IRB DETERMINATION FORM_02434 007 (Task 7)_4 12 11

REVIEW OF SAFEGUARDS FOR HUMAN SUBJECTS
American Institutes for Research
1000 Thomas Jefferson Street, NW
Washington, DC 20007
Institutional Review Board
IRB00000436
Project number: 02434.007
Project Director/Proposal Author: Kristin Carman
Project/Proposal title: Patient and Family Engagement (Task 7)
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 amendment 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: approval of project amendment is granted and data collection can
proceed. 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 7/16/11.
Approval Denied: approval of insert "project/study/proposal or other descriptive"
is denied and data collection may not proceed for the following reasons:

02434.007 – Patient and Family Engagement, 4.12.11

IRB Approval, 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 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 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 project amendment, as described
in the materials you submitted, is approved. The risks to the participants are minimized. The
current participants are over the age of 25 years. There are no questions of a personal or
sensitive nature. The staff of the project is requesting a waiver of documentation of informed
consent for the semi-structured interviews and the observation of the health care providers.
The waiver is granted because the research presents no more than minimal risk to participants
for which consent is required outside of the research context. In addition, patient surveys
will be handed to them as they are leaving the hospital. Since the data are to be collected by
means of a mailed survey form, return of a completed survey booklet can be interpreted as
indicating consent to participate. Thus, the procedures for obtaining informed consent are
appropriate. The procedures for protecting the confidentiality of the collected data are
adequate as well.
6. IRB Signature(s):
4/12/11
Date
Mary B. Tierney, MD
IRB Representative

Please keep in mind that any material changes made to the study or the study procedures require
advance IRB review and approval.
02434.007 – Patient and Family Engagement, 4.12.11

IRB Approval, Page 2