FILL Program Participation

What is FILL?

FILL stands for “Following Infants with Low Lymphocytes.” It is a program of the United States Immunodeficiency Network (USIDNET) and the Clinical Immunology Society designed to track what happens to infants who are born with lower than normal levels of lymphocytes. Lymphocytes are a kind of white blood cell that helps fight infection. This program is part of a research study that involves people who are known or suspected to have primary immunodeficiency diseases. This is considered a research study because data is being collected about people with known or possible primary immunodeficiency diseases and the data collected can be used for research purposes.

Some babies are checked for low lymphocytes because an affected relative had an immune problem or because of clinical symptoms. In addition, many states in the U.S. screen all newborns for Severe Combined Immune Deficiency (SCID), an inherited disorder in which lymphocytes are very low or absent. SCID and other inherited conditions affecting ability to fight infections are all together known as primary immunodeficiency diseases (PI). People with PI have an immune system that does not work as it should, and they have a greater risk for infections. If your baby was found to have low lymphocytes, it does not necessarily mean that he or she has PI, but it may mean that your doctor will continue to monitor your baby’s immune system for some time. The FILL Project collects information from the medical records of babies with low lymphocytes and stores it in the USIDNET Registry so that it can be used for research in PI. Researchers wish to understand more about what can cause low lymphocytes at birth, which infants may be most at risk for infection, and whether low lymphocytes get better during the first year of life and beyond.

What is the USIDNET registry?

USIDNET is a group of researchers who study and treat known and suspected primary immunodeficiency diseases (PI). USIDNET has established a registry containing medical data on over 4,000 patients of all ages with PI. Because these diseases are rare, it is important to have a collection of data from patients all over the U.S. that can be used for research. Physicians and researchers use what’s known as “de-identified” data, which means it cannot be traced back to you, from the registry to gain a better understanding of PI, their outcomes, and treatments.

By joining the FILL Project, you allow us to:

• Store your child’s name and birthdate in the USIDNET Registry.
• Combine the information you enter about your child with medical information provided by your physician.
• Share your child’s de-identified data with researchers in PI and other related fields to advance the knowledge and treatment of PI.

Advarra Institutional Review Board, Inc. (Advarra) has approved the information in this consent document and has given approval for the study doctor to do the study. An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. This does not mean the IRB has approved your participation in the study. You must think about the information in this consent document for yourself. You must then decide if you want to be in the study.

What are the risks of the study, and how will confidentiality be maintained?

We will make every effort to safeguard your child’s privacy. While agreeing to participate in FILL and USIDNET does not involve any physical risk, we know that the risk of loss of privacy is a concern for you. It is for us as well, so we will take the following steps to maintain your child’s data in a safe and private manner. Absolute confidentiality, however, cannot be guaranteed.

• Only administrators will have access to identifying information such as name and address.
• The study investigator, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records which identify your child by name.
• If reports or articles are written about the study, your child’s name will not be identified in them
• We will share only de-identified data with researchers.
• We will never give your child’s contact information to an outside entity without your consent.
• We will notify you immediately if there is ever a breach in your or your child’s privacy.
• You will always have the opportunity to remove your child from the FILL Project and revoke your consent at any time.

Are there any benefits for me or my child?

Contributing to research may improve care for patients in the future, and you can feel good about helping with that effort.

What do I do if I want my child to participate in the study?

If you agree to allow USIDNET to keep your child’s information in its registry, you will be directed to an online form where you can enter your child’s information as well as your doctor’s contact information. USIDNET staff will take care of getting the information from your child’s doctor to enter into the registry.

You may hear from us occasionally if there are other research opportunities that become available for which your child may be eligible.

If you have any questions about your involvement in this research study, please contact Dr. Ramsay L. Fuleihan of the Immune Deficiency Foundation at 866-939-7568 or 443-632-2556.

What are my and my child's rights?

Participation in FILL and USIDNET, as with any research, is completely voluntary. You have the right to stop your child from participating at any time. You can choose not to have your child participate now or even withdraw your child’s participation in the future, and it will not affect your child’s medical treatment or access to care in any way and will involve no penalty or loss of benefits to which your child is otherwise entitled.

The study doctor, local institution, or sponsor may remove your child/legal dependent’s information from the Registry at any time without your consent and may also remove the child/legal dependent’s information from the Registry at any time if they indicate that they no longer wish to participate in the study.

You will be asked to sign a separate form to authorize the use and disclosure of your child’s medical information for research or regulatory purposes related to this study. You have the right, however, to cancel this authorization to use and disclose your child’s medical information at any time. You can do this by giving written notice to the Dr. Fuleihan at the Immune Deficiency Foundation informing him that you are canceling your authorization to use and disclose medical information. The contact information is listed at the beginning of this consent form. If you cancel this authorization to use and disclose your child’s medical information, the information that has already been collected in your child’s study records may continue to be used and disclosed (by “Sponsor” and its consultants) as described above, however, no new information will be obtained or added.

If you have any questions about your or your child’s rights as a research subject, and/or concerns or complaints regarding this research study, you should write to Advarra Institutional Review Board, Inc. 6940 Columbia Gateway Drive, Suite 110, Columbia, MD 21046 USA, or call toll-free 866-992-4724 during business hours Monday – Friday 8:00 a.m. to 6:00 p.m. ET.

Source of funding for the study

Funding for this Registry will be provided by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Health (NIH) an agency of the Department of Health and Human Services (DHHS). The FILL Project is also supported by the Clinical Immunology Society from the Jeffrey Modell Foundation.

Other important information for you to consider

In addition to the risk listed above, there may be some unknown or infrequent and unforeseeable risks associated with your child’s participation in this study.

• You will be informed in a timely manner both verbally and in writing of any new information, findings or changes to the way the research will be performed that might influence your willingness to continue your child’s participation in this study.
• Your child’s participation in this study is ongoing; unless and until the program is closed or if at any time you choose to withdraw your child’s participation in the program.
• There are no costs for your child to be involved in this study. There will be no tests for this study since the Registry only collects medical information obtained as part of your child’s regular medical care.
• There will be no compensation for participating in this research study.
• The alternative is not to be part of the Registry and to not permit your child to participate in this study.
• There is no money to pay for injuries or treatment from being part of this study. If you believe that your child has suffered an injury related to this study, you should contact your doctor, or Dr. Ramsay L. Fuleihan of the Immune Deficiency Foundation at 866-939-7568.
• You do not waive any of your or your child’s legal rights by consenting for your child to participate in this research study.