GuLFOMBattachment3REVISEDAppendix_E_-_Informed_Consent_Quick_Reference_Guide_-_Post_Dec_IRB

GuLFOMBattachment3REVISEDAppendix_E_-_Informed_Consent_Quick_Reference_Guide_-_Post_Dec_IRB.pdf

Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers (NIEHS)

GuLFOMBattachment3REVISEDAppendix_E_-_Informed_Consent_Quick_Reference_Guide_-_Post_Dec_IRB

OMB: 0925-0626

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Appendix E:

Informed Consent Quick Reference Guide

Page 1 of 2

Informed Consent Form for
Active Follow-up
Quick Reference Guide

OMB#0925-XXX
EXP:xx/xxxx

Please read the Informed Consent Form before signing.
The GuLF Study is about the potential health effects of oil spill clean-up.
You already completed a survey about your experience in oil spill clean-up.
By joining the Active Follow-up part of the study, you agreed to do the following:
During the in-home visit 1. Complete a 1-hour interview about your health, habits and other jobs
2. Allow an examiner to take your blood pressure, measure your height, weight, hips and waist,
and test your lung function (if eligible)
3. Provide blood, hair, toenail, urine, and possibly saliva samples
4. Allow our staff to collect dust from your home
Throughout the study 5. Update your contact information once a year
6. Complete a 30-minute telephone questionnaire every two years
7. Allow us to follow your health using state and national health records such as death certificates
or cancer registries
8. Allow us to contact you about related health studies
9. Allow us to share your coded information with other qualified researchers.
Length of Study: The study will last at least 10 years. You may quit the study at any time.
Use of Information Collected: The information you shared will be used for research on the potential
health effects of clean-up activities related to the Deepwater Horizon oil spill in the Gulf of Mexico. The
consent form explains in more detail how we will use the information and samples you gave for this study.
Results of Tests: We will give you information about your blood pressure, body mass index, lung
function, complete blood count (if measured), and urine glucose (sugar) level. If you want, we will send
any abnormal test results to your doctor or health clinic. We can refer you to a doctor or clinic in your
area, if you want. We will send you regular reports that summarize study findings. We can only share
results of tests done in approved certified clinical laboratories. Individual results of tests done in research
labs will not be shared.
Benefits: You may benefit from getting the results of medical screening tests. These results will let you
know if you might benefit from seeing a doctor. We can help you find a doctor or clinic if you do not have
one. You will not receive other direct benefits. You may be proud to be part of a research study that may
help others.
Risks: Some of the questions we ask may make you uncomfortable. There is a small risk of bruising or
infection from the blood draw. The lung function test may cause coughing and a feeling of
lightheadedness. If this occurs, they will go away shortly after the test. There is also a slight risk your
private study information could become known to others. The consent form explains what we will do to
keep that from happening.
Confidentiality: Every effort will be made to protect the information and samples you provide. The Gulf
Study has a Certificate of Confidentiality that helps protect your information.
Costs: There are no costs to you other than your time.
Payment to Participants: If you complete the in-home visit, you will receive a $50 gift card. You may be
eligible for other payments in the future.

Page 2 of 2


File Typeapplication/pdf
File TitleAppendix A:
AuthorRichard Kwok
File Modified2011-01-14
File Created2011-01-14

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