1. Regulatory requirements: children, assent, and consent waivers and waiver of documentation Bob Craig, 2007

2. 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)

3. 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.

4. 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

5. Documentation of Assent Normally required from all capable children in the study.

6. 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.

7. 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.

8. 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.

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

10. 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.

11. 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.

12. 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.

13. 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.

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

15. 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 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.

16. 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.

17. Waiver of consent process

18. 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.

19. 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

20. 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

21. Emergency Waiver Emergency Research Consent Waiver can be used in certain situations.

22. 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.

23. 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”.

24. Waiver of documentation

25. 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 the IRB

26. 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.