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Researcher discussing assent form with parent and child

Research Involving Children

Protection of Vulnerable Subjects SOP [C3.0100]

[D22.0000] UK IRB Policy on Children in Research

Children are considered a vulnerable research population because their intellectual and emotional capacities are limited, and they are legally incompetent to give valid consent. Special procedures and considerations are, therefore, required by federal regulations for the review of research involving children.

Whenever feasible, appropriate studies should be conducted on animals, adults, and older children before young children are involved as research subjects. If you are proposing research involving individuals under the age of 18, read the requirements described below and select appropriate categories in the IRB application. 

Methods for Obtaining Parent Permission and Assent

The Institutional Review Board (IRB) is required to consider the degree of risk inherent in the proposed research and the methods for obtaining the assent of the children, as well as the permission of parents or guardians. The IRB's policy with respect to obtaining permission from the parents or guardians and assent from children is specified below: 

  1. Parental permission must be obtained if the research involves children under the age of 18, unless the individuals are legally emancipated or the IRB waives the requirement.  A written form must be used to document parental permission.  The permission process and form must include the elements of informed consent set forth in federal regulations and outlined in the informed consent template included in the IRB expedited and full review applications.  The parental permission form should be written from the perspective of a parent being informed about what their child is being asked to experience (i.e., “Your child is being asked…”, “Your child will…”).     
  1. Subjects 6 years of age or older should be involved in the decision to participate in a research project unless the requirement for assent is waived (see below for conditions of waiving assent).
     
    The Investigator should, at a minimum, provide an explanation to the children about the proposed research procedures in language appropriate to the child's age, maturity, and condition (i.e., assent script).  See the ORI Informed Consent/Assent webpage for instructions and a sample assent form containing appropriate elements. 
  1. When the IRB determines that assent is required, the regulation permits the IRB to also determine whether and how assent must be documented. Unless the requirement is waived by the IRB, signatures are generally required on the assent for subjects aged 12-17.  The child should be given an explanation, at a level appropriate to the child's age, maturity, and condition, of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research.  In most cases, a written assent form should be used to document assent. A copy of the assent form must be submitted to the IRB for review.  The form should include a simplified version of the elements of informed consent (see ORI Informed Consent/Assent webpage for instructions and a sample assent form containing appropriate elements). 
  1. For clinical research, individuals under the age of 18 may possibly be considered emancipated in accordance with state law.  For a complete definition of emancipated minors, see the section on Emancipated Individuals in the Informed Consent SOP.  Legal counsel will make a determination whether subjects in a study meet state requirements for being legally emancipated.  Investigators should contact UK Legal Counsel before submitting the IRB application to the IRB. 

Federally Mandated Categories

Federal regulations specify that the conditions for approval of research involving children vary in accordance with the following four federally mandated categories of research based on the degree of potential risk and benefit: 

  1. Research does not involve greater than minimal risk[i];
  2. Research involves greater than minimal risk but presents the prospect of direct benefit to the individual subjects[ii];
  3. Research involves greater than minimal risk, and no prospect of direct benefit to an individual subject, but is likely to yield generalizable knowledge about the subject’s disorder or condition; or
  4. Research does not fall under Category 1, 2, or 3 listed above; however, the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. 

The investigator selects the applicable category and addresses the federal requirements by completing the IRB expedited and full applications. The IRB applies federal regulations when conducting reviews of studies involving children. The IRB may approve only those clinical investigations that satisfy the criteria described in Categories 1, 2, and 3. Should the research fall under Category 4, a report must be sent to the applicable federal agency for review, and the IRB may not independently approve the research.

Guidance Regarding FDA Associated Studies*:

Children should not be enrolled in clinical investigations unless their participation is necessary. For example, for products that are being developed for use in adults and children, if effectiveness in adults can be extrapolated to children, then adult studies ought to be used to minimize the need to collect effectiveness data in children (this is unlikely for neonates, which would likely need a separate study). Further, clinical investigations involving children should be designed to maximize the amount of information gained and minimize the number of subjects involved. Additionally, as with all human subject research, studies need to ensure an balanced selection of subjects.

IRBs should consider the cumulative risk if more than one non-therapeutic procedure is planned and should ensure that procedures be performed at a high-volume center with dedicated pediatric sedation service, rigorous scientific justification for non-therapeutic procedures, a description of risk minimization if there is a sedation procedure in the protocol, children with chronic conditions are carefully monitored or excluded, non-therapeutic procedures are terminated if complications arise or sedation is inadequate, sedation not withheld if the purpose is solely to avoid risk, and that clear communication occurs with both the subjects and their parents to include formal assent/consent as applicable. 

A placebo control arm of a pediatric clinical trial must be categorized under either Category 1, 3, or 4.  The FDA has indicated that the administration of a placebo would not meet Category 2 because it would not offer a prospect of direct benefit. In addition, the FDA does not consider the concept of enhanced safety monitoring or follow-up provided to subjects in a placebo arm to constitute a prospect of direct benefit. In a study that has one arm meeting Category 3 and another arm meeting Category 1 or 2, the protections included under the more stringent Category 3 would be applied to the entire study (e.g., provisions to solicit permission of both parents/guardians).   

Intravenous catheters placed solely to administer a placebo and not needed for clinical management or routine clinical care should be considered part of the risk assessment. Further, a peripheral intravenous catheter should be considered minimal risk or a minor increase over minimal risk, whereas a central intravenous catheter should be generally considered to exceed the minor increase over minimal risk threshold in regard to placebo administration. However, further consideration of risk regarding central intravenous access devices may be necessary for studies in which the length of the study may cause issues for participants, where peripheral venous access is painful and/or traumatic, and assent and consent have been obtained for placement. 

View May 2017 Minutes of a Joint Meeting of the Pediatric Advisory Committee and Pediatric Ethics Subcommittee

Placebo-controlled drug trials requiring injections or infusions administered over the course of one or two years have been justified as a minor increase over minimal risk, depending on whether appropriate risk mitigation strategies are included as part of the protocol. For example, in a placebo-controlled study lasting 2 years, one could use a 2:1 randomization or cross-over after an appropriate interval to mitigate the risk associated with receiving a placebo over a prolonged period. 

View May 2018 Minutes of a Joint Meeting of the Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee

Whereas, large organ biopsies, such as liver or kidney biopsies, when done for research purposes only, have been considered to exceed a minor increase and should not be done in children unless the procedure is performed as part of routine clinical care for their condition. 

Additionally, to offer the prospect of direct benefit, any dose planned for use should have the potential to have therapeutic effects based on available scientific information. Adaptive designs involving titration may help in establishing/achieving sufficient dosing. 

Federal regulations also have additional requirements for studies that involve children who are wards of the state.

See the Summary of Children Regulations (Subpart D) for a detailed description of the regulatory categories and conditions of approval.  

Additional requirements may apply when research with children is supported by or involves other federal agencies (e.g., Department of Education, Environmental Protection Agency).  For summary guidance and IRB checklists for other federal agencies, see the Federal Agency Specific Requirements section of the IRB Survival Handbook.

*Some information in this section is based on non-finalized guidance from the FDA.

 

i Examples of minimal risk interventions may include blood draws, physical exams, chest X-rays, MRIs without contrast or sedation, or surveys.

ii Potential harm should be transient, reversible, and severe pain should be extremely small or nonexistent. The setting and experience level of the investigator may impact this evaluation. Examples of minor increase over minimal risk interventions are urine collection via catheter, bone marrow aspirate with topical pain relief, MRIs with contrast or sedation, single lumbar punctures, single muscle biopsy, or administering a single dose of an investigational drug with adequate safety information.

Waiver of Assent and/or Parental Permission

The IRB may waive its requirements for obtaining or documenting assent if the IRB determines:

  1. The capability of the child is limited such that (s)he cannot be reasonably consulted;
  2. The children are not capable of providing assent based on their age, maturity, or psychological state; or
  3. The research intervention or procedure(s) involved hold 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 investigation; or
  4. a) The research involves no more than minimal risk to the participants; and
    b) The waiver will not adversely affect the rights and welfare of the participants; and
    c) The research could not practicably be carried out if assent was required; and
    d) When appropriate, pertinent information is provided after participation.

If the IRB determines that any of the above criteria are met and waives the requirement for obtaining assent, the IRB determines and documents which children are not required to assent.   

The IRB regulatory requirements for waiving parental/guardian permission are summarized below.

  1. The IRB may waive the requirements for parental/guardian permission in non-FDA regulated studies if the conditions outlined in 45 CFR Subpart D 45.408(c) or 45 CFR 46.116(e)(f) are met. (See ORI/IRB Informed Consent SOP).
  2. IRB cannot waive parental/guardian permission for FDA-regulated studies that are greater than minimal risk, except for research meeting the regulatory category of Emergency Research (21 CFR 50.24). The IRB may consider criteria for waiver of parental/guardian permission in Category 1 only.
  3. The IRB may determine that permission of one parent is sufficient if the research is not greater than minimal risk (Category 1) or greater than minimal risk but presents the prospect of direct benefit to individual subjects (Category 2). 

For all other risk categories of research (Categories 3 and 4), permission of both parents or guardians is required unless one parent is not reasonably available, deceased, unknown, legally incompetent, or when only one parent has legal responsibility for the care and custody of the child. Parental permission documents should be formatted to accommodate both signatures.

Exemptions

The IRB may determine that some research involving children can be exempt from the federal policy for the Protection of Human Subjects. Research that involves children and falls into categories under 45 CFR §46.104 (Category 1,4,5,& 6) may be found to be exempt. However, the exemption category under 45 CFR §46.104 (Category 2), pertaining to survey or interview procedures or observations of public behavior, does not apply to research involving children, except for research involving public behavior when the Investigator does not participate in the activities being observed. In addition, the exemption category under 45 CFR §46.104(Category 3), benign behavioral interventions, does not apply to interventions involving children. 

State Law

State and local laws must be followed when they provide additional protections beyond those provided by federal regulations.  For assistance with applying state law to research involving children, contact the University of Kentucky’s legal counsel at (859) 257-2936. 

For research conducted outside the state of Kentucky, the Principal Investigator (PI) is responsible for identifying the applicable state law(s) to determine which individuals are “children” or “guardians”.  The PI should contact legal counsel if unable to identify applicable state law(s).  The PI provides the information to UK legal counsel for review and determination prior to approval by the IRB.

Definitions for “child/children”, “legally authorized representative”, “emancipated”, “guardian”, “assent”, and “permission” are included in the ORI/IRB Informed Consent SOP.

Additional Regulatory Protection for Children and Prisoners

The revised common rule regulations now allow for the application of all exempt categories to research involving the use of pregnant women, human fetuses, and neonates, assuming all the research activities fall within one or more exempt categories as determined by the IRB. 

Certain research activities cannot be exempt because additional protection has been granted by federal regulations for vulnerable populations.  The kinds of research that cannot be exempt because they are subject to the federal requirements of subparts C and D are as follows: 

  1. Research that involves surveying and/or interviewing children;  
  1. For Category 2, research involving the administration of educational tests and/or the observation of public behavior of children if the investigators actively participate in the test administration or the activities being observed; 
  1. For category 3, research involving benign behavioral intervention with children;  
  1. Research involving prisoners when prisoners are the intended/targeted population for enrollment (Note: prisoners may be allowed if the research is aimed at involving a broader subject population and the involvement of the prisoner(s) is only incidental).

[Excerpt from Exempt Review webpage.]

[D61.0000] Summary of Children Regulations (IRB Review)

OHRP/HHS and FDA have regulations governing the conduct of research involving children. The IRB must review research/clinical investigations involving children as subjects covered by Subpart D and approve only those protocols that satisfy the criteria and conditions described below.

Additional requirements may apply when research with children is supported by or involves other federal agencies (e.g., Department of Education, Environmental Protection Agency).

Department of Health and Human Services (HHS) 45 CFR Part 46 Subpart D 

Food and Drug Administration (FDA) 21 CFR Part 50 Subpart D

Definitions [FDA 21 CFR 50.3(s) & DHHS 45 CFR 46.402]

  • Minimal Risk: 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 examination or tests.
  • Guardian: An individual who is authorized under state and local law to consent on behalf of a child to general medical care.
  • Permission: The agreement of the parent(s) or guardian to the participation of their child or ward in research or a clinical investigation.
  • Assent: A child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Risk/Benefit Categories

The IRB must review research/clinical investigations involving children as subjects covered by this Subpart D and approve only those clinical investigations that satisfy the criteria described in Categories 1, 2, and 3. Should the research fall under Category 4, a report must be sent to the applicable federal agency for review, and the IRB may not independently approve the research.

Risk/Benefit Category 1: Not Greater than Minimal Risk (46.404 and 50.51)

The IRB must find that:

  1. Adequate provisions have been made for soliciting the assent of the children as set forth in 46.408 and 50.55;
  2. Adequate provisions have been made for soliciting the permission of their parents or guardians as set forth in 46.408 and 50.55. (Permission of one parent is sufficient if approved by the IRB.)

Risk/Benefit Category 2: Greater than Minimal Risk, but Prospect of Direct Benefit to Individual Subjects (46.405 and 50.52)

IRB must find that:

  1. Risk is justified by anticipated benefit;
  2. Relation of the benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches;
  3. Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians. (Permission of one parent is sufficient if approved by the IRB.)

Risk/Benefit Category 3: Greater than Minimal Risk, No Prospect of Direct Benefit to Individual Subjects, but Likely to Yield Generalizable Knowledge about the Subject's Disorder or Condition (46.406 and 50.53)

IRB must find that:

  1. Risk represents a minor increase over minimal risk;
  2. The intervention or procedure presents experiences to the subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
  3. The procedure is likely to yield generalizable knowledge about the subjects' disorder or condition, which is of vital importance for understanding or amelioration of the subjects' disorder;
  4. Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians; (except under specific circumstances, permission must be obtained from both parents).

Risk/Benefit Category 4: Research not otherwise approvable, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (46.407 and 50.54). 

To approve requires:

  1. IRB finds the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem.
  2. Review by the HHS Secretary or the FDA Commission after consultation with a panel of experts and public comment.

FDA Expectations in Applying Categories in Placebo-Controlled Studies:

Upon final adoption of FDA Subpart D, the FDA provided an interpretation of category assessment relative to placebo-controlled studies. The FDA has indicated that administration of a placebo would not meet Category 2 (21 CFR 50.52) because it would not offer a prospect of direct benefit. In addition, the FDA does not consider the concept of enhanced safety monitoring or follow-up provided to subjects in a placebo arm to constitute a prospect of direct benefit.

FDA expects the IRB to conduct a component analysis of each arm of a placebo-controlled trial. The placebo arm of a pediatric clinical trial should be categorized under either Category 1, 3, or 4.

Assent Requirements: FDA and DHHS [FDA 21 CFR 50.55 & DHHS 45 CFR 46.408]

Assent is required if Children are capable of Assent

To determine if a child is capable of assent, the IRB must consider:

  1. Age
  2. Maturity
  3. Psychological State
  4. All Children or
  5. Each Child

Assent is NOT required IF:

  1. Capability limited/cannot reasonably be consulted OR
  2. Prospect of direct benefit important to health/well-being and available only in the context of investigation OR
  3. No More than Minimal Risk and will not adversely affect the rights and welfare, and could not practicably be carried out when appropriate, provided pertinent information after participation.

Assent Documentation:

IRB must determine whether and how assent must be documented.
 

Parental Permission [FDA 21 CFR 50.55 & DHHS 45 CFR 46.408]

IRB must determine that provisions are in place to solicit and document permission of each child’s parent(s) or guardian in accordance with basic elements of informed consent (i.e., FDA 21 CFR 50.25 & 50.27; DHHS 45 CFR 46.116 & 46.117).

When the IRB requires both parents’ permission (e.g., Research Categories 3 & 4), only one parent’s permission is needed if one parent is:

  • Deceased;
  • Unknown;
  • Incompetent;
  • Not reasonably available;
  • Only one parent has legal responsibility for the care and custody of the child.
     

Parent Permission Sample

Key Information Page:

Consent to Participate in a Research Study

KEY INFORMATION FOR STUDENT PERCEPTIONS OF PHYSICAL ACTIVITY BREAKS, MINDFULNESS, AND STRESS

We are asking you to choose whether or not to allow your child to volunteer for a research study about their perception of activity breaks they choose to take, mindfulness, and stress. We think it might help children at other schools if they had similar opportunities. This page is to give you key information to help you decide whether to allow your child to participate. We have included detailed information after this page. Feel free to ask the research team questions. The contact information for the research investigator in charge of the study is below.

WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?

The purpose of this study is to learn how children feel about activity breaks they choose to take, mindfulness, and stress. Your child's participation in this research will take about 4 hours spread over 6 weeks.

These physical activity breaks are about 5-minute breaks that a student can choose to take at any time during the school day in a designated area of the school, to walk and move around. Students taking their chosen breaks will be monitored by school personnel for safety purposes. Teachers may stop a student at any time if the student is misbehaving or they feel the breaks are becoming more distracting to the student.

WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO ALLOW YOUR CHILD TO VOLUNTEER FOR THIS STUDY?

You might choose to allow your child to volunteer for this study because children who participate will be able to share their opinions, and this might help others in the future. For a complete description of benefits and/or rewards, refer to the Detailed Consent.

WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO ALLOW YOUR CHILD TO VOLUNTEER FOR THIS STUDY?

You might not choose to allow your child to volunteer for this study because we will ask them to take a few minutes at the end of each school day to fill out a log, as well as some time at the beginning and end of the study to complete surveys and an interview. For a complete description of risks, refer to the Detailed Consent.

DOES YOUR CHILD HAVE TO TAKE PART IN THE STUDY?

If you decide to allow your child to take part in the study, it should be because you really want to allow them to volunteer. Your child will not lose any services, benefits, or rights they would normally have if you choose not to allow them to volunteer.

Always include this statement if working with child subjects in classroom settings.

As a student, if your child does not take part in this study, this choice will not affect their academic status or class grades. 

WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS, OR CONCERNS?

If you have questions, suggestions, or concerns regarding this study or you want to withdraw your child from the study, contact (name) of the University of Kentucky, Department of (department name) at 859-257-XXXX or XXXX@uky.edu.

If you have any questions or concerns about your rights as a volunteer in this research, contact staff in the University of Kentucky (UK) Office of Research Integrity (ORI) between the business hours of 8 am and 5 pm EST, Monday-Friday, at 859-257-9428 or toll-free at 1-866-400-9428. 

Detailed Consent:

DETAILED CONSENT:

ARE THERE REASONS WHY YOUR CHILD WOULD NOT QUALIFY FOR THIS STUDY?

There are no reasons why your child would not qualify for this study unless they are not a 3rd -5th grade student at Example Elementary School.

WHERE WILL THE STUDY TAKE PLACE, AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED?

The research procedures will be conducted at your child’s school in Lexington, KY. The total amount of time your child will be asked to volunteer for this study is approximately 4 hours over the next 6 weeks.

WHAT WILL YOUR CHILD BE ASKED TO DO? 

The form should be written to the parent, about the child. Ensure you refer to the child as the subject throughout the form.

Your child will be asked to do three things:

  1. Complete four questionnaires about mindfulness and stress,
  2. Log each day whether they chose to take a break to get some physical activity,
  3. Take part in a group interview, asking their opinions on these breaks and how they affected mindfulness and stress.

At the beginning, your child will complete two surveys about mindfulness and stress. These will take about 20 minutes. Then, at the end of each school day, your child will be asked to fill out a log about whether they chose to take a physical activity break. Each log will take about 5 minutes. At the end of the 6 weeks, your child will be asked to complete four surveys about mindfulness and stress. Two of these are the same surveys they filled out at the beginning of the study. These will take about 40 minutes total. Finally, we will ask your child to participate in a group interview that will last about 30 minutes.

Your child may skip questions on the surveys and interviews that they do not want to answer.

WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?

To our knowledge, the things your child will be doing have no more risk or discomfort than they would experience in everyday life.

WILL YOUR CHILD BENEFIT FROM TAKING PART IN THIS STUDY?

We do not know if your child will get any benefit from taking part in this study. However, some people have become more aware of how physical activity breaks have helped them with anxiety or stress.

IF YOUR CHILD DOESN’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES?

If your child does not want to be in the study, there are no other choices except not to take part in the study.

WHAT WILL IT COST FOR YOUR CHILD TO PARTICIPATE?

There are no costs associated with taking part in this study.

WHO WILL SEE THE INFORMATION THAT YOUR CHILD GIVES?

When we write about or share the results from the study, we will write about the combined information. We will keep your child’s name and other identifying information private.

We will make every effort to prevent anyone who is not on the research team from knowing that your child gave us information or what that information is. We will keep all data stored in a locked office, and the researchers will be the only ones who have access.

There are some circumstances in which we may have to show your child’s information to other people. For example, the law may require us to share the information with:

  • Authorities, if your child has a reportable disease, if your child reports information about a child being abused, if your child poses a danger to themself or someone else; and/or
  • To ensure the study is conducted properly, officials at the University of Kentucky may look at or copy pertinent portions of records that identify your child.

CAN YOUR CHILD CHOOSE TO WITHDRAW FROM THE STUDY EARLY?

Your child can choose to leave the study at any time. They will not be treated differently if they choose to stop being in the study. If your child leaves the study early, data collected until that point will remain in the study database and may not be removed.

WILL YOUR CHILD RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY?

Your child will not receive any rewards or payment for taking part in the study.

WILL YOUR CHILD BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS/SURVEYS?

Generally, surveys done for research purposes are not meant to provide results that apply to individuals. We will not provide you with your child’s individual research results.

WHAT ELSE DO YOU NEED TO KNOW?

If your child volunteers to take part in this study, they will be one of about XX children to do so.

WILL YOUR CHILD’S INFORMATION BE USED FOR FUTURE RESEARCH?

Your child’s information collected for this study will NOT be used or shared for future research studies, even if we remove the identifiable information like [list some identifiers you will collect; examples include name and date of birth].

INFORMED CONSENT SIGNATURES

This consent includes the following:

  • Key Information Page
  • Detailed Consent

You are the research volunteer or are authorized to act on behalf of the research volunteer. You will receive a copy of this consent form after it has been signed.

The signature section should have spaces for: the parent/guardian to sign and date, the parent/guardian’s printed name, the relationship of the signatory to the child, and the child’s printed name. You should only include the “Printed name of authorized person obtaining informed consent” if parents will sign in your presence. Leave that off if you’re sending the forms home!

 

Parent Permission Sample document

Waiver of Parental Permission

DHHS 46.408 – Parental Permission May be Waived if:

  • Research protocol designed for conditions or research protocol designed for subject population for which parental/guardian permission is not a reasonable request to protect subjects and
  • Provided an appropriate mechanism for protecting children is substituted and
  • Waiver not inconsistent with Federal, State, or Local law.

DHHS 46.116 – Parental Permission May Be Waived if:

  • Research is no more than minimal risk and
  • Rights and welfare are not adversely affected and
  • Research could not be practicably conducted without a waiver and
  • Subjects provided with pertinent information after participation, if applicable

FDA 50.24

Does not allow waiver of parental or guardian permission for studies that are greater than minimal risk, with the exception of Emergency Research (21 CFR 50.54)

IRB Review of Research with Wards of the State [FDA 21 CFR 50.56 DHHS 45 CFR 46.409]

IRB must determine that the research meets the following categories:

  1. Related to status as wards OR
  2. Conducted in schools, hospitals, or similar settings in which the majority of children involved are NOT wards

Required Safeguard:

  1. An advocate must be appointed for each child

Advocate:

  1. Serves in addition to a guardian or in loco parents
  2. May serve for more than one child
  3. Must have background and expertise, and serve throughout the study
  4. Cannot be associated with a Study, Investigator, or Guardian organization

 

Children's Online Privacy Protection Act (COPPA) [16 CFR 312] Summary

COPAA is administered by the Federal Trade Commission and applies to:

  • Operators of commercial websites, online services, and mobile apps that are directed at children under 13 and “collect, use, or disclose personal information” from those kids.
  • And operators of websites and online services that are for a general audience but have “actual knowledge” that they are collecting, using, or disclosing personal information from children under 13.
  • COPPA generally does not apply directly to state government agencies, schools, or nonprofits.
  • COPAA could affect researchers if they meet the criteria above

This Act protects children's privacy by giving parents tools to control what information is collected from their children online. The Act requires the Commission to announce the regulations and require operators of commercial websites and online services directed to children under 13 or knowingly collecting personal information from children under 13 to:

  1. Notify parents of their information practices;
  2. Obtain verifiable parental consent for the collection, use, or disclosure of children’s personal information;
  3. Let parents prevent further maintenance, use, or future collection of their child’s personal information;
  4. Provide parents access to their child’s personal information;
  5. Not require a child to provide more personal information than is reasonably necessary to participate in an activity; and
  6. Maintain reasonable procedures to protect the confidentiality, security, and integrity of the personal information.

Personal information (as described in the regulations) means individually identifiable information about an individual collected online, including:

  1. A first and last name;
  2. A home or other physical address, including street name and name of a city or town;
  3. Online contact information as defined in this section;
  4. A screen or user name where it functions in the same manner as online contact information, as defined in this section;
  5. A telephone number;
  6. A Social Security number;
  7. A persistent identifier that can be used to recognize a user over time and across different websites or online services. Such persistent identifier includes, but is not limited to, a customer number held in a cookie, an Internet Protocol (IP) address, a processor or device serial number, or a unique device identifier;
  1. A photograph, video, or audio file where such file contains a child’s image or voice;
  2. Geolocation information sufficient to identify street name and name of a city or town; or
  3. Information concerning the child or the parents of that child that the operator collects online from the child and combines with an identifier described in this definition.

Schools may act as the parents’ agent and consent to the collection of information if:

  • The consent is limited to information related to the education context; and
  • Information must be for the use and benefit of the school and not for commercial purposes

There are fines for non-compliance. Contact UK ORI’s Privacy Officer if you have any questions.

Additional Resources

Assent Process

Informed Consent (Children under 18 years of age)

Go to the Assent Process web page

Students as Subjects

Go to Students as Subjects web page

Contact us

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University of Kentucky
Lexington, KY 40506-0057
Phone: 859-257-9428
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