Adult Informed Consent To Participate In A Research Study (Page 2 of 7) in pdf

Adult Informed Consent To Participate In A Research Study Page 2

3. If you had a diagnosis of HG, you will be asked to send your medical records

confirming your diagnosis by a medical professional and the use of IV

(intravenous – into the vein) therapy, IV nutrition, or other forms of tube feeding

to treat HG. You are not required to send your medical records to participate,

and we do not need your entire set of records relating to your pregnancy(s). We

are asking you to send copies of the pages of your records confirming diagnosis

and treatment (with IV therapy, IV nutrition, or other forms of tube feeding) in

one pregnancy, if possible. Please review what you are sending to protect

yourself against sending us medical information you do not wish to disclose.

Only Dr. Fejzo will review medical records. All medical records confirming

diagnosis and treatment will be kept in a locked file cabinet accessible only to Dr.

Fejzo and any information in the records that does not relate to HG diagnosis

and treatment will be shredded.

The genetic analyses that are done in this study are for research purposes only

and you will not be provided with the results.

WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?

Saliva: There are no known risks associated with the saliva collection process

used to collect approximately 2 mls (1/2 teaspoon) saliva.

Genetic Research: This study involves research in genetics that could be used to

develop genetic testing in the future. At this time, any information obtained

from this research cannot provide meaningful information about the future

health of any study participant. If you decide to participate in this study, you will

be involved in genetic research only. If you are asked by your insurance

company, you can answer that you have not had genetic testing.

There have been concerns about the possibility of discrimination based on

genetic findings. Despite this concern, to date, this has not been a significant

problem, with only very rare reports. Federal and State legislation provide some

protection against employment or health insurance discrimination based on

genetic findings.

Questionnaire: Some of the questions may make you feel uneasy or

embarrassed. You may choose to skip questions that make you uncomfortable.

This research may involve risks that are currently unforeseeable.

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 Page 2