Form 6f Pediatric Amendment of Cooperative Group Protocol

N CI Pediatric CIRB

REVIEWER WORKSHEET

Amendment to Cooperative Group Protocol

OMB#: 0925 – 0625

Expiry Date: 01/31/2014

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined for all participants and reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0625). Do not return the completed form to this address.

STUDY ID:      

STUDY TITLE:      

NAME OF CIRB REVIEWER:      

DATE COMPLETED:      

1. I have reviewed the following documents (check all that apply):

NCI Pediatric CIRB Application for Treatment Studies or NCI Adult/Pediatric CIRB Application for Ancillary Studies  

Summary of CIRB Application Revisions

Summary of Changes related to the Amendment

Study Protocol

Cooperative Group Model Informed Consent Document(s)

Other (specify):      

2. The amendment includes the following changes (check all that apply):

Increase or decrease in accrual (impacts statistical design)

Addition or deletion of a treatment group/arm

Addition or deletion of a study drug

Change in treatment period/treatment design

Changes in the informed consent document(s)

Editorial and/or administrative changes

Other:      

3. Please provide a brief summary of the current approved protocol. (Note to reviewer: Not applicable for amendments containing solely editorial and/or administrative changes)

     

4. Please provide the rationale for the amendment. (Note to reviewer: Not applicable for amendments containing solely editorial and/or administrative changes)

     

5. Do the changes in the amendment alter the risk/benefit ratio to the participants?

If Yes, explain whether the benefits continue to outweigh the risks.:      

No

If Uncertain, please explain:      

6. Do any of the changes in this amendment include significant new findings that might relate to the participant’s willingness to continue participation in the research?

If Yes, describe what plans are included to notify/re-consent participants and indicate whether the plans are sufficient.:      

If No, please explain:      

7. Please provide your comments and/or concerns regarding the amendment.

     

8. Please provide your recommendation for CIRB action on the amendment.

     

Pediatric Risk Assessment

9. 45 CFR 46.404: Research no involving greater than minimal risk

Minimal Risk

Explanation based on study documentation:      

Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 46.408.

Explanation based on the study documentation:      

Permission required from

One Parent

Both Parents

10.    45 CFR 46.405: Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects

Greater than minimal risk 

Explanation based on study documentation:      

Prospect for direct subject benefit

Explanation based on study documentation:        

The risk is justified by the anticipated benefit to the subjects 

Explanation based on study documentation:        

The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches 
Explanation based on study documentation:      

Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 46.408. 
Explanation based on study documentation:      

Permission required from

One Parent

Both Parents

11. 45 CFR 46.406: 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

Greater than minimal risk 

Explanation based on study documentation:       

The risk represents a minor increase over minimal risk 

Explanation based on study documentation:       

The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations 
Explanation based on study documentation:       

The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition 
Explanation based on study documentation:       

Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in 46.408. Both parents will provide permission. 
Explanation based on study documentation:       

12.  45 CFR 46.407: Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

The IRB does not believe meets the requirements of 46.404, 46.405, 46.406 

Explanation based on study documentation:       

The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children 
Explanation based on study documentation:       

13.    45 CFR 46.408: Requirements for assent by children

Assent requirement waived

Capability of some or all of the children is so limited that they cannot reasonably be consulted 
OR

Procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children AND the intervention is available only in the context of the research 
OR  

Assent may be waived in accord with 45 CFR 46.116 
Explanation based on study documentation:         

Assent required 
Age where assent is expected. Standard age ranges will be determined and provided as options.   

Adapted from ePanel© 05/10/13