Working with Minors

All of the necessary forms and documents to be presented for IRB review are listed in the bottom of this page.  Please read all the sections here before starting your paperwork.  

MTSU IRB’s Classification of Research with Minors

Children are considered to be vulnerable because of their lack of cognitive ability to make their own decision.  Moreover, children and adolescents exhibit communicative vulnerability due to their intellectual and emotional limitations.  Furthermore, they are legally incompetent to give valid informed consent.  The MTSU IRB has has long instituted ethical and safety standards to be followed by its researchers when dealing with minors.  The studies are classified under one of the following three categories based on the proposed intervention:

1. Educational tests
   1. Studies involve either standard or novel education practices
   2. The survey instruments will only involve educational testing 
   3. Standard educational evaluations may qualify for exemption – please contact [email protected]
   4. Most studies will qualify to be reviewed under the expedited mechanism
   5. If the study involves more than minimal risk, then complete Minors Additional Information Page
2. Psychological and/or Behavioral evaluation
   1. Studies may involve educational tests or not but the specific aims encompass the understanding that pertains beyond mere educational analysis
   2. The study instruments probe the minor’s behavioral ability
   3. Although most studies qualify for the expedited process, please be advised that the IRB may require your study to be reviewed by a full committee should the protocol propose procedures that require a convened discussion
   4. Must complete and submit “Additional Information Page” regardless of the risk level
3. Physical evaluation
   1. The minors will be asked to perform or part-take in physical activities or procedures
   2. Other types of tests including medical, clinical or pharmaceutical intervention
   3. There is a good chance that your study may require a full committee review
   4. Must complete and submit “Additional Information Page” regardless of the risk level

Mandatory Requirements to Involve Minors

 The federal law mandates the following minimum requirements in order for the IRB to approve a study involving minors:

• The researcher has to demonstrate that the study entails no more than minimal risk
  • The study can still be approved if the risk is more than minimal, but the outcome of the study directly benefits subject and the procedures can only be conducted within the context of the research
• Consent from parent (both parents in certain cases) or legal guardian(s) when applicable
• Assent from the participating child
• Except for a few educational research scenarios, all of the studies that use minors as participants are overseen through the IRB’s expedited or full committee review

Provision for Education Researchers

In certain research projects that enroll school teachers as participants, the study would also include the analysis of student records of those teachers.  In such instances, when applicable and approved by the IRB, a special provision is allowed to delegate the delivery and collection of parental consent forms and administer child assent.  The details and restrictions are determined on a case-by-case manner.  Since the teachers would be considered as “co-investigators” temporarily, they are required to complete appropriate training.  If approved by the IRB, the teachers may be trained by the senior investigator of the protocol.  Click here to obtain additional information on this provision.  If you would like to use this provision, then a suggested training material on basics of human subject research involving minors can be obtained by clicking here.  Additional training may be required by the IRB based on the methods and procedures of the protocol.  This delegation of school teachers will be allowed only when the study is considered as lower than minimal risk. 

Exempt versus Expedited for Research Involving Minors

Although minors are considered to be vulnerable, few types of studies can potentially be approved under the EXEMPT mechanism.  Depending on the type of study, a parental consent requirement may be waived when the study involves normal education activities that a minor student would have carried out whether the study is conducted or not.  In order to qualify for the exemption status, the study has to fit with the “normal education practices” definition.  Answer the following questions to determine if your study involving minors would clarify to be “educational practice.”

1. Other than non-identifiable demographics, will the data collection involve name(s), addresses and other types of personal information, including health data of the minors or their relatives?
   1. YES – the study is NOT exempt
   2. NO – go to question 2
2. Will the study involve the delivery of education?
   1. NO – the study is NOT exempt
   2. YES – go to question 3
3. Does the education delivery entail typical curriculum and activities involving testing?
   1. NO – the study is NOT exempt
   2. YES go to 4
4. Will the data collection involve videotaping or recording the voices of the minors?
   1. YES – the study is NOT exempt
   2. NO – go to 5
5. Will an evaluation assessment be conducted to address a “research” question? (Refer to the FAQ page on OHRP’s definition of “research”)
   1. YES – the study is NOT exempt
   2. NO – the testing is done to evaluate an education method or technique – go to question 6
6. Will the students in class do the same activity/activities?
   1. NO – the study MAY NOT BE exempt AND go to question 7
   2. YES – go to question 7
7. Regardless of your response to question 6, Will you be recruiting participants randomly or through purposeful selection
   1. YES – the participants will be selected randomly through a clear acceptable inclusion criteria
   2. NO – the participants will be selected purposefully – you will need parental consent and child assent

 Approval Criteria used by the IRB

The IRB has to determine that the research can be approved under one or more of the following OHRP-recommended criteria:

1. The research does not involve more than minimal risk to the participant (Section 404)
   1. Examples: Standard educational tests that are conducted to evaluate an school program
   2. Evaluation of a non-standard teaching procedure that was conducted over a short period of time with the focus to improve education in general
2. The research poses more than minimal risk to the participant, but the outcome of the study results is directly beneficial to the subject (Section 405)
   1. Examples: A new drug with no- or limited clinical knowledge that has the potential to treat the subject’s existing condition for which no alternative treatment procedures are available
   2. Psychological or behavioral evaluations using children are often categorized as “more than minimal” risk because of the nature of the intervention.  Nonetheless, the intervention must lead to an advancement in knowledge whether the subject is the direct beneficiary or not
3. The research poses more than minimal risk and it does not directly benefit the subject – However, the intervention or procedure presents experiences to the subject that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or education situation AND the it is likely to yield vital generalizable knowledge about the subject’s disorder (Section 406)
   1. Examples: A new drug with no- or limited clinical knowledge that has the potential to become part of treatment of similar conditions of other children but may not necessarily cure the subject
   2. A novel educational practice aimed at instructing children of certain deficiency that may not immediately help the subject’s current academic performance but outcome of the research has the potential to benefit other children who are experiencing a similar condition

The fourth category of approval research involving children is identified in Section 407, has not be done at MTSU yet, and it requires the IRB to make certain findings and refer the proposed research activity to the Secretary of HHS for further review and approval.In all of the above categories, the risk has to be only a small increase from the acceptable minimal risk to the subject.

Definition of “No more than Minimal Risk”

Classifying a particular activity into one of the above  categories involves, among other things, determining whether the proposed research involves “minimal risk” to the subjects. The regulations rely on the definition of “minimal risk” provided in Subpart A of the regulations, as follows:

“Minimal Risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)).

Determining that a research activity presents “no more than minimal risk” involves comparing the possible harms or discomforts experienced in normal daily life or during routine physical or psychological examinations or tests with the possible harms or discomforts that will be faced by subjects as a consequence of research participation. The nature of the harms or discomforts (e.g., physical, psychological, legal) should be considered, as well as the chances that they will occur and the seriousness of their impact if they were to happen. Depending on what kind of experience(s) are involved in participation in a specific research activity, it may be easier to compare the anticipated experience of participation in research to the possible harms or discomforts of daily life, or to the possible harms or discomforts of a routine physical or psychological examination or test. Including measures to prevent or decrease the likelihood of harm or discomfort from the research may affect whether the proposed research activity involves no more than minimal risk.

Parental Consent

SCENARIOS:

Regulatory Category of Research with Children	One Parent’s or Both Parents’ Permission
Minimal Risk (45 CFR 46.404, 21 CFR 50.51)	One parent/legal guardian may be sufficient
Greater than Minimal Risk, Direct Benefit to Subject (45 CFR 46.405, 21 CFR 50.52)	One parent/legal guardian may be sufficient but IRB must determine whether one or two is required
Greater than Minimal Risk, No Direct Benefit to Subject, but Likely to Yield Generalizable Knowledge about Subject’s Condition (45 CFR 46.406 21, CFR 50.53)	Both parents/legal guardians, unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the child.
Greater than Minimal Risk, No Direct Benefit to Subject, but Results May Alleviate Serious Problems of Children’s Health or Welfare (45 CFR 46.407 21 CFR 50.54)

What happens when Parents Disagree?

If there are two parents available to give permission but they disagree about allowing their child to participate in the study, the child may not be enrolled unless that disagreement can be resolved. This applies to all permissible categories–even if only one parent’s signature is required, when both parents are involved in the decision, they must agree for the child to be enrolled. If a parent who was not involved or available for the original consent later becomes involved or available, the two parents must then agree.  Under such circumstances, the MTSU IRB requires that the researchers remove the child from the list of enrollment until the parental dispute has been resolved.  

Parental consent and Child Assent – Basics

• 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 that parental abuse of the minor(s) is evident
  • 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

NOTE: Both parental consent and child assent CANNOT BE WAIVED at the same time under any research scenarios

Who may give Parental Consent?

• The following individuals may provide parental consent for a child to participate in a research study:
  • Natural or adoptive parents
  • Legal custodians or legal guardians
  • Individuals who posses 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 reseearcher 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

Waiver of Obtaining Parental Permission or Child Assent or both

The MTSU IRB will consider a waiver or a request for alternation only under the following conditions:

• The parental consent can be waived ONLY if there is proof that parental abuse of the minor(s) is evident.  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
• Both parental consent and child assent CANNOT BE WAIVED at the same time under any research scenarios

Working with Minors – Forms 

• Expedited/Full Applicaiton
• Permission letter on appropirate stationary (PDF scan) from school, hospital, childcare facility, etc.
• Evidence for completion of CITI training i Social & Behavioral Research, Students in Research (if applicable), Research with Children, Research in Primary/Secondary schools (if applicable), Internet-based Research (if applicable.
• Recruitment Letter/Script (if applicable)
• Parental Consent Form (age appropriate)
• Child Assent Form (age appropriate)
• Additional Information Page when conducting research in non-educational subjects or if the study may involve more than minimal risk

---

Click here to visit the IRB forms page

Click here for instructions for delegating teacher participants

Click here for training material to be used to educate teachers who may play a dual role of participant and co-investigator

---

Review the Federal Code for Working with Minors