Att L_IRB

IRB Determination
Institutional Review Board
American Institutes for Research
1000 Thomas Jefferson Street, NW
Washington, DC 20007
IRB00000436 FWA00003952
B&P Number:
Project number:
Project/Proposal title:
Program:
Project Director:
IRB Reviewer:

87414
Patient/Provider Messagin
Practice Area w/ Strategy
Hanno Petras
Coretta J. Mallery

1. Type of Review:
Initial review
2. Is the activity a systematic investigation designed to contribute to generalizable knowledge? [45
CFR 46.102(d)]
Yes
3. Does the activity involve living individuals about whom the investigator conducting research
obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information?
Yes
4. Is this activity eligible for expedited IRB review, as authorized by 45 CFR 46.110 and 21 CFR
56.110?

Yes
5. Does the project meet any of the exemption categories (45 CFR 46.101)?

Yes
6. After reviewing this submission, 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 meets
one of the six exemption categories defined in 45 CFR §46.101(b). This research meets the
following exemption category: Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of
public behavior, unless: (i) information obtained is recorded in such a manner that human

subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any
disclosure of the human subjects' responses outside the research could reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, or reputation.
7. Determination:
On the basis of this review, the IRB has determined that the activity is exempt. The activity
involves an online survey focused on a) clinicians' beliefs, attitudes, and cultural frames
informing alcohol use, b) clinicians; view of providing interventions within clinical visits and
perceptions of self-efficacy to administer SBI and counsel patients, c) perceptions of/agreement
with the National Center on Birth Defects and Developmental Disabilities (NCBDDD)
guidelines regarding alcohol abstinence, and d) perceptions of issue relevance of alcohol
consumption during pregnancy and FASD in relationship to other patient risk factors; Clinician
telephone interviews into above described issues and to establish areas to avoid or target with
message framing; and Face-to-face interviews with women to explore women's beliefs, cultural
norms, and attitudes about alcohol and pregnancy as well as their perceptions about discussing
their alcohol use with their healthcare provider. Therefore, according to 45 CFR §46.101(2)(b),
the activity is exempt and IRB oversight does not apply.
8. IRB Signature(s):

Coretta J. Mallery, IRB Representative
04/10/2018
Please keep in mind that any material changes made to the study or the study procedures require the
submission of an updated IRB package.