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Research with ChildrenWest Virginia UniversityOffice of Research Integrity & ComplianceHuman Research Protections ProgramChildren Some DefinitionsA 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 IssuesWhat level of review?Exemptcommonly accepted educational practices, observations in public, studies using existing dataNOT for interviews/surveys or observations in which the researcher participatesExpeditedno more than minimal riskQuorumall other studies of children

Why Study Children?Children are a societys most precious resourceSome diseases only affect childrenSome diseases/conditions are expressed differently in children than in adultsChildren learn in different ways than adultsWe have an obligation to learn about, and optimally care for, our childrenIs the Question Important?The IRB is charged with determining the scientific validity of all proposalsAdequate sampleAppropriate analysisAdequate justification based on prior studies or pilot data, if available, or sound principles

Reasons to Include Children1998 NIH Guidelines of the Inclusion of Children as Participants in Research Involving Human SubjectsChildren cannot be excluded in NIH-supported research unless there are scientific or ethical reasons to do soExamplevery little information exists on risks and benefits of drugs in children, especially those younger than 6 yearsWhat we dont 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 ConsentApplies to parents/guardiansMust specify exact procedures, information being collected, expected outcomesLanguage is your child will.

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

Informed AssentWritten documentMost appropriate for older children (typically > age 7)Must be written at an appropriate level for the childs educationDescribes 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 childandThe intervention or procedure is available only through participation in the research

Documentation of Consent/AssentLikely more than just a signed formResearchers are responsible for showing thisConsiderationsSafeguards against coercionE.g. my Mom will be mad if I dont do thisUse of appropriate incentivesE.g. $100 gift card for a 5-year-oldContinuing assentE.g. child begins to cry during questioningThere are no SET answers for all situations.

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

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

Waiver of AssentAssent 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 ChildrenThere are four categories of risk, Category 1,2,3, & 4Which category a particular study comes under, must be determined by the IRB and documented.

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

No Greater than Minimal Riskthe 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 ChildrenCategory 2Research 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 BenefitMust 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 ChildrenCategory 3All 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 ChildrenCategory 3The 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 ChildrenCategory 3Requires 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 BenefitExample: 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 childExample: new training program to teach children how to accurately report inappropriate touching

Levels of Approval NeededNo more than minimal riskAssent and consent of one parentMay qualify for expedited reviewMore than minimal risk, but potential for direct benefitAssent and consent of 1 parentIf 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 benefitAssent and consent of both parents

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

Risk Categories for ChildrenCategory 4 FDA Regulated ResearchThe research is subject to FDA regulationsThe research satisfied the conditions of 21 CFR 50.51, 50.52, or 50.53 orThe research presents an opportunity to better understand serious problem and Will be conducted in accordance with sound ethics andAdequate provisions for assent and permission is made.

Risk Categories for ChildrenCategory 4The 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 ApprovableProjects 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 StateExtra protections involved due to the history discussed earlierImportant to improve health and welfare of these childrenImportant not to embarrass these children by excluding them from activities in which their peers in a group setting would participateIRB review is very strictMust have an advocate for EACH child who is independent of the research or guardian organization appointed by the IRB

For Further Questions, Contact:Lilo AstLilo.Ast@mail.wvu.edu304-293-7555Barbara WhiteBarbara.White@mail.wvu.edu304-293-5971http://oric.research.wvu.edu

Portions of this PowerPoint presentation created by Anne Swisher, PT, PhD, CCS and Bob Craig, Ph.D.