Ethical Considerations in
Human Subjects Research
Presenter: Dr. Debbiesiu L. Lee
Associate Professor/ Associate Chair
Educational and Psychological Studies Department
School of Education and Human Development
University of Miami
Outline and Purposes of
Presentation
(1) Define human subjects research and Institutional
Review Boards (IRB)
(2) Review the basic ethical principles of human
subjects research
(3) Review the application of these ethical principles
Defining Research &
Human Subjects Research
Research is the systematic collection, analysis,
and interpretation of data to answer a certain
question or solve a specific problem.
Human Subjects Research
Any research that involves human beings as
providers of information or data.
The Research Process
Discovery of New Knowledge
(research)
Dissemination of Knowledge
(publication, education)
Application of Knowledge
(translation of research to policies and practices
in the community)
Why do we need
Human Subjects Protection?
Premises
(1) Human subjects are essential to conducting
research intended to improve human health and wellbeing.
(2) The relationship between investigator/s and
research participants should be based on trust,
honesty, and respect.
(3) Investigators (who design and implement research)
should understand their obligations to protect the
rights of research participants.
Institutional Review Boards (IRB)
Institutional Review Boards are establishments (typically
associated with institutions of higher learning) that are
responsible for and oversee the protection of human
subjects.
IRBs are also responsible for ensuring that the
investigators understand and fulfill their obligations to
protect the rights and welfare of research participants.
IRB monitors the research to ensure the rights and
welfare of research participants.
Basic Ethical Principles
Guiding
Human Subjects Research
Basic Ethical Principles Guiding
Human Subjects Research
(1) Respect for Persons
(respect people’s decisions, protect the vulnerable)
(2) Beneficience
(do no harm, do good)
(3) Justice
(treat people equitably)
1. RESPECT FOR PERSONS
a. Individuals should be treated as autonomous
agents.
• “Participants, to the degree that they are capable,
should be given the opportunity to choose what
shall or shall not happen to them.”
b. Individuals with diminished autonomy are
entitled to special protections.
•
Children
• People who are mentally incapacitated
• Prisoners
2. BENEFICENCE
a. Do no harm
b. Maximize potential benefits and minimize possible
harms (risks).
3. JUSTICE
(1) Individuals and groups be treated fairly and
equitably in terms of bearing the burdens and
receiving the benefits of research.
(2) Investigators “should not offer potentially
beneficial research only to some patients who are in
their favor or select only ‘undesirable’ persons for
risky research ”.
Application of Ethical
Principles Into
Research Practices
APPLICATION OF ETHICAL
PRINCIPLES INTO RESEARCH
(1) RESPECT FOR PERSONS: Informed Consent
(2) BENEFICIENCE: Assessment of Risks and Benefits
(3) JUSTICE: Selection of Participants
Informed Consent
A legally-effective, voluntary agreement that is given
to a prospective research participant following
comprehension and consideration of all relevant
information pertinent to a decision to participate in
a study.
(1) Information
(2) Comprehension
(3) Voluntariness
Reduces the potential for coercion or undue
influence .
INFORMED CONSENT
(1) Information
Researcher should ensure that potential participants
are informed of the research procedures, and
potential risks and benefits of participating in the
research.
INFORMED CONSENT
(1) Information
1. The purpose of the study
2. Any reasonably foreseeable risks to the individual
3. Potential benefits to the individual or others
4. Alternatives to the research protocol
5. The extent of confidentiality protections for the
individual
6. Compensation
7. Contact information for questions regarding the study,
participants’ rights, and in case of injury
8. The conditions of participation, including right to
refuse or withdraw without penalty.
INFORMED CONSENT
(2) Comprehension
Individuals must have the mental or decisional
capacity to understand the information presented to
them in order to make an informed decision about
participation in research.
Participants must be able to accurately comprehend
(1) the risks and benefits associated with research,
(2) weigh them according to their own opinions,
beliefs, and values, and
(3) should be able to take appropriate action.
INFORMED CONSENT
(2) Comprehension
Special Protections for Vulnerable Populations
“Special provisions may need to be made when an individual’s
comprehension is severely limited or when a class of research
participants is considered incapable of informed decision making”
• children,
• people who are mentally incapacitated,
• prisoners.
In some cases, respect for persons may require seeking the
permission of other parties, such as a parent or legal guardian.”
Children’s Participation in Research
• Children may not have full capacity to make decisions in
their own best interests; and therefore :
• Children are unable to provide “legally effective
informed consent ”
• Because children cannot provide informed consent,
children provide assent to participate in research, to the
extent that they are able, and parents/guardians give
permission for a child to participate in research .
• Assent: “Affirmative agreement to participate in research.
Mere failure to object should not, absent affirmative
agreement, be construed as assent.”
INFORMED CONSENT
(3) Voluntariness
Individuals’ decisions about participation in research
should not be influenced by anyone involved in
conducting the research: “...consent must be freely
given or truly voluntary.”
Avoiding influencing potential participants’ decisions
either through (coercion) or through (undue
influence)
INFORMED CONSENT
(3) Voluntariness
Coercion (threats)
“Influencing an individual decision about whether or
not to do something by using explicit or implied
threats (loss of good standing in job, poor grades,
etc.)”
INFORMED CONSENT
(3) Voluntariness
Undue Influence (Excessive rewards)
“
An offer of an excessive, unwarranted, inappropriate, or
improper reward or other overture in order to obtain
compliance”
• “offers that are too attractive may blind prospective
subjects to the risks or impair their ability to
exercise proper judgment; and
• they may prompt subjects to lie or conceal
information that, if known, would disqualify them
from enrolling — or continuing — as participants in
a research project ”.
INFORMED CONSENT/ Voluntariness
Undue Influence –vs- Compensation
• Some types of research involve a significant
commitment from research participants in terms
of time or effort, and investigators may wish to
provide compensation.
• Compensation is meant to reimburse research
participants for their time, research-related
inconveniences, and/or research-related
discomforts.
• Compensation is not a benefit of the research.
INFORMED CONSENT
Obtaining Informed Consent
• Investigators should present informed consent in a
manner that is understandable to the potential
participants.
• Methods used in addition to a consent form to
enhance individuals’ comprehension:
• Oral presentations (opportunity to discuss the
information and ask questions),
• Providing additional educational materials, such
as brochures,
• Video presentations.
INFORMED CONSENT
Requirements for Documentation
• Informed consent must be documented using a
written form that either contains all of the required
elements, or a short form that states that all of the
required elements have been presented orally.
• This form must be signed by either the participant
or the participant’s legally authorized
representative.
APPLICATION OF ETHICAL
PRINCIPLES INTO RESEARCH
(1) RESPECT FOR PERSONS: Informed Consent
(2) BENEFICENCE: Assessment of Risks and Benefits
(3) JUSTICE: Selection of Participants
Assessment of Risks and Benefits
Benefits Greater than Potential Harms
• Research requires that:
• Risks are minimized .
• Unavoidable risks are justified as necessary for
sound scientific design.
• Research studies should provide important, new
knowledge for society.
Assessment of Risks and Benefits
Potential Risks in Research
A. Physical
• Physical risks may include pain, injury, and
impairment of a sense such as touch or sight.
These risks may be brief or extended, temporary or
permanent, occur during participation in the
research or arise after.
• Should follow protocols to minimize risks.
Risk in Research (cont.)
B. Psychological
Psychological risks can include anxiety, sadness, regret
and emotional distress, among others.
Possible ways to protect against psychological risks:
(1) reminding participants of their right to withdraw
from research
(2) limit their participation if they become
uncomfortable
(3) providing counseling or psychological support for
participants who experience distress
Risk of Research (cont.)
C. Social
• Social risks can range from jeopardizing the
individual’s reputation and social standing, to
placing the individual at-risk of political or social
reprisals.
• Minimizing social risks to participants involves
protecting confidential data.
Privacy and Confidentiality
Protecting privacy of individuals
•
Privacy means being “free from unsanctioned
intrusion”.
•
Do not ask more personal questions than needed
to answer the research questions.
Confidentiality of data
• Confidentiality means holding secret all
information relating to an individual, unless the
individual gives consent permitting disclosure
APPLICATION OF ETHICAL
PRINCIPLES INTO RESEARCH
(1) RESPECT FOR PERSONS: Informed Consent
(2) BENEFICIENCE: Assessment of Risks and Benefits
(3) JUSTICE: Selection of Participants
3. Justice/
SELECTION OF PARTICIPANTS
(1) Individuals and groups be treated fairly and
equitably in terms of bearing the burdens and
receiving the benefits of research.
(2) Arises in decisions about inclusion and exclusion
criteria for participation in research.
(3) Investigators “should not offer potentially
beneficial research only to some patients who are in
their favor or select only ‘undesirable’ persons for
risky research ”.
INCLUSION/ EXCLUSION CRITERIA
Equitable Distribution
• In order to achieve an equitable distribution of the
risks and potential benefits of the research,
• Investigators must determine the distribution of
different groups (men and women, racial or ethnic
groups, adults and children).
• These should be reported.
References and Links:
CITI. Collaborative Institutional Training Institute.
• https://about.citiprogram.org/en/homepage/
National Institute of Health. NIH Office of Extramural Research. Protecting
Human Research Participants
• https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html
Belmont Report
• https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/
Thank you!