What do I need to know about Informed Consent, Parental Consent and Child Assent forms?

 

The consent procedure is probably the most important step in the human subject research along with the protection of participant confidentiality.  Although it is possible that the importance of obtaining informed consent could get lost in the paperwork, it needs to be stressed that this process is more a conversation than merely filling out a form.  The researchers have to clearly state what they plan to do in the proposed research and why they need consent from the participant.  It may be very worthwhile if the researchers prepare their consent form first and then work their methodology.

Obtaining Consent for EXEMPT Research

The consent process and its related documents can be simpler than those required for review mechanisms.  A one page consent template is located at the last page of the Exempt Application; however, verbal or implied consent can be utilized for some studies (e.g., a consent statement at the top of an anonymous, non-sensitive survey).  Verify with the Office of Compliance if your choice of consent is adequate for the study you plan to conduct.  

Exempt consent documents/statements should include the following:

  • That the activity involves research and participation is voluntary.
  • A brief description of what the study will involve.
  • A statement informing subjects they can stop participating at any time.
  • Name and contact information for the investigator. 

Click here to watch an OHRP video on General Informed Consent Requirements

 

 

 

Obtaining Consent for EXPEDITED and FULL Review projects

No investigator should involve human subjects in research unless the investigator has obtained legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate, and in a manner that minimizes the possibility of coercion or undue influence. The consent process is not just about getting the signature; consent is an ongoing process throughout participation.  A consent template is available on the forms page which covers all of the required elements (see below).

Required elements of informed consent:

  • 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, that might be advantageous to the subject;
  • A statement describing the extent to which confidentiality of the records identifying the subject will be maintained;
  • For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained;
  • An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits which the subject is otherwise entitled and the subject m
  • A statement that the study involves research, an explanation of the purposes of that research, and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures experimental in nature;
  • A statement that subjects may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements of informed consent 

  • A statement that treatment or procedure(s) may involve risk(s) to the subject and are currently unforeseeable;
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  • Any additional costs to the subject that may result from participation in the research;
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  • The approximate number of subjects involved in the study.

Click here to watch an OHRP video on General Informed Consent Requirements

 

Research Involving Children/Minors

  • Children are considered as “vulnerable” because their intellectual/emotional capacities are limited
  • Moreover, they are legally incompetent to give valid informed consent
  • The federal law mandates the following requirements in order to obtain anIRB approval:
    • The researcher has to demonstrate that the study entails no more than minimal risk
    • Consent from parent(s) or legal guardian(s)
    • Assent from the participating child
  • The IRB can impose further constraints and requirements depending on the participants’ age and the proposed activities

Parental consent and Child assent basics and waiver conditions

  • Parental consent:
    • Children below the age of 18 cannot legally give valid informed consent.
    • Permission from parent(s)/guardian(s) must be obtained before beginning the intervention (s)
    • The researcher must describe all of the procedures and interventions to be performed on their child
    • The parental consent can be waived ONLY if there is proof of parental abuse of the minor(s) or evidence that such parental abuse is likely if the parental consent is sought
    • The researchers have to receive an active written consent from the parent(s) or guardian(s)
  • Child Assent:
    • Although the child cannot enroll in a study directly, every minor subject has the right to withdraw from the study
    • The researcher cannot assume the child has approved only based on the parental consent
    • However, in case of life threatening events, only parental consent would suffice – Nonetheless, the child must be given full explanation of the intervention if the IRB approves a waiver for child assent

IMPORTANT: The MTSU IRB will not approve the simultaneous waiver of both parental consent and child assent under any research scenarios

Parental Consent and Scenarios

  • Who may provide parental consent for a child to participate in a research study?
    • Natural or adoptive parents
    • Legal custodians or legal guardians
    • Individuals who possesses power of attorney or authorized by a court to consent
    • Minors emancipated by marriage or court order
  • Situations when only ONE parent can provide consent:
    • When one parent is deceased, unknown, incompetent, or not reasonable available, or when only one parent has legal responsibility for the care and custody of the child
    • The researcher must document this in the subject’s research record
  • Situations when a guardian can provide consent:
    • When both parents are deceased, unknown, or incompetent
    • Research with more than minimal risk but presents NO DIRECT BENEFITS to the subject(s)
  • Who may NOT consent a child?
    • Stepparents
    • Grandparents
    • Adult siblings
    • Foster parents
    • Minors emancipated by pregnancy outside of marriage or by adjudication as an adult

 

 

Child Assent Process

In instances where the participant is not legally capable of giving informed consent (e.g., minors) or where the participant is cognitively impaired, the IRB must find that adequate provisions are made for obtaining the assent of the participant when the participant is capable of doing so. Permission must also be obtained from the legally authorized representative (e.g., parent). An assent template is available on the IRB forms page.  

Federal regulation and most State statutes require that minors assent to participate in research
  • Assent is defined as a minor’s affirmative agreement to participate
  • Unless approved by the IRB, this process must be documented in writing when the subjects are 7 years or older
  • The IRB can require assent from children younger than seven
  • The assent process requires allowing voluntary participation of the child

 Child Assent Form - Elements

The following elements must be included in the child assent form.
  • What is the study about?
  • Why the child is eligible to participate?
  • What are the procedures the child will perform or will be performed on the child?
  • What are the potential risks and discomforts the child will be experiencing?
  • What are the potential benefits to the child or the society?
  • A statement clearly notifying the child that he/she can choose whether to participate and can withdraw at any time without any negative consequences
  • An invitation to ask questions at any time
  • Names and phone numbers of whom to contact should the child have any questions

Child Assent Procedure - Elements

The following is an outline for a typical child assent procedure:
  • The assent process is different with age of the participants – typically, the documentation for children under 7, between 7-12 and adolescents (13-17) are different and so are the procedures
  • As we all know, children constantly change age groups during the span of a study. Therefore, it is vital that the assent process is refreshed at a periodic basis
  • The consent/assent are not a one-time process; It is important that the researcher reminds the participants and the parents that the participation is voluntary and they can withdraw at any time.
  • For the purpose of educational studies, the researcher can explain the elements of the IRB-approved assent document to the participants as a group
  • For non-educational intervention, the assent process needs to take several factors into consideration
  • The researcher must give “enough” time for the minors to make a decision to whether to participate or not
  • There should be time for the minors to ask questions about the study

Acceptable Child Assent Procedure

The process for obtaining oral and/or written consent for children is similar to that of obtaining consent for adults.  As listed in the OHRP requirements, the MTSU IRB instructs all its researchers who enroll minors in their study to follow below described minimal requirements:
  • Conducting the process in a manner and location that ensures participant privacy
  • Giving adequate information about the study in a language understandable to the participant
  • Providing adequate opportunity for the participant to consider all options
  • Responding to the participant’s questions
  • Ensuring the participant has understood the information provided
  • Obtaining the participant’s voluntary agreement to participate
  • Continuing to provide information as the participant or research requires.
  • The assent process is different with age of the participants – typically, the documentation for children under 7, between 7-12 and adolescents (13-17) are different and so are the procedures

 

Approval for Consent Waiver or Permission to Alter the Consent Process

In certain cases, the Federal Regulations allow for approval of procedures which alters the elements of informed consent or waives the requirement to obtain any informed consent. A waiver must be completed and submitted with the application form. The following criteria must apply:

  • The research involves no more than minimal risk to subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subject will be provided with additional pertinent information after participation.

Waiver of Obtaining Signed Consent Forms

Federal regulations allow for approval of a waiver of obtaining signed consent forms if:

  • Consent waiver will not be approved just to address administrative ease of the protocol or for the convenience of the research practice
  • Waiver for signed consent forms will be allowed only in situations where the signed document could be a threat to the participant.  The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, or
  • The research presents no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context.
  • A waiver request must be completed and submitted with the application form.
  • The parental consent can be waived ONLY if there is proof for existing or potential parental abuse.  The researchers must receive an active written consent from the parent(s) or guardian(s) in all research projects involving minors.
  • Child Assent Waiver: in case of life threatening events, only parental consent would suffice – Nonetheless, the child must be given full explanation of the intervention if the IRB approves a waiver for child assent

IMPORTANT: The MTSU IRB will not approve the simultaneous waiver of both parental consent and child assent under any research scenarios

Other Questions about Informed Consent?

Visit the US Department of Health Office for Human Research Protections FAQ section on Informed Consent (http://answers.hhs.gov/ohrp/categories/1566)

 

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