Form 6D Pediatric Continuing Review of Cooperative Group Protoco

N CI Pediatric CIRB

REVIEWER WORKSHEET

Continuing Review of 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 National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Initiative is protected by The Privacy Act of 1974, as amended. The purpose of the information collection is to conduct reviews of clinical trial studies. Although your participation in NCI-sponsored research and completion of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The information you provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 1 hour 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 Adult/Pediatric CIRB Application for Continuing Review

Study Protocol

Cooperative Group Model Informed Consent Document(s)

CIRB Approved Informed Consent Document(s)

DSMB/Safety Monitoring Committee Report

Presentations or publications for the study

Relevant information relating to participants’ risks and benefits

Management plan to address new or revised conflicts of interest

Other (specify):      

2. Are there any important changes in the risks, benefits, or protocol schedule that you believe have an impact on the CIRB's approval of this protocol?

No

Yes

     

3. In your judgment, do the benefits of this study continue to outweigh the risks?

Yes

No

Uncertain

4. If No or Uncertain, please explain:      

5. Do you recommend that the CIRB approve continuation of this study?

Yes

No

Uncertain

6. If No or Uncertain, please explain:      

7. Additional Remarks.      

Pediatric Risk Assessment

8. 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

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  

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