Purpose of Research
You are invited to participate in a research study to collect umbilical cord blood, a tissue that is typically discarded as post-partum medical waste. Your participation will play a key role in furthering basic, translational and clinical research here at Stanford. Your cord blood will be used in a research context, and you will not be told the results of this study.
If you decide to discontinue your participation in this study, please notify Matthew Porteus at (650) 725-6520. This research study is looking to enroll expectant mothers delivering at Lucille Packard Children’s Hospital.
Your participation in this study is entirely voluntary. You may choose not to participate, without there being any negative effect on you or your medical care. You may also decide to participate now, but withdraw your consent and participation in the study at a later time without any loss of benefits or medical care to which you are entitled.
Duration of Study Involvement
Collection of cord blood is done in either an ‘in-utero’ or ‘ex-utero’ fashion. For ‘in utero’ collections, after the baby is born and cut from the umbilical cord in the normal way, and the placenta is still inside the uterus, your obstetrician will perform the cord blood collection. This involves venipuncture of the umbilical cord and drainage or cord blood into a collection bag. No blood is taken directly from you or the baby, rather taken from the umbilical cord that is normally discarded. The collection of the cord blood is short, approximately one minute, and does not affect the delivery process. The obstetrician will be trained on the collection procedure by cord blood coordinators. The health of the mother and baby is the primary concern of the obstetrician. Circumstances may arise which prevent the collection of cord blood. For ‘ex utero’ collections, after the baby is born, the umbilical cord is clamped and cut in the normal way, the placenta is then delivered. The cord blood will be collected by draining the placenta of the blood into a collection bag by the cord blood coordinator (or their trained representative). The ‘ex utero’ collection is usually done outside of the delivery room but can occasionally be done inside the delivery room. Since the ‘ex utero’ collection is performed after the baby and placenta are delivered, it will have no effect on the baby or you. As above, the health of the mother and baby is the primary concern of the obstetrician.
You are scheduled to deliver your baby at Lucile Packard Children’s Hospital. This banking study will not change your medical treatment or surgical procedure.
The future use of your cord blood may result in new products, tests or discoveries which may have potential commercial value. Donors of tissues do not retain any property rights to the materials. As such, you would not share in any financial benefits from these products, tests or discoveries. The results of the study of your samples will be used for research purposes only.
There is a wide range of research that can be conducted with cord blood. You may answer “no” to genetic testing, future contact, stem cell usage, while still retaining the ability to donate cord blood, if you wish. You may also choose to answer “yes” to some components of this consent, and “no” to others. The way you answer these questions will direct your unit to different types of research.
Cord Blood Sampling for Research
Research using cord blood is an important way to study human disease. You have been given this information because the investigators want to include your cord blood in a research project and because they want to save the samples for future research. The results of the study of your samples will be used for research purposes only; they will not be used for treatment purposes.
Your cord blood will be processed by a cord blood coordinator and distributed to Stanford laboratories that will use it to further their research.
Tissue Sampling for Genetic Research
The analyses of your cord blood may include genetic research. Genetic research is research that studies genetic information, including gene characteristics and alternate gene versions, or alleles, that children inherit from their parents. Genetic research may involve holistic analysis, connecting information about one’s DNA sequences, or genotype, to their physical appearance, or phenotype, as well as the overall study of coding sequences, genetic landmarks, biochemical traits, individual and family medical histories, reactions to medications and responses to treatment. Genetic research raises certain questions about informing you, the donor, of any results. Possible risks of knowing the results include: anxiety; other psychological distress; the possibility of insurance and job discrimination. On the other hand, a possible risk of not knowing the results is being unaware of the need for treatment. These risks are subject to change, depending on the results of the research and whether or not there exists a treatment or cure for a particular disease.
In the past, some patients have been required to furnish information from genetic testing for health insurance, life insurance, and/or a job. A federal law, the Genetic Information Nondiscrimination Act of 2008 (GINA), generally prohibits health insurance companies, group health plans, and employers with 15 or more employees to discriminate against you based on your genetic information.
Your umbilical cord blood will be de-identified upon collection, at which point it will be referenced by the randomly assigned barcode number (designated as “Participant ID”) at the bottom of this page. Therefore, you will not be informed of the results of the research specific to your cord blood, as we will be unable to trace the results back to you for follow up contact.
Information from analyses of your coded (de-identified) samples and your coded (de-identified) medical information will be entered into one of the National Institutes of Health (NIH) databases along with information from the other research participants for future research. These databases will be accessible via the Internet. Only anonymous information from the analyses will be entered into a completely public database, available to anyone on the Internet.
No traditionally-used identifying information about you, such as your name, address, telephone number, or social security number, will be entered into the public database. While the public database will not contain information that is traditionally used to identify you, people may develop ways in the future that would allow someone to trace your genetic or medical information in our databases back to you. For example, someone could compare information in our databases with information from you (or a blood relative) in another database and be able to identify you (or your blood relative). It also is possible that the security of the computer systems used to store the codes linking your genetic and medical information to you could be compromised.
While these scenarios are unforeseeable, your privacy is regarded with the utmost priority, and will implement our best safety measures for its protection. Despite our best efforts, we cannot guarantee that your identity will never become known.
Stem Cell Research
Your cord blood may also be used for somatic stem cell research. This work would be conducted on the Stanford campus. No new stem cell lines will be developed from the donated cord blood cells. It is possible that adult (non-pluripotent) stem cells purified from the cord blood may be introduced into animals for research but only after approval is obtained from the relevant oversight committee. Introducing these cells into a non-human, animal model allows for the study of their biological function. Otherwise, there are no further restrictions on the ultimate recipients of these cells or cell products.
* Please be aware that the cord blood may be preserved for an extended period of time if not requested immediately, and therefore may be used by researchers at Stanford for purposes that are currently not foreseeable. These projects may involve genetic manipulation, but will be subject to the same (or perhaps more stringent) regulations regardless.
As a participant, your primary responsibilities are to ask questions as they occur to you and to notify the Protocol Director or research staff of any changes in your decision to participate in this study.
Withdrawal from Study
If you first agree to participate and then change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your current medical care and you will not lose any benefits to which you would otherwise be entitled.
If you decide to withdraw your consent to participate in this study, please notify Matthew Porteus, Protocol Director, at (650) 725-6520.
If you retroactively withdraw your consent, please be aware of the possibility that your cord blood may have already been used for Stanford research. In this case, we would be unable to retrieve your sample.
The Protocol Director may also choose to withdraw you from the study without your consent for one or more of the following reasons:
- The Protocol Director decides that continuing your participation could be harmful to you.
- The study is cancelled.
- Other administrative reasons.
- Unanticipated circumstances.
Possible Risks, Discomforts, and Inconveniences
There are no anticipated risks associated with this study. As this is not a treatment study, you will not receive any direct benefit from your participation. We cannot and do not guarantee or promise that you will receive any benefits from this study.
Risks involved with this study include minor inconvenience during delivery as the obstetrician will be collecting the cord blood during your delivery. If at any time your physician, your family, or you feel you want to stop participating or change your mind, you can do so at any time.
We cannot and do not guarantee or promise that you will receive any benefits from this study. General benefits include the advancement of scientific research.
Alternatives to donating cord blood are to privately bank, at a financial cost to you. This program is not affiliated with private banking. The other alternative would be to dispose of the cord blood per standard protocol.
You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, please notify the Protocol Director.
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified.
Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
Authorization to Use Your Health Information for Research Purposes
Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law.
What is the purpose of this research study and how will my health information be utilized in the study?
Umbilical cord blood contains a wide variety of cell types, many of which are powerful tools for research. This research will be conducted here at Stanford to study different human diseases. A cord blood coordinator will use your health information to screen you for eligibility for cord blood donation. The coordinator will then direct your unit, based on your health information, to different laboratories that have different inclusion and exclusion criteria for their research.
Do I have to sign this authorization form?
You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study. Signing the form is not a condition for receiving any medical care outside the study.
If I sign, can I revoke it or withdraw from the research later?
If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to:
Stanford University School of Medicine
Department of Pediatrics
Stem Cell Transplantation and Regenerative Medicine
Lorry Lokey Stem Cell Research Building, G3045
265 Campus Drive West, MC 5462
Stanford, CA 94305
What Personal Information Will Be Obtained, Used or Disclosed?
Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to, age, disease status, ethnicity/race.
Who May use or Disclose the Information?
The following parties are authorized to use and/or disclose your health information in connection with this research study:
- The Protocol Director Matthew Porteus
- The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
- Research Staff
Who May Receive or Use the Information?
The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
- The Office for Human Research Protections in the U.S. Department of Health and Human Services
- The Food and Drug Administration
Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.
When will my authorization expire?
Your authorization for the use and/or disclosure of your health information will end on December 31, 2045 or when the research project ends, whichever is earlier.
You will not receive payment for your participation in this research study.
There is no financial cost to you for participating in this study.
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, please contact the Protocol Director, Matthew Porteus at (650) 725-6520. You may contact him now or later.
Injury Notification: If you feel you have been hurt as a result of participating in this study, please contact the Protocol Director, Matthew Porteus, at (650) 725-6520.
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 3000 El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306.