Attach 22 IRB Approval Letter

Chair:
Doug Herman, Geographer, NMAI

Smithsonian Institution
Human Subjects Institutional Review Board
FWA #0005809

Members:
Mary Jo Arnoldi
Harold Closter
Rebecca Jahandari
Peter Jaszi
David Karns
Pino Monaco
Farleigh Earhart

Katie Nagy
Ann Post
Fath Ruffins
Fernando Santos-Granero
Linda Thrift
Beth Ziebarth
Susan Askren

MEMORANDUM
TO:

Laura Koehly

SUBJECT: Research Protocol Involving Human Subjects
DETERMINATION DATE:

March 6, 2013

TITLE: Genomics and Society Surveys in Conjunction with Smithsonian Museum of Natural
History Genome Exhibit
PROTOCOL NUMBER: HS13023
This is to advise you that the Institutional Review Board for Human Subjects Research has
determined that your research protocol submitted March 4, 2013 is exempt under paragraph 7 of the
Exemption section of Smithsonian Directive 606. Provided there are no changes to your research project
or key personnel, you do not need to submit your project for continuing review and you do not need to
submit progress reports to the IRB.
Changes or Amendments: If you plan to make changes in your protocol or in the personnel
involved in the project, please submit these changes immediately to the IRB for further review. The
proposed changes may not be initiated without IRB review and approval, except where necessary to
eliminate apparent immediate hazards to research subjects. The currently approved project personnel
are Laura Koehly, Barbara Biesecker, Vence Bonham, Gillian Hooker, Christopher Marcum, Colleen
McBride, Susan Persky, Philip Shaw, Tyra W olsburg, David Kanney, Andy Baxevanis and William Klein.
Adverse Events: Any injuries or other unanticipated problems involving risks to research
subjects or others resulting from this study must be reported promptly to the Office of Sponsored Projects
([email protected]). If the problem is serious, approval may be withdrawn pending further review by the
committee.
Completion of Study and Record Retention: Please notify the Office of Sponsored Projects
(OSP) as soon as the research has been completed. Study records, including full protocols and any
signed consent forms (originals) for each subject, must be kept in a secured location by the investigator
for 3 years following the study’s completion.
If you have any questions, please contact OSP by phone or email at the address below. All forms
referred to herein are available from OSP.

Smithsonian Institution
Office of Sponsored Projects
P.O. Box 37012, MRC 1205
Washington, D.C. 20013-7012
202.633.7110 Telephone
202.312.1981 Fax
[email protected]

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVING HUMAN SUBJECTS
FAX:

301-480-3108

To:

Persky,Susan

Exempt:#:

11817

NHGRI
Building 31- Claude D Pepper Bldg, B1B54D
Front Office of Human Subjects Research (OHSR)
Nature of Research Activity:
Within the upcoming Genome exhibit at the Smithsonian Museum ot Natural History, we will have a display
inviting visitors to text their responses to questions related to genomics and genomic information (Appendix
B). Displays will also contain a word cloud based on the aggregated,anonymous responses that visitors text
to these questions. Text message content will be collected via Poll Everywhere,a short code texting service.
The re!\e:m-:h te::m will downlord visitor!\' de-identfiiecl li.e..!'ilrit)tlP.d of mohilf'! nhonP. numher\ text messr oe
Original Request Received in OHSR on:

2/19/2013

Responsible NIH Research lnvestlgator(s):

Susan Persky, NHGRI

OHSR review of your request dated Fri. Feb 15,2013 has determined that:

0

181
0
0
0
0
0

Federalregulations for the protection of human subjects do not apply to above named activity. The OHSR
determination of Not Human Subjects Research is based on the interpretation of 45 CFR 46 under "Research
Involving Coded Private Information or Biological Specimens" (OHRP,Revised October 16,2008) and Guidance
on Engagement of Institutions in Human Subjects Research (October 16, 2008). NOTIFY OHSR VIA AN E-MAIL
AMENDMENT OF ANY CHANGES THAT MAY ALTER THIS RESEARCH ACTIVITY.
The activity is designated fXfMe!. and has been entered in the OHSR database. PLEASE NOTIFY OHSR
OF ANY SIGNIFICANT CHANGES THAT MAY ALTER THE EXEMPT STATUS OF THIS RESEARCH
ACTIVITY.
NOT EXEMPT. OHSR recommends IRB review. Please forward your request to the Chair of your IRB, who
may ask you to provide additionalinformation In order to determine whether expedited or full review is
aoorooriate.
Confidentiality Agreement
Reliance
Amendment
Other

v

{5.r'.cJc..e

Lynnette Nieman,MD'

J7r·'

Signature

Admin Assist. CB

Office Person HB

Note:
3/1/2013: Smithsonian Exhibit and Surveys

Director, OHSRP

3/1/2013

Title

Date

Domeslicllnternational:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

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