Appendix D IRB Approval

DEPARTMENT OF HEALTH & HU SERVICES

(l-~"'''.'È
't+ ..

Memorandum

"'~
"'b'IVM

Date March 23, 2007

From Chair, NIOSH HSRB

Subject Report ofNIOSH HSRB -- Protocol No. HSRB 07 -DRDS-02XP "Long-Term Effcacy of a
Program to Prevent Beryllum Disease"

To Christine R. Schuler, Ph.D.
Project Officer, FSB, DRDS

Through: /Chief, FSB, DRDS ~_

/Director, DRDS__

General Comments and IRB Actìons

I reviewed the subject protocol using the expedited procedure in that the research involves the use
of sureys/interviews and the accessing of existing records (criterion #7) and a blood draw of
healthy adults (criterion # 2) as provided for in the criteria cited for expedited review in
the Certificate of
Confidentiality to protect the genetic data and
45CFR46.110. The issuance of
other data protection practices cited in the protocol make this a minimal risk study. I should also
note that the consent process and general protocol approach have been previously approved in other
studies reviewed by the NIOSH HSRB. The protocol is therefore approved.
Human
Research Protections (OHRP), to cover NIOSHIBrush Wellman collaborative research, I noted that
In reviewing the FWA (Federalwide Assurance), filed by Brush

Wellman with the Office of

the expiration date is December 15,2007. Brush Wellman wil either have to extend their FW A

(citing the NIOSH HSRB as the IRB of record) or fie a new one to cover the data collection period
specified in the current protocol. Please provide the HSRB office with documentation that this has
occured before collecting data beyond the December 15,2007 expiration date. Additionally,
attached is a completed CDC 0.1372A "IRB Authorization Agreement~Outside Institution relying
on a CDC IRBINIOSH HSRB (2 copies). Please print 2 copies and obtain approval/signature for
both copies and forward both to the NIOSH HSRB Office for approval/signatue. One original wil
be returned to the Brush Wellman Inc. approving officiaL. We wil also forward an approved
electronic copy agreement to the CDC principal investigator.
Finally, I would like to compliment you for an extremely well-written and clearly organized
protocol. Your concise discussion of the issues relevant to human subject protections (e.g.,
conditions of the study, risks and benefits, recruiting strategies and related documents, consent and
notifications procedures, etc.) greatly faciltated the review of this protocol. If you make any
substantive changes, or any adverse reactions occur in any study participants, please notify me
immediately.
Protocol Issues, Consent Form Issues, Addenda Issues - None.
End of

report

cc:
HSRB 07-DRDS-02XP

0.1379

Centers for Disease Control and Prevention

Date received

NIQSH HSRB

f;u/ò7

Research Review

Signature Page for Human
Protocols and

Related Documentation

Use ths signatue page when submittg FIO form to your center-level Humn Subjects
SAFER.HEALTHIER.PEOPUW Contact. When submittg materials wîth these form, please consecutively number all

pages, beginng with the protocol title page and followed by consent forms) and ancilary documents. See HRPO
Review Board) refers to the NIOSH HSRB
Guide: Overview for fuer details. NOTE: IR (Institutional

(National Institnte for Occupational Safety and Health (NIOSH) Human Subjects Review Board (HSRB) of
the CDC Human Research Protection Offce (HRO).

1

Protocol identifiers

CAN# 927Z6RG

(optional)

Leave protocol ID blank if not yet assigned.
Februar 2007

CDC protocol ID: _If.L 07 -.jR- -0 -iX P . Protocol version number 1 version date

Protocol title: long:-.:~rlll-EfftçRø-lfR_l-rQgram toJ~L~y~tll~ryllum Qjsease
Amendment number (ifapplicable): _________

2 Key CDC personnel
Name and degrees

User ID

SEV#

CDC NC/division

?:ii:2

14~~

NJQSHfRPS

(FirstName LastName, Degrees)

Priry contact Çl-s1jni:R,Sçhllc:r,_lll,Q,
(required)

......................_....................._..c.._................._..........,.":.::;;':......._.,."'~......,.~...._........................._...........'-

Principal investigator çhi§tlll~_R,-SJ;hJller..Ji..D:;' '~ zie9

1~22

NIO~SlIBIS
~"', ~~';¡ ~.... ".,' . "';\

(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.

3 Forms submitted with this signature page
Check all that apply

in the appropriate colum.

IR-reviewed protocols

Exempted protocols

.0.1250: Intial Review by IRB
0.1251: Contiuing Review of Approved Protocol

Changes to Approved Protocol

.0.1252: Review of

0.1250X: Initial Review for Exemption
0.1251X: Contiuing Review of

0.1252X: Review of

Exempted Protocol
Changes to Exempted

Protocol

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

Human

Research Review

.0.1370: CDC's Research Parters

0.1253: End of

Humn Research Review

0.1370: CDC's Research Parters

.0.1371: CDC Rely on a Non-CDC IRB

.0.1372: Outside Institution Rely on a CDC IR
.0.1373: CDC Cover an Individual Investigator

CDC Form 0.1379 NIOSH
Version 1.02006-04-13

Page 1 of 2

Signature page for human research review - NIOSH HSRB

4

Signatures
As pricipal investigator, I hereby accept responsibilty for conductig ths CDC-sponsored research project in an
ethcal maer, consistent with the policies and procedures contained in CDC's Procedures
for Protection of Human
Research Participants, and to abide by the priciples outlined in federal policies for the protection ofhui
subjects at 45 CFR part 46, 21 CFR part 50, and 21 CFR par 56.

-Slgnature Date

Remarks

Pricipal CDC Investigator:

---------~--------~-~

.i/;i1IrJ1

As a supervisor of the pricipal investigator, I hereby accept responsibilty for ensurg tht ths CDC-sponsored
research project is conducted in an ethcal maer, consistent with the policies and procedures contained in CDC's
Procedures for Protection of
policies for the protection of

Human Research Participants, and to abide by the principles outlined in federal
humn subjects at 45 CFR part 46,21 CFR part 50, and 21 CFR par 56.

- -~- -----

--~e~ii-I!;d:---- -.. ..---------------- ........ .---------~~!~----------------Ch:crifpÏis-Tëam-i:eá(FII----------

_._........_._....__....._...._..._._._.._..._.............._-_...---_._.__.__._._----_....-.._...-.-...._._-.

Branch Offcial (e.g., Chief or Senior Scientist):

J:j~~l~-~_ ~

~~~

Division Official (e.g., Director or ADS):

Check if

PI is Branch Offcial:..

'3. (, . Ie 1-

7.16.D7

Checkif llis Di'\isi()ll OffCiaL.

the policies and procedures contained
in CDC's
Human Research Participants and with other applicable CDC and national center

I concur that this CDC-sponsored research project is consistent with
Procedures

for Protection of

policies.

C:;f::.I/!!J_=_

Slg!lll!!lr~.................................i/.................-........._....................................................-............... ...... ......-_.

Other Clearance Offic 1/ ~............ .....
("g" CooO,,,ti,li,, Off" """''tiog C~,,,/Offoo Ofci~l)

Date

Remarks

¥io2

5 Additional comments

6 Reminder regarding other regulatory clearance processes
The pricipal investigator is responsible for obtaing other regulatory reviews as needed, which may include OMB
Reduction Act (PRA) for federally sponsored informtion collections. Approval by
clearance under the Paperwork
or exemption from the IRB is unelated to OMB clearance requirements under the PRA. For more inormtion on
whether your study requires clearance under PRA or other regulations, please consult the appropriate offcials within
your national center.

COC Form 0.1379 NIOSH

Version 1.0 2006-04-13

Page 2 of 2

Centers for Disease Control and Prevention

0.1250

Request for Initial

Review by

Date received

~/OÎ

Institutional Review Board

an

Use ths form to submit a protocol for its first review by a CDC IR or a non-CDC IR. If
seekig review by a non-CDC IR, also include form 0.1371. See HRPOGuide: IRB
Review Cycle for fuher details on how to complete ths form.

1 Protocol

identifiers

Leave protocol ID blan if not yet assigned.

CDC protocol ID: _.J,fU o7-::RbS-o 2ì(p Protocol version number 1. version date Fel;ruaIYcfQQI
Protocol title: LQl'T~i:_Jjffiçaty_Q.Lalrogr-a:l10 Pn:yeIltBtIYl! Dis_t;R_s§

Suggested keywords (optional). Enter each term in a separate cell:

n-~ITllll s~llilÌRtlQ.
l".§piratQIY diseas§

2 Key eDe personnel
User ID

SEV#

CDC NC/division

:ti~9

i4s~§

-N-lQSHmliS

:tl~9

H~~Q

Nl-QSB/R.lS

Investigator 2 Raçh~LL,_S_Ri-~y,-M,R,

f~llf

i~4U

WQ§HmRPß

Investigator 3 Katl~~l1JÇr_t:.is_s."M,l2,

kx.

nOn

W.QßH/RQS

Investigator 4 W.iUi-ai;liE-,_Mil~r,J~~l,S,

w~mQ

1.1~~J

Investigator S MRrç.iR_L,_Stmlgp--_-E,s-

:tfcs

4.417

NIQSHmBJS
NlQSHmRDS

Name and degrees
(FirstName LastName, Degrees)

Priry contact ÇI:_Slill~_R,Sçl:lll.§r,-lb,Q.,
(required)
Pricipal investigator ÇI:s-til1~R"Sçbll~r~_lbJ1

(required)

SEY # is cnc's Scientific Ethcs Verification Number. CDC NC/division is the national center (or equivalent) and
division (or equivalent), or coordinatig center or offce if submitted at that leveL.
List all other CDC investigators, if any (name and degrees, user ID, SEY #, CDC NC/division):

çarre ThoniPJi.D ,Jy(i~_lf~~ 2S-,_Nl-Sll RDS
Ainsl~y W~ston,Ph.l2,--Rgw8-,J209S, NIQSHIDRltS
il~rrRIlYllç~sgy.,_l-h,R,y-RlÜ__17~~rL_Nl-QSH!E_L.R

3 eDe's role in project
Check yes or no for each ofthe followig.

1& .. CDC employees or agents will obtain data by intervenig or interactig with parcipants.
1& .. CDC employees or agents wil obtain or use identifiable (including coded) private data or biological
specimens.

li ii CDC employees or agents wil obtain or use anonymous or unined data or biological specimens.

1& .. CDC employees will provide substantial techncal assistance or oversight.
It.. CDC employees will participate as co-authors in presentationes) or publication(s).
"Agents" includes on-site contractors, fellows, and others appointed or retained to work at a CDCfacìlity
conducting activities under the auspices of CDe.

COC Form 0.1250

Version 3.0 2006-04-13

Page 1 of 5

Request lor initial review by

an IRB

.

\

4 eDe's research partners
Research parers include all direct and indirect recipients of CDC fudig (e.g., grants, cooperative agreements,
contracts, subcontracts, purchase orders) an other CDC support (e.g., identifiable private inormtion, supplies,
products, drgs, or other tangible support) for ths research activity, as well as collaborators who do not receive such
support. See HRPO Guide: CDC's Research Partners for fuer details. Check one of the following.
II No research parers.
II Research parers are listed on form 0.1370, which accompanes this form

5 Study participants-planned demographic frequencies
Report estited counts (rather thn percentages). Include

partcipants at domestic and foreign sites. See HRPO

Guide: IRE Review Cycle for defmitions.
Numer of

partcipants 579

Location of parcipants
Partcipatig at domestic sites

Parcipatig at foreign sites

S22
Q

Sex/Gender of parcipants

Female
Male
Sex/gender not available

144
4SS
Q

Ethicity of parcipants
Hispanic or Latino
Not Hispanc
or Latino
Ethicity
not
available

~(i

423
Q

Asian 4

Race of parcipants

American Indian or Alaska Native ~.

Black or Afrcan American 14

Whte
More thn one54.&
race 1Q

Native Hawaiian or Other Pacific Islander Q

Race not available Q
Comments on demographics
l-rQjl:~!iQ~Wl"I~ni!St:_Q_Q!l_d~rilQgrRpmc-fre.gllellçl~.s_lll_:injQLS:i~ys_attb~~_LaçmlÌsl_S,

6 Regulation and policy

6.1 Mode of IRB review on CDC's behalf
Location ofIRB (check one):

II CDC IR
II Non-CDC IRB though IRB authoriation agreement (submit form 0.1371 L
Intitution or organation providing IR review: _----_
IR registration number (if
known):
Federalwide assurance numer (if any):

CDC Form 0.1250
Version 3.02006-04-13

Page 2 of 5

an IRB

Request for ìnital revìew by

risk to subjects (check one):

Suggested level of

II Minal
Greater thn mimal
Suggested level ofIR review (check one):
See HRPO Worksheetfor Expedited .Review for detailed assistance. Ifrelyig on a non-CDC IR, please indicate
the level of review that you thnk is appropriate under humn research regulations.
Convened-board review is suggested
Not eligible for expedited review. For example, poses greater th mial risk;
involves use of
drg, biologic, or device under IN or IDE; involves collection oflargeamount of
blood; use of
x-rays or microwaves; a~esthesia; or physically invasive procedures
. Other specified reason:

II Expedited review is suggested, under the following categories (check .all that apply):
la Study of drgs not requirg Investigational New Drug exemption from FDA

1 b Study of medical devices not requirg Investigational Device Exemption from FDA
from

healthy, nonpregnant adults; below volume limit, miimlly invasive

112a Collection of

blood

.2b Collection of

blood from other adults and children; below volume limt, milly invasive

. 3 Prospective nonivasive collection of

biological specimens for research pmposes

4 Collection of data though routie, nonivasive procedures, involving no general anesthesia,

sedation, x-rays, or microwaves

Ils

.6

Research that uses previously collected niterils

117

Research that uses interview, program evaluation, humn factors, or quality assurance methods

Collection of data from voice, video, digital, or imge recordings made for research puroses

6.2 Vulnerable populations
Characterie the intention to include each of the following vulnerable populations. Choose one option in each row,
and indicate the page(s) where inclusion or exclusion is justified in the protocol.

.. .. ..
.
.

Targeted Allowed Excluded

Pregnant women or fetuses
Children (including viable neonates)
Prisoners

NA

Page(s)

II
II
II

Describe other groups of potentially vulnerable subjects intended to be included or excluded, such as neonates of
uncertain viability or nonviable neonates, persons with mental disabilities, or persons with economic or educational
disadvantages.

6.3 Free and informed consent
Characterie requested changes to required featues of the informed consent process. If a waiver is requested, enter

the page number of the protocol where the waiver is justified.

Whch exceptions to the consent process are requested? Check all that apply:
. Waiver or alteration of elements of informed consent for adults

pg ---"...~~

. Waiver of assent for children capable of providing assent

pg----~

. Waiver of parental permssion

pg

CDC Form 0.1250
Version 3.0 2006-04~13

Page 3 of 5

Request for initial review by

an IRB
.

Whch exceptions to documentation of inormed consent are requested? Check all tht apply:

II Waiver of documentation of inormed consent for adults
II Waiver of documentation of assent for children capable of providig assent
II Waiver of documentation of parental permssion
II Waiver or alteration of authorization under HIPAA Privacy Rule

pg~

pg-pg -~pg ~---

How is it shown tht the consent process is in understandable language? Check all that apply:

pgi4

II Reading level has been estimated

II Comprehension tool is provided

pg -~---

II Short form is provided

pg~--

II Tranlation plaed or pedormed

pg-

II Certfied translation/translator

II Translation and back-translation to/from target language(s)

pg-------

II Other method (specif,:

pg-~------

6.4 Other regulation and policy considerations
Check all that apply.
If requesting the exception to the PHS policy on informg those tested about HIV serostatus, enter the page number
of the protocol where the waiver is justified.

II Exception is request to PHS inormg those tested about HIV serostatus. pg
II Human genetic testing is planned now or in the futue.
II This study includes a registrable cliical tral.
II This study involves long-term storage of identifiable biological specimens.
II Ths study involves a drg, biologic, or device.

See HRPO Worksheet to Determine FDA Regulatory Coverage for guidance on whether or not FDA
regulations apply.

IIThis study wil be conducted under an Investigational New Drug (IN)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
withn the US, then check NAin each row.
Granted Pending
Certficate of

Confdentiality (30

i

(d))

Assurance of Confidentiality (308( d))

II
II

II
II

No

NA

II

II

li

li

Describe any other forml confidentiality protections tht are planed or are in place:

CDC Form 0.1250
3.0 2006-04-13

Version

Page 4 of 5

.

.

,

Request for initial review by

an IRB

7 Material submitted with this form
Check all tht apply. Describe additional material in the comments section.
II Complete protocol

II Peer reviewers' comments or division waiver (NIOSH)
II Consent, assent, and permssion documents or scripts
ads, brochures, flyers, scripts)
II Other inormtion for recruits or partcipants (e.g.,
scripts, record abstraction tools)
II Data collection intrments (e.g., questionnires, interview
. Certfication of IRE approval or exemption for research parters

Additional comments

CDC Form 0.1250
Version 3.02006-04-13

Page 5 of 5

0.1370

Centers for Disease Control and Prevention

Date received

s/~Jo/

CDC's Research Partners
Use ths form to report curent inormtion on CDC's research parters whenever a parer
SAFER. HEALTHIER- PEOPLEm

intitution or individual is added or inormtion chages. Supply individual name and SEV number
only for investigators collaboratig with CDC under an individual investigator agreement (IIA). See
HRPO Guide: eDe's Research Partners and either the HRPO Worksheet for Basic Tracking of

Research Partners or the HRPO Worksheet for Advanced Tracking of Research Partners for details
on how to complete ths form.

Leave protocol ID blan if not yet assigned.
CDC protocol ID: _.... ó7-l)£ÌS ..02. X P Protocol version number 1 version date Februar 2001

Protocol title: Lo-lg:I~TIll-Effl-ç!lY.QtRI)-lQgr~'! to PreY~ll!ß~!yllut-lJia~-R~~

I Partner 1Partner 2

r---_.._~._...~~._._.._.__.__._.._-~-.-._-~-_._--_._-~.-_.._-~-----------_..__._._.~----------r--.-~.._~-~_.-.._~-~-~_._--_.._.~------~-----~---

i Institution name: ß-l.u~h_Wellmiilnp-, I Institution name:
I Intitution location: E-im()re_Q.H~_Iyg;oll.AZ,Jl,e_agjllg-l A Institution location:

! Individual name (IIA only): Individual name (IIA only):
I Reportg status: lm!iRi-L~pQ;i: Reportg status: R~'pQl:!ID~R!.S?

I Regulatory coverage: EllgageglnQl1:e;Kemp! Regulatory coverage: &llgagegJ_E.xe-IJ:'l

I,Finncial
support:
NQ_IllRllÇlaLs.ul?PQtl
filllpiaLsYP-p9I!'l
Support
award
number: SupportFinancial
award support:
number:
____--

Support end date: Support end date:_---

Nonfnancial support:SuPP1i-~sLPL()duç!s,drgs Nonfnancial support: l"()nfll_al1cial.supmtlJ

FW A number: QQQ.Q_72;?1 FW A number:

SEV number (IIA only): SEV number (IIA only):

IR review status: Re1yjgQllÇDÇJRI IR review status: lßl-re_,,~'y~!!-tsJ
IR approval expiration date: IR approval expiration date:

Comments: Comments:
Partner 3

Partner 4

Intitution name: Institution name:
Institution location: Intitution location:
Individual name (IIA only): Individual name (IIA only):

Reportg status: R~PQitKS!atyS'l Reportg status: R~PQI!gstR-ts?
Regulatory coverage:Engag~glE;K~mpt'l Regulatory coverage: EngRg~dl_E;K~mptl
Finncial support: FIDiiçi,LsYPpQtll Financial support: FÏlllÇj,aLsYPPQtl?

Support award number: ______ Support award number: __________

Support end date:_______ Support end date:__~--

Nonfnancial support: N!1lmiiçi.aLsYPP-Qtl? Nonfancial support: N..1lll--m;lRLsyp-potl?

FW A number: FW A number:

j SEV number (IIA onlY):c___ SEV number (IIA only):____---

:: :;;:;:;~:~~~-t~~~:~-StallS? j' :::;;:;:;~~;~~~:~;:~~status? J

I Comments: Comments:

_.....___...._..__....__.__________...........___._._...._...._.._...._..._.........._______._....____c..~_..._.__._.__.__.......__.._.__.__c.._._._.____.._._._.____.__...___.....~"_..__~.____.___...._.___._.__,..~.._..._~_.._...__...._______.____,._....._.___"__.___.______

CDC Form 0.1370
Version 1.02006-04-13

Page 1 of 2

COC's research partners

Partner 5

Partner 6

Institution nae:

Intitution nae:

Intitution location:

Institution location:

Individual nae (IIA only):

Reportg status: ßgortg status?
Regulatory coverage: ~g¡gt-g? Exempt?
I Finncial support: EID1Icial S1!Rim!t?

! Support award number: ~_

Individual name (IIA only): ~
¡ Reportg statu: R!qQ.rfg stalls?
Reguatory coverage: Engaged? Exemt?
Finncial support: Fincial support?
Support award number: ~-_-~_

Support end date: __~__
Nominancial support: l,!!i:nci.!l s1!pim1

I¡ Support
end date: --~--~
FW A number: ____~_-_

Nonfnancial support: NQnfIDci~LslPllortZ
FW A number:

SEV numer (IIA only): ____-----

SEV number (IIA only): _______

IR review status: ~_r~yl~""--t!ms?

IR review status: ~_-lev~w-stRmsZ

IRB approval

expiration date:

IR approval expiration date:____~

Comments:

Comments:

Partner 7

Partner 8

Institution name:

Institution name:

Institution location:

Intitution location:

Individual name (IIA only):

Individual name (IIA only): ~_~"___

Reportg status: R~PQi:gst-Rms7

Reportg status: R~PQi:RSt!ms7

Regulatory coverage: E.lgaged1_E2lemptZ

Regulatory coverage:E.lgag~d'LExempJ:Z

Financial support: lÌl.lclaLimpport7
Support award number:
Support end date:

Financial support: EmIDçlal-s.!pport7
Support award number:

Nonfnancial support: NQ.I1Iilci.!ls1!ppm:t7

Support end date:
Nonfnancial support: No.I1IilclRlsllpj2m:t7

FW A number:

FW A number:

SEV number (IIA only):

SEV number (IIA only):
IRB review status: IRB review status?
IRB approval expiration date:
Comments:

IRB review status: IR review status?
IRB approval expiration date:
. Comments:

Partner 9

Partner 10

Institution name:
Institution location:
Individual name (IIA only):

Institution name:
Institution location:
Individual name (IIA only):

Reportg status: R~PQi:gstamsZ

Reportg status: R~PQ.rgstat1Z

Regulatory coverage: E.lgage_dZE2l~mptl

Regulatory coverage:E.lgRgeg7_.I:i~mpt7

Financial support: FmRllclRl-S1lPPQrt7

Financial support:

Support award number:
Support end date:
N onfnancialsupport: NQ.IlIani!!_S1l1lP!!rtl

Nonfinancial support: NQ..IlIRllÇl_Rl-llPRQJ:Z

FW A number:

FW A number:

EmR.lçl!lsll1lllQrt7
Support award number:
Support end date: __----_-

SEV number (IIA only):_____

SEV number (IIA only): _________

IR review status: lRBi:tyi~w_stRms7

IR review status: ~_Ie.Y~.w_stRt!_7

IR approval .expiration date: ________

IRB approval expiration date:______
Comments:

Comments:

CDC Form 0.1370
Version 1.02006-04-13

Page 2 of 2