Form 6g Adult 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.

     

Adapted from ePanel© 05/13/13