Informed Consent - University of Hawaii at Manoa

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Human Studies Program
Office of Research Compliance
Vice Chancellor for Research and Graduate Education
Denise Lin-DeShetler, M.P.H., M.A.
Director, Human Studies Program
CTE Dissertation Series - IRB Series 2
October 27, 2014
What is informed consent and why is it
important?
1.
Informed Consent Process:
1.
◦
◦
◦
◦
2.
Who will obtain consent?
Where will consent be obtained?
When will consent be obtained?
How will consent be obtained?
Types of “Informed Consent” and what is
appropriate
Human Studies Program
Office of Research Compliance

Based on the Belmont principle of “Respect for
Persons,” informed consent involves 3 requirements:
1. INFORMATION
 Disclosing to potential participants information needed to make
an informed decision;
2. UNDERSTANDING
 Facilitating the understanding of what has been disclosed; and
3. VOLUNTARY AGREEMENT
 Promoting the voluntariness of the decision about whether or
not to participate in the research

Informed consent must be legally effective (e.g.,
signed by participant) and prospectively obtained.
Human Studies Program
Office of Research Compliance

Informed consent is an active PROCESS of sharing
information between investigator and participant:
◦ Starts with initial outreach (i.e., recruitment) and
continues until completion of the research study
◦ Means:

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Recruitment materials
Informed Consent
Q&A
Updated information on risks
Informed consent is very IMPORTANT because it
is commonly the ONLY mean of how participants
get information about the research
Human Studies Program
Office of Research Compliance
Coercion: overt or implicit threat of
harm is intentionally presented by one
person to another in order to obtain
compliance.
Undue influence: an offer of an
excessive or inappropriate reward or
other overture in order to obtain
compliance

Hierarchical relationship between
researcher and participant
◦ Teacher-researcher to student
◦ Physician-researcher to student
◦ Employer-researcher to employee
Human Studies Program
Office of Research Compliance
Suggestions:
 Have research assistants collect
consent forms and do not disclose
who consented until after power
relationship between investigator and
participant has ceased.
 Provide alternatives to participation
 In consent, state explicitly that
consent or refusal to participate will
not affect relationship (e.g., service to
patient, grades of student, etc.)
Human Studies Program
Office of Research Compliance


Privacy is essential to the consent process
◦ Should be conducted in a private setting where no
one else can overhear the discussion.
Settings can heavily impact one’s decision
to participate (i.e., peer pressure in
classroom setting).
◦ Who is around?
◦ Does the setting provide adequate time for
potential participants to ask questions or read
through the consent to fully understand the
study?

Even if research is presented in a group
setting, it is important to give each
participant individual attention when
consenting so that they are given full
opportunity to ask questions (i.e.,
intimidation factor).
Human Studies Program
Office of Research Compliance


Consent MUST ALWAYS be obtained PRIOR to
conducting any research activity (except when
to remove a immediate threat or harm to
participant) in the approved consent method.
Active participants should be re-consented
with the most currently approved informed
consent, such as:
◦ New findings of risks to participants,
◦ Contact information for participants,
◦ Conflict of Interest of a new PI for the study
Human Studies Program
Office of Research Compliance

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Directly (face-to-face) vs. Indirectly (electronically)
Type of Consent
◦ Written vs. waiver or alteration of informed consent
Tools to enhance understanding
◦ Pre-screening for mental capability
◦ Length and readability level of consent form
◦ For complex studies, use of flowchart, brochures and other
aids
◦ Having participant re-iterate consent back to researcher
Documentation of Informed Consent Process
Human Studies Program
Office of Research Compliance

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Written “long form” consent
Study Information Sheet
Short Form
Translated informed consent
Oral consent
Parental Consent
Child Assent
What type of informed consent you use for your research
depends on the appropriateness of your study population in
order to meet the three requirements:
(1)
Disclosure of information,
(2)
Understandable, and
(3)
Promotes Voluntariness
Human Studies Program
Office of Research Compliance
Purpose
Research Activities
1.
2.
◦
◦
Potential Benefits and Risks
3.
◦
4.
5.
6.
7.
What part is experimental
Duration of involvement
To participant, group, and/or society
Privacy and Confidentiality
Alternatives to Participation
Voluntary
Contact Information
Human Studies Program
Office of Research Compliance
Informed Consent Document
•Introduction
of researcher and purpose of study
•Extent of subject participation
Informed Consent Document
•Describe
potential risks and benefits; don’t be pretentious about
benefits
•Privacy and Confidentiality should include how data will be kept secure
Informed Consent Document
•Compensation
section
for time and effort in participating should go under this
•
Waiver of a signed informed consent can be requested, and if granted,
would include the language on the right in lieu of the left
Human Studies Program
Office of Research Compliance

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Audio Recording
Video Recording
Use of real names instead of pseudonyms
Permission to contact for future studies
Human Studies Program
Office of Research Compliance

Age or mental capacity

Vulnerable Population

Setting

Primary language
◦ Minors
◦ Diminished mental capacity
◦ Prisoners
◦ Children
◦ Homeless
◦ Institutionalized
◦ Prison Facility
◦ Schools
Human Studies Program
Office of Research Compliance
A research may qualify for a waiver or alteration of consent if some
or all of the following conditions are met:
1.
The research involves no more than minimal risk to the
participants;
2.
The waiver or alteration will not adversely affect the rights and
welfare of the participants;
3.
The research could not practicably be carried out without the
waiver or alteration; and
4.
Whenever appropriate, the participants will be provided with
additional pertinent information after participation
Examples:
 Anonymous online survey on brand preferences of jogging shoes
 Interview of domestic violence victims on the availability and
accessibility of counseling services in their community
 Looking at prevalence of racial stereotyping among college
students of different culture
Human Studies Program
Office of Research Compliance

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Anonymous online survey on
brand preferences of jogging
shoes
Interview of domestic
violence victims on the
availability and accessibility
of counseling services in their
community
Looking at prevalence of
racial stereotyping among
college students of different
culture
Case Example

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Study Information Sheet:
written consent form given, but
no signature collected
Oral consent: written consent
form read to participant,
consent usually recorded
Debriefing Form: consent form
disclosing deception and reason
why it was necessary, asks
participants if data can be used
Type of Alteration or Waiver

In most cases, research in which participants are
minors parental consent and assent must be obtained
before participation.
◦ Includes exempt normal educational curriculum studies –
permission to use data; UH IRB follows HIDOE regulations

What is considered consent:

Waiver of parental informed consent:
◦ Even if parent consents, child does not participate unless
he or she assents
◦ If child assents and parent does not consent, child cannot
participate
◦ Abused minors
◦ Runaway minors
Human Studies Program
Office of Research Compliance

Translated informed consents should be provided to
participants whose primary language is not English

Translated Materials:
◦ Use professional translation services = $$$$
◦ Forward and backward translation by two different
individuals fluent in English and the other language
 Certification of translation/ back translation
** Translated materials should be provided to the IRB
for review and approval before use
Human Studies Program
Office of Research Compliance


Use of an INTERPRETER is
appropriate and encouraged
during the informed consent
process to facilitate any Q&A, if
investigator cannot speak the same
language
Use of “short form consent” is used
to document consent between
investigator and participant with
assistance of interpreter
** Good Practice: Researcher should
speak to and make contact with
participant, not interpreter. The
interpreter should be placed between
researcher and participant
Human Studies Program
Office of Research Compliance


For individuals who may have diminished capacity to
consent, an assessment of their capacity must be
made prior to enrolling the participant in the study.
Depending on institutional policies (i.e., hospital
regulations), state and local laws, there are specific
requirements for consenting adults with limited
capacity:
◦ Assent: potential participants object or are not capable of
objecting are not enrolled in the research
◦ Legally Authorized Representative (LAR): an individual or
court-appointed body authorized under applicable law to
consent on behalf of the the potential participant

If there is an expectation that the mental capacity of
subjects may become diminished during the course of
their participation, a monitoring plan should be
included in the protocol/ research proposal on how
the investigator would test for diminished capacity.
Human Studies Program
Office of Research Compliance
Per Belmont Report, such types of research is
only justifiable if:
1. Incomplete disclosure is truly necessary to
accomplish the goals of the research,
2. There are no undisclosed risks to
participants that are more than minimal,
and
3. There is an adequate plan for debriefing the
participants, when appropriate
Human Studies Program
Office of Research Compliance

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Used for studies involving deception
Violates Belmont principle #1 – full
understanding of research – but if research
cannot be practically done without deception,
then IRB may grant this alteration
Debriefing Form is given immediately after
completion of participation
Discloses true purpose of study
“Re-consents” participants asking permission
from participant on whether or not data
collected can be used.
Human Studies Program
Office of Research Compliance

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Introduce yourself and why you are doing this
research project
Include your inclusion criteria (e.g., “you are asked to
participate because you are….. And 18 years of age”)
Make sure you know the difference: Anonymous vs.
confidential
Storage and destruction of data
◦ Where are you keeping the data?
◦ How long are you going to keep the identifiable data?
Compensation is not a benefit
Optional section with a “yes” and “no” to initial
◦ Audio recording
◦ Contact for future study
◦ Use of real names in publication
Human Studies Program
Office of Research Compliance

An Informed consent has three basic
requirements:
◦ (1) Informative,
◦ (2) Understandable,
◦ (3) Voluntary Agreement


There are many forms of informed consent
documentation, and appropriate form should suit
the research’s level of risk, study population, and
research setting
Informed Consent is not just a paper, it is a
process!
Human Studies Program
Office of Research Compliance
Templates of consents can be found at
https://manoa.hawaii.edu/researchcompliance/templates
Contact Us:
Human Studies Program
Office of Research Compliance
UH Manoa
Biomedical Building B-104
(808) 956-5007
[email protected]
Website: https://manoa.hawaii.edu/researchcompliance/humanstudies
Human Studies Program
Office of Research Compliance
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