with the
individual
OR
➢ Identifiable private information
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IRB Role
Review consent for
➢ Autonomy
➢ Protection
➢ Risk and benefit
Review consent forms for clarity and process
Additional protections
Assessing risk and benefit
Assessing consent forms and process
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Recruitment
Plans and materials must be reviewed by IRB
Public service announcement or ads must also be
reviewed
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Approval Categories
Exempt: low risk, nonvulnerable, not sensitive, short
duration (six categories [e.g., educational])
Expedited review: minimal risk (no substantive increase
beyond risks of ordinary life), nonvulnerable, nonsensitive
topic (nine categories [e.g., chart review, questionnaires])
Full board review
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Full Board Review
All members participate and review
All members participate in discussion and make comments
Decision is rendered by a majority of assembled quorum
No member has a conflict of interest
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Comprehension
Not valid unless subject understands
Responsibility for understanding rests with
researcher, who must consider:
➢ Nature of population
➢ Type of information
➢ Circumstance and timing
➢ Language and culture
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Approval Criteria
Risks minimized
Risks balanced by benefit
Subject selection equitable
Procedures for obtaining informed consent
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Approval Criteria
Procedures for consent documentation
Data monitoring provisions
Privacy and confidentiality measures
Safeguards for vulnerable subjects
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Risk Assessment
Probability of harm occurring as a result of
participation
Quantified by probability and magnitude
Types: social, legal, physical, economic, psychological
May apply to individual or society
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Benefit Assessment
Valued or desired outcome, an advantage
Quantified by probability or magnitude
Types: medical, psychological, kinship
May apply to individual or society
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Special Considerations
Vulnerable subjects
➢ Children
➢ Prisoners
➢ Mentally disabled persons
➢ Economically disadvantaged
➢ Educationally disadvantaged
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
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Special Considerations
Vulnerable subjects
➢ Subtle vulnerabilities: language, culture, pregnancy,
students, employees, chemical use, health status
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32
Assurance of Anonymity and
Confidentiality
The right to privacy is also protected through
individually identifiable health information (IIHI)
➢ IIHI must be de-identified under Health Insurance
Portability and Accountability (HIPAA) Privacy Rule.
➢ Data are part of a limited data set, and
data use agreement with the researcher
is in place.
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33
Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
Describes federal standards to protect patients’ medical
records and other health information
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Protecting Basic Human Rights of
Vulnerable Groups
Research with children-assent
Research with pregnant woman, fetuses, and neonates
Research with prisoners
Research with the elderly
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Appraising the Evidence: Legal and
Ethical Aspects of a Research Study
Was the study approved by an IRB or other agency?
Was informed consent obtained from all subjects?
How was it obtained?
Were the subjects protected from physical or
emotional harm?
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
36
Appraising the Evidence: Legal and
Ethical Issues of a Research Study
Were the subjects informed about the purpose of the
study?
Were the subjects informed about potential risks?
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
37
Appraising the Evidence: Legal and
Ethical Issues of a Research Study
Were benefits maximized and risks minimized?
Was the privacy of subjects safeguarded?
How have data been kept anonymous or
confidential?
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
38
Appraising the Evidence: Legal and
Ethical Issues of a Research Study
Were subjects coerced or unduly influenced?
Did they have the right to refuse or withdraw
without penalty?
Were vulnerable subjects used?
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.
39
Appraising the Evidence: Legal and
Ethical Issues of a Research Study
Were subjects coerced or unduly influenced?
Did they have the right to refuse or withdraw
without penalty?
Were vulnerable subjects used?
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40
Who is legally and ethically
responsible to protect study subjects
from physical or mental harm or
discomfort?
A. The researcher
B. The research team
C. The nurse
D. The caregiver
E. All of the above
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41
Unethical research studies have taken
place in the United States as recently
as:
A. the 1890s
B. the 1940s
C. the 1970s
D. the 1990s
E. None of the above
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42
At what grade level should informed
consent be written?
A. Third grade
B. Sixth grade
C. Eighth grade
D. Twelfth grade
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43
At what age can children give sole
consent to research?
A. 6 years
B. 14 years
C. 18 years old
D. 21 years old
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44
Which term refers to subjects’ identity
not being identifiable or linked to
their individual response even by the
researcher?
A. Anonymity
B. Confidentiality
C. HIPPA
D. Privacy
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45
Belmont Report Educational Video
Duration: (9:11)
User: n/a – Added: 1/11/07
HHS’s Office for Human Research Protections (OHRP) developed a Belmont
Report Educational Video that provides the context for the Belmont Report for
those who are not familiar with its principles and uses.
Human Subjects Research Training: “Protecting Human Subjects” – Module 1
Duration: (22:14)
User: n/a – Added: 3/8/12
Informational video about protection of human subject.
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