IRB Approval-AIR

REVIEW OF SAFEGUARDS FOR HUMAN SUBJECTS
American Institutes for Research
1000 Thomas Jefferson Street, NW
Washington, DC 20007
Institutional Review Board
IRB00000436
Project number: 02434.008
Project Director/Proposal Author: Steven Garfinkel
Project/Proposal title: SAUL (Small Scale Trial)
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 8/28/10.
Approval Denied: approval of insert "project/study/proposal or other descriptive"
is denied and data collection may not proceed for the following reasons:

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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 study, as described in the
materials you submitted, is approved. The risks to the participants are minimized. The
subjects are nursing home residents. There are no physical or emotional risks since it is a
review of health records such as infection logs. The content of the study is not of a sensitive
or personal nature. It is a study of the use of antibiotics in nursing homes. The procedures
for protecting the confidentiality of the collected data are adequate.
The data is collectd by the Texas quality improvement organization (QIO): TMF Health
Quality Institute in partnership with Texas A&M. The information will be abstracted by
TMF and will contain no personal identifiers. The data will be abstracted by licensed health
care professionals who are experienced abstractors. The data that will be abstracted will not
contain any of the 18 identifiers specified by HIPAA as protected health information.
In addition, a HIPAA waiver of authorization of consent was previously granted on February
18, 2010 and contiues to stand. The project staff has reqested both a waiver of consent and a
waiver of documentation of consent. The waiver of informed consent is granted because it
involves no more than minimal risk to the subjects because of the reasons discussed in this
paragraph. The waiver will no adversely affect the rights or welfare of the subjects. The
research can not be practicably be carried out without the waiver. The staff collecting the
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data would have to determine the current cognitive status of the subject, determine their
location and schedule a personal interview. This would result in their gathering personal
identifying information which is not appropriate for this study. There is also no need to
provide the subject with additional information after the completion of the study. A waiver
of documentation of consent is also granted. The only record linking the subject with the
research would be the consent document and would result in a breach of confidentiality. In
addition the research presents no more than minimal harm for which written consent is
required outside of the research context.
6. IRB Signature(s):
6/25/10
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.

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