Regulatory requirements: children, assent, and consent waivers and waiver of documentation

Bob Craig, 2007

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)

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.

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 Assent Normally required from all capable

children in the study.

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 childrenCategory 1 The research involves no more than

minimal risk. The research requires the consent of one

parent or guardian.

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.

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.

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.

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.

Category 4 Research not otherwise approvable, which

presents an opportunity to understand, prevent, or alleviate a serious problem affecting health or welfare of children.

Category 4FDA regulated research

The research is subject to FDA regulations The research satisfied the conditions of 21 CFR

50.51, 50.52, or 50.53 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.

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.

Waiver of consent process

Waiver of consent process All of the following must be true: The research could not practicably carried

out without a waiver or alteration The research involves no more than

minimal risk The waiver will not adversely affect the

rights and welfare of participants.

Waiver of consent Consent process may be waived if research is

conducted by or for state and local government officials

and the study is designed to study or examine Public benefit or service programs Or procedures for obtaining benefits from these programs Or to cause possible changes to these programs And, the research could not practicably be carried out without

this waiver And the research is not subject to FDA regulation

Waiver of consent The study uses leftover specimens

And the specimens are not individually identified

And the individuals caring for the patients are different from those doing research

And the study has been reviewed by an IRB and is not subject to DHHS regulation

Emergency Waiver Emergency Research Consent Waiver can

be used in certain situations.

The consent process may be waived in an IDE study if: The study involves an in vitro diagnostic device

investigation and The testing is noninvasive and The testing does not require an invasive sampling

procedure and The testing does not introduce energy into a

subject and The device is not used as a diagnostic procedure

without confirmation by established method.

Device waiver And the device is labeled “for research use

only. Not for use in diagnostic procedures” or

for testing prior to full commercial marketing, labeled “For investigational use only. The performance characteristics of this product have not been established”.

Waiver of documentation

Waiver of consent documentation May be used if

The procedure carries no more than minimal risk

The only record linking the participant to the research would be the consent document.

The principal risk would be potential harm resulting from breach of confidentiality.

The investigator must explain thoroughly to theIRB

Waiver of documentation If the use of a consent form is waived, the

participant must be provided an information sheet with all additional element of consent disclosure or

An information sheet is not appropriate (unless the investigator can provide justification)

The research must not be subject to FDA regulation.