For Additional Information and Guidance on Parental Permission Requirements, Please See

NOT-11

45 CFR 46.404

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 45 CFR 46.404, in accordance with 45 CFR
46.408(b). The IRB determined that the permission of one parent is sufficient for this research.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

OR

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 45 CFR 46.404, in accordance with 45 CFR
46.408(b). The IRB determined that the permission of 2 parents is required, unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the care and custody of the child. Not reasonably available means that the other parent is not present during the consenting process, or will not be available prior to the start of research procedures. Examples of not reasonably available are the other parent is at work, caring for other children, or traveling.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

21 CFR 50.51

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 21 CFR 50.51, in accordance with 21 CFR
50.55. The IRB determined that the permission of one parent is sufficient for this research.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

OR

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 21 CFR 50.51, in accordance with 21 CFR 50.55. The IRB determined that the permission of 2 parents is required, unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the care and custody of the child. Not reasonably available means that the other parent is not present during the consenting process, or will not be available prior to the start of research procedures. Examples of not reasonably available are the other parent is at work, caring for other children, or traveling.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

45 CFR 46.405

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 45 CFR 46.405, in accordance with 45 CFR
46.408(b). The IRB determined that the permission of one parent is sufficient for this research.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

OR

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 45 CFR 46.405, in accordance with 45 CFR
46.408(b). The IRB determined that the permission of 2 parents is required, unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the care and custody of the child. Not reasonably available means that the other parent is not present during the consenting process, or will not be available prior to the start of research procedures. Examples of not reasonably available are the other parent is at work, caring for other children, or traveling.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

21 CFR 50.52

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 21 CFR 50.52, in accordance with 21 CFR
50.55. The IRB determined that the permission of one parent is sufficient for this research.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX

OR

Dear Dr. X,
The IRB approved your Protocol entitled "XXX" at the XXX IRB meeting. Your study includes children and was approved under 21 CFR 50.52, in accordance with 21 CFR 50.55. The IRB determined that the permission of 2 parents is required, unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the care and custody of the child. Not reasonably available means that the other parent is not present during the consenting process, or will not be available prior to the start of research procedures. Examples of not reasonably available are the other parent is at work, caring for other children, or traveling.

For additional information and guidance on parental permission requirements, please see

I have attached a copy of your consent form to this email, which includes a note after the parental signature lines regarding the IRB’s finding. This version of the consent form has also been uploaded into your eProtocol application. Please be sure to use this version when consenting participants.

Thank you,

XXX