Consent forms

Consent to be in a NIOSH Health Hazard Evaluation
(RETAINED SPECIMENS) Insert title of the study here

1 Who is
conducting
the study?

2 What is the
purpose?

3 What will I
do?

NIOSH is a federal agency that studies worker safety and health. We are part
of the Centers for Disease Control and Prevention (CDC). NIOSH’s Health
Hazard Evaluation (HHE) Program conducts worksite investigations.

This health hazard evaluation was requested by (requestor) because of
(reported illness/exposures). The purpose of this evaluation is to measure
exposures in the work environment, test for _________, and identify potential
health effects from exposure to ______.

Briefly explain, in terms participants will understand, the tasks, procedures,
therapies, tests, etc., involved in the HHE. You can use bullets. You can
provide separate information sheets for complex or varied procedures. Inform
participants if you will be recording images, or videos of them.

A. You will fill out a questionnaire about your work history, certain medical
conditions, and symptoms you have when working around _____________,
(including any sensitive topics). Either [the questionnaire will be
administered by a NIOSH representative] or [You will be asked to complete
the questionnaire yourself, but a NIOSH representative will (be present to)
(assist you and) check it for completeness (when you return it).] It should
take from to minutes.
B. You will have your blood taken to test for ____ and ________ in #
tubes (about X number of teaspoons) of blood will be taken from a vein in
your arm. The needle stick may produce some discomfort and possibly some
soreness and discoloration of the skin due to blood leaking from the vein; this
discoloration may last a few days but it is generally harmless. Infrequently,
drawing blood causes someone to faint. This blood draw procedure should
take only a few minutes.
C. You will do breathing tests to assess your lung function. You will be asked
to breathe in as deeply as you can and forcefully blow out as quickly and
completely as possible through a tube that you place in your mouth. You will
be asked to do this at least (three) times, and possibly more times. This test
may be tiring, and you may feel momentary lightheadedness or chest
discomfort. If, at any time, you feel unable to continue, the test will be
stopped. The test typically takes five to ten minutes.
D. You will do urine tests for ________ and ______________. You will be
asked to urinate, in private, into a container that a NIOSH representative will
give you. The only time involved is that required to produce the urine
specimen and return it to the technician.
Page 1

Consent to be in a NIOSH Health Hazard Evaluation
(RETAINED SPECIMENS) Insert title of the study here

4 What other
tests will my
blood, urine,
or ___ be
tested for?

Your (blood, urine, other biological material) will be used only for the tests
specified above. The specimen(s) will be identified only by an arbitrary
number, which can be linked to you only by the HHE medical investigators,
not the laboratory. The specimens will 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, NIOSH 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.

5 Are there any
risks?

A. One risk, 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.
B. The test(s) on your (blood, urine, other biological material) are
experimental. Guidelines do not exist regarding the(se) test(s) or their
breakdown products or how to interpret the levels. The tests may not
measure all the drugs you are exposed to at work, and the results may not
be interpretable. Although we will be using the most up-to-date medical
information available, we may not be able to tell you what the tests mean
in terms of your health.

We will not share the results of your ______ tests or your questionnaire
responses with anyone, but your results will be combined with others and
reported as a group.
There is a risk of loss of confidentiality regarding participation, questionnaire
responses, and _______ analysis results. To minimize the risk of loss of
confidentiality, we will use identification numbers and not put your name on
the urine specimens or the questionnaires. Results will be kept in locked,
secured filing cabinets in the project officers’ offices.
If you have any comments about the tests/procedures, you should contact
(name, title, and phone of Medical Officer).

Page 2

Consent to be in a NIOSH Health Hazard Evaluation
(RETAINED SPECIMENS) Insert title of the study here

6 Is my
participation
voluntary?

7 What if I’m
injured or
harmed?

8 Will I be

The NIOSH Health Hazard Evaluation is voluntary. You may choose to be in
the Health Hazard Evaluation or not. You may choose to answer any or all
questions. You may drop out any time for any reason without consequences
to you. You can inform participants of the importance of full participation or
that it is necessary if they are to be included in the HHE results. NIOSH
employees should be informed of IRB policy on being a participant (NIOSH
employees) http://inside.niosh.cdc.gov/hsrb/Checklists.html

On-site emergency treatment will be provided. 911 will be called if needed.
Medical care or compensation will not be provided. If you are injured through
negligence of a NIOSH employee you may be able to obtain reimbursement
under Federal Law. If you are injured or harmed through the negligence of a
NIOSH contractor, your claim would be against the contractor.

You will not be paid or reimbursed for participating in the Health Hazard
Evaluation.

reimbursed or
paid?

9 Are there
other
benefits?

List results of clinically relevant medical procedures or diagnostic tests, and
other useful information provided to the participant and their physician with
permission. If there are no personal benefits, state so. Workplace or societal
benefits can be noted secondarily.
Your participation may benefit you, your coworkers, 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 under number
3 above.

10 Will my
personal
information
be kept
private?

11 Will I or
anyone else
receive study
results?

Recommended language: NIOSH is authorized to collect your personal
information and will protect it to the extent allowed by law. There are
conditions under the Privacy Act where your information may be released to
collaborators or contractors, health departments or disease registries, to the
Departments of Justice or Labor, or to Congressional offices. If applicable,
note Assurance (308d) or Certificate (301d) of Confidentiality. You can add
that personal identifiable information will be destroyed at some specified time.
Or: The study is anonymous. We will not be collecting or recording any
personal identifiable information.

We will send you a letter with your individual results of the ___________
sampling and the (blood, urine or biological material) tests. We will send your
employer and an employee representative a letter with summary results. Your
individual results will not be shared. Upon completion, we will send a final
report to your employer and employee representative. The report will be
posted on the NIOSH web site.

Page 3

Consent to be in a NIOSH Health Hazard Evaluation
(RETAINED SPECIMENS) Insert title of the study here
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.

12 Who can I talk
to if I have
more
questions?

13 Your
signature

For questions about the research study, contact the principal investigator,
name at e-mail address or telephone number.
For questions about your rights, your privacy, or harm to you, please contact
the Chair of the NIOSH Institutional Review Board (IRB) in the Human
Research Protection Program at phone # (513) 533-8591.

The study was explained to me. My questions were answered. I agree to be in
the study.
__________________________________________________________
Printed name of participant [Optional]
__________________________________________________________
Participant signature
Date

I have accurately described this study to the participant. [Optional]
________________________________________________________
NIOSH representative signature
Date

14 Additional
consent

Additional signature lines or to-be-checked boxes can be included to provide
an opportunity to opt in or out of ancillary elements of the protocol such as the
use of photographs, requesting that medical results be sent to a personal
physician, or allowing data or biological samples to be used in future research.

Page 4

Consent to be in a NIOSH Health Hazard Evaluation
(DISCARDED SPECIMENS) Insert title of the study here

1 Who is
conducting
the study?

2 What is the
purpose?

3 What will I
do?

NIOSH is a federal agency that studies worker safety and health. We are part
of the Centers for Disease Control and Prevention (CDC). NIOSH’s Health
Hazard Evaluation (HHE) Program conducts worksite investigations.

This health hazard evaluation was requested by (requestor) because of
(reported illness/exposures). The purpose of this evaluation is to measure
exposures in the work environment, test for _________, and identify potential
health effects from exposure to ______.

Briefly explain, in terms participants will understand, the tasks, procedures,
therapies, tests, etc., involved in the HHE. You can use bullets. You can
provide separate information sheets for complex or varied procedures. Inform
participants if you will be recording images, or videos of them.

A. You will fill out a questionnaire about your work history, certain medical
conditions, and symptoms you have when working around _____________,
(including any sensitive topics). Either [the questionnaire will be
administered by a NIOSH representative] or [You will be asked to complete
the questionnaire yourself, but a NIOSH representative will (be present to)
(assist you and) check it for completeness (when you return it).] It should
take from to minutes.
B. You will have your blood taken to test for ____ and ________ in #
tubes (about X number of teaspoons) of blood will be taken from a vein in
your arm. The needle stick may produce some discomfort and possibly some
soreness and discoloration of the skin due to blood leaking from the vein; this
discoloration may last a few days but it is generally harmless. Infrequently,
drawing blood causes someone to faint. This blood draw procedure should
take only a few minutes.
C. You will do breathing tests to assess your lung function. You will be asked
to breathe in as deeply as you can and forcefully blow out as quickly and
completely as possible through a tube that you place in your mouth. You will
be asked to do this at least (three) times, and possibly more times. This test
may be tiring, and you may feel momentary lightheadedness or chest
discomfort. If, at any time, you feel unable to continue, the test will be
stopped. The test typically takes five to ten minutes.
D. You will do urine tests for ________ and ______________. You will be
asked to urinate, in private, into a container that a NIOSH representative will
give you. The only time involved is that required to produce the urine
specimen and return it to the technician.
Page 5

Consent to be in a NIOSH Health Hazard Evaluation
(DISCARDED SPECIMENS) Insert title of the study here

4 What other
tests will my
blood, urine,
or ___ be
tested for?

5 Are there any
risks?

Your (blood, urine, other biological material) will be used only for the tests
specified above. The specimen(s) will be identified only by an arbitrary
number, which can be linked to you only by the medical investigators, not the
laboratory. The specimens will 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. 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 will contact you first and will not perform any additional tests or save
your (blood, urine, other biological material) unless you provide written
consent.
C. One risk, 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.
D. The test(s) on your (blood, urine, other biological material) are
experimental. Guidelines do not exist regarding the(se) test(s) or their
breakdown products or how to interpret the levels. The tests may not
measure all the drugs you are exposed to at work, and the results may not
be interpretable. Although we will be using the most up-to-date medical
information available, we may not be able to tell you what the tests mean
in terms of your health.

We will not share the results of your ______ tests or your questionnaire
responses with anyone, but your results will be combined with others and
reported as a group.
There is a risk of loss of confidentiality regarding participation, questionnaire
responses, and _______ analysis results. To minimize the risk of loss of
confidentiality, we will use identification numbers and not put your name on
the urine specimens or the questionnaires. Results will be kept in locked,
secured filing cabinets in the project officers’ offices.
If you have any comments about the tests/procedures, you should contact
(name, title, and phone of Medical Officer).

6 Is my
participation
voluntary?

The NIOSH Health Hazard Evaluation is voluntary. You may choose to be in
the Health Hazard Evaluation or not. You may choose to answer any or all
questions. You may drop out any time for any reason without consequences
to you. You can inform participants of the importance of full participation or
that it is necessary if they are to be included in the HHE results. NIOSH
employees should be informed of IRB policy on being a participant (NIOSH
employees) http://inside.niosh.cdc.gov/hsrb/Checklists.html

Page 6

Consent to be in a NIOSH Health Hazard Evaluation
(DISCARDED SPECIMENS) Insert title of the study here

7 What if I’m
injured or
harmed?

8 Will I be

On-site emergency treatment will be provided. 911 will be called if needed.
Medical care or compensation will not be provided. If you are injured through
negligence of a NIOSH employee you may be able to obtain reimbursement
under Federal Law. If you are injured or harmed through the negligence of a
NIOSH contractor, your claim would be against the contractor.

You will not be paid or reimbursed for participating in the Health Hazard
Evaluation.

reimbursed or
paid?

9 Are there
other
benefits?

List results of clinically relevant medical procedures or diagnostic tests, and
other useful information provided to the participant and their physician with
permission. If there are no personal benefits, state so. Workplace or societal
benefits can be noted secondarily.
Your participation may benefit you, your coworkers, 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 under number
3 above.

10 Will my
personal
information
be kept
private?

11 Will I or
anyone else
receive study
results?

Recommended language: NIOSH is authorized to collect your personal
information and will protect it to the extent allowed by law. There are
conditions under the Privacy Act where your information may be released to
collaborators or contractors, health departments or disease registries, to the
Departments of Justice or Labor, or to Congressional offices. If applicable,
note Assurance (308d) or Certificate (301d) of Confidentiality. You can add
that personal identifiable information will be destroyed at some specified time.
Or: The study is anonymous. We will not be collecting or recording any
personal identifiable information.

We will send you a letter with your individual results of the ___________
sampling and the (blood, urine or biological material) tests. We will send your
employer and an employee representative a letter with summary results. Your
individual results will not be shared. Upon completion, we will send a final
report to your employer and employee representative. The report will be
posted on the NIOSH web site.
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.

Page 7

Consent to be in a NIOSH Health Hazard Evaluation
(DISCARDED SPECIMENS) Insert title of the study here

12 Who can I talk
to if I have
more
questions?

13 Your
signature

For questions about the research study, contact the principal investigator,
name at e-mail address or telephone number.
For questions about your rights, your privacy, or harm to you, please contact
the Chair of the NIOSH Institutional Review Board (IRB) in the Human
Research Protection Program at phone # (513) 533-8591

The study was explained to me. My questions were answered. I agree to be in
the study.
__________________________________________________________
Printed name of participant [Optional]
__________________________________________________________
Participant signature
Date

I have accurately described this study to the participant. [Optional]
________________________________________________________
NIOSH representative signature
Date

14 Additional
consent

Additional signature lines or to-be-checked boxes can be included to provide
an opportunity to opt in or out of ancillary elements of the protocol such as the
use of photographs, requesting that medical results be sent to a personal
physician, or allowing data or biological samples to be used in future research.

Page 8