Minor/Children Subjects Worksheets

Vulnerable Populations Worksheets

Minor/Children Subjects Worksheets

Emory University IRB

Children Subjects Worksheet

45 CFR 46, Subpart D & 21 CFR 50, Subpart D

PI:

Short Study Title:

____ Full Board ____ ExpeditedDate:______FDA-regulated? Y N

Annotate according to findings, using space for protocol-specific notes.

PART I: RISK (Find 1 of 4)(Highest risk level amongst procedures sets the overall study level)

46.404/50.51: Minimal risk AND adequate provisions made to solicit

___Assent of child, with ___signature line OR___separate assent form AND

___Permission of Parent/Guardian

See Part II also.

46.405/50.52: More than minimal risk but with prospective direct benefit to individual subjects

AND

___(a) Risk is justified by anticipated benefit AND

___(b) Risk:benefit ratio is at least as favorable to subjects as available alternatives AND

___(c) Assent of child or separate assent form AND

• (d) Permission of parent/guardian is solicited per 46.408, with signed consent form (___).

See Part II also.

46.406/50.53: Greater than minimal risk with no prospective direct benefit but likely to produce generalizable knowledge about subject’s disorder or condition[1]AND:

___(a) Risk is only minor increase over minimal risk AND

___(b) Research intervention is about the same as actual or expected situations AND

___(c) Research intervention is likely to yield generalizable knowledge of vital importance to understanding or improving the subject’s disorder or condition.[2] AND

___(d) Assent of child and permission of parent/guardian provided AND

___(e) Both parents required unless exception applies[3].

See Part II also.

46.407/50.54: Not otherwise approvable (none of the above) but

___(a) Research presents reasonable opportunity to further understanding, prevention or alleviation of serious problem in pediatrics or children's welfare; AND

___(b) Secretary of HHS consults with experts, publishes for public review and comment, and determines research may proceed (see regs for bases) AND

___(c) Both parents required unless exception applies[4].

See Part II also.

PART II: CONSENT & ASSENT

Annotate with protocol-specific details as appropriate.

46.408(a)(1)/50.55 Assent of Child is REQUIRED for age range______

Considerations:

___Age/maturity/psychological state of the children

___Capability

___Prospect exists of direct benefit important to health or well-being of the children and available only in research/clinical investigation

___Documented (signed)by ____separate form OR ___assent line on parent permission form OR ___Oral (documentation is waived) Use Waiver of Documentation Worksheet

___Consent document given to subject to keep ____Not given (explain)

46.408(a)(2)/50.55 Assent of Child is WAIVED for age range ______because:

___Capability of individual/some/all subjects to assent is limited OR

___Direct benefit offered only in research OR

• Like Consent, it may be waived under

____46.116(c). Research focuses on public benefit or services and is subject to approval or direct supervision of state or local government officials AND to get Consent/Assent would make the research impracticable.

OR

____46.116(d)/50.55(d). Research/clinical investigation is minimal risk; waiver won't hurt rights or welfare of subject; Consent/Assent would make the research impracticable; AND subjects will get appropriate extra info after participating.

46.408(b)/50.55Permission of Parent/Guardian is REQUIRED

___Documented OR ___Oral (documentation waived; use Waiver of documentation worksheet) __

___Copy of consent document given

___One parent suffices (if 46.404/50.51 or 46.405/50.52 is found in Part I above) OR

___Both parents required (46.406/50.53 or 46.407/50.54

46.408(c) (NOT PERMISSIBLE for FDA-regulated clinical investigations)

Permission of Parent/Guardian is WAIVED[5]

___Because not a reasonable way to protect children (e.g., neglected, abused)

AND

___Other protections of children are provided

AND

___Waiver does not violate law.

___Permission may be altered or waived under 46.116(d) for certain minimal risk projects, subject to applicable state law.

PART III is on separate page, for CHILDREN WHO ARE WARDS.

PART III: CHILDREN WHO ARE WARDS (in addition to Parts I and II)

46.409(a)/50.56 Wards of State or any other organization may participate in research/clinical investigations permissible under 46.406/50.43 or 46.407/50.54 ONLY IF research/clinical investigation is:

 (1) related to ward status OR

 (2) done with most child subjects who are not wards

(b) If terms of 46.409(a)/50.56(a) are met, IRB must appoint a Ward Advocate for each child participant who is a ward (not necessary for 46.404/50.51 or 46.405/50,52).

• Advocate serves in addition to guardian or individual acting in loco parentis.
• One individual may serve as advocate for more than one child.
• Advocate must be an individual with the background/experience to act in and agrees to act in the best interest of the child for the duration of the child’s participation

• May be IRB member
• May not be otherwise affiliated with the research/clinical investigation, the investigators, or the guardian organization

If applicable, describe arrangements for Ward Advocate(s).

[1] CANNOT INVOLVE NORMAL CONTROLS.

[2] CANNOT INVOLVE NORMAL CONTROLS.

[3]“…unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.” 45 CFR 46.408(b).

[4]“…unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.” 45 CFR 46.408(b).

[5] FDA did not adopt 46.408(c ) waiver of parental permission in its Subpart D. FDA Subpart D is an interim rule. FDA is consulting with other agencies on inclusion of 408(c) type regulation in the final regulation. SACHRP Subpart D Subcommittee Guidance November 1-2, 2005.