8. Research Involving Children

Question 1

Definition of a child

Answer 1

Persons who have not attained the legal age of consent to treatments or procedures invoked in the research under the applicable law of the jurisdiction in which the research will be conducted - DETERMINED BY STATE LAW

Emancipates/mature minors - determined by state law (??can provide consent)

Question 2

What is the “sliding scale” for research involving children?

Answer 2

Regulations for research involving children are classified into 1 of 4 categories according to the RISK and potential for DIRECT BENEFIT to the child

As risk benefit relationship of the research becomes less favour able, additional requirements must be satisfied

Question 3

What is category 404 and what are the requirements?

Answer 3

No greater than minimal risk

Requires
1. Parent consent (singular)
2. Child assent
3. Risk justified by benefit

Question 4

What is category 405 and what are the requirements?

Answer 4

Greater than minimal risk; potential for DIRECT BENEFIT

Requires:
1. Parent consent (singular)
2. Child assent
3. Risk/benefit is as favorable as alternative

Question 5

What is category 406 and what are the requirements?

Answer 5

Greater than minimal risk, NO potential for direct benefit; yield generalizable knowledge about SUBJECT’S DISORDER or condition

Requires:
1. MINOR increase over minimal risk
2. Intervention presents experiences commensurate with those inherent in actual or expected situations (would be doing anyway)
3. Procedure likely to yield knowledge of vital importance to understanding or alleviating a condition
4. BOTH parents consent
5. Child assent

Question 6

What is category 407 and what are the requirements?

Answer 6

Not otherwise approvable but opportunity to understand, prevent, alleviate serious problem of children.

Requires:
1. HHS/FDA panel of experts to review
2. Public comment
3. BOTH parents consent
4. Child assent

Question 7

T/F neither child nor parent can give true “consent”

Answer 7

True

Parental permission
Child assent

Question 8

3 points to consider for child assent

Answer 8

1. Affirmative agreement
2. Mere failure to object is not assent
3. No specific age: consider maturity, psychological, emotional, developmental state

Question 9

When can child assent be waived?

Answer 9

1. Child not capable (due to age, maturity, psychological state, coma)
2. Research presents direct benefit, important to child’s well being, available only in context of research (ex life saving chemo drug accessed through a study)

Judgement to determine whether assent is required is based on protocol risk/benefit assessment

Question 10

What is IRB role in determining child assent?

Answer 10

1. IRB must determine adequate provisions are made for soliciting assent when it is required
2. IRB determines children are capable
3. Judgement can be made for all children involved in research or for each child as IRB determined appropriate
4. IRB determines whether and how assent must be documented

Question 11

What are 3 other waiver considerations for obtaining consent in child studies?

Answer 11

1. Parent/guardian permission would jeopardize subject welfare or fail to provide additional subject protection
2. There is a reasonable argument that informing parents may result in harm to the child OR
3. There is a reasonable argument that parent permission may not be in the child’s best interest bc of conflicts in parental role as it relates to the research