Post on 19-Jan-2016
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.