Attachment G - IRB_Approval

Attachment G - IRB_Approval.pdf

Use of Deliberative Methods to Enhance Public Engagement in Comparative Effectiveness Research

Attachment G - IRB_Approval

OMB: 0935-0199

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Attachment	G:		
Documentation	of	IRB	Approval	
	
 
	
		
 

REVIEW OF SAFEGUARDS FOR HUMAN SUBJECTS
American Institutes for Research
1000 Thomas Jefferson Street, NW
Washington, DC 20007
Institutional Review Board
IRB00000436

Project number: 02916
Project Director/Proposal Author: Marilyn Moon
Project/Proposal title: Citizens Forum
1. Type of review:
(Check one)
Expedited review
Full IRB review

(Check one)
Initial review
Scheduled re-review (e.g., annual)
Requested re-review (e.g., new data
collection component, research plan
change)

2. Review determination:
After reviewing the above project, the Institutional Review Board (or member signing below)
has determined the following:
Determination of Exemption: the project is exempt from further IRB review
because it does not constitute research or because it does not involve human subjects.
Provisional Approval: the submitted insert "project/study/proposal or other
descriptive" is approved pending development of the research plan (45CFR46.118),
which must be reviewed before enrollment of subjects or collection of data can begin.
Proposed date of review:
Conditional Approval: data collection of insert "project/study/proposal or other
descriptive" can proceed after meeting the following conditions:
Approval renewal: approval of the project is granted and data collection can
continue. In keeping with our Federalwide Assurance mandate, the IRB must
conduct reviews at least annually for each project. This project will be reviewed
again on 6/13/12.
Approval Denied: approval of insert "project/study/proposal or other descriptive"
is denied and data collection may not proceed for the following reasons:

IRB Approval Renewal, Page 1

3. Consent Procedures
The Institutional Review Board has determined that consent procedures:
are not applicable to the project.
must be reviewed on

.

are approved as previously submitted.
are approved under the following conditions:
are not approved for the following reasons:
4. Individually Identifiable Information Safeguards
The Institutional Review Board has determined that the safeguards planned for individually
identifiable information:
are not applicable to the project.
must be reviewed on

.

are approved as previously submitted.
are approved under the following conditions:
are not approved for the following reasons:
5. Comments
On the basis of this review, the IRB has determined that the Progress Report for the project, as
described in the materials you submitted, is accepted. Approval status is extended for one year.
The next IRB review date for this project is June 13, 2012, at which time an IRB Progress or
Final Report will be due.
6. IRB Signature(s):
7/13/11
Date

Erin Wallace
IRB Administrator

Please keep in mind that any material changes made to the study or the study procedures
require advance IRB review and approval.

IRB Approval Renewal, Page 2


File Typeapplication/pdf
File TitleMicrosoft Word - Attachment G - IRB Approval.docx
AuthorJWaddell
File Modified2011-10-19
File Created2011-10-19

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