Adult Informed Consent To Participate In A Research Study printable pdf download

Adult Informed Consent To Participate In A Research Study

ADULT INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY

TITLE OF PROJECT: IDENTIFICATION OF GENES AND RISK FACTORS

FOR HYPEREMESIS GRAVIDARUM

PRINCIPAL INVESTIGATOR: MARLENA S. FEJZO, PH.D.

DEPARTMENT: DEPARTMENT OF MEDICINE, UCLA

24-HOUR TELEPHONE NUMBER: (310) 383-3581

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WHY IS THIS STUDY BEING DONE?

We invite you to take part in a research study conducted by Marlena S. Fejzo,

Ph.D., Department of Medicine, UCLA. This study is about Hyperemesis

Gravidarum (HG), a condition of severe nausea and vomiting during pregnancy.

We hope to learn if there are any differences in genes between affected

individuals and unaffected friend controls (a control is a study participant who

did not have HG who will be compared to the study participant with HG). You

are invited as a possible participant, because you had HG or because you are a

friend of a study participant with HG and would like to participate as an

unaffected control for the study. About 2,400 individuals will take part in this

study.

If you are a relative of a participant in a large family with HG (3 or more affected

individuals), we are inviting you to participate now in the collection of samples

and information for a follow-up family study to confirm our findings in this study.

WHAT IS INVOLVED IN THE STUDY?

If you decide to take part, this is what will happen:

1. You will be asked to answer a questionnaire regarding your medical history,

family history and other possible risk factors for HG. The survey will be

completed online and contains sensitive questions such as “How many

voluntary/therapeutic terminations?” , “Is this child healthy and well-functioning

(normal) at this time?”, “5.5 How long did HG affect you emotionally? (number

months, years, ongoing, describe)” You do not have to answer any questions

that cause you distress.

2. You will be asked to donate saliva samples (about 2 mls or 1/2 teaspoon of

saliva). The sample collection will be self-administered (collected by you) via a kit

we mail to you with directions on how to collect the sample and mail it back to

the study site. If you have questions about any part of this process, you may

Protocol ID:IRB#11-001681

UCLA IRB Approved Approval Date: 9/15/2014 Through: 9/14/2015 Committee: Medical IRB 1

Adult Informed Consent To Participate In A Research Study