FAQs
What are my rights as a participant?
Your participation is voluntary and you have the right to withdraw your consent or discontinue participation in any part of this study at any time without penalty or loss of benefits to which you are otherwise entitled. The results of this research study may be presented at scientific or professional meetings or published in scientific journals. However, your identity will not be disclosed. You have the right to refuse to answer particular questions in the survey or discontinue follow-up surveys.
Who should I contact if I have questions, concerns or complaints?
During the study, if you have questions, concerns or complaints about the study, please contact the investigator on the first page of the consent form you were given.
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact:
By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
or call toll free: 877-992-4724
or by email: adviser@advarra.com
Please reference the following number when contact the Study Subject Adviser: Pro00054839
What are the risks and benefits to my participation?
The risks associated with this study include a potential discomfort, bruising or very rarely infection from the blood draw, and the unlikely, but potential chance of loss of confidentiality. We cannot and do not guarantee or promise that you will receive any benefits from this study. Your decision whether or not to participate in this study will not affect your employment/medical care.
Potential benefits include possibly discovering a cause for your miscarriage if you choose to learn the results of your genetic analysis. Even if you receive no direct benefit, your participation may help doctors and scientists improve our knowledge of pregnancy loss and other related conditions.
As part of the analysis on your specimens, the investigators will do genetic testing. Genetic research is research that studies genes, including gene characteristics and gene versions that are transmitted by parents to children. Genetic research may include looking at information, such as personal appearance and biochemistry, gene sequences, genetic landmarks, individual and family medical histories, reactions to medications and responses to treatment. Genetic research raises certain questions about informing you of any results. Possible risks of knowing results include: anxiety; other psychological distress; and the possibility of insurance and job discrimination. A possible risk of not knowing includes being unaware of the need for treatment. These risks can change depending on the results of the research and whether there is a treatment or cure for a particular disease.
With genetic sequencing we may identify gene changes that are associated with pregnancy loss. You will be given the option to receive these types of results if found. Participation in this study should not be considered a substitute for clinically recommended testing. If you wish to learn about your results, genetic counseling will be provided at that time. It is unlikely that the results will be used to guide clinical care as it may take up to 1-2 years to complete our analysis. Any abnormalities found in this study will need to be verified by a clinical laboratory.
If you elect to receive your results and are found to have a significant genetic change that could impact your future health our study team will help confirm this finding in a genetic testing lab and provide you with genetic counseling and refer you for follow up. If you elect to not receive these results, we will not contact you with your results.
When whole genome sequencing is performed, there is a small chance (approximately 3-5%) that we might find a genetic change or a variant that may cause a future health risk or predispose you to a certain genetic condition that is unrelated to pregnancy or pregnancy loss. These types of results might be important for your health now or in the future. We expect that only a 3-5% of people will get results like this. You can decide if you want to learn about these conditions or not.
Sometimes 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 makes it illegal for health insurance companies, group health plans, and employers with 15 or more employees to discriminate against you based on your genetic information.
There are no costs to the patient to participate. No patient will be denied standard of care treatment or follow up, either by participating or declining to participate. The costs of all standard of care testing and treatments will be the responsibility of the patient and their insurance companies. The alternative to enrolling is to not enroll. All participants and those not enrolling should follow up with their healthcare team to obtain standard testing and treatment.
How can family members help?
Additional family members will only be contacted by the study team after the participants have had a chance to discuss the study with them and obtain their permission to contact. For children, their only involvement will be saliva or blood sampling on a single occasion. For adult family members, they will provide telephone interviews to obtain a reproductive history and then provide a DNA sample by saliva nor blood draw.
I’ve only experienced one miscarriage. Can I still participate?
Yes, please join our registry.
How will I know that my confidentiality will be protected?
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.
