West Virginia University Office of Research Integrity & Compliance Human Research Protections Program

Children – Some Definitions A child is anyone who has not reached the legal age for consent when and where the research will be conducted. In West Virginia, the age of consent is 18 years – unless the child is an “emancipated minor” (has been declared emancipated by court order)

Protocol Issues What level of review? Exempt—commonly accepted educational practices, observations in public, studies using existing data NOT for interviews/surveys or observations in which the researcher participates Expedited—no more than minimal risk Quorum—all other studies of children

Why Study Children? Children are a society’s most precious resource Some diseases only affect children Some diseases/conditions are expressed differently in children than in adults Children learn in different ways than adults We have an obligation to learn about, and optimally care for, our children

Is the Question Important? The IRB is charged with determining the scientific validity of all proposals Adequate sample Appropriate analysis Adequate justification based on prior studies or pilot data, if available, or sound principles

Reasons to Include Children 1998 NIH Guidelines of the Inclusion of Children as Participants in Research Involving Human Subjects Children cannot be excluded in NIH-supported research unless there are scientific or ethical reasons to do so Example—very little information exists on risks and benefits of drugs in children, especially those younger than 6 years What we don’t know COULD hurt us!

Pediatric Research Equity Act (2004) Enables FDA to REQUIRE testing of drugs intended for pediatric use to be tested on children

Parental/Guardian Informed Consent Applies to parents/guardians Must specify exact procedures, information being collected, expected outcomes Language is “your child will….”

More Definitions Assent is the agreement by a child or any individual who is unable to give legally valid informed consent to participate in research.

Informed Assent Written document Most appropriate for older children (typically > age 7) Must be written at an appropriate level for the child’s education Describes all risks, benefits, procedure, etc. Language is “you will….”

Who Must Provide Assent? All children over age 7 if they are capable of understanding unless The intervention or procedure may directly benefit the child and The intervention or procedure is available only through participation in the research

Documentation of Consent/Assent Likely more than just a signed form Researchers are responsible for showing this Considerations Safeguards against coercion E.g. my Mom will be mad if I don’t do this… Use of appropriate incentives E.g. $100 gift card for a 5-year-old Continuing assent E.g. child begins to cry during questioning There are no SET answers for all situations.

Sample of Rewording “We are interested in the negotiation and articulation of gender roles in childhood recreational activities” (grade level = 16.2) Versus “We want to find out why boys or girls might choose different sports” (grade level = 2.1)

Waiver of Assent Assent may be waived or altered if: The research involves no more than minimal risk, and the waiver will not adversely affect the rights and welfare of the participants, and the research could not practicably be carried out without the waiver or alteration, and wherever appropriate, the participants will be provided with information after study is over.

Waiver of Assent Assent is not required if the capability of some or all of the children is so limited that they cannot be reasonably consulted.

Categories of Risk for Research Involving Children There are four categories of risk, Category 1,2,3, & 4 Which category a particular study comes under, must be determined by the IRB and documented.

Risk Categories for Children Category 1 The research involves no more than minimal risk. The research requires the consent of one parent or guardian.

No Greater than Minimal Risk “the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or routine medical or psychological examination, of healthy children” (CITI) Examples: blood sample (limited number), urine collection (non-invasive), x-ray (minimal exposure to radiation), psychological tests (reasonable length and types of questions), classroom observation (not intervention)

Risk Categories for Children Category 2 Research involves greater than minimal risk, but presents the prospect of direct benefit to the child. The risk is justified by the anticipated benefit and the risk-benefit ratio is at least as favorable as alternative approach. Requires the consent of one parent or guardian.

Greater than Minimal Risk but with Prospect of Direct Benefit Must potentially benefit THIS subject (not others with the condition) Example: new antibiotic regimen for ear infections that might involve shorter treatment time

Risk Categories for Children Category 3 All must be true: More than minimal risk with no prospect of direct benefit to participant. Risk is a minor increase over minimal risk.

Risk Categories for Children Category 3 The participants have a disorder or condition. The intervention is likely to yield generalizable knowledge of importance to the disorder or condition. and does not involve wards of the state or if so, meets the criteria of the state for study with wards.

Risk Categories for Children Category 3 Requires the consent of both parents unless the other parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the child.

Greater than Minimal Risk without Potential for Direct Benefit Example: new laboratory test for bone marrow cells in children with leukemia that will require additional collection of a sample but not change treatment for that child Example: new training program to teach children how to accurately report inappropriate touching

Levels of Approval Needed No more than minimal risk Assent and consent of one parent May qualify for expedited review More than minimal risk, but potential for direct benefit Assent and consent of 1 parent If benefit to child would not be available except by participating in the research, assent is not required (e.g. cancer drug study) Greater than minimal risk, without potential for direct benefit Assent and consent of both parents

Risk Categories for Children Category 4 Research not otherwise approvable, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting health or welfare of children.

Risk Categories for Children Category 4 – FDA Regulated Research The research is subject to FDA regulations The research satisfied the conditions of 21 CFR 50.51, 50.52, or or The research presents an opportunity to better understand serious problem and Will be conducted in accordance with sound ethics and Adequate provisions for assent and permission is made.

Risk Categories for Children Category 4 The research does not involve wards or the State or the research meets the criteria for involvement of wards of the State. Requires the consent of both parents unless the other parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for care and custody.

Research Not Otherwise Approvable Projects not covered on the previous categories, but hold potential to understand, prevent or alleviate a serious problem affecting the health or welfare of children (CITI). Reviewed by a panel of experts appointed by the Secretary of the DHHS.

Research on Wards of the State Extra protections involved due to the history discussed earlier Important to improve health and welfare of these children Important not to embarrass these children by excluding them from activities in which their peers in a group setting would participate IRB review is very strict Must have an advocate for EACH child who is independent of the research or guardian organization appointed by the IRB

For Further Questions, Contact: Lilo Ast Barbara White Portions of this PowerPoint presentation created by Anne Swisher, PT, PhD, CCS and Bob Craig, Ph.D.