IRB Certification

~~

for Disease Control Prevention

0.1

Date received

7/;;7/07

NIQSH HSRB

'j g Protocols and Related Documentation ~ ~ ~r7
~ u" th '¡gna_ pago whon ,ubmitt BlUO forr tu yo",,,mt,,-lov,mum Subj,,~

1':11111
Signature Page for Human Research Review
PEOPLE'. Contact. When submitting materials with these forms, please consecutively number all
SAFER,

HEALTHIER.

pages, beginning with the protocol title page and followed by consent formes) and ancilary documents. See HRPO
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 (HRPO).

1

Protocol identifiers

CAN#

(optional)

Leave protocol ID blank if not yet assigned.

CDC protocol ID: IlSRB 05-IUP-OlXl Protocol version number version date
Protocol title:

EvaliiatÌQll afall QcciipatÌpnalSafetyallCIIlea1tli lrQgraii fortlie Snill1311siness Wood. Pallet

Industry
Amendment number (if applicable):

2 Key CDC personnel
Name and degrees

User ID

SEV#

CDÇ NC/division

ry8

19558

NIOSH/EID

ry8

19558

NIOSH/EID

(FirstName LastName, Degrees)

Primary contact Robert Malkin
(requited)

Principal investigator Robert Malkn
(required)

or equivalent and

SEV # is CDC's Scientific Ethics Verification Number. CDC NC/division is the national center

division or equivalent, or coordinating center or office if submitted at that leveL.

3 Forms submitted with this signature page
Check all that apply in the appropriate column.

IRB-reviewed protocols

Exempted protocols

0.1250: Initial Review by IRE

0.1250X: Initial Review for Exemption

0.1251: Continuing Review of Approved Protocol

0.1251X: Continuing Review of

0.1252: Review of Changes to Approvèd Protocol

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

Human Research Review

0.1370: CDC's Research Parters

0.1371: CDC Rely on a Non-CDC IRB

0.1372: Outside Instituion Rely on a CDC IRE
0.1373: CDC Cover an Individual Investigator

COC Form 0.1379 NIOSH
Version 1.02006-04-13

Page 1 of 2

Sìgnature page for human research revìew - N/QSH HSRB

4

Signatures
As principal investigator, I hereby accept responsibility 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
Research Participants, and to abide by the principles outlined in federal policies for the protection of
subjects at 45 CFR part 46, 21 CFR part 50, and 21 CFR part 56.

pr~/Ç~
Signature

7)iió?

Remarks

As a supervisor of the principal investigator, I hereby accept responsibility for ensuring that ths CDC-sponsored
research project is conducted in an ethcal manner, consistent with the policies and procedures contained in CDC's

Procedures for Protection of Human Research Participants, and to abide by the principles outlined in federal
human subjects at 45 CFR part 46,21 CFR part 50, and 21 CFR part 56.
policies for the protection of

Signature Date Remarks

~

PI is Team Lead:

Team Lead: Check if

Branch Offcial (e.g., CH. r Senior Scientist):

~~ff ~~VV

-l ¡'''/Oì

7/YO 7

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

r~Y: ~~

Check if

PI is Branch Official:

Check if

PI is Division Offcial:

í¡Írjo7

I concur that this CDC-sponsored research project is consistent with the policies and procedures contained in CDC's

Procedures for Protection of Human Research Participants and with other applicable CDC and national center
policies.

Signature
Date Remarks
Cha*~~ ?~21-()7

(,g'~=:~~E~
Other Clearance Offcial:

5

Additional comments ~ OMß ~..

6

Reminder regarding .other regulatory clearance processes
The principal investigator is responsible for obtaining other regulatory reviews as needed, which may include OMB
clearance under the Paperwork Reduction Act (PRA) for federally sponsored inforination collections. Approval by
or exemption from the IRE is umelated 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.

COC Form 0.1379 NIQSH
Version 1.02006-04-13

Page 2 of 2

for

1 1

Control and Prevention

received
7/023 I/)7

.,~,
''''AI

1'..1 m.~1

SAFER. HEALTHIER- PEOPLEm

Request for Continuing Review of
IRB-Approved Protocol

4r ~ cPl)o7

Use this form to submit a protocol for continuing review by a CDC IR or a non-CDC IRE.
how to
(See 45 CFR 46.109(e).) See HRPO Guide: IRE Review Cycle for further details on
complete this form.

1 Protocol identifiers
CDC protocol ID: ILSRL OS:EIP:OIXl Protocol version number version date
Protocol title: EvaluatiQll Qf aiiOCCllpational Safetyal1dHealtlilrQgram fQr tlie Sni1l )3llsi1ess WoodPallet
Industry

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

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

Primary contact Robert Malki1
(required)

Principal investigator Robert Malkin

ry8

19558

NIOSHIEID

ry8

19558

NIOSH/EID

(required)

Investigator 2
Investigator 3

Investigator 4
Investigator 5

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. Include name and degrees, user ID, SEV #, CDC NC/division:

3 CDC's research partners
Research parters include all direct and indirect recipients of CDC funding (e.g., gral1ts, cooperative agreements,
contracts, subcontracts, purchase orders) and other CDC support (e.g., identifiable private information, supplies,
products, drugs, or other tangible support) for this research activity, as well as collaborators who do not receive such
support. On continuing review, HRPO needs curent informtion on parters that have been added or dropped since
the last review, were receiving support for nonexempt research. See HRPO
the last review and parters thi;t, as of
the following.
Guide: CDC's Research Partners for further details. Check one of
No research parters are reported

with this submission. (This may occur because there are no parters, or

because no partners .are being added, or because no previously reported parters are still both supported by
CDC and engaged in nonexempt research.)

!I Research partners are listed on form 0.1370, which accompanies this form.

COC Form 0.1251
Version 3.0 2006"04-13

Page 1 of 4

Request for contìnuìng review

4 Study participants-cumulative demographic frequencies
Have any participants been emolledin the last 12 months? yes II no
Report estimated counts (rather than percentages). Include participants at domestic and foreign sites. See HRPO
Guide: IRB Review Cycle for definitions.

Number of participants 0
Location of participants

Participating at domestic sites 0

Participating at foreign sites 0

Female
Male 0Q

Sex/Gender of participants

Sex/gender not available 0

Ethnicity of participants

Hispanic or Latino 0

Not Hispanic or Latino Q
Ethnicity not available 0

Asian 0
White 0

Race of participants

American Indian or Alaska Native 0

Black or African American 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, obtaining consent,
enrollment, and collection of data and biological specimens directly from participants. Check one of thefollowing.
Study is not designed to involve research-related contact with participants (e.g., research using existing records);
-L.."..,., study activities involve only access to or analysis of data or biological specimens and writing reports.
the following:
II Study is designed to involve contact with participants. Check one of
Contact with participants has not yet begun.
Contact with participants has begun and continues; this may include follow-up for debriefing or
notification of results,.
writing.
Contact with participants is completed; study activities involve only data analysis or report

COC Form 0.1251
Version 3.0 2006-04-13

Page 2 of 4

Request for contìnuìng revìew

5.2 Consent status
following.
The IRE previously waived all requirements both to obtain and to document consent in this study.
complete).
Although not waived, there is no fuher need to obtain or document consent (e.g., enrollment is

"Consent" includes adult consent, child assent, and parental permission. Check one of

the

Participants will be asked to provide consent (with or without documentation).
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
summarize study progress and interim findings. Include the. number
this study involves a
registrable clinical trial, summarizè registration status.
No research activities to date
Summary of study changes reviewed and approved since the last continuation. Do not include changes submitted
with or before approval of this continuation but not yet approved.
None
Summary of research activities to date. Briefly
of

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

Summary of any recent literature or other inormation relevant to the research study (not limited to information with
CDC co-authorship).
None
Summary of all adverse events to date. In partcular, address adverse events that were serious, unexpected (or more
frequent or severe than expected), or at least possibly related to the research.
None
Summry 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,

DSM report, multi-center trial report, but not reports to PGO).
No monitoring reports on safety or compliance
Summary of remaining research activities, emphasizing future contact with subj ects, use of identifiable private data
and biological
specimens, and preparation of primary reports.
Contact pallet companies by telephone and enrOll studypartcipants

7 Regulation and policy

7.1 Mode of IRB review on cnc's behalf
Location ofIRE (check one):
.. CDC IRE

fi Non-CDC IRE though IRE authorization agreement( submit form 0.1371 if this is a new request)
Instltution or organization providing IRE review:

known):
Federal wide assurance number (if any):

IRE registration number (if

IRE-determned level of risk to subj ects (check one):
Minimal
Greater than minimal

COC Form 0.1251
Version 3.02006"04-13

Page 3 of 4

Request forcontìnuìng revìew
Suggested level of IRB review (check one):
See HRPO Worksheet
the level of

for Expedited Review for detailed assistance. Ifrelying on a non-CDC IRB, please indicate
review that you think is appropriate under human research regulations.

Convened-board review is suggested
Reason for convened review:
Expedited review is suggested, under the following categories (check all that apply):
1 a Study of drgs not requiring Investigational New Drug exemption from FDA
1 b Study of medical devices not requiring Investigational Device Exemption from FDA

blood from healthy, nonpregnant adults; below volume limit, miimally invasive
Collection of
blood from other adults and children; below volume limit, minimally invasive
Prospective noninvasive .collection of
biological specimens for research purposes
Collection of data through routine, noninvasive procedures, involving no general anesthesia,
sèdation, x-rays, or microwaves

.1 2a Collection of

Research that uses materials collected solely for nonresearch puroses

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

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

Continuing review of research previously approved by the convened IRE where
8a the research is permanently closed to the enrollment of new subjects; all subjects have

completed all research-related interventions; and the research remains active only for
long-term follow-up of subjects
.lSl)' no subjects have been enrolled and no additional risks have been identified

8c the remaining research activities are limited to data analysis
research,.

9 Continuing review of

not under INIIDE, where categories 2 through 8 do not apply but

the IRE has determned and documented at a convened meeting that the research involves no

greater than minimal risk and no additional risks have been identified

8 Material submitted with this form
Check all that apply. Describe additional material in the comments section. Required items are indicated. Optional
items may be requested by HRPO or the IR.
research poses more than minimal risk to subjects, is under IND/IDE, or has
Complete protocol (required if
changed in the past 12 months)

Consent, assent, and permssion documents or scripts (required if consent wil be sought in the future from
prospective subjects or their representatives (see section 5.2))
Other information for recruits or participants (e.g., ads, brochures, flyers, scripts; required if consent wil be
.2 sought in the futue from prospective subjects or their representatives)

protocol
has changes in the past 12 months)
Certification .of IR approval or exemption for research partners (required only for parters being added or for
supported/nonexempt partners)
Progress and monitoring reports (recommended when available)

II Data collection instrments (e.g., questionnaires, interview scripts, record abstraction tools; required if

9 Additional comments
Basedon OMB's requirement we hav.e increaSed. recruitjng toassure ad.eqiiatesarnplesi:zeandadded certain

required words to the introduction. The introduction was reworded to improve its readibility. No changes were
made to the final sample size of

COC Form 0.1251
Version 3.0 2006-04-13

the project and

nothing

was removed from the introduction.

Page 4 of 4

for Disease Control

1

Prevention

COC's Research Partners

7jJ/ÕÎ
~la 6J)/o1

Use this form to report curent information on CDC's research parters whenever a parter
SAFER. HEALTHIER. PEOPLEm

institution or individual is added or inormtion changes. Supply individual name and SEV number
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 ths form.
Leave protocol ID blank if

not yet assigned.

CDC protocol ID: HSRE-015-EID-OIXP Protocol version number version date
Protocol title:

Evaluatioii of

an Qccupational Safety anclHealth Prograrn for tlie Snill Biisiness Wood Palletjndustry

Partner 1

Instituion name: ÇOriyergys
Institution location: Ciriçinnati, OIl
Individual name (IIA only):

/

Reporting status: PrevioiislyrepQrteCi
Regulatory coverage: Erigaged/riQri~e)(ernpt
Financial support: COritraçt/siibcontraçt

Support award number: 211-2005-M-13379
Support end date: 08/31/09
Nonfinancial support: Identifiable

private informtion

Partner 2

Institution name:
Institution location:
Individual name (IIA only):
Reporting status: Reportingstatus?
Regulatory coverage: Engagecl7E)(ernpt?

Financial support: FiriallçialsiiPport?
Support award number:

Support end date:
Nonfinancial support: Nonfinancial support?

FW A number: 00009353

FW A number:

SEV number (IIA only):
IRE review status: Relying on CDC IRE
IRE approval expiration date: 08/0112007

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

Connents:

Connents:

Partner 3

Partner 4

Institution name:
Institution location:
Individual name (IIA only):
Reporting status: Reporting status?
Regulatory coverage: Engagecl? Exernpt?
Financial support: Financial support?
Support award number:
Support end date:
Nonfinancial support: Nonfinancial. support?

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

FW A number:

FW A number:

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

SEV number (IIA only):

Connents:

Comments:

COC Form 0.1370
Version 1.02006-04-13

Reportg status: Reportingstatus?
Regulatory coverage: Erigagecl?Exernpt?

Financial support: Financial support?
Support award number:

Support end date:
Nonfinancial support: NQnfiiaricial support?

IR review status: IRE review status?
IRE approval expiration date:

Page 1 of 2