Attachment 3_OHSR LPF Amendment approval Aug 2010

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

301,402-0341

To:

Gill. Michael

Exempt: #:

5080

NLM
38A - Lister Hill Center. 1OS1 014
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The proposed research activity will evaluate the effectiveness of NLM's newly developed information
technology tools to assist in reunifying family members in the wake of a disaster, in this case the January
2010 earthquakes in Haiti. The activity aims both to provide immediate assistance to people affected by the
earthquakes in Haiti and to inform further development and refinement of information technology tools for
fRmilv rp.1 mifk~Rtion

Original Request Received in OHSR on :

1/27/2010

Responsible NIH Research Investigator(s):

Michael Gill. NLM

OHSR review of your request dated Wed. Jan 27. 2010 has determined that:

181

o

o
o
o

Federal regulations 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 EXEMPT. 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 additional information in order to determine whether expedited or full review is
aoorooriate.
Confidentiality Agreement
Reliance

~

~Amendment 1/,51 W
o Other

AIr--_/

-------SPC
di§-,!slers

I~JU~lflUUI

Admin Assist. CB

the world with no completion date. This

1/28/2010
Date
Domesticll nternational:
Dom.llnt.
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

01

02

03

04

05

06

Page 1 ofL

OHSR (NIH/DDIR)
From:

Gill, Michael (NIH/NLM/LHC) [El

Sent:

Friday, August 27,20101:37 PM

To:

OHSR (NIH/DDIR); Pursley-Crotteau, Suzanne (NIH/OD) [El

Cc:

Thoma, George (NIH/NLM/LHC) [El; Antani, Sameer (NIH/NLM/LHC) [El; Goodwin, Rebecca (NIH/NLM/LHC)
[El

Subject:

FW: please submit email request for amendment to Office of Human Subjects Research (Lost Person Finder)
FW: GiIIM_NLM_5080_CY2010

Attachments: GiIIM_NLM_5080_CY2010.pdf; FW:; IRS Exemption Request - Haiti - For Submission-8-27-10amendmentVersion&Signed. pdf

,

;uzanne

j

lorry for the delay ... here it is with requested changes.
Vlike
:rom: Goodwin, Rebecca (NIH/NLM/LHC) [E]
;ent: Thursday, August 26, 2010 3:57 PM
ro: Thoma, George (NIH/NLM/LHC) [E]; Gill, Michael (NIH/NLM/LHC) [E]; Antani, Sameer (NIH/NLM/LHC) [E]
;ubject: please submit email request for amendment to Office of Human Subjects Research (Lost Person Finder) FW:
;iIlM_NLM_5080_CY2010
)r. McDonald and I met with Suzanne Pursley-Crotteau (Office of Human Subjects Research - OHSR) yesterday about a different
)roject, but she inquired about the Lost Person Finder (Haiti Earthquake Person Locator) project.

;he needs you to send an email to ohsr nih [email protected] the following request (and include the attached pdf and emai
nessage):

'lease amend the Request for Review (GiIIM_NLM_5080_CY2010) to expand the original project to an omnibus project for the use
)f this technology for all disasters.
Nature of Research Activity
The proposed research activity will evaluate the effectiveness of NLM's newly developed information technology tools to
assist in reunifying family members in the wake of a disaster, 11'1 t"'is ease t"'e JBl'ltfBI ( 2919 eBfl:"'EjtfBlte il'l Ilaiti. The
activity aims both to provide immediate assistance to people affected by disasters tile eBI~"Ejtfaltes il'l Ilaiti and to inform
further development and refinement of information technology tools for family reunification.
'lease also amend the project end date to be "indefinite."

lebecca Marel (Brown) Goodwin, J.D.
'roject Manager & Advisor to the Director
.ister Hill National Center for Biomedical Communications
,ational Library of Medicine, National Institutes of Health, HHS
lirect:
(301) 451-4635
.HC Main: (301) 496-4441
:mail: [email protected]

:rom: OHSR (NIH/DDIR)
;ent: Friday, August 13, 2010 11:04 AM
ro: Miller, Karen (NIH/NLM) [E]; Goodwin, Rebecca (NIH/NLM/LHC) [E]

8/3112010

Page 2 of2

)ear Karen,
~ere is the protocol that needs an amendment from Dr. Gill. I have also attached a scanned copy of the e-mail traffic related to the
leed for an amendment.

'lease let me know if you have any questions.
3est regards,
3uzanne

8/3112010

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVI~G HUMAN SUBJECTS
FAX:

301-402-0341

To:

Gill, Michael

ExeJl1pt: #:

5080

NLM
38A - Lister Hill Center, 10S1014
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The proposed research activity will evaluate the effectiveness of NLM's newly developed Information
technology tools to assist in reunifying family members In the wake of a disaster, in this case the January
2010 earthquakes In HaitI. The activity alms both to pr6vide immediate assistance to people affected by the
earthquakes in Haiti and to inform further development and refinement of information technology tools for
fflmilv rAllnifir.Ation

Original Request Received in OHSR on:

1/27/2010

Responsible NIH Research Investigator(s):

Michael Gill, NLM

OHSR review of your reQuest dated Wed, Jan 27, 2010 has determined that:

181

o

o
o
o
o
o

Federal regulations 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 EXEMPT, 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 C~air of your IRB, who
may ask you to provide additional information in order to determine whether expedited or full review Is
aoorooriate.
Confidentiality Agreement
Reliance
Amendment
Other
Office Person SPC

Admin Assist. CB

1/28/2010

Date
Dom.llnt.
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

01

02 03 04 05 06

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVI~G HUMAN SUBJECTS
FAX:

301-402-0341

To:

Gill. Michael

Exe~pt:

5080

#:

NLM
38A - Lister Hill Center. 10S1014
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The proposed research activity will evaluate the effectiveness of NLM's newly developed information
technology tools to assist in reunifying family members in the wake of a disaster, in this case the January
2010 earthquakes in Haiti. The activity aims both to prt>vide immediate assistance to people affected by the
earthquakes in Haiti and to inform further development and refinement of information technology tools for
f~milv

rp.llnifiC'..Rtion

Original Request Received in OHSR on:

1/27/2010

Responsible NIH Research Investigator(s):

Michael Gill, NLM

OHSR review of your reQuest dated Wed. Jan 27. 2010 has determined that:
~

o

o

Federal regulations 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
AIVIENDIVIENT OF ANY CHANGESTHAT MAY ALTER THIS RESEARCH ACTIVITY.
The activity is designated EXEMPT, 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 C~air of your IRB, who
may ask you to provide additional information in order to determine whether expedited or full review is
aoorooriate.

o

Confidentiality Agreement

o

Reliance

o
o

Amendment
Other
Office Person SPC

Admin Assist. CB

1128/2010
Date

OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

01

02

03

04

05

06

REQUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN
SUBJECTS
INSTRUCTIONS: Please type directly on this form. You can expand the docwnent if
you need more space. If your research involves a sUrveyor questionnaire, please attach it
to this completed form.
Completed forms (with all required signatures) may be sent to OHSR by FAX (301402·
3443), email to ohsr nih [email protected], or by mail (2CI46). If you have any
questions, call OHSR at (301) 402-3444.
Date:

January 27,2010

To:
From:

Miehael GUl,c;.~~~~4:::::.!:U~~
.Sameer Antanl, Ph.D• ..".c.-'!IJ---.",...".~-

ThroU:: :.R Thoma~-

(Signature of appropriate Official for IC, e.g., LabIBranch Chief)

Protoeol Title:
Investigation 'into use of information hosting and delivery for famHy unifieation in a
disaster using the following tools: "Earthquake in Haiti People Loeator"
Notifieation Wall Web site and "Found in Haiti" iPhone app.
Name oc'NIH Prineipal Investigator(s): Miehael GUl and Sameer Antani
Ie NLM LaboratorylBranch Communieations Engineering Braneh (LHC)
Building & Room No. 38A, 10S1014, and 38A110S1010
Tel. No. ~01-435·3212 and 301-435-3218
FAX No. 301·402-0341
,

.

Is the Prineipal investigator an NIH employee? _X_Yes

No

!fno, please explain:_ _ _-:--_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
1. What is the proposed researeh aetivity that you intend to perform at NIH (please
use lay terms):
.
The proposed research activity will evaluate the effectiveness ofNLM's newly
developed information technology tools to assist in reunifYing family members in the
wake of a disaster, in this case the January 2010 earthquakes in Haiti. The activity

aims both to provide immediate assistance to people affected by the earthquakes in
Haiti and to inform further development and refmement of information technology
tools for family reunification.
The NLM's "Earthquake in Haiti People Locator" Web site (henceforth, NLM People
Locator) is an interactive Web-based system that will be used to provide information
about people that are still missing or who have been found. in Haiti after the
devastating earthquake in January 2010. This Web site offers the public a tool for
searching for people who have been found in Haiti (e.g., recovered by medical staff
and other relief workers) and for voluntarily posting information about people who
are still missing. Information on recovered individuals is gathered voluntarily from
medical and relief personnel, such as medical staff aboard the USNS Comfort, who
use the "Found in Haiti" application developed by NLM for the iPhone or who submit
information by email via computer or cell phone. The iPhone application enables
submission of photographs and descriptive information about recovered victims in a
structured format, e.g., name (if available), age category, gender, general status
(healthy, injured), location. In addition, the site will be populated daily with
information downloaded from the Google Person Finder which is being widely used including by US Government agencies - as a service for locating people involved in
the Haiti earthquake. Information submitted directly to NLM People Locator will be
transferred to the "Google Person Finder" to ensure that users of either system can
search the complete set of available data for their family members and loved ones and
to ensure that use of the NLM system in no way interrupts or distracts from the
operation or use of other personal fmder systems.
The tools NLM has developed for submitting information to the People Locator and
for searching for matching offer several unique features that are not currently
available in the Google Person Finder system or other systems currently used to assist
in reuniting families and friends. These include the iPhoneliPod Touch application,
which assists in the quick and easy subrnissiQn of photos and other descriptive data in
a standard format. In addition, the NLM People Locator can also accept information
from any type of carnera-equipped cell phone or computer. The NLM People Locator
also provides search capabilities not yet available in other systems. Currently, Google
and other tools require a user to enter part of a name. NLMs system will allow for
other types of searches including retrieval of individuals whose name is not known,
by age (adult or child), and gender. The NLM People Locator also includes a
"notification wall" that provides a scrolling display of images of victims added in the
last I or 24 hours. Finally. NLM is developing a federated system to provide one-stop
searching across all known lost person fmders, including Google.
The research will aim to examine the utility and effectiveness of the NLM People
Locator system in reunifying family members, as well as to analyze technical
parameters of the system. Specific technical considerations to be examined include
the ability of the system to identify duplicate records, the effectiveness of the image
processing software in analyzing content (e.g., person wearing a red shirt). in locating
and improving the visibility of faces in submitted photographs, and in fmding similar

?

faces. Lessons will ;:uso be drawn about data management approaches for crises and
issues of data hosting, networking, and extensibility of the system to other
emergencies. The research will make use of publicly available information about
missing and recovered persons in Haiti. Results of this analysis will inform efforts to
improve the People Finder System for deployment during other disasters, in particular
in the context of the Bethesda Hospitals Emergency Preparedness Partnership
(BHEPP, http://www.bhepp.org),ofwhichNLMand NIH are participating
orgariizations.
2. If applicable, list your non~NIH CoUaborating Investigator(s).

Name

Address Tel. # FAX #

Institution

3. Proposed start date of your research Jan 25, 2010
Proposed completion date: Cessation of U.S. Relief Effort in Haiti

4. Will you be _ _ _ _these samples or data?
Collecting
Receiving
Sending

YeslNe

YesINe
YeslNe

S. Do the samples or data:
(a) Alreadyexist?_X_Yes

No

Data will be provided to the NLM People Locator from existing public sources of
information, including the Ooogle Person Finder Web site (which contained more
than 40.000 records as of January 25,2010), from members of the public who are
searching for missing family members or loved ones, and from emergency responderS
and others who are assisting the relief efforts in Haiti as people are found (recovered).
The NLM People Locator system will provide a means of structuring collected data in
ways to make it more searchable and improve the ability to find matches. All of the
data are being collected as part of the emergency response efforts in Haiti and will be
made publicly available via the NLM People Locator, Ooogle Person Finder, and
other person finder systems that source information from Ooogle. As indicated
above, collected data will include the name (if available), estimated age (or agegroup)~ general health status (alive & well, injured, deceased, unknown), picture and
location information.
(b) Or are they being' collected for the express purpose of this study? _Yes _X_No
(c) Ora combination of (a) and (b)?

__Yes -

X- No-,

G. What role will you have in tbis research project? (Check all that apply)
_X_Analyze samples/data only.
_

Consultant/advisor to collaborator(s) listed above.

_ Author of the protocol that is being implemented by your collaborating investigator
(identified in question #2).
_X_ Co-authorship on publication(s)/manuscript(s) pertaining to this research.
You or NIH hold an IND for this research.
_X_Decisional authority over the design or implementation of the research at the IRB
approved site? If so, please explain.
The system to be studied in this project has been developed as part ofNLM's disaster
information management research mission within BHEPP and will be deployed by NLM.
The system is intended to assist first responders by helping. organize, and structure
relevant personal information so that the family members, relief workers, and other
interested parties may be able to search and obtain information about loved ones affected
in a disaster. To ensure that collection of information for this project does not detract
from other ongoing efforts to reunify families and loved ones during the relief effort,
collected information will be shared with lost person finder systems operated by other
institutions and agencies (e.g .• Google).
_Other (If necessary, use this space to describe your role in this research).

7. Where are the subjects of this research activity located?
This research activity will make use of publicly available data about missing and found
persons that is submitted to publicly accessible person locator systems, such as the
system operated by Google, or directly to the NLM People Locator system by relief
personnel or by members of the public who are who are searching for missing family
members or loved ones in Haiti.
8. If human subjects are located elsewhere (not at NIH), will you have direct
contact or intervention with them? (Examples: as subjecfs physician; in obtaining
samples directly from the subject; by interviewing the subject?) _ _ Yes _X_No

9. What kind of human samples (e.g., tissue, blood) or data (e.g., private
information, responses to questionnaires) will be involved in your research?

T.1I~t

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The research will involve publicly available data about missing and recovered persons in
Haiti. Information will include name (if available), gender, estimated age or age group,
photograph, general health status (alive & well, injured, deceased, unknown), and
location. Information on found individuals will be voluntarily submitted to the NLM
system by emergency responders (medical and relief workers) in Haiti, and information
on missing individuals will be submitted by family members and friends who are
searching for them. All those who submit information to the system will be presented a
Privacy Notice indicating that submitted information will be made publicly
available/searchable on a Web site and shared with other person finder systems (such as
the one operated by Google) that are also intended for public use.
10. If the samples, .data do not come from an ~ approved protocol, do they come
from:

(a) Repository __Yes _X_. No
(b) Pathological waste _

Yes _X_No

(c) Autopsy material_ Yes _X_ No
(d) Publicly available source _X_Yes _

No

(e) Other_

Will come from a publicly available source (the Google PersQn Finder), others will .
come from care provides and other relief workers located in
Haiti
----------~-------------------------------------

11. Please check the box(es) that apply(ies) to the samples/data tbat you win receive.

(a) __ Samples andlor data will be anonymizedlunlinked. (The samples/data cannot
be linked to individual subjects.by you or your c911aborators at other sites.)
Samples andlor data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.

(b) _

(c) _ Samplesandlor data will be coded so that the provider of the samples/data .
can link them to specific individuals but the receiver will not be able to do so.
The data being gathered in this study is for the specific purpose of locating and reuniting
affected parties in a disaster zone. Consistent with this objective, all information
collected about the Victims will be made available to the public, as is being done via
other person-finder tools, such as the tool developed by Google.

12.
Will you send results back to the provider(s) (listed in question 2 of this
form)?
(a) _X_ No, I will not send results back to the provider(s).

(b) _

Yes, I will send aggregate results to the provider(s).

(c) _ Yes, I will send results to the provider(s) that are linked to identifiable
individuals.
If yes, does the provider intend to link your data to identifiableindividuaIs?
_ _Yes
No
13. Has the research activity that you are proposing in this form been approved by
an Institutional Review Board (lRB) elsewhere?
_ _ _ _ yes, the NIH research activity has been reviewed by the following IRB (s)
(Please provide the following information for each IRB):
Name of institution that provided the review
Address of reviewing institution
Name of PI for the IRB approved protocol

Title of IRB approved protocol and protocol #
Federal Wide Assurance (FWA) number··

__X_ _No IRB review of the research activity described in question #1 above has
taken place

(··An FWA is a contract between the U.S. Department of Health and Human Services
(DHHS) and an entity receiving DHHS funds to conduct clinical research that the latter
will follow ethical guidelines and federal regulations for,the protection of human
subjects. For a list of domestic and international institutions go to
http://oIn:p.cit.nih.gov/search/asearch.asp#ASUR

, ,Ad rp.vi!i:pil R/.4/0Q

14. Per NIH guidance***, have conflicts of interest by NIH employees, if any, been
resolved?
_X_Yes _ _No

If your answer iSBo, please see your Clinical Director about this matter before
proceeding with this research.

***The January 5, 2005 NIH Guide to Preventing Conflict ofInterest applies to all
research conducted at NIH, http:Uohsr.od.nih.govlNew/mpafwa docs,html

T.1I~t

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7

Page 1 of1
OHSR (NIH/DDIR)
From:

OHSR (NIH/DDIR)

Sent:

Friday, January 29, 2010 12:43 PM

To:

Gill, Michael (NIH/NLM/LHC) [E]

Cc:

Antani, Sameer (NIH/NLM/LHC) [E]

Subject:

Request for Review Determination_OHSR 5080

Attachments: GiIlM_NLM_5080_CY201 O.pdf
Good afternoon Dr. Gill,
Attached, please find OHSR's determination of your Request for Review of Research, OHSR #5080.
Please contact OHSR with any questions.
Sincerely,

Chris Brentin
Administrative Assistant
OD/OHSRlNIH

10 Center Drivel Rm. 2C-146
Bethesdal MD 20892
301-402-8631 (Direct)
301-402-3443 (Fax)

1129/2010