Human Research Review & Sample Consent Form

~~

0.1379

Date received

Centers for Disease Control and Prevention

NIQSH HSRB

3/1l, /07
Signature Page for Human Research .Revlew l.JDJ

Protocols and Related Documentation ~ ¿Í /(f VJ
Use ths signatue page when submittng HRO form to your center-level Human Subjects

Contact. When submittng materials with these form, please consecutively number all
pages, beging with the protocol title page and followed by consent forme s) and ancillary documents. See HRPO

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

(National Institute for Occupational Safety and Health (NOSH) Human Subjects Review Board (HSRB) of
the CDC Human Research Protection Offce (HRPO).

1

Protocol identifiers

CAN#

(optional)

Leave protocol il blan if not yet assigned.

CDC protocol il: i4.$ R ß Cf I - l)~ N-e FS"- oq
Protocol title:_6~~eric (OhÇe~t f-r", ,.. ~~.\+l

Protocol version number

version date

N~~o.J '&C~\-"ll\ll-~

Amendment number (if applicable):

2 Key CDC personnel
Name and degrees

User ID

SEV#

CDC NC/division

121124

l G2GQ

mOSHmSHElS

QP.Q4

J 62GQ

NIOSHISHEF:S

(FirstName LastName, Degrees)
Primry contact S_ruç_t:__S~m!lig,_Ml?,MlH

(required)

Principal investigator Bruce Bernard, MP-,~lyH
(required)

SEV # is CDC's Scientific Ethcs Verification Number. CDC NC/division is the national center or equivalent and
division or equivalent, or coordinatig center or office if submitted .at that leveL.

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

IRB-reviewed protocols
0.1250: Initial Review by IRE
II 0.1251: Contiuing Review of Approved Protocol
0.1252: 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

II 0.1254: Incident Report

0.12548: Supplemental Adverse Event Report
0.1253: End of

Human Research Review

II 0.1370: CDC's Research Parters

0.1253: End of

Human Research Review

0.1370: CDC's Research Parters

0.1371: CDC Rely ona Non-CDC IRE

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

COC Form 0.1379 NIQSH
Version 1.02006-04-13

Page 1 of 2

Signature page for human research review - N/OSH HSRB

4

Signatures
investigator, I hereby accept responsibility for conductig ths CDC~sponsored research project in an
Human

As pricipal

ethcal manner, consistent with the policies and procedures contained in CDC's Procedures for Protection of

humn

Research Participants, and to abide by the priciples outlined in federal policies for the protection of

subjects at 45 CFR part 46, 21 CFR part 50, and 21 CFR part 56.
~!gnatl!I'~_~_____________"___~_________~______-late __________

Remarks

Principal CDC Investigator:

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

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

Procedures for Protection of

~~t;---~~-~pi-ire~-- .-

-B~~~ch off~i~f(ë~g.~ Chief or Senior Scientist): ----_.------ Che&-ifPI is-Branch Official: .--

llvhJ~Ù:S)'~- -~.-.~ 21: :-- ---Ch~k ,£PI m:~~:o~c: ~.:

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.
.._Slg-i!t':I:tl_

Date

Remarks

Chair, NIOS

;;--

Other Clearanc

.....l!f-C!-z-

(e.g., Confidentiali

5

Additional comments __
-r'd; /'tai.¡e... øf ;:.. f/).F C-o~S'e,.T lON'" ¡s- re.l',I",Æ C-S () c.~/'r~sl ia tiE: /1Ié=

........r::Jtt5~;h1~_~~~_~~?~~:".I= N~=~~~UJ L~_~ _CA /'~sep-_~_~~_ 6-~~~_~~ry _~~~d_~~~? j/CiíN3

6

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

CDC Form 0.1379 NIQSH
Version 1.02006-04-13

Page 2 of 2

Centers for Disease Control and Prevention

0.1251

Request for Continuing

Review of

IRB-Approved Protocol

Date received

~j/~/o1

Ând£ ~;67

Use this form to submit a protocol for continuig review by a CDC IRE or a non-CDC IRE.
SAFER-HEALTHIER.PEOPUN (See 45 CFR 46. 109(e).) See HRPO Guide: IRE Review Cycle for fuher details on how to

complete this form.

1 Protocol identifiers
CDC protocol ID:21:i?SllES:Q2 Protocol version number

version date Q9LQ2

Protocol title: Q~m;iI-ç"çQnse-ll-lQI!_fQLll~lfll:lilg_Ey~l!at-I-QllS

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

Name and degrees User ID SEV # CDC NC/division
(FirstName LastName, Degrees)
Primary contactßJ1q:I'.:e~milg-,M,P-,,_M.I',H. apa4
(required)

Principal investigator :ellç~I',St:-I'lJirg,MJ)., M,I'.ll. ap1?4

169(iQ

N-iaSllStæES

192(iQ

NIQSllSIlElS

(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 parers include all direct and indirect recipients of CDC funding (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. On continuing review, HRPO needs curent information on parers that have been added or dropped since
the last review, were receiving support for nonexempt research. See HRPO
the following.
Guide: CDC's Research Partners for fuher details. Check one of

the last review and parters that, as of

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

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

CDC and engaged in nonexempt research.)
Research parers are listed on form 0.1370, which accompanies this form.

COC Form 0.1251
Version 3.0 2006-04-13

Page 1 of 5

Request for continuing review

4

Study participants-cumulative de~. 0 raphic frequencies r .1/ K.~
Have any paricipants been enrolled in the last 12 months?;P, yes (/p/ /; 3lJlo'1 ~

Report estimated counts (rather than percentages). Includ pa icipants at domestic and foreign sites. See HRPO
Guide: IRE Review Cycle for definitions.

Number of participants lQS
Location of participants

Paricipating at domestic sites 102
Paricipating at foreign

sites 0

M~e ~Q
Female lQS

Sex/Gender of paricipants

Sex/gender not available Q

Ethnicity of paricipants

Hispanic or Latino :2.8.

Not Hispanic or Latino G-77

Ethnicity not available 0

~an
0
VVue 437

Race of participants

American Indian or Alaska Native 0

Black or African American 268

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

the following.

Study is not designed to involve research-related contact with paricipants (e.g., research using existing records);
study activities involve only access to or analysis of data or biological specimens and writing reports.
the following:
to involve contact with paricipants. Check one of
ii Study is designed
Contact with participants has not yet begun.
Contact with paricipants has begun and continues; this may include follow-up for debriefing or
results.
notification of
Contact with paricipants is completed; study activities involve only data analysis or report writing.

CDC Form 0.1251
Version 3.0 2006-04-13

Page 2 of 5

"

Request for continuing review
5.2 Consent status
"Consent" includes adult consent, child assent, and parental permission. Check one of the following.

The IRB previously waived all requirements both to obtain and to document consent in this study.
Although not waived, there is no fuher need to obtain or document consent (e.g., enrollment is complete).
II Paricipants wíl be asked to provide consent (with or without documentation).

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.
If

6 Study status-overall conduct
Sumar of research activities to date. Briefly sumarize study progress and interim fidings. Include the number
this study involves a
potential subjects who declined enrollment and the number who withdrew from the study. If

of

registrable clinical trial, sumarize registration status.
W~fQ!11Inue_t(:U2Ils!le our worksite investigations, Health Hazard Evaluation-- to determine whether empwyees a~
~~PQ_s-~gor hared from PPj!sin-le w.Qr-&r-~latt:d heaJJ1i_tJfeçl-S__tÌQJIl C~m.jç1lJ~~pgSJJ_~s-'!g-p-l~ical_¡lnt-s~_lit:Jg
t:J'_algations ~1:e CQ!iillÇl~gJ2_a1t!L:i-,-l!l-ç-illgmgJ!J!1~cljf_~lcQf:f&tr.Jin_m_gJ.rrial_hygkllj-st,-a!1g.-S1!PPQrt_s-~f-,il
llsl~ded,~Tl:.t_inl:_cliç-11L~pig~n!iQIQgiçal_ÇQmI!ommtQf th~~yaluatiQ-lLrange :flLn;-1_Q-le QI_nYQQmrYIsit ~QnsistmKQf
a'y~lk :1hr.QllKl:S.!_t:~_Ætl:TIi~:w§_witl:~inply~~s-, aIcl-levit:W.QLav¡ijlaQl~gata1~Llltl-&~i:-s~alt

llleJli£flÚmigtm.Ü:ilQgLç-SlllQj.t-s_yvhiçl:_ç_alli!!ç-iud~j!!forml:liçoIlsenLall(Lq~_stiQnna!r_§._MQIt:_IRrt:-iy,j-ii§~
my~sligatjQlls-.ç~!1i!1ç-lllQt:~n-iQIQgiçaLll.Q-lÜtgimg,-limil~g:rt:"giç¡iJ~Kams-,'!g1ts1s.

changes reviewed and approved since the last continuation. Do not include changes submitted
Summary of study
with or before approval of this continuation but not yet approved.

Summary of any recent literatue or other information relevant to the research study (not limited to information with
CDC co-authorship).
Summary of all adverse events to date. In paricular, address adverse events that were serious, unexpected (or more
frequent or severe than expected), or at least possibly related to the research.
Summary of

(a) incidents that are not adverse events and (b) other substantial concerns since last continuation.

progress or monitoring reports on safety or compliance (e.g., site monitor, safety review,
include copies of
DSM report, multi-center trial report, but not reports to PGO).
List and

Summar of remaining research activities, emphasizing futue contact with subjects, use of identifiable private data

and biological specimens, and preparation of primary reports.

7 Regumuon and policy

7.1 Mode of IRS review on CDC's behalf
Location ofIRB (check one):
II CDC IRB
Non-CDC IRE 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):
IRE registration number (if

CDC Form 0.1251
Version 3.02006-04-13

Page 3 of 5

"

Request for continuing review

risk to subjects (check one):

IRB-determined level of

II Minimal
Greater

than minimal

Suggested level of IRB review (check one):
relying on a non~CDC 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:

See HRPO Worksheetfor Expedited Review for detailed assistance. If

II Expedited review is suggested, under the following categories (check all that apply):
1a Study of drgs not requiring Investigational New Drug exemption from FDA
1 b Study of medical devices not requiring Investigational Device Exemption from FDA
112a Collection of
112b Collection of

blood from healthy, nonpregnant adults; below volume limit, minimally invasive
blood from other adults and children; below volume limit, minimally invasive

I~3 Prospective noninvasive collection of

biological specimens for research puroses

I~4 Collection of data through routine, noninvasive procedures, involving no general anesthesia,
sedation, x-rays, or microwaves

5 Research that uses materials collected solely for nonresearch puroses
I~6 Collection of data from voice, video, digital, or image recordings made for research puroses
I~7 Research that uses interview, program evaluation, human factors, or quality assurance methods
Continuing review of research previously approved by the convened IRE where
new subjects; all subjects
have
completed all research-related interventions; and the research remains active only for
long-term follow-up of subjects

8a the research is permanently closed to the enrollment of

8b no subjects have been enrolled and no additional risks have been identified

8c the remaining research activities are limited to data analysis
Continuing review of
research, not under IND/lDE, where categories 2 through 8 do not apply but
the IRB has determined 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 IRB.
research poses more than minimal risk to subjects, is under IND/lDE, or has
Complete protocol (required if
changed in the past 12 months)

;~i Consent, assent, and permission documents or scripts (required if consent wil be sought in the futue from
prospective subjects or
their representatives (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)
Data collection instrments (e.g., questionnaires, interview scripts, record abstraction tools; required if protocol
has changes in the past 12 months)
Certification ofIRB approval or exemption for research parters (required only for parters being added or for
supported/nonexempt parers)

Progress and monitoring reports (recommended when available)

CDC Form 0.1251
Version 3.0 2006-04-13

Page 4 of 5

.'

Request for continuing review

9 Additional comments

COC Form 0.1251
Version 3.0 2006-04-13

Page 5 of 5

(HETAB consent form for biological specimens retained)

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)
CENTERS FOR DISEASE CONTROL AND PREVENTION
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CONSENT TO PARTICIPATE IN A HEALTH HAZRD EVALUATION
You have been asked to participate in a NIOSH health hazard evaluation of (problem) at
your
participation, describe your rights,
and specify how NIOSH wil treat your records.

(companv/location). We explain here the nature of

i. DESCRIPTION

1. Title:
2. Project Officer:

3. Purpose and Benefits:

This health hazard evaluation was requested by (requestor) because of (reported
ilness/exposures). The purpose of this evaluation is no determine if (health effect a) is
associated with (exposure b)l. Your participation may benefit you, your co-workers, and possibly
learned from this health hazard evaluation. Other benefits to
other people, as a result of what is
you from participating in this evaluation include receiving the information from the results of the
free medical tests described in Section II in this consent (below).

II. CONDITIONS OF THE HEALTH HAZARD EVALUATION
1. The health hazard report wil include (some or all of) the following procedures: (*the following are
examples.1
A. A questionnaire about your work history, health history, and health-related activities, including
a NIOSH representative.) .(You
anvsensitive topics). (The questionnaire will be administered by

wil be asked to complete the questionnaire yourself, but a NIOSH representative wil (be present
to) (assist you and) check it for completeness (when you return it).) It should take from _ to
minutes.
B. Blood tests for _ and~. Li tubes (about _ teaspoons) of blood wil be taken from

a vein in your arm. The needle stick may produce momentary discomfort and possibly some
residual soreness and discoloration of the skin due to blood leaking from the vein; this
discoloration may last a few days but is generally harmless. Infrequently, the procedure causes
someone to faint. This blood draw procedure should take only a few minutes.

C. Pulmonary function tests. You wil be asked to breathe in as deeply as you can and forcefully
as possible through a tube that you place in your mouth. You
blowout as quickly and completely
wil be asked to do this at least (three) (five) times, and possibly several more times. This test
may be tiring, and you may feel momentary Iightheadedness or chest discomfort. If, at any time,
you feel unable to continue, the test will be terminated. The test typically takes five to ten minutes.

D. Urine tests for _ and~. You will be asked to urinate, in private, into a container that a
NIOSH representative will provide. The only time involved

is that required to produce the urine

specimen and return it to the technician.

E. Chest x-ray. A single back-to-front chest x-ray will be made. If, as occasionally happens, this

is not of adequate qualiy, or if your chest is too large to fit on a single film, another chest
x-ray
x-ray will be made. The radiation exposure wil be about 30 millrems (mrem) per film. The
National Council on Radiation Protection and Measurements recommends an occupational
exposure limit of 2000 mrem per year and a
general population limit of 100 mrem per year from
sources other than medical and natural background.
All together, including time spent waiting your turn at the various test stations, your participation should
take about minutes.

Your (blood, urine, other biological material) wil be used only for the tests specified above. The
specimen(s) wil be identified only by an arbitrary number, which can be linked to you only by the
medical investigators, not the laboratory. The specimens wil be retained for six months after the
health hazard evaluation final report is issued in order to re-test the specimens in case a question
about the original analysis arises.*
* (If pertinent) In addition, Nl0SH would like your permission to store your remaining (blood, urine,
other biological material) for future research purposes not related to the current health hazard
evaluation. In this case, we would remove any personally identifying information from the stored
specimens so that they can no longer be linked to you. There is no direct benefit to you for allowing us
to use these specimens for research purposes other than making a contribution to science. You may
participate in the health hazard evaluation even if you choose not to allow us to store your specimens

anonymously.
2. There are some possible disadvantages to your participation. One disadvantage, besides the slight
discomfort and inconvenience from the medical tests as previously described,is that a test result may
be

outside the range of "normal" even though nothing

is wrong. This could result in a recommendation

for further medical evaluation that, ultimately, may not have been necessary. If you have any
comments about the tests/procedures, you should contact (name, title, phone).

3. All of the procedures described above are standard medical tests; (there are no alternative procedures
OR Alternative procedures are (less reliable) OR (riskier) OR (more difficult to interpret) OR (more
time-consuming.)*

4. Injury or harm from this project is unlikely. But if it results, medical care is not provided, other than
emergency treatment. If you are
injured through negligence of a NIOSH employee you may be able to
obtain reimbursement under Federal Law. If you want to file a claim against the Federal government
your contact point

is: Public Health Service Claims Office: 301-443-1904. If you are injured or harmed

through the negligence of a NIOSH contractor, your claim would be against the contractor, not the
federal
government. If .an injury or harm should occur to you as the result of your participation, you
should .contact (project officer's name, title, phone) or (name, phone), the chair of the NIOSH Human
Subjects Review Board.

5. If you have questions about this health hazard evaluation, contact (name and telephone of project
officer). If you have questions
about your rights as a member of this health hazard evaluation, contact
(name, title, phone of Chair, HSRB).
6. Your participation is voluntary and you may withdraw your consent and your participation in this health
hazard report at any time without penalty or loss of benefits to which you are otherwise entitled.

7. NIOSH will provide you and your doctor (if you wish) with all findings from your medical tests (and any
other examinations). We will do this when the health hazard report is finished, or sooner, if appropriate.
The overall health hazard report results (without names or other personal identifying information) will be
provided to the company and union (or other employee representative); the company is required to post a
copy of the final report in a place accessible to employees for a period of 30 days. In addition, if you so
request, NIOSH will send you a copy of the final report.

'.
."

III. USE OF INFORMATION

This health hazard evaluation is being done by The National Institute for Occupational Safety and Health

(NlOSH). NIOSH is part of the Centers for Disease Control (CDC), a government agency in the

Department of Health and Human Services. We collect this information in order to learn about various
kinds of work hazards that may influence the health of the American worker.

NIOSH is allowed to collect and keep information about you, including your results from this health hazard
security number (if applicable), because of three
laws passed by
Congress. These laws are:

evaluation, along with your social

1. The Public Health Service Act (42 U.S.C 241)
and Health Act (29 U.S.C. 669)
3. The Federal Mine Safety and Health Act of 1977 (30 U.S.C. 951)
2. The Occupational Safety

You wil decide whether you want to provide us with this information by being in this health hazard
evaluation. You are free to choose not to be in this health hazard evaluation. It is
up to you. If the
information we are collecting is maintained and retrieved by personal identifiers, such as your name and

social security number, it wil become part of the CDC record system and we wil protect it to extent
allowed by law. You should know, however, that there are conditions under the Privacy Act when we
could be authorized to release this information to outside sources. These conditions under which we might
release this information are
in Appendix A (the Privacy Act).
listed

IV. SIGNATURES
I have read this consent form and received a copy of the conditions for data release under the Privacy

Act (Appendix A). I agree to participate in this health hazard evaluation.
Age

PARTICIPANT

(signature)
Date

(and Guardian, if required)

I, the NIOSH representative, have accurately described this health hazard evaluation to the participant.

REPRESENTATIVE

Date

(signature)

"

."

(Proiect Offcer - This page is not part of the consent document. It is to be used when you plan to send
medical findings to the participant's physician.)
REQUEST AND AUTHORIZATION FOR RELEASE OF INFORMATION
I, , request and permit the project officer to inform the following
physicians or health care facilties (whose names and addresses 1 have entered below) of any
leave blank. Write

significant findings from this health hazard evaluation that concern me. (Do not

"No" where you do not wish to give a name and address.)
1. My personal physician(s):

Dr.

Street
City

State

Zip

2. Other physician or health care facilties:

Dr.

Street
City

State

Zip

Participant
(and Guardian if required)

1 copy to participant
1 copy to project officer

Date

'.
,.

Appendix A
provide wil become
you
part of the CDC Privacy Act System, 09-20-0147,
"Occupational Health Epidemiological Studies and EEOICPA Program Records" and may be

The Information

disclosed to
. Appropriate state or local heath departments to report communicable diseases;

Registry to report cases of cancer where the state has a legal reporting
program providing for confidentiality;

. A State Cancer

. Private contractors assisting NIOSH;
. Collaborating researchers under certain circumstances to conduct further

investigations;

. One or more potential sources of vital statistics to make determinations of death, health
known address;
status or to find last
. The Department of Justice or the Department of Labor in the

event of litigation;

. Congressional offices assisting an individual in locating his or her records;
. The Department of Justice to assist in determining the eligibilty for compensation to
uranium workers or their

survivors (optional but must be used if health hazard evaluation

pertains to uranium workers)
You may request an accounting of the disclosures made by NIOSH.
Except for these and .other permissible disclosures authorized by the Privacy Act, or in limited

circumstances required by the Freedom of Information Act, no other disclosures may be made
without your written consent.
NOTE TO PROJECT OFFICER

This is an example of the listing for one NIOSH system of records. You need to verify which system
and check what disclosures may be made underfhat system.

applies to your health hazard evaluation

(HETAB consentformfor biological specimens discarded)
INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)
FOR DISEASE CONTROL AND PREVENTION
U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES

NATIONAL

CENTERS

CONSENT TO PARTICIPATE IN A HEALTH HAZRD EVALUATION
You have been asked to participate in a NIOSH health hazard evaluation of (problem) at
your participation, describe your rights,
And specify how NIOSH wil treat your records.

(company/location). We explain here the nature of

i. DESCRIPTION

1. Title:
2. Project Officer:

3. Purpose and Benefits:

This health hazard evaluation was requested by (requestor) because of (reported
effect a) is
illness/exposures). The purpose of this evaluation is rto determine if (health
associated with (exposure b)l. Your participation may benefit you, your co-workers, and possibly
other people, as a result of

what is learned from this health hazard evaluation. Other benefits to

you from participating in this evaluation include receiving the information from the results of the
free medical tests described in Section II in this consent (below).

II. CONDITIONS OF THE HEALTH HAZRD EVALUATION
1. The health hazard report wil include (some or all of) the following procedures: ¡*the following are

examples:j
A. A questionnaire about your work history, health history, and health-related activities, including
any sensitive topics). (The questionnaire will be administered
by a NIOSH representative.) (You
will be asked to complete the questionnaire yourself, but a NIOSH representative wil (be present

to) (assist you and) check it for completeness (when you return it).) It should take from _ to
minutes.
B. Blood tests for _ and _' L1 tubes (about _ teaspoons) of blood will be taken from

a vein in your arm. The needle stick may produce momentary discomfort and possibly some
residual soreness and discoloration of the skin due to blood leaking from the vein; this
discoloration may last a few
days but is generally harmless. Infrequently, the procedure causes
someone to faint. This blood draw procedure should take only a few minutes.
in as deeply as you can and forcefully
a tube that you place in your mouth. You
will be asked to do this at least (three) (five) times, and possibly several more times. This test
may be tiring, and you may feel momentary Iightheadedness or chest discomfort. If, at any time,
you feel unable to continue, the test wil be terminated. The test typically takes five to ten minutes.
C. Pulmonary function tests. You wil be asked to breathe
blowout as quickly and completely as possible through

D. Urine tests for _ and _' You will
NIOSH representative wil provide. The only time

specimen and return it to the technician.

a container that a
involved is that required to produce the urine

be asked to urinate, in private, into

E. Chest x-ray. A single back~to-front chest x-ray will be made. If, as occasionally happens, this
x-ray is not of adequate quality, or if your chest is too large to fit on a single film, another chest
x-ray will be made. The radiation exposure wil be about 30 millrems (mrem) per film. The
National Council on Radiation Protection and Measurements recommends an occupational
exposure
limit of 2000 mrem per year and a general population limit of 100 mrem per year from
sources other than medical and natural background.
All together, including time spent waiting your turn at the various test stations, your participation should
take about minutes.

Your (blood, urine, other biological material) will be used only for the tests specified above. The
specimen(s) wil be identified only by an arbitrary number, which can be linked to you only by the
medical investigators, not the laboratory. The specimens wil be retained for six months after the
issued
in order to re-test the
health
hazard evaluation final report is
specimens in case a question
about the original analysis arises. After this period they will be destroyed. In the event that a NIOSH
researcher sees a reason to perform additional tests beyond those described in this form or to save
your (blood, urine, other biological material) for future uses beyond this six-month period, NIOSH wil
contact you first and will not perform any additional tests or save your (blood, urine, other biological
material) unless you provide written consent.

2. There are some possible disadvantages to your participation. One disadvantage, besides the slight
discomfort and inconvenience from the medical tests as previously described, is that a test result may
be outside the range of "normal" even though nothing is wrong. This could result in a recommendation
for further medical evaluation that, ultimately, may not have been necessary. If you have any
should contact (name, title, phone).
comments about the tests/procedures, you

3. All of the procedures described above are standard medical tests; (there are no alternative procedures
OR Alternative procedures are (less reliable) OR (riskier) OR (more difficult

to

interpret) OR (more

time-consuming.)*

4. Injury or harm from this project is unlikely. But if it results, medical care is not provided, other than
emergency treatment. If you are injured through negligence of a NIOSH employee you may be able to
obtain reimbursement under Federal Law. If you want to file a claim against the Federal .government
your contact point is: Public Health Service Claims Office: 301-443-1904.
If you are injured or harmed
through the negligence of a NIOSH contractor, your claim would be against the contractor, not the
federal government. If an injury or harm should occur to you as the result of your participation, you
should contact (project officer's name, title, phone) or (name, phone), the chair of the NIOSH Human
Subjects Review Board.

5. If you have questions about this health hazard evaluation, contact (name and telephone of project

officer). If you have questions about your rights as a member of this health hazard evaluation, contact
(name, title, phone of Chair, HSRB).

6. Your participation is voluntary and you may withdraw your consent and your participation in this health

hazard report .at any time without penalty or loss of benefits to which you are otherwise entitled.
7. NIOSH wil provide you and your doctor (if you wish) with all findings from your medical tests (and any
other examinations). We will do this when the health hazard report is finished, or sooner, if appropriate.
The overall health hazard report results (without names or other personal identifying
information) will be
provided to the company and union (or other employee representative); the company is required to post a
copy of the final report in a place accessible to employees fora period of 30 days. In addition, if you so
request, NIOSH will send you a copy
of the final report.
III. USE OF INFORMATION

Institute for Occupational Safety and Health
in the
(NIOSH). NIOSH is part of the Centers for Disease Control (CDC), a government agency
Department of Health and Human Services. We collect this information in order to learn about various
influence the health of the American worker.
kinds of work hazards that may

This health hazard evaluation is being done by The National

NIOSH is allowed to collect and keep information about you, including your results from this health hazard
evaluation, along with your social security number (if applicable), because of three laws passed by
Congress. These laws are:
1. The Public Health Service Act (42 U.S.C 241)
2. The Occupational Safety and Health Act (29 U.S.C. 669)
3. The Federal Mine Safety and Health Act of 1977 (30 U.S.C. 951)

You wil decide whether you want to provide us with this information by being in this health hazard
evaluation. You are free to choose not to be in this health hazard evaluation. It is up to you. If the
information we are collecting is maintained and retrieved by personal identifiers, such as your name and
it to extent
allowed by law. You should know, however, that there are conditions under the Privacy Act when we
could be authorized to release this information to outside sources. These conditions under which we might
release this information are listed in Appendix A (the Privacy Act).
social security number, it wil become part of the CDC record system and we will protect

IV. SIGNATURES
I have read this consent form and received a copy of the conditions for data release under the Privacy
Act (Appendix A). I agree to participate in this health hazard evaluation.

Age

PARTICIPANT

(signature)
Date

(And Guardian, if required)

evaluation to the participant.

I, the NIOSH representative, have accurately described this health hazard

Date

REPRESENTATIVE

(Signature)

(proiect Officer - This page is not part of the consent document. It is to be used when you plan to send
medical findings to the participant's physician.)
REQUEST AND AUTHORIZATION FOR RELEASE OF INFORMATION
I, , request and permit the project officer to inform the following
physicians or health care facilities (whose names and addresses I have entered below) of any
significant findings from this health hazard evaluation that concern me. (Do not leave blank. Write
"No" where you do not wish to give a name and address.)
1. My personal physician(s):

Dr.

Street
City

State

Zip

2. Other physician or health care facilties:

Dr.

Street
City

State

Zip

Participant
(And Guardian if required)

1 copy to participant

1 copy to project officer

Date

Appendix A

Information you provide wil be.come part of the CDCPrivacy Act System, 09-20-0147,
"Occupational Health Epidemiological Studies and EEOICPA Program Records" and may be

The

disclosed to
. Appropriate state or local heath departments to

. A State Cancer Registry to report cases of cancer where the

report communicable diseases;
state has a legal reporting

program providing for confidentiality;
. Private contractors assisting NIOSH;
. Collaborating researchers under certain circumstances to conduct further

investigations;

. One or more potential sources of vital statistics to make determinations of death, health
status or to find last known address;
. The Department of Justice or the Department of Labor in the event of litigation;

. Congressional offices assisting .an individual in locating his or her records;

. The Department of Justice to assist in determining the eligibilty for compensation to

uranium workers or their survivors (optional but must be used if health hazard evaluation
pertins to uranium workers)
You may request.an accounting of
Except for these and

the disclosures made by NIOSH.
other permissible disclosures authorized by the Privacy Act, or in limited

circumstances required by the Freedom of Information Act, no other disclosures may be made
without your written consent.
NOTE TO PROJECT OFFICER
This is an example of
the listing for one NIOSH system of records. You need to verify which system
applies to your health hazard evaluation and check what disclosures may be made under that system.