Protecting Human Research
Participants
Training for Paraprofessionals
Roll Call
•
•
•
•
•
•
Box Elder
Cache
Carbon
Duchesne
Iron
Juab
•
•
•
•
•
•
Kane
Salt Lake
Summit
Tooele
Washington
Weber
Introduction
WHO?
- This course is for paraprofessionals who will be involved with
obtaining informed consent and collecting data for human research
studies.
WHAT?
- After this course, nutrition education paraprofessionals will
understand their obligation to protect the rights and welfare of human
research subjects and how to do so.
WHY?
- As a part of our commitment to protect human research subjects.
What we will talk about today
• History
– Nazi Medical War
Crimes
– Syphilis Study at
Tuskegee
• Belmont Report
– Three ethical principals
• Respect for Persons
– Informed Consent
– Vulnerable populations
– Local culture
• Beneficence
– Risk
– Balancing
benefits and
risks
– Privacy and
confidentiality
– Compensation
– IRBs
• Justice
Learning Objectives
• Describe the history and importance of human subjects protections
• Identify the three principles of ethical human research from the
Belmont Report
• Understand the requirements for informed consent
• Identify vulnerable populations
• Understand special protections for pregnant women and children
• Identify possible risks and benefits
• Discuss issues involved in balancing risks and benefits
• Understand methods to protect privacy of individuals and
confidentiality of data
• Define the role of an IRB
• Understand fair and equitable sharing of benefits and burdens of
research
History
In this unit:
• Describe the history and importance of
human subjects protections
History: Nazi War Crimes
• A large number of harmful research
experiments were conducted on
thousands of unwilling prisoners
• In response, the War
Crimes Tribunal created
the Nuremberg Code,
a set of rules for how
to treat human subjects.
History: Syphilis Study at Tuskegee
• Study of untreated syphilis in Black men in
Alabama, US 1932-1972
• Participants were recruited without
informed consent, and were told that
research procedures were treatment
• Even after the cure was discovered in
1940s, participants were not treated or
informed that treatment was available
History: Syphilis Study at Tuskegee
• Public outcry after the study was covered
in the national press led to a government
efforts to make sure such experiments
would never again happen:
– National Research Act of 1974
– National Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research—wrote the Belmont
Report
Belmont Report
In this unit:
• Identify the three principles of ethical
human research from the Belmont Report
Belmont Report
3 Principles of Ethical Human Research
1.) Respect for persons
2.) Beneficence
3.) Justice
Belmont Report: Respect for Persons
Respect for Persons
• People should decide on their own
whether or not to participate in research
after being given the information they need
to decide
• People who can’t make an informed
decision should be protected further
Belmont Report: Respect for Persons
Respect for Persons Challenge:
1) Making sure that potential participants
comprehend the risks and potential benefits
of participating in research.
2) Avoiding influencing potential participants’
decisions either through explicit or implied
threats (coercion) or through excessive
compensation (undue influence).
Think about it: Coercion
• If you ask your nutrition education
participants to join a research study, do
you think it is possible that they might feel
pressure to participate?
• Why or why not?
• How can we try to avoid pressuring them?
Belmont Report: Beneficence
Beneficence:
• Do no harm
• Maximize benefits and minimize harms
Belmont Report: Beneficence
The challenge with Beneficence:
1) How to determine when potential benefits
outweigh considerations of risks and vice
versa.
Belmont Report: Justice
Justice
• Persons and groups need to be treated
fairly and equitably in terms of bearing the
burdens and receiving the benefits of
research.
Belmont Report: Justice
The Challenge with Justice
1) To question whether groups are
considered for inclusion simply because of
their availability or their vulnerability – rather
than for reasons important to the research
question.
Check Your Knowledge
We should allow persons to make their own
decisions.
A) Respect for persons
B) Beneficence
C) Justice
Check Your Knowledge
We should design research studies to
maximize benefits and minimize risks.
A) Respect for persons
B) Beneficence
C) Justice
Check Your Knowledge
Persons who are less able to make
decisions for themselves require additional
protections
A) Respect for persons
B) Beneficence
C) Justice
Check Your Knowledge
The burdens and benefits of research
should be fairly shared among persons,
groups, societies, etc.
A) Respect for persons
B) Beneficence
C) Justice
Respect for Persons
In this unit:
• Understand the requirements for informed
consent
• Identify vulnerable populations
• Understand special protections for
pregnant women and children
Respect for Persons: Informed Consent
3 important parts of informed consent:
1) Voluntariness
2) Comprehension
3) Disclosure
Respect for Persons: Informed Consent
Voluntariness:
People’s decisions about participation in
research should not be influenced by
anyone involved in conducting the research:
“…consent must be freely given or truly
voluntary.”
Respect for Persons: Informed Consent
Comprehension:
Persons must be able to understand the
information presented to them in order to
make an informed decision about
participation in research.
Respect for Persons: Informed Consent
Disclosure:
We need to tell people:
a) The purpose of the study
b) Any risks
c) Potential benefits
d) Alternatives to the research protocol
e) The extent of confidentiality protections for the person
f) Contact information for questions
g) The conditions of participation, including right to refuse or
withdraw without penalty.
Respect for Persons: Informed Consent
• The informed consent process must be
delivered in “…language that is
understandable to the subject…” (45 CFR
46.116).
• We are responsible for providing
information during the informed consent
process in a manner that is
understandable to the potential
participants.
Respect for Persons: Informed Consent
• Do not enroll anyone in a study unless you
are confident that the person understands
all information and agrees to procedures
described during the informed consent
process.
Think about it: Comprehension
• How can we know if someone
understands the information we’ve
presented for the informed consent
process?
Respect for Persons: Informed Consent
• Potential participants must understand that
enrolling in the research is voluntary and
that they may withdraw from the study at
any time without penalty or loss of
benefits.
• In order for participation in research to be
voluntary, the potential for coercion and
undue influence must be minimized.
Respect for Persons: Vulnerable Populations
Vulnerable populations include, but are not
limited to:
•
•
•
•
•
Pregnant women
Human fetuses and neonates
Prisoners
Mentally disabled persons
Economically and/or educationally disadvantaged
persons
Respect for Persons: Vulnerable Populations
An person’s ability to make decisions for
themselves should be assessed based on:
– The person’s ability to understand
– The complexity and risks of the study, i.e., the ability to
understand needed for an person to be able to
understand the study well enough to consent to
participate.
Respect for Persons: Vulnerable Populations
Again, because it is so important:
• Do not enroll anyone in a study unless you
are confident that the person understands
all information and agrees to procedures
described during the informed consent
process.
Respect for Persons: Vulnerable Populations
Participation of Pregnant Women
• Risks must be reduced by conducting
early studies in non-pregnant women
• The risks and potential benefits for both
the fetus and pregnant woman must be
considered
• We are not allowed to encourage women
to terminate a pregnancy or be involved in
this decision or the viability of the fetus.
Respect for Persons: Vulnerable Populations
Participation of Children
• Children are a vulnerable population because they may
not be able to make decisions in their own best interests
• Children are unable to provide legally effective informed
consent. Instead:
– 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.
Respect for Persons: Local Culture
• Cultural norms should be followed whenever possible or
appropriate
• For example:
– If community consent is the cultural norm, it may be appropriate to
obtain community consent in advance of obtaining informed
consent from individuals. Community consent cannot replace the
informed consent from individuals.
– If cultural norms require permission from a family member before
an individual may enroll in research, it may be appropriate to
obtain permission from the family member in addition to informed
consent from the prospective research participant.
• In unfamiliar settings:
– Become familiar with local cultural norms and
– Seek guidance from community advisors and the IRB
Check your knowledge
• Explain the three parts of informed
consent in your own words:
– Voluntariness
– Comprehension
– Disclosure
Check your knowledge
• To have true informed consent, potential
participants need to:
– Voluntariness: give their consent freely and
voluntarily
– Comprehension: have the ability to
understand the information presented to them
– Disclosure: be provided complete information
about the study
Beneficence
In this unit:
• Identify possible risks and benefits
• Discuss issues involved in balancing risks
and benefits
• Understand methods to protect privacy of
individuals and confidentiality of data
• Define the role of an IRB
Beneficence: Risk
• All research involves some level of risk.
• Not just physical harms:
– Physical
– Psychological
– Social
– Legal
– Economic
Beneficence: Risk
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.
Beneficence: Risk
Psychological: Psychological risks can
include anxiety, sadness, regret and
emotional distress, among others.
Psychological risks exist in many different
types of research in additional to behavioral
studies.
Beneficence: Risk
Social: Social risks exist whenever there is
the possibility that participating in research
or the revelation of data collected in the
course of the research, if disclosed to
persons or entities outside of the research,
could negatively impact others’ perceptions
of the participant. Social risks can range
from jeopardizing the person’s reputation
and social standing, to placing the person
at-risk of political or social reprisals.
Beneficence: Risk
Legal: Legal risks include the exposure of
activities of a research subject “that could
reasonably place the subjects at risk of
criminal of civil liability.”
Beneficence: Risk
Economic: Economic risks may exist if
knowledge of one’s participation in research,
for example, could make it difficult for a
research participant to retain a job or to find
a job, or if insurance premiums increase or
loss of insurance is a result of the disclosure
of research data.
Beneficence: Risk
• Because research involves risks, everyone
on the research team must take
responsibility for protection participants
against risks
• Protections vary according to the kind of
risk.
Beneficence: Risk
• Physical: well-trained personnel, monitoring participants
health, carefully following protocols, recruiting
appropriate populations, and providing clinical care when
needed
• Psychological: reminding participants of their right to
withdraw or limit their participation, providing counseling,
thoroughly debriefing
• Social: protecting confidential data, protecting
confidentiality of the fact of participation
• Legal: protecting confidential data, protecting
confidentiality of the fact of participation
• Economic: protecting confidential data, protecting
confidentiality of the fact of participation
Think about it: Risk Protections
Risk Category Risk Example
Physical
Fatigue
Social
Stigma
Psychological
Anxiety
Legal
Disclosure of
illegal drug
use
Economic
Loss of job or
advancement
Protection Example
Think about it: Risk Protections
Risk Category Risk Example
Protection Example
Physical
Fatigue
Supervision by physical trainer for signs or measures
of fatigue beyond those defined as acceptable in the
research protocol.
Social
Stigma
Research team members do not disclose identifiable
data to research participant’s co-workers.
Psychological
Anxiety
Friend or spouse can stay with participant during
study procedures
Legal
Disclosure of
illegal drug
use
Research team members increase protections for
research participant’s data from legal subpoena by
obtaining a Certificate of Confidentiality
Economic
Loss of job or
advancement
Research team members do not disclose information
data to research participant’s employer
Beneficence: Risk
• In general, the goal of research is to
benefit society by contributing to
knowledge
• HHS regulations require that:
– Risks are minimized
– Unavoidable risks are necessary for a good study
– Research studies are anticipated to make progress
toward important, generalizable knowledge.
Beneficence: Risk and Benefits
• After minimizing risks to the extent
possible, consider:
1) Protection against risks
2) How potential benefits to participants balance
against risks
3) Importance of the knowledge to be gained
Beneficence: Risks and Benefits
• When balancing the risks and
benefits consider three main factors:
– Equipoise (gaining new knowledge)
– Protecting privacy and confidentiality
– Protect the rights and welfare of
research participates
Beneficence: Risks and Benefits
• Equipoise: the study must provide
new data.
Beneficence: Privacy and Confidentiality
Protecting privacy and confidentiality
• We are responsible for:
– Protecting privacy of persons
– Confidentiality of data
• Privacy means being “free from unsanctioned intrusion.”
• Confidentiality means holding secret all information
relating to an person, unless the person gives consent
permitting disclosure.
Beneficence: Privacy and Confidentiality
Ways to Protect Confidentiality
– Properly disposing of data sheets and
other paper records
– Limiting access to identified data
– Storing research records in locked
cabinets or secured databases.
– Removing direct identifiers from data
Beneficence: Compensation
• Compensation is NOT a benefit of the
research
• Compensation is meant to reimburse
research participants for their time,
inconveniences and/or discomforts
• The informed consent process should
explain what the compensation is for and
how it works
Beneficence: Compensation
• Avoiding Undue Inducement:
• Offering too much compensation can cause potential
subjects to have poor judgment
• When figuring out how much compensation to offer,
you should consider vulnerabilities of your population
including:
–
–
–
–
–
–
Medical status
Employment status
Education
Financial resources
Emotional resources
Community resources
Beneficence: IRBs
• Institutional Review Boards (IRBs)
– specialized committees
– required by HHS regulations
– safeguard the rights and welfare of
human subjects.
Beneficence: IRBs
• The major roles of IRBs in the oversight of
research are:
– Review of the proposed research activity
– Ensuring that the proposed informed consent process
meets legal requirements
– Providing continuing oversight for progress reports
and protocols for ongoing research studies.
Beneficence: IRBs
General Criteria for IRB Approval of Research
• Risks to human subjects are minimized
• Risks to human subjects are reasonable in relation to benefits and
the importance of the knowledge to be gained.
• Selection of human subjects is fair.
• Informed consent is used and documented as required by HHS
regulations
• When appropriate, data is monitored to ensure the safety of the
human subjects
• When appropriate there are adequate provisions to protect the
privacy of human subjects and to maintain the confidentiality of data.
Check Your Knowledge: Beneficence
• The Belmont principle of beneficence
involves maximizing ___________ and
minimizing _________to research
participants
Justice
In this unit:
• Understand fair and equitable sharing of
benefits and burdens of research
Justice
The definition of Justice:
• Participants are selected fairly
• The distribution of research benefits and
burdens is fair
Justice
Two types of Justice:
– Person Justice: good studies should not be offered
only to people we like, and risky studies should not be
offered only to ‘undesirable’ persons
– Social Justice: groups chosen as subjects should be
able to bear the burdens of the research
Justice
Social Justice:
• Do not select groups for research easy availability,
compromised position, or manipulability.
• Examples of such groups: welfare patients, particular
racial and ethnic minorities, or persons confined to
institutions
• The participants should be from groups who are likely to
benefit from the research.
Justice
Note:
• Justice does not mean treating groups and
individuals equally (exactly the same way)
• Justice means treating groups and
individuals fairly (equitably)
Justice
• To make sure groups are fairly included
we need to include people who:
– May be affected by the disease or condition under
study
– Is anticipated to benefit from the knowledge gained
through the research
• The challenge is to make sure:
– That participants are not unfairly burdened
– Participants reflect the population that will benefit
Check your Knowledge: Justice
• Justice Requires:
– Fair selection of _______________
– Fair fair distribution of
_________________
Certification of Training
• Review signature page
• Answer questions