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Memorandum
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Date Januar 9, 2007
From Chair, NIOSH HSRB
Subject Report ofNIOSH HSRB -- Protocol No. HSRB 06-HELD-11XP "Experimental and Theoretical
Study of Early Detection and Isolation of Infuenza" Approval of Protocol
To Wiliam Lindsley, Ph.D.
Project Officer, PPRB, HELD
Through: /Chief, PPRB, HELD ~_
/Director, HELD __
General Comments and IRB Actions
I received your revised protocol and consent document (letter dated December 19,2006) and find
that it is responsive to the issues raised in my December 14, 2006, expedited review of your
original submission. The revised protocol and consent document are approved for one year and
wil serve as the documents of
record (dated 1/9/2007) for this study (renewal date 12/14/2007).
However, if you make any substantive changes, or any adverse reactions occur in any study
paricipants, please notify me immediately.
Protocol Issues - None.
Consent Form Issues - None.
Addenda Issues (Scripts, questionnaires, brochures, etc.) - None
End of report
~~
~ Michael J. Collgan Ph.D.
cc:
HSRB 06-HELD-11XP
"
0.1379
Date received
Centers for Disease Control and Prevention
NIOSH HSRB
/--lY"'CY/
Signature Page for Human Research Review
Protocols and Related Documentation
Use this signatue page when submitting HRO forms to your center-level Human Subjects
submitting materials with these forms, please consecutively number all
SAFER'HiiALTHIiiR,..iiO"L£~ Contact. When
pages, beginning with the protocol title page and followed by consent formes) and ancilar documents. See HRPO
Guide: Overview for fuher details. NOTE: IR (Institutional Review Board) refers to the NIOSH HSRB
Board (HSRB) of
(National Institute for Occupational Safety and Health (NIOSH) Human Subjects Review
the CDC Human Research Protection Offce (HO).
1
Protocol identifiers
CAN# !l~ZQg~s
(optional)
Leave protocol ID blan if not yet assigned.
CDC protocol ID: HSßEQa:HELP:IIXl Protocol version number Z.. version date iZÜ2LiQQQ
Protocol title: E~PtlrÏll:lltala¡c:.Ilil:orl:tlc;al.Stlic:y .ofEarlY.Ptlttlc;tjQIla¡c:Isolati.on..of.lllfl1!tllla
Amendment number (if applicable):
2 Key CDC personnel
Name and degrees
User ID
SEV#
CDC NC/division
wd17
7980
NlQStlLP
wd17
79SO
NIQSH!ELR
(FirstName LastName, Degrees)
Primar contact WiiiialD, LinC:sltlY, lli
(required)
Principal investigator Will.a G.LlJ:cisltlY
(required)
SEV # is CDC's Scientific Ethics Verification Number. CDC NC/division îs the national center or equivalent and
divisîon or equivalent, or coordinating center or offce if submitted at that leveL.
3 Forms submitted with this signature page
Check all that apply in the appropriate colum.
Exempted protocols
IR-reviewed protocols
0.1250X: Initial Review for Exemption
0.1250: Initial Review by IRB
0.1251: Continuing Review of Approved Protocol
Changes to Approved
0.1252: Review of
Protocol
1251X: Continuing Review of
Exempted Protocol
0.1252X: Review of Changes to Exempted Protocol
0.1254: Incident Report
1254S: Supplemental Adverse
0.1253: End of
Event Report
Human Research Review
~i0.1370: CDC'sResearch Parers
0.1253: End of
Human Research Review
0.1370: CDC's Research Parers
0.1371: CDC Rely on a Non-CDCIRB
0.1372: Outside Institution Rely on a CDC IRB
0.1373: CDC Cover an Individual Investigator
COC Form 0.1379 NIQSH
Version 1.0 2006-04-13
Page 1 of 2
"
Signature page for human research review - NIQSH HSRB
4
Signatures
As principal investigator, I hereby accept responsibilty for conducting this CDC-sponsored research project in an
ethical manner, consistent with the policies and procedures contained in CDC's Procedures for Protection of Human
human
principles outlined in federal policies for the protection of
Research Participants, and to abide by the
subjects at 45 CFR par 46, 21 CFR par 50, and 21 CFR par 56.
~nature Date
Remarks
Principal CDC Investigator:
OllQlLiOQl
........~.~
As a supervisor of
the principal investigator, I hereby accept responsibilty for ensuring that this CDC-sponsored
r ese arch p rOjefQt con.du cted in an e. thical manner, consisten tWl't h. th e.pol i cies and procedures contained inCD.....C........'.S...
Procedures for otection of
Human Research Participants, and to abide by the
principles outlined in federal
policies for the tection ~fhl¡an s~ts at 45 CFR par 46, 21 CFR par 50, and 21 CFR par 56,
--~
V~m
Signatiir~.. . ...¿,u-#.t2~.. . ..D..~teLl~3I()t. ..R~~~r;~;_........
PI is Team Lead:.
Team Lead: '" - - - 0 ~ Check if
l/.iLczz
Branch Official (e.g., Chief or Senior Scientist):
.ÖlieCl¿TrliTsBrancliÖrficiåEII
. "Ölieck
~1!U:toror ADS):
If
lI
is
Division
ÖffciåE
II
\::0l.. i-________~___.__
I concur that this enC-sponsored research project is consistent with the policies and procedures contained in cnc's
Procedures for Protection of
Human Research Participants and with other applicable CDC and national center
policies.
Signature Date Remarks
Chair, NIOS
J/ZT~ 7
5 Additional comments
6 Reminder regarding other regulatory clearance processes
The principal investigator is responsible for obtaining other regulatory reviews as needed, which may include OMB
information collections. Approval by
clearance under the Paperwork Reduction Act (PRA) for federally sponsored
or exemption from the IRE is unelated to OMB clearance requirements under the PRA, For more information on
whether your study requires clearance under PRA or other regulations, please consult the appropriate offcials within
your national center.
CDC Form 0.1379 NIOSH
Version 1.0 2006-04-13
Page 2 of2
Date received
Centers for Disease Control and Prevention
0.1250
/-/J?"' 0'1
Request for Initial Review by
an Institutional Review Board
Use this form to submit a protocol for its fist review by a CDC IRE or a n.on-CDC IRE. If
SAFIE.HiiLTHIiiR,..iiO"Lii~ seeking review by a n.on-CDC IRB, also include form 0.1371. See HRPO Guide: IRE
Review Cycle for fuher details on how to complete this form.
1 Protocol identifiers
Leave protocol 10 blan if
not
yet assigned.
2 . ... version date lZl19aQQQ
CDC protocol ID: HSBJ1QQ:HELl):11Xl Protocol version number
Protocol title: -E~p.lri!Jl:ntalaIlQThtlOI.ltjÇal_S.t\c:Y.of-EarIYl)l:t.lçtiollanc:lsolaljolloflifllJl:n~
in a separate cell:
Suggested keywords (optional). Enter each term
infllJtlll:za
a(roaoJ
aIiPQrntl...trans!Jisslon
panQ.l!Jiç
ç\opM
C;OlJgli
2 Key CDC personnel
User ID
SEV#
CDC NC/division
wdl7
7980
NIOSHILD
~Q17
798_Q
NIOSH/ELD
Investigator 2 J)onald Beezholq, Phl
zec i-
8919
Investigat.or 3 Francoise Blachere, MS
czv3
1~~
Investigator 4 Bean T. Chen
bdc4
18185
NIOSHlLQ
NIOSHlLJ)
NIOSHILD
Investigator 5 Qavid G. Frazer._.PhD
dgl
3011
NIOSlI.1D
Name and degrees
(FirstName LastName, Degrees)
Primary contact Willia!J Q.. LilllsIl:y,lliJ)
(required)
Principal investigator Wiliam_G. Lindsley..Phl
(required)
SEV # is CDC's Scientific Ethics Verification Number. CDC NC/division is the national center (or equivalent) and
division (or equivalent), .or coordinating center or offce if submitted at that leveL.
List all other CDC investigators, if any (name and degrees, user ID, SEV #, CDC NC/division):
Ja!JtlsSJaYtln,..MS,...ct08,..IZ7(j7,NlOSlILl);..Rohl:rtIlil:wH¡;,JIl09l:grl:tl),Il:tQ,41a3,.NIOSlILl)
3 CDC's role in project
Check yes or no for each of
the following.
II CDC employees or agents wil obtain data by intervening or interacting with paricipants.
II CDC employees or agents wil obtain or use identifiable (including coded) private data or biological
specimens.
II CDC employees or agents wil obtain or use anonymous or unlinked data .or biological specimens.
CDC employees wil provide substantial technical assistance or oversight.
CDC employees wil paricipate as co-authors in presentationes) or publication(s).
"Agents" includes on-site contractors, fellows, and others appointed or retained to work at a CDC facilty
conducting activities under the auspices ofCDe.
CDC Form 0.1250
Version 3.0 2006-04-13
Page 1 of 5
Request for initial review by an IRB
4 CDC's research partners
Research parers include all direct and indirect recipients ofCDC fuding (e.g., grants, cooperative agreements,
contracts, subcontracts, purchase orders) and other CDC support (e.g., identifiable private information, supplies,
products, drgs, or other tangible support) for this research activity, as well as collaborators who do not receive such
support. See HRPO Guide: CDC's Research Partners for
fuher details. Check one of
the following.
No research parers.
Research parers are listed on form 0.1370, which accompanies this form.
5 StUdy participants-planned demographic frequencies
Report estimated counts (rather than percentages). Include paricipants at domestic and foreign sites. See HRPO
Guide: IR/ Review Cycle for defmitions.
Number of paricipants 85
Location of participants
Paricipating at domestic sites
Participating at foreign sites
Sex/Gender of
85
o
paricipants
Female
Male
Sex/gender not available
43
4Z
o
Ethicity of paricipants
Hispanic or Latino
Not Hispanic or Latino
Ethnicity not available
Q
Q
85
Asian Q
Race of
paricipants
American Indian or Alaska Native Q
Wh~ Q
Black or African American Q
Native Hawaiian or Other Pacific Islander Q
More than one race 0
Race not available SS
Comments on demographics
B,ac;slJmÇl l:tliic;ity'WUlnotpl:lli.l:çl asi.tlltlçtiollc;ritl:IIaançl 'WillnotPl:JtlçorçlSiçlçlllmgJlitlStiçly.
(; Regulation and policy
6.1 Mode of IRS review on coe's behalf
Location of IRB (check one):
CDC IRB
Non-CDC IRB through IRB authorization agreement (submit form 0.1371)
Institution or organization providing IRB review:
known):
IRB registration number (if
Federalwide assurance number (if any):
CDC Form 0.1250
Version 3.0 2006-04-13
Page 2 of 5
Request for initial review by an IRB
Suggested level of risk to subjects (check one):
JI Minimal
II Greater than minimal
Suggested level of IR review (check one):
See HRPO Worksheet for Expedited Review for detailed assistace. If relying on a non-CDC IRB, please indicate
the level of review that you thin is appropriate under human research regulations.
Convened-board review is suggested
Not eligible for expedited review. For example, poses greater than minimal risk; involves use of
blood; use of
drg, biologic, or device under IN or IDE; involves collection of large amount of
x-rays or microwaves; anesthesia; or physically invasive procedures
Other specified reason: ~__
Expedited review is suggested, under the following categories (check all that apply):
la Study of drgs not requiring Investigational New Drug exemption from FDA
lb Study of
from FDA
medical devices not requiring Investigational Device Exemption
2a Collection of
blood from healthy, nonpregnant adults; below volume limit, minimally invasive
2b Collection of
blood from other adults and children; below volume limit, minimally invasive
3 Prospective nonivasive collection of
biological specimens for research puroses
4 Collection of data through routine, noninvasive procedures, involving no general anesthesia,
sedation, x-rays, or microwaves
5 Research that uses previously collected materials
6 Collection of data from voice, video, digital, or image recordings made for research puroses
7 Research that uses interview, program evaluation, human factors, or quality assurance methods
6.2 Vulnerable populations
the following vulnerable populations. Choose one option in each row,
and indicate the page(s) where inclusion or exclusion is justified in the protocol.
Characterize the intention to include each of
Targeted Allowed Excluded
Pregnant women or fetuses
~
II
Children (including viable neonates)
lI
Prisoners
NA
Page(s)
~
-
ll
8
Describe other groups of potentially vulnerable subjects intended to be included or excluded, such as neonates of
uncertin viabilty or nonviable neonates, persons with mental disabilties, or persons with economic or educational
disadvantages.
N/A
6.3 free and informed consent
Characterize requested changes to required featues of the informed consent process. If a waiver is requested, enter
the protocol where the waiver is justified.
the page number of
Which exceptions to the consent process are requested? Check all that apply:
informed consent for adults
Waiver or alteration of e.1ements of
Waiver of assent for children capable of providing .assent
parental permission
Waiver of
CDC Form 0.1250
Version 3.0 2006-04-13
pg
pg
pg
Page 3 of5
Request for initial review by an IRB
Which exceptions to documentation of informed consent are requested? Check all that apply:
adults
consent for
II Waiver of documentation of informed
Waiver of documentation of assent for children capable of providing assent
parental permission
Waiver of documentation of
Waiver or alteration of authorization under HIP AA Privacy Rule
How is it shown that the consent process is in understandable language? Check all that apply:
Reading level has been estimated
pg
pg
pg
pgpg 21..Ii 40
Comprehension tool is provided
Short form is provided
pg
pg
Translation planned or performed
pg-
Certified translation/translator
pg
pg
Translation and back-translation to/from taget language(s)
Other method (specify:
6.4 Other regulation and policy considerations
Check all that apply.
If requesting the exception to the PHS policy on informing those tested about HIV serostatus, enter the page number
ofthe protocol where the waiver is justified.
Exception is request to PHS informing those tested about HIV serostatus. pg
Human genetic testing is planed now orin the futue.
This study includes a registrable clinical triaL.
This study involves long-term storage of identifiable biological specimens.
This study involves a drg, biologic, or device.
See HRPO Worksheet to Determine FDA Regulatory Coverage/or guidance on whether or not FDA
regulations apply.
This study wil be conducted under an Investigational New Drug (IND) exemption or Investigational Device
Exemption (IDE).
IN/IDE number(s):
6.5 Confidentiality protections
If at least one research site is within the US, then check either Granted, Pending, or No in each row. If no sites are
within the US, then check NA in each row.
NA
No
Granted Pending
Certificate of
Confidentiality (30
1
(d))
Assurance of Confidentiality (308( d))
li
..
.-..'.'.....,
Describe any other formal confidentiality protections that are planed or are in place:
CDC Form 0.1250
Version 3.0 2006-04-13
Page 4 of 5
Request for initial review by
an IRB
7 Material submitted with this form
Check.all that apply. Describe additional material in the comments section.
Complete protocol
Peer reviewers' comments or division waiver (NIOSH)
Consent, assent,
and permission documents or scripts
Other information for recruits or paricipants (e.g., ads, brochures, flyers, scripts)
II Data collection instrents (e.g., questionnaires, interview scripts, record abstraction tools)
Certification of IRB approval or exemption for research parers
8 Additional comments
CDC Form 0.1250
Version 3.02006-04-13
Page 5 of 5
Centers for Disease Control and Prevention
0.1370
Date received
J:Jii) 0 L
COC's Research Partners
Use this form to report curent information on CDC's research parers whenever a parer
changes. Supply individual name and SEV number
institution or
individual is added or information
only for investigators collaborating with CDC under an individual investigator agreement (IIA). See
HRPO Guide: CDC's Research Partners and either the HRPO Worksheetfor Basic Tracking of
Research Partners or the HRPO Worksheet for Advanced Tracking of Research Partners for details
on how to complete this form.
Leave protocol ID blan if not yet
assigned.
CDC protocol ID:/lM 0 ¡, '" IIEL)) - / 1)( P Protocol version number
Protocol title: EXPtrimental and Theoretical Stu-g of
Early Detection and Isolation of
Influenza
Partner 1
Partner 2
Instituion name: Wl:stYirgmiallIllY-tISi.ty
Institution name:
Instituion location: MorgalltoWl,wy,llSA
Institution location:
Individual name (IIA only):
Reporting status: IllitjaLIl:port
Individual name (IIA only):
Reporting status: Rl:portingstatis?
Regulatory coverage: Ellgagtli:1l01l:l:~l:Jlpt
Regulatory
Financial support: Grant
Financial support: Financial support?
Support award number: ROlOHOQ9037-01
Support end date: 20QliQQ2
version date
coverage: Ellgagl:d?E~l:i:pt?
Support award number:
IRB approval expiration date:
Comments:
Support end date:
Nonfinancial support: NollflIallçiaLsllPport?
FWA number:
SEV number (IIA only):
IRB review status: iRBi~yil:Wmstatis?
IRB approval expiration date:
Comments:
Partner 3
Partner 4
Nonfinancial support: NolloiiflIallC;ialSllPPort
FW A number: 00005078
SEV number (IIA only):
IRB review status: RtlIymgonÇpçJßE
Regulatory coverage: Engaged? Exempt
Institution name:
Institution location:
Individual name (IIA only):
Reporting status: Bgportmgstatis?
Regulatory coverage: Engaged? Exempt?
Financial support: Fmarrc;iaLsllPPort?
Financial support: Einanc;ial SllPport?
Support award number:
Support award number:
Support end date:
Nonfinancial support: Nonfinancial sUPQort?
Support end date:
Nonfinancial support: Nonfmancial support?
FW A number:
FW A number:
SEV number (IIA only):
IRB review status: IRB_ryview status?
IRB approval expiration date:
Comments:
SEV number (IIA only):
IRB review status: IRB revi~w status?
IRB approval expiration date:
Comments:
Institution name:
Institution location:
Individual name (IIA only):
Reporting status: Rl:portmg statis?
CDC Form 0.1370
Version 1.0 2006-04-13
page 1 of 2
, '
COC's research partners
Partner 5
Partner 6
Institution name:
Institution name:
Institution location:
Institution location:
Individual name (IIA only): .
Reporting status: Rl:P9rtmgst!ltis?
Individual name (IIA only): ______
Reporting status: R~po_rtmKslat:s?
Regulatory coverage: Eng!l~Ji1.E~l:mpl?
Regulatory coverage: Eng!gtl"c::LE~l:mp!?
Financial support: Financial support?
Support award number:
Support end date:
Financial support: Financial support1
Support award number:
Support end date:
Nonfmancial support: Nonfmancial sUPRort1
Nonfiancial support: Nonfiancial S1lRport?
SEV number (IIA only):
IRE review status: I:R rtlyi~w statis?
IRE approval expiration date:
Comments:
FWA number:
SEV number (IIA only):
IRE review status: IßEItlyil:WStat:S?
IRE approval expiration date:
Comments:
Partner 7
Partner 8
Institution name:
Individual name (IIA only):
Reporting status: Reporting-status?
Institution name:
Institution location:
Individual name (IIA only):
Reporting status: Reporting status?
Regulatory coverage: Engaged? Exem12t?
Regulatory coverage: Eng~ed? Exempt?
Financial support: Fmallc;i.aLs1lPPort?
Financial support: Fm¡mc;.iaLs1lPPort?
Support award number:
Support award number:
Support end date: ~
Nonfmancial support: Nonfllançials1lPPort?
Support end date:
Nonfinancial support: Nonfllallçi!lLsupport?
FW A number:
FW A number:
SEV number (IIA only):
IRE review status: IRE review status?
IRE approval expiration date:
Comments:
SEV number (IIA only):
IRE review status: IRE review status?
Partner 9
Partner 10
Institution name:
Institution name:
Institution location:
FW A number:
Institution location:
Institution location:
Individual name (IIA only):
Reporting status: Rl:portmgslatis?
Regulatory coverage: Ellg!lgtlçl?EKtlllpt?
Financial support: FmançiaLsiipRort?
Support award number:.__~
IR approval expiration date:
Comments:
Individual name (IIA only): ~
Reporting status: RtlPortmgslatl_S?
coverage: Ellg!lgl:c:?E~~llpt?
Regulatory
Financial support: Fmi.çiaLs1lPPort?
Support award number: ~__
Support end date:
Support end date: ...
Nonfiancial support: N9nfllanc;iaLs1lPP9rt?
Nonfinancial support: Nonfllanc;ial S1lPPort?
FW A number:
FWA number:
SEV number (IIA only):
SEV number (IIA only):
IRE review status: lßEIl:yil:WStatiS?
IRE approval expiration date:
Comments:
CDC Form 0.1370
Version 1.0 2006-04.13
IRE review status: JRieyil:w_statis?
IRE approval expiration date:
Comments:
Page 2 of 2
| File Type | application/pdf |
| File Title | eCopy |
| Author | Copier User |
| File Modified | 0000-00-00 |
| File Created | 2007-01-09 |