Attachment 11 - IRB letters

0.1379 cenie~ir~=líon
Dale
received
NIOSH HSRB cP/slò?
Signature Page for Human Research Review

Protocols and Related Documentation ~ c& o/z. 9/07

Use this signatue page when submitting HRPO forms to your center-level Human Subjects
SAFER'HEALTlllER'PEOPLE~ Contact. When submitting materials with these forms, please consecutively number all

pages, beginning with the protocol title page and followed by consent formes) and ancilary documents. See H1?O

Guide: Overview for fuher details. NOTE: IRB (Institutional Review Board) refers to the NIOSH HSRB

(National Institute for Occupational Safety and Health (NIOSH) Human Subjects Review Board (HSRB) of

the CDC Human Research Protection Offce (HO).

1

Protocol identifiers

CAN#9270QJ~__.~_ (optional)

not yet assigned.

Leave protocol ID blank if

COC protocol ID: OS~FlELP~()5X.P

Protocol version number 1 version date JO/5(:005

Protocol title: AerQsQIGtiIltiratiQnby CQugh
Amendment number (if applicable):

2 Key CDC personnel
Name and degrees

User ID

SEV#

COC NC/division

wdl7

7980

NIOSH/HELD

(FirstName LastName, Degrees)

Primary contact Wiiiiam.G,Lindsley, Ph.P.
(required)

Principal investigator (same)
(required)

SEV # is CDC's Scientific Ethics Verification Number. CDC NC/division is thti national center or equivalent and
division or equivalent, or coordinating center or offce if submitted at that leveL.

with this signature page

3 Forms submitted

Check all that apply in the appropriate colum.

IR-reviewed protocols
0.1250: Initial Review by IRB

'ii 0.1251: Continuing Review of Approved Protocol
0..252: Review of

Changes to Approved Protocol

Exempted protocols
0.1250X: Initial Review for Exemption
0.1251X: Continuing Review of

Exempted Protocol

0.1252X: Review of Changes to Exempted Protocol

0.1254: Incident Report
0..254S: Supplemental Adverse Event Report
0.1253: End of

Human Research Review

0..370: CDC's Research Parters

0.1253: End of

Human Research Review

0.1370: COC's Research Parters

0.1371: COC Rely on a Non-COC IRE

0.1372: Outside Instituion Rely on a COC IRB
0.1373: COC Cover an Individual Investigator

CDC Form 0.1379 NIQSH
Version 1.02006-04-13

Page 1 of 2

.-

Sìgnature page for human research revìew - N/OSH HSRB

4

Signatures
As principal investigator, I hereby accept r(;sponsibilty for conducting this COC-sponsored research project in an
ethical manner,
consistent with the policies and procedures contained in COC's Procedures for Protection 0/ Human
Research Participants,
and to abide by the principles outlined in federal policies for the protection of
human
subjects at 45 CFR part 46, 21 CFR par 50, and 21 CFR par 56.

Signature Date
Principal COC Investigator:

Remarks

7 Ltl1Jo7

.~~ ....f:
As a supervisor of
the principal investigator, I hereby accept responsibilty for ensuring that this COC-sponsored
_arh pr~e is cond_d in. an e' hi" I maner, con,i_. with the pOlide.' and proures contain ed in.C.O... C"
Procedues or rotecnoo 01 H~earch ParnÔpants, and to abide hy the principle, outline¡ in fedral

~=;~ . e.:.eco °SZ:';_:P:;::~)~R,Li~;'~~~.~P:5_6___.,.....,.:..............

~~~

Team Lead: 'zr- ... Check ifPI is Team Lead: .
Branch Official (e.g., Chief or Senior Scientist):

~l1~&~

?(~Y/¡)2
Checkiflii;' BranchOffiCia:Ï:.

Oivision Offcial (e.g., Oirector or AOS):

Check if

PI is Oivision Official:1i

¡/ufQ?

I concur that this COC-sponsored research project is consistent with the policies and pro
Procedures/or Protection o/Human Research Participants and with other applicable C

i~1:'~~~~~Dlte øf//!
Other Clearance
(e.g., Confidentiality Offcer, Coordinating Center/Offce Offcial)

t;fk¿.~Æ1J-ij /¡Il~

,~M~A
L1/
() /v b J
'iLc.f:'t~¿'.IIQiæ)(

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 OMS
clearance under the Paperwork Reduction Act (PRA) for federally sponsored information collections. Approval by
or exemption from the IRB 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

'"

0.1251

Centers for Disease Control and Prevention

Request for Continuing Review of

Date received

cP/3/oÎ
/k ~ o/z.io7

IRB..Approved Protocol
continuing review by a COC IRB or a non-COC IRE.
(See 45 CFR 46.109(e).) See H1?O Guide: IRE Review Cycle for fuher details on how to
complete this form.

Use this form to submit a protocol for

SAFER. HEALTHtER. PEOPLE~

1 Protocol identifiers
COC protocol ID: ()S~flLP~QSXl

Protocol version number 1 version date l()/S/ZQQS

Protocol title: AelQSOI .Gentirationby Collgh

2 Key CDC personnel
II No change in key COC personneL. Ifno changes, please list only the primar contact and principal investigator.

Name and degrees User ID SEV # COC NC/division
(FirstName LastName, Degrees)

Primary contact Willam.G. Lindsley,phP
(required)

wdl7

7980

NIOSH/ELO

Principal investigator WjUjamQ,Ljndsltiy,lhD

wdl7

7980

NIOSI:ELO

(required)

Investigator 2
Investigator 3

Investigator 4
Investigator 5

SEV # is COG's Scientific Ethics Verification Number. COC NC/division is the national center (or equivalent) and
division (or equivalent), or coordinating center or offce if sllbmitted at that leveL.
any. Include name and degrees, user ID, SEV #, COC NC/division:
List all other COC investigators, if

3 CDC's research partners
Research parters include all direct and indirect recipients ofCOC funding (e.g., grants, cooperative agreements,
contracts, subcontracts, purchase orders) and other COCsupport (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. On continuing review, HRPO needs current information on parters that have been added or dropped since
the last review, were receiving support for nonexempt research. See H1?O
the following.
Guide: CDC's Research Partners for further details. Check one of

the last review .and parters that, as of

II No research parters are reported with this submission. (This niay occur because there are no parers, or

because no parers are being added, or because no previously reported parters are stil both supported by

COC and engaged in nonexempt research.)
II Research

parters are listed on form 0.1370, which accompanies this form.

ODe Form 0.1251
Version 3.02006-04-13

Page 1 of 4

Request for contìnuìng revìew

4 Study participants-cumulative demographic frequencies
been enrolled in the last 12 months? Ii yes II no

Have any participants

Report estimated counts (rather thi: percentages). Include paricipants at domestic and foreign sites. See HRPO
Guide: IRB Review Cycle for definitions.

Number ofparicipi:ts Q
Location of participi:ts

Paricipating at domestic sites ()

Paricipating at foreign sites 0

Female
Male 00

Sex/Gender of paricipants

Sex/gender not available 0

Hispi:ic or Latino 0

Ethnicity of participi:ts

Not Hispanic or Latino 0
Ethnicity not available 0

~i: ()

Race of participants

American Indian or Alaska Native ()

Black or African American 0

VVite 0

Native Hawaiian or Other Pacific Islander 0

More than one race 0
Race not available 0
Comments on demographics

5 Study status-participant involvement
5.1 Contact status
"Contact" means intervention or interaction with participants, such as recruitment, screening, obtaìning consent,
enrollment, and collection of data and.biological specimens directly from participants. Check one of the following.

involve research-related contact with participi:ts (e.g., research using existing records);
study activities involve only access to or analysis of data or biological specimens and writing reports.

li Study is not designed to

Study is designed to involve contact with participants. Check one of

the following:

Contact with participi:ts has not yet begun.
Contact with participi:ts has begun and continues; this may include follow-up for debriefing or

notification of results.
Ii Contact with participi:ts is completed; study activities involve only data analysis or report writing.

eDC Form 0.1251
Version 3.0 2006-04-13

Page 2 of4

Request for contìnuìng revìew

5.2 Consent status
"Consent" includes adult consent, child assent, and parental permission. Check one ofthefollowing.
The IRB previously waived all requirements both to obtain and to document consent in this study.
Although not waived, there is no further need to obtain or document consent (e.g., enrollment is complete).
provide consent (with or without documentation).
II Partcipants wil be asked to
If you check the third box, please include all current consent, assent, and

parental permission materials (e.g.,

scripts, documents) from each study site with this submission.

6 Study status-overall conduct
research activities to date. Briefly summarize study progress and

Summary of
of

potential subjects who declined enrollment and the number who withdrew from the study. If

interim fmdings. Include the number
this study involves a

registrable clinical trial, sumarize registration status.
QMßaPprQYalfQIthlssmdyjsstiUmmdiIlg,NQxtistlarçhactiyjtitiShaYtibti.til:LCQnducttid,
Summary of study changes reviewed and approved since the last continuation. 00 not include changes submitted
with or before approval of
this continuation but not yet approved.
NQIlti

Summar of any recent literature or other information relevant to the research study (not limited to information with

COC co-authorship).
None

particular, address adverse events that were serious, unexpected (or more
severe than expected), or at least possibly related to the research.

Summary of all adverse events to date. In
frequent or

None
Summary of (a) incidents that are not adverse events and (b) other substantial concerns since last continuation.
None
List and include copies of progress or monitoring reports on safety or compliance (e.g., site monitor, safety review,
OSM report, multi-center trial report, but not reports to PGO).
None
Summary of
remaining research activities, emphasizing future contact with subjects, use of
identifiable private data
and biological specimens, and preparation of

primar reports.

Ihti.stidYhas .IlQt YtitJ)egnrbticaiise. QMitaPprQYaLisPtiIldIig. A1Iplanrtid research..actiyitiesrtimain.

7 Regulation and policy

7.1 Mode of IRB review on CDC's behalf
Location ofIRB (check one):
II COC IRB
Non-COC IRB through IRB authorization agreement (submit form 0.1371 if

this is a new request)

Institution or organization providing IRB review:

known):
Federalwide assurance number (if any):
IRB registration number (if

IRB-determined level of risk to

subjects (check one):

II Minimal

Greater than minimal

eDC Form 0.1251
Version 3.0 2006-04-13

Page 3 of 4

Request for contìnuìng revìew

Suggested level ofIRB review (check one):
See H1?O Worksheet for Expedited Review for detailed assistance. If relying on a non-COC IRB, please indicate
the level of
review that
you think is appropriate under human research regulations.
Convened-board review is suggested
Reason for convened review:

II Expedited review is suggested, under the following categories (check all that apply):
1 a Study of drgs not requiring Investigationi:l New Orug exemption from FOA

medical devices not requiring Investigational Oevice Exemption from FOA
Collection of
blood from healthy, nonpregnant adults; below volume limit, minimally invasive
Collection of
blood from other adults and children; below volume limit, minimally invasive

Ib Study of

biological specimens for research purposes
Collection of data through routine, noninvasive procedures, involving no general anesthesia,
sedation, x-rays, or microwaves
uses materials collected solely for nonresearch purposes
Ii 5 Research that
Collection of data from voice, video, digital, or image recordings made for research purposes
Prospective noninvasive collection of

7 Research that uses interview, program evaluation, human factors, or quality assurance methods
Continuing review of

research previously approved by the convened IRB where
new subjects; all subjects

have

l'-k c;) Ii 8i: the research is permanently closed to the enrollment of

~11 Y~1~ l~.............. ~i :t-;;:: ::l~ ~~::i7.:aJ:~t:n'erentio os; and the rese" ch remains active only for

f-. ~) H~8b no subje~t~ have been enr~ll~~and n~ a~ditional risks hav~ been identified
,. i.)1 IL i Ii 8c the remaining research activitIes are limited to data analysis
research, not under IND/IOE, where
P"nllJlI' 9 Continuing review of

categories 2 through 8 do not apply but

() .l /' the IRB has determined and documented at a convened meeting that the research involves no

0'1' greater than minimal risk and no additional risks have been identified

with this form

8 Material submitted

Check all that apply. Oescribe additional material in the comments section. Required items are indicated. Optional
items may be requested by HRPO or the IRB.
Complete protocol (required if research poses more than minimal risk to subjects, is under INO/IDE, or has
changed in the past 12 months)

Consent, i:ssent, and permission documents or scripts (required if consent wil be sought in the future from
prospective subjects or their representi:tives (see section 5.2))

II Other information for recruits or participants (e.g., ads, brochures, flyers, scripts; required if consent wil be
sought in the futue from prospective subjects or their representatives)
Oata collection instrments (e.g., questionnaires, interview scripts, record

abstraction tools; required ifprotocol

has changes in the past 12 months)
Ii Certification of IRB approval or exemption for research parters (required only for parers being added or for

supported/nonexempt parters)

Progress and monitoring reports (recommended when avi:ili:ble)

9 Additional comments

CDC Form 0.1251
Version 3.02006-04-13

Page 4 of 4