Initial Or Continuation Review

Initial Or Continuation Review

IRB REVIEWER FORM

INITIAL OR CONTINUATION REVIEW

HRPP Document Number 098

APPENDIX B (CHILDREN)

SPECIAL REVIEW AND DETERMINATIONS CONCERNING RESEARCH WITH CHILDREN

From 45 CFR 46 – Subpart D – USE IF STUDY INVOLVES CHILDREN

For studies involving children, indicate the category you will recommend below by checking the box by the Category. Reminder: The Common Rule indicates that both parents/guardians must give their permission unless: one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for care and custody of the child. All determinations marked with a * need to have protocol specific findings justifying the determination documented in the minutes or records.

Please select Category 1-4 for each study.

CATEGORY 1 Research not involving greater than minimal risk (45 CFR 46.404). Minimal risk means that the probability and magnitude of the harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests.

The IRB must find that: (All of the following must apply and must be checked if you choose this Category.)

No greater than minimal risk to children is presented*, and

Adequate provisions are made for soliciting the assent of the children, and

Adequate provisions are made for the permission of their parents or guardians.

In your opinion, does the research meet the definition of Category 1?Yes No

Do you agree with the investigators’ analysis that research with this population is justified

in the protocol?Yes No

Has adequate supporting documentation been submitted as part of the application process? Yes No

If no, explain what additional documentation is needed:

The consent of : One Parent will be required for this research study.

Both Parents, if reasonably available will be required for this research study.

If Category 1, please skip to page 4.

CATEGORY 2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (45 CFR 46.405). This category involves more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being.

The IRB must find that: (All of the following must apply and must be checked if you choose this Category.)

The risk is justified by the anticipated benefit to the subjects*, and
The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches*, and
Adequate provisions are made for soliciting the assent of the children, and

Adequate provisions are made for the permission of their parents or guardians.

In your opinion, does the research meet the definition of Category 2?Yes No

Do you agree with the investigators’ analysis that research with this population is

justified in the protocol?Yes No

Has adequate supporting documentation been submitted as part of the application process? Yes No

If no, explain what additional documentation is needed:

The consent of : One Parent will be required for this research study.

Both Parents, if reasonably available will be required for this research study.

If Category 2, please skip to page 4.

CATEGORY 3. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition (45 CFR 46.406). This category involves more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject

The IRB must find that: All of the following must apply and must be checked if you choose this Category.

The risk represents a minor increase over minimal risk*, and

The intervention/procedure presents experiences to subjects that are reasonably commensurate with those inherent in

their actual or expected medical, dental, psychological, social, or educational situations*, and
The intervention/procedure is likely to yield generalizable knowledge about the subject’s disorder or condition which is

of vital importance for the understanding or amelioration of the subject’s disorder or condition*, and
Adequate provisions are made for soliciting assent of the child, and

Adequate provisions are made for the permission of their parents or guardians

Do you agree with the investigators’ analysis that research with this population is justified

in the protocol? Yes No

Has adequate supporting documentation been submitted as part of the application process? Yes No

If no, explain what additional documentation is needed:

The consent of : Both parents or guardian will be obtained 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.

If Category 3, please skip to page 4.

CATEGORY 4. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (45 CFR 46.407).

Research in Category 4 could not be reviewed and approved by the local IRB initially. Research in this category requires:

The IRB must find that: all of the follow must apply and must be checked if you choose this Category,

The research does not meet the requirements of §46.404, §46.405 and §46.406*

The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a

serious problem affecting the health or welfare of children.*

The Secretary of DHHS, after consultation with a panel of experts in pertinent disciplines and following opportunity for public review and comment has determined either:

(1) that the research in fact satisfies the conditions of 404, 405, or 406, or

(2) the research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles and adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians.

Once the Secretary, DHHS has completed the required review and comment, and such findings were published in the Federal Register, the research could then be submitted for local IRB review.

Adequate provisions are made for soliciting assent of the child, and

Adequate provisions are made for the permission of their parents or guardians.

Do you agree with the investigators’ analysis that research with this population is justified

in the protocol?Yes No

Has adequate supporting documentation been submitted as part of the application process? Yes No

If no, explain what additional documentation is needed:

The consent of : Both parents or guardian will be obtained 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.

If Category 4, please skip to page 4.

ADEQUATE PROVISIONS FOR SOLICITING THE ASSENT OF CHILDREN

One of the following is true:

Assent is required for each child who is capable of providing assent based on age, maturity, and

psychological state:

Assent is NOT required based on the age, maturity, or psychological state or because the capability of some or all

the children is so limited that they cannot reasonably be consulted.

Assent is NOT required because both of the following are true:

The intervention or procedure in the research holds out a prospect of direct benefit that is

important to the health or well-being of the children.

The intervention or procedure involved in the research is available only in the context of the

research.

The requirement for assent is waived or altered because all of the following are true:

The research or demonstration project is to be conducted by or subject to the approval of state or

local government officials

The research or demonstration project is designed to study, examine, or otherwise examine one

of the following:

Public benefit or service programs

Procedures for obtaining benefits or services under those programs

Possible changes in or alternatives to those programs or procedures

Possible changes in methods or levels of payment for benefits or services under those

programs

The research could NOT practicably be carried out without the waiver or alteration, because:

(State reasons here)

The research is NOT subject to FDA regulations (See checklist for Determining Whether a Proposed

Activity is Human Research According to DHHS or FDA Regulatory Regulations)

The requirement for assent is waived or altered because all of the following are true:

The research involves no more than minimal risk to the participants because:

(State reasons here)

The waiver of alteration will NOT adversely affect the rights and welfare of the participants

because:

(State reasons here)

The research could NOT practicably be carried out without the waiver or alteration because:

(State reasons here)

Whenever appropriate, the participants will be provided with additional pertinent information after

participation because:

(State reasons here)

When assent is a requirement, will assent be documented? Yes No

When assent is documented, describe the process to document assent.

IRB approved Assent form is used by the investigator and signed by the study

participant who is 12 years or older.

The reported provisions for soliciting the assent of children are:Adequate

NOT Adequate

ADEQUATE PROVISIONS FOR SOLICITING THE PERMISSION OF PARENTS OR GUARDIANS

One of the following is true:

All of the following are true:

The permission of each child’s parents or guardian will be obtained 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.

Permission will be obtained appropriately (See checklist for Informed Consent Requirements)

Either of the following is true:

Documentation of permission is waived (See checklist for Waiver of Documentation of Informed

Consent)

Permission will be appropriately documented (See checklist for Documentation of Informed

Consent)

All of the following are true:

The permission of one parent is sufficient because:

(State reasons here)

Either of the following are true:

The permission of one parent is consistent with State law

The research is NOT subject to FDA regulations (See checklist for Determining Whether a Proposed

Activity is Human Research According to DHHS or FDA Regulatory Definitions)

The research involves Categories 1 or 2 in the checklist for Review of Research Involving Children

Permission will be obtained appropriately (See checklist for Informed Consent Requirements)

Either of the following is true:

Documentation of permission is waived See checklist for Waiver of Documentation of Informed

Consent)

Permission will be appropriately documented (See checklist for Documentation of Informed Consent)

The requirement for parental permission is waived because all of the following are true:

The research or demonstration project is to be conducted by or subject to the approval of state or

local government officials

The research or demonstration project is designed to study, evaluate, or otherwise examine one of

the following:

Public benefit or service programs

Procedures for obtaining benefits or services under those programs

Possible changes in or alternatives to those programs or procedures

Possible changes in methods or levels of payment for benefits or services under those

programs

The research could NOT practicably be carried out without the waiver or alteration, because:

(State reasons here)

The research is NOT subject to FDA regulations (See checklist for Determining Whether a Proposed

Activity is Human Research According to FDA Regulatory Definitions)

The requirement for parental permission is waived because all of the following are true:

The research involves no more than minimal risk to the participant because:

(State reasons here)

The waiver of alteration will NOT adversely affect the rights and welfare of the participants

because:

(State reasons here)

The research could NOT practicably be carried out without the wavier or alteration because:

(State reasons here)

Whenever appropriate, the participants will be provided with additional pertinent information after

participation because:

(State reasons here)

The research is NOT subject to FDA regulations (See checklist for Determining Whether a Proposed

Activity is Human Research According to FDA Regulatory Definitions)

The requirement for parental permission is waived because all of the following are true:

The research protocol is designed for either of the following

Conditions for which parental or guardian permission is NOT a reasonable requirement

to protect the participants

(State reasons here)

A participant population for which parental or guardian permission is NOT a reasonable

requirement to protect the participants

(State reasons here)

The research protocol is designed for either of the following:

An appropriate mechanism for protecting the children who will participate as participants in the

research is substituted

The research is NOT subject to FDA regulations (See checklist for Determining Whether a Proposed

Activity is Human Research According to FDA Regulatory Definitions)

The waiver is consistent with Federal, State or local law.

The reported provisions for soliciting the permission of parents or guardians is Adequate

NOT adequate

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Revised Version - May 27, 2011