Form 6h Pediatric Cooperative Group Response to CIRB Review

N CI Pediatric CIRB

REVIEWER WORKSHEET

COOPERATIVE GROUP RESPONSE TO CIRB REVIEW

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 60 minutes 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. This Cooperative Group response is in reference to (check one):

CIRB Stipulations from Initial Review

CIRB Stipulations from Amendment/Revision/Update Review

CIRB Stipulations from Continuing Review

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

Cooperative Group Response Letter/Memo

Revised Protocol Version

Revised Cooperative Group Informed Consent Document(s)

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

Summary of CIRB Application Revisions

Other (specify):      

3. Has the Cooperative Group and/or Study Chair adequately addressed the CIRB stipulations and/or recommendations from the prior CIRB review?

Yes

No

4. Did the Cooperative Group response include additional changes aside from the CIRB stipulations and/or recommendations?

Yes (if yes, check all that apply below)

No (if no, skip to Question 6)

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

Yes

No

6. Please provide your comments and/or concerns (if any) regarding the Cooperative Group response and revised documentation.

     

7. Please provide your recommendation for CIRB action on the Cooperative Group response and revised documentation.

     

8. 45 CFR 46.404:  Research not 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 study documentation:       

Permission required from:

One Parent

Both Parents

9. 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

10. 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:        

11. 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:        

12. 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  

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

Assent required for those above seven years old. 

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

Adapted from ePanel© 05/13/13