Transcript The Goals and Principles of Human Participant Protection Part 3: Informed Consent Acknowledgements  We thank the University of Texas at Austin for permission to adapt.

The Goals and Principles of
Human Participant
Protection
Part 3:
Informed Consent
Acknowledgements
 We thank the University of Texas at Austin
for permission to adapt and use their IRB
training materials.
 Much of the material in this presentation
was taken from the Code of Federal
Regulations, Title 45, part 46; Protection of
Human Subjects.
 Other material came from the Food and
Drug Administration Regulations, 21 CFR,
parts 50 & 56.
Objective
 The purpose of this presentation is to
raise the level of understanding of all
Tarleton State University faculty,
students, and staff regarding the
regulations governing research involving
human subjects, and
 Enable them to apply these regulations
to specific research studies.
Informed Consent
Informed consent is the voluntary consent
of a person to participate in a study once
they have had the study explained to them
and they understand the following:
Informed Consent
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Confidentiality procedures
What to do in case of injury
Possible conflict of interest
Study purpose
Study procedures
Expected benefits
Possible risks
Withdrawal of consent
Participation alternatives
Contact telephone numbers
Informed Consent: Documentation
 Informed consent must be documented
before the person participates in any study
protocol.
 Documentation of informed consent
involves the person signing a formal
consent form.
 The consent form should clearly explain:
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Study procedures
Risks
Benefits
Contact information
Withdrawal options and procedures
Participants should always be
given a copy of the consent
form.
Informed Consent
 The PROCEDURES section of the
consent form must include:
 Identification of the methodology used.
 All steps involved in participation in the
study.
Informed Consent
 The RISKS section of the consent
form must include:
Psychological risks or discomforts
Social risks
Legal risks
Financial risks
Possible disclosure of confidential study
data to persons outside the study
 Physical or medical risks
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Informed Consent
 The BENEFITS section of the consent
form:
 May not list payment as a benefit
 May not overstate the benefits
 Due to the tenuous nature of research,
benefits should be stated as ‘possible’
 The phrase ‘will benefit’ should be avoided
Informed Consent: Protecting
Confidentiality
 Subjects should be told the extent to
which their private, identifiable
information will be kept in confidence
and should be informed as to who will
have access to their records.
 Be careful not to use the word
‘anonymous’ in place of ‘confidential’.
Informed Consent: Protecting
Confidentiality
Confidentiality refers to the treatment
of information an individual has
disclosed to the researcher in trust
and with the expectation it will not be
divulged without that individual’s
permission in any manner
inconsistent with the informed
consent.
Informed Consent: Protecting
Confidentiality
 In some studies keeping a participant’s
identity confidential may be as or more
important than keeping the data about that
person confidential.
 For example, having one’s name linked to a
study of pedophiles may be more damaging
than the data itself.
 In cases such as this, any written record
linking a particular person to the study,
including a signed consent form, may
create a threat to confidentiality.
Informed Consent: Protecting
Confidentiality
Current federal policy allows the IRB
to waive the requirement for a
researcher to obtain a signed consent
form in cases where it will be the only
record linking participants to the
research and when a breech of
confidentiality is the principal risk
that may result from the research.
Informed Consent: Protecting
Confidentiality
 When data is being collected dealing with
sensitive issues the data may become of
interest to law enforcement agencies.
 Judges are rarely responsive to a
researcher’s claim that the information
cannot be released due to a promise of
confidentiality.
 More than one researcher has been jailed
for refusal to comply with a subpoena.
Informed Consent: Protecting
Confidentiality
 Federal law allows researchers to obtain a
Certificate of Confidentiality prior to
beginning the research.
 These certificates may create a measure of
protection for the researcher who refuses to
violate promises of confidentiality.
 Such certificates are not ‘iron clad’ and may
not protect the researcher from certain
inquiries, subpoenas, or open records
requests.
Informed Consent: Protecting
Confidentiality
 In most research, confidentiality my be assured
through routinely:
 Substituting codes for identifiers.
 Encrypting identifiable data.
 Removing face sheets containing identifiers such as
names and addresses from survey instruments
containing data.
 Properly disposing of computer sheets and other
papers.
 Limiting access to identifiable data.
 Storing paper records in locked cabinets and/or
providing security codes for computerized records.
 Educating the research team on the importance of
confidentiality.
Informed Consent: Privacy
 Private information is defined as any
information about behavior occurring within
a context in which an individual has a
reasonable expectation that no observation
or recording is taking place.
 It also includes information provided by
someone for specific purposes with the
expectation it will not be made public.
 The IRB reviews studies to ensure adequate
privacy protections and to prevent
invasions of privacy.
Informed Consent: Privacy
 The informed consent process should
disclose any risks to privacy and
explain how the research team
specifically plans to protect privacy.
 The best means of protecting privacy
is by maintaining anonymous data
collection.
Informed Consent: Withdrawal
From the Study
 Federal regulations require a clear
statement in all consent forms:
 Participation in the study is voluntary
 Refusal to participate will not involve a
penalty or loss of benefits
 Subjects may withdraw from the study at
any time
Informed Consent: New Findings
 Federal regulations require the inclusion of a separate
statement regarding new information (for example, a
change in the risk-benefit ratio or new alternatives to
participation) that may affect a subject’s willingness
to continue their participation.
 The subjects should be told they will be informed
promptly of any new findings related to the study.
 Should new findings occur during the study, the IRB
will advise the lead researcher whether subjects
should be asked to sign a revised consent form.
Informed Consent: Non-English
Speaking Participants
 Non-English speaking participants must
have informed consent information
presented in a written language they can
understand [-21 CFR 50.20-27].
 IRB approved informed consent documents
must be available in English and other
languages as appropriate to the subject
population(s).
Informed Consent: Waiver of
Consent
 A waiver of informed consent can be
granted by the IRB if all of the
following conditions are met:
 The research involves minimal risk
 A waiver will not adversely affect rights
and welfare of subjects
 Research could not practicably be carried
out without the waiver
 Subjects will be debriefed, when
appropriate.
Informed Consent:
Written versus Oral
For research purposes, oral consent is
not the same as written consent and
should not be regarded as such.