Message:
Individuals must voluntarily and freely consent to take part in research studies
before any human subject research procedure can begin.
Implication:
Juvenile justice professionals are ultimately responsible for educating the
potential participants about risks and benefits associated with
the research, obtaining their consent before involving them in research,
and keeping them informed throughout the study.
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Informed consent reflects the ethical principle of respect
for persons. The potential research participant must
first comprehend what is involved in the study and then voluntarily
agree to participate with the understanding that there is
the option to withdraw from the research study at any time.
Fundamentally, it is a person’s right to know about
the purpose of the research, what they may experience during
the research activity, any potential risks and benefits, and
other factors that may affect a person’s decision to
participate.
The following scenario illustrates a common practice and process of obtaining
parental consent. If you were Paul, would you make the same
judgment and accept the parents’ signatures as informed
consent? The information that follows should help you
with your decision.
Paul is a juvenile court intake officer for a large urban county.
In addition to many other forms, Paul asks parents/guardians
accompanying youth at intake to sign consent forms describing
a program evaluation funded by the county. One of the data
collection methods for the evaluation is an interview by the
evaluator with youth to learn about their past and present
alcohol use. Many parents appear anxious during the intake
interview. Some do not read the consent form, but sign it;
others appear confused when they do read the form, but also
sign it. Paul perceives the evaluation to be valuable to drug
and alcohol program planners and decides to accept the signatures
as their consent for their child to participate in the interview
regardless of his feelings about the forms.
- Does it really matter that parents/guardians fully understand
the consent process?
- Is there a potential for harm if youth participate in the
interview?
- How would you decide?
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Informed consent is not the consent form or a signature. Informed
consent is a mandatory ongoing educational process that
begins with an initial meeting to determine whether each potential
participant is capable of giving consent. Once it is determined
that an individual is able to give consent, the purpose and
the potential risks and anticipated benefits of the study are
described. The potential participant is invited to ask questions
and to discuss concerns. The responsibility of the researcher
is to present to the individual information that is comprehensive
yet simple and straightforward. The perspective participant
should be given time to make a decision and should not feel
hurried or pressured. The researcher may not involve any human
participants in a research study prior to obtaining their informed
consent.
There are two exceptions to the requirement of written documentation
of informed consent. The first exception involves situations
where the consent document is the only record linking the
participant with the research and the principle risk of participation
is breach of confidentiality. Studies on sensitive
topics, such as sexual deviancy, fall within this possible
exclusion. The second exception involves research that presents
no more than minimal risk and involves procedures that do
not require written consent when the procedures are performed
outside of a research setting, such as an opinion poll in
a public place where respondents are unidentified and questions
are innocuous. Even when a study meets the criteria for one
or more of the exceptions, researchers must not waive or modify
the consent process. This authority rests in the hands of
the IRB.
Informed consent must be documented by the use of a written consent
form approved by the IRB and signed by the participant or
by the participant’s legally authorized representative.
The informed consent document must contain the basic elements
of consent [Common Rule 28 CFR Part 46.116 and 46.117] and
any additional elements of consent as required by the IRB.
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Informed
Consent Checklist - Basic Elements
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A statement that the study involves research.
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An
explanation of the purposes of the research.
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The
expected duration of the subject's participation.
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A
description of the procedures to be followed.
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Identification
of any procedures which are experimental. |
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A
description of any reasonably foreseeable risks or discomforts
to the subject. |
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A
description of any benefits to the subject or to others
which may reasonably be expected from the research. |
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A
disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the
subject. |
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A
statement describing the extent, if any, to which confidentiality
of records identifying the subject will be maintained. |
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For
research involving more than minimal risk, an explanation
as to whether any compensation, and an explanation as
to whether any medical treatments are available, if injury
occurs and, if so, what they consist of, or where further
information may be obtained. |
( ) Research Qs
( ) Rights Qs
( ) Injury Qs
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An
explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights,
and whom to contact in the event of a research-related
injury to the subject. |
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A
statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled, and the subject
may discontinue participation at any time without penalty
or loss of benefits, to which the subject is otherwise
entitled. |
| http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm |
Details of the study must be contained in the consent document including
the potential risks and benefits of participating in the study.
This information must be communicated in simple, straightforward
non-technical language that is free of jargon and contain the
elements listed below. Nevertheless, the document should not
be a substitute for a thorough discussion with the perspective
participant with opportunities for questions and answers.
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Informing Prospective Research Participants
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- Obtain IRB approval of human subjects research.
- Provide potential subject with consent document.
- Review consent document with potential subject, explain key points relative to
the study and participation. Discuss risks and benefits. Answer
all questions.
- Provide prospective subject with a copy of the consent signature form.
- Allow prospective participant time to discuss participation with friends and family.
- Meet with prospective participant to answer any additional questions. Ask
participant key questions about the research study in order to check for understanding.
- If individual chooses to participate in the study, have him or her sign the
consent form. Provide participant with a signed copy of the form.
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http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm
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When children are the subjects of human research, special ethical and regulatory
considerations must be given. Because children lack full intellectual
capacity and emotional maturity, they are legally unable to give valid
consent. Furthermore, youth in the custody of the juvenile justice
system may be unable to make a voluntary and uncoerced decision whether
or not to participate. Along with the required adherence to the Common
Rule, the institution or the IRB may want to extend protection
to vulnerable populations as described in 45 CFR 46 Subpart D. These
special regulations require the permission of the parent(s)
and the assent of the youth or minor in place of informed
consent. When the research involves greater than minimal
risk, the IRB must determine whether the signature of both parents
is required and the conditions under which one parent is considered
not reasonably available. The requirement for parental permission
may be inappropriate when youth are older adolescents who, under law,
may consent on their own behalf or when there is serious doubt that
the parents’ interest adequately reflects the interest of the
youth. Subpart D of 45 CFR 46 also includes consent provisions for
youth who are wards of the state. For any youth who is a ward of the
state, the IRB must require an appointment of an advocate
in addition to any other individual acting on behalf of the youth
as a guardian or in loco parentis.
Subpart D recognizes that although youth do not have the legal capability
to give informed consent, they may have the ability to
assent or dissent from participation. A youth’s
assent is required if the IRB determines that a particular child
has the cognitive and emotional maturity to understand the conditions
of the research and to decide whether to participate. The majority
of children between ages 8 and 17 are considered capable of granting
assent. Parental consent can only overrule the child’s
refusal to assent when the research condition is important to the
child’s well-being and is available only within the context
of the research study. Similar to the informed consent process,
the proposed research should be explained to the child in language
that is appropriate to the child’s age, experience, and maturity.
The child is to be given the opportunity to ask questions and discuss
concerns about the research. The child’s agreement to participate
is documented on an assent form. This form outlines the
same basic elements of consent identified on the consent form but
is written at the child’s level of understanding and reading
ability.
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Special
Requirements - 45 CFR 46 Subpart D - Additional DHHS Protections
for Children Involved as Subjects in Research
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| Assent/Waiver |
The
IRB shall determine that adequate provisions are made
for soliciting the assent of the children, when in the
judgment of the IRB the children are capable of providing
assent. If the IRB determines that the capability of some
or all of the children is so limited that they cannot
reasonably be consulted, or that the intervention or procedure
involved in the research holds out a prospect of direct
benefit that is important to the health or well-being
of the children, and is available only in the context
of the research, the assent of the children is not a necessary
condition for proceeding with the research. Even where
the IRB determines that the subjects are capable of assenting,
the IRB may still waive the assent requirement under circumstances,
in which consent may be waived in accord with §46.116
of Subpart A. |
| Parents |
The
IRB may find that the permission of one parent is sufficient
for research to be conducted under §46.404 or §46.405. |
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Where
research is covered by §46.406 and §46.407,
and permission is to be obtained from parents, both parents
must give their permission, unless one parent is deceased,
unknown, incompetent, or not reasonably available, or
when only one parent has legal responsibility for the
care and custody of the child. |
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If
the IRB determines that a research protocol is designed
for conditions or for a subject population, for which
parental or guardian permission is not a reasonable requirement
to protect the subjects (for example, neglected or abused
children), it may waive the consent requirements in Subpart
A of this part and paragraph (b) of this section, provided
an appropriate mechanism for protecting the children who
will participate as subjects in the research is substituted,
and provided further that the waiver is not inconsistent
with Federal, state or local law. |
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http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm
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As part of the
ongoing process, Federal policy also requires investigators to inform
research participants about changes in the study that may affect
their willingness to continue to participate in the research project.
This may require a new informed consent. Changes may be the result
of new findings or new reports of risks associated with participation.
New information can come from the current study or from an outside
study. Continuing consent is important because participants retain
the right to withdraw at any time during the research.
Federal informed consent regulations require that all research activities must
comply not only with Federal regulations but also with the law of
the state in which the research is performed. Researchers must be
aware of state laws affecting consent for the proposed research.
Laws governing age of consent, the right of parents to consent on
behalf of their children, and emancipation differ from
state to state.
Now, what is your response to Paul’s decision?
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- Does it really matter that parents/guardians fully understand the consent process?
- Is there a potential for harm if youth participate in the interview?
- How would you decide?
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Paul should inform the evaluator about his observations of parents and
what appears to be lack of understanding about the program evaluation.
The current informed consent process is in violation of the ethical
principle of respect for persons defined in the Common Rule. The parents
must first comprehend what is involved in the study and then voluntarily
give permission for their child to participate with the understanding
that they have the option to withdraw the youth from the research
study at any time. The parents have a right to ask questions about
the purpose of the research, the research activities, the overall
experience of participating in the project, and any potential risks
and benefits. The process may also violate youths’ right to
assent or refusal to assent. Youth who have the cognitive and emotional
maturity to understand the conditions of the research also have the
right to decide whether or not to participate. Both parents and youth
must have a clear understanding that the evaluation will focus on
past and present alcohol use. The risks associated with breach of
confidentiality concerning the participant’s involvement in
the research should be discussed along with the precautions that will
be taken to minimize this risk.
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The
voluntary consent of the human subject is absolutely essential.
The consent process must assure that prospective participants
understand the risks and benefits of participation and are capable
of agreeing to participate.
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