The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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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.

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?

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.

Informed Consent Checklist - Basic Elements
  A statement that the study involves research.
  An explanation of the purposes of the research.
  The expected duration of the subject's participation.
  A description of the procedures to be followed.
  Identification of any procedures that are experimental.
  A description of any reasonably foreseeable risks or discomforts to the subject.
  A description of any benefits to the subject or to others that may reasonably be expected from the research.
  A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
  A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
  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
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.
  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://www.hhs.gov/ohrp/policy/consentckls.html

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.

Informing Prospective Research Participants
  • 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.
http://www.hhs.gov/ohrp/policy/consentckls.html


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.


Special Requirements - 45 CFR 46 Subpart D - Additional HHS Protections for Children Involved as Subjects in Research
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.
  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.
  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.
http://www.hhs.gov/ohrp/policy/consentckls.html

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?

 
  • 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?
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.

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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