An Observations Study of Hepatitis C Virus (HCV) in Pregnancy

HCV Screening Consent

Center for Women’s Reproductive Health

(205) 934-1322

HCV Study Screening

STUDY PURPOSE

HCV is a virus that is usually passed from person to person via blood sharing in some way.  It can affect the liver of those who have it, including your child.  Some people get sick when first infected, but most people are not aware that they have been infected. When your body is first exposed to HCV, it is possible that you fight and clear the infection. It is also possible that you are unable to fight the virus completely, and it will continue to live in your body. If so, then there is a chance you may pass it to your baby during pregnancy.

The way we will know whether you have been exposed to HCV is by testing your blood. The purpose of this study is to see if HCV antibodies (i.e. substances that target and help the immune system destroy the HCV) exist in your blood which would indicate that you have been exposed to HCV. Since the number of women who have been exposed to HCV is small, we anticipate that approximately 160,000 women will be screened for this study.

The HCV screening tests and results provided by this study are research results only.  Any decisions your Doctor makes regarding your clinical care will not be based on these tests.

In order to determine eligibility for the study, a small amount of blood (about 1 tsp) will be drawn with your prenatal lab work to be tested for HCV. There is no additional needle stick for the blood draw and no expected additional risks. There is no cost to you for this HCV screening blood test. Your participation in this screening is voluntary.  You will not be paid for the screening blood test.

WHAT HAPPENS IF YOU ARE  ELIGIBLE FOR THE STUDY?

If you are eligible for the study, you may be contacted by a study research nurse who will explain the details of the study and ask for your written consent to participate.

There is no obligation to take part in the study if you are eligible.

By signing this form, you agree to the use of your blood to screen for this research study as described above. If any blood remains after testing, you agree that it may be discarded after six months. You do not sign any of your legal rights away by signing this consent form.

CONFIDENTIALITY

The information gathered during this study will be kept confidential to the extent permitted by law.  However, representatives of NICHD, Office for Human Research Protections (OHRP), and the IRBs for UAB and George Washington University will be able to inspect your medical records and have access to confidential information that identifies you by name. The results of your HCV antibody test will be sent to the data coordinating center, The George Washington University Biostatistics Center in Rockville, Maryland,  with a unique code, even if you choose not to enroll in the study.  Only the research staff at UAB will have access to the key code that can identify you. The results of the treatment,  including lab tests, may be published for scientific purposes; however your identity will not be revealed.

To help us protect you and the information we will be collecting from you, this study has been given a Certificate of Confidentiality from the NICHD National Institutes of Health. This certificate means that the research staff cannot be forced, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, to disclose any information that may identify you. The research staff will use the Certificate to resist any demands for information that would identify you, except as explained below. The Certificate cannot be used to resist a request for information from the United States government employees if the request is for auditing or evaluation of federally funded projects.

This Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information to any person about yourself and your involvement in the study. If you give your written consent to release study information to an insurer, employer or other person, the Certificate cannot be used to withhold this information.

Date: ________________

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Participant Signature

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Signature of parent or legally authorized representative (if under 14 years of age)

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Signature of person obtaining consent

Patient Contact information:

Name________________________________

Address: _____________________________

_____________________________________

Phone number:_________________________

You will be given a blank copy of this form to keep for your records.

For more information contact Cheryl Lee or Stacy Harris (205) 934-1322

Disclosure of Health Information for research

Study personnel will use medical information and personal identifiers including  your name, medical record number, and phone number. The researchers want to use your health information as part of the research protocol listed above. People who may use this information include the physicians, nurses and staff working on the research protocol (at UAB), as necessary for their operations; the IRB and its staff; the sponsor of the research and its employees; and outside regulatory agencies, such as the Food and Drug Administration. Your health information that is given to the study sponsor will remain private to the extent possible, even though the study sponsor is not required to follow the federal privacy laws.  However, once your information is given to other organizations that are not required to follow federal privacy laws, we cannot assure that the information will remain protected.  Your authorization for the uses and disclosures described in this section does not have an expiration date. You may cancel this authorization at any time by notifying the Director of the IRB, in writing, referencing the Research Protocol and IRB Protocol Number.  If you cancel this authorization, the study doctor and staff will not use any new health information for research.  However, researchers may continue to use the health information that was provided before you cancelled your authorization.  You have a right to request to see your health information.  However, to ensure the scientific integrity of the research, you will not be able to review the research information until after the research protocol has been completed.  

In addition to notifying the IRB Director in writing, you may contact Dr. Tita at (205)996-6262 if you would like to cancel your authorization for use and disclosure of your health information, or if you have any questions about the research or a research related injury. You may contact the Office of the IRB if you have any questions, concerns, or complaints about the research at (205) 934-3789 or toll free at 1-855-860-3789.

PI: Alan T. N. Tita, MD, PhD

Sponsor: Eunice Kennedy

Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH)

IRB-120904002

Version 03/23/18 

Maternal-Fetal Medicine Units Network