Appendix 4

Examples of Templated Language

Risk categories:

1.  [Research not involving greater than minimal risk]{.underline} (45
    CRF 46.404 and 21 CFR 50.51)

> Participation in this study poses no more harms or discomforts to
> research participants than they may experience in normal daily life or
> during routine physical or psychological examinations or tests.

2.  [Research involving greater than minimal risk but presenting the
    prospect of direct benefit to the individual
    participants]{.underline} (45 CFR 46.405 and 21 CFR 50.52)

> Participation in this study involves procedures or interventions that
> are greater than a minor increase over minimal risk, but present the
> prospect of direct benefit to the individual child subjects.

3.  [Research involving greater than minimal risk and no prospect of
    direct benefit to individual participants, but likely to yield
    generalizable knowledge about the participant\'s disorder or
    condition]{.underline} (45 CFR 46.406 and 21 CFR 50.53)

> The procedures/interventions in this study do not hold any direct
> benefit to the child participant, but present a minor increase in
> minimal risk and the prospect of yielding generalizable knowledge
> about the child's disease and/or condition.

[Research not otherwise approvable]{.underline}

For research not otherwise approvable (45 CFR 46.407 and 21 CFR 50.54),
consult with DAIDS Office for Policy in Clinical Research Operations
(OPCRO) before proposing a study of this nature.

Parental/Guardian Permission Choices:

1.  [Minimal Risk]{.underline} (45 CRF 46.404 and 21 CFR 50.51)

> Permission will be sought from at least one parent or guardian in
> accordance with local IRB/EC approved procedures unless the IRB/EC has
> waived the requirements for obtaining parental or guardian permission
> in accordance with 45 CFR 46.408(c).

2.  [Greater that minimal risk]{.underline} (45 CFR 46.405 and 21 CFR
    50.52)

> Permission will be sought from at least one parent or guardian in
> accordance with local IRB/EC approved procedures unless the IRB/EC has
> waived the requirements for obtaining parental or guardian permission
> in accordance with 45 CFR 46.408(c).

3.  [Greater than minimal risk, no benefit, but would yield
    generalizable knowledge]{.underline} (45 CFR 46.406 and 21 CFR
    50.53)

> Permission will be sought from both parents or guardians in accordance
> with local IRB/EC-approved procedures 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
> unless the IRB/EC has waived the requirements for obtaining parental
> or guardian permission in accordance with 45 CFR 46.408(c).

4.  [Research not otherwise approvable]{.underline}

> For research not otherwise approvable (45 CFR 46.407 and 21 CFR
> 50.54), consult with DAIDS OPCRO before proposing a study of this
> nature.
>
> Child Assent Choices:

1.  [Assent not sought based on study risks and
    procedures/intervention]{.underline}

> Assent of the children involved in this study will not be sought
> because the IRB/EC waived the assent requirements in accordance with
> the regulations at 45 CFR 46.116(c), 46.116(d) or 21 CFR 50.55, unless
> required in accordance with local IRB/EC-approved policies and
> procedures.

2.  [Assent not sought based on age of children]{.underline}

> Assent of some or all of the children involved in this study will not
> be sought because they are too young to be capable of providing
> assent, unless required in accordance with local IRB/EC-approved
> policies and procedures.

3.  [Assent not sought based on possible direct benefit only available
    from the research]{.underline}

> Assent of the children involved in this study will not be sought
> because there is the prospect of individual direct benefit that is
> important to the health/well-being of the children and is only
> available in the context of the research unless required in accordance
> with local IRB/EC-approved policies and procedures.

4.  [Assent to be sought]{.underline}

> Assent of the children involved in this study will be sought in
> accordance with the regulations at 45 CFR 46.408(a) or 21 CFR 50.55
> and local IRB/EC-approved policies and procedures.