LCBD Registry |
Overview
We invite you to participate in a research study being conducted by investigators from Washington University in St. Louis.
You are being asked to participate in this research study because you have a child under the age of 18. The purpose of the study is to compile a database of families who are interested in participating in our studies.
If you agree to participate, we would like you to answer the following questions about yourself and your child(ren). These questions will include basic demographic questions as well as personal health questions. This should take about 10 minutes to complete. You are free to skip any questions that you prefer not to answer.
If you do not wish to participate, you may choose to not continue to the survey. There is no penalty to choosing to not participate and we will not contact you if you choose to not participate.
No clinically relevant research results will be produced as a result of this database, as a result, no results will be shared with participants.
- Identifiers may be removed from your private information, including data, and used for future research or shared with others. If this occurs, we will not ask you for additional consent.
Approximately 1000 people will take part in this study at Washington University.
Are there any risks or costs to joining the registry?
There are no known risks from being in this study, and you will not benefit personally. However we hope that others may benefit in the future from what we learn as a result of this study.
You will not have any costs for being in this research study.
You will not be paid for being in this research study.
How will you keep my information safe?
We will keep the information you provide confidential by assigning an ID code number to each survey. Your information will only be available to the research team and other entities, such as the Human Research Protection Office, to protect your rights as a research participant.
Any report or article that we write will not include information that can directly identify you. The journals that publish these reports or articles require that we share your information that was collected for this study with others to make sure the results of this study are correct and help develop new ideas for research. Your information will be shared in a way that cannot directly identify you.
Federal regulatory agencies and Washington University, including the Washington University Institutional Review Board (a committee that reviews and approves research studies) and the Human Research Protection Office may inspect and copy records pertaining to this research. If we write a report about this study we will do so in such a way that you cannot be identified.
As part of this study we will generate Protected Health Information, or PHI. PHI is health information that identifies you and is protected by law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this study you must give the research team permission to use and disclose your PHI as explained in this letter. The research team will follow state and federal laws and it is possible that other people may become aware of your participation in this study and may inspect records pertaining to the research. This could include university representatives, to complete university responsibilities, and government representatives (including the Office for Human Research Protections and the Food and Drug Administration), to complete federal or state responsibilities.
Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.
The research team will only use and share your information as talked about in this letter. When possible, the research team will make sure information cannot be linked to you (de-identified). Once information is de-identified, it may be used and shared for other purposes not discussed in this letter. If you have questions or concerns about your privacy and the use of your PHI, please contact the University's Privacy Officer at 866-747-4975.
Although you will not be allowed to see the study information, you may be given access to your health care records by contacting your health care provider.
If you do not provide authorization for us to use your PHI it will not affect your treatment or the care given by your health provider, insurance payments or enrollment in any health plans, or any benefits to which you are entitled. However, it will not be possible for you to take part in the study. If you verbally agree, you authorize the use of your PHI for this research, and your authorization will not expire. You may later change your mind and not let the research team use or share your information.
In order to revoke your authorization, you will need to complete a withdrawal letter. Please contact the Human Research Protection Office for more information on how to revoke your authorization or contact the research team to request the withdrawal letter. If you revoke your authorization, the research team may only use and share information already collected for the study. Your information may still be used and shared as necessary to maintain the integrity of the research, for example, to account for a participant's withdrawal from the research study or for safety reasons. You will not be allowed to continue to participate in the study.
Can I change my mind about participating?
Your participation in this study is completely voluntary. You may choose to participate in as many or as few studies or study parts as you would like. You may choose not to take part at all. If you decide to participate in the study you may stop participating at any time. Any data that was collected as part of this study will remain as part of the study records and cannot be removed. If you decide not to take part in the study or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify.
If you do not wish to participate in this study or want to end your participation in the study, you may choose to do so at any time. You may return the survey without answering any of the questions or may skip any questions you would prefer to leave blank. You will not be penalized or lose any benefits for which you otherwise qualify.
Contact Us!
We encourage you to ask questions. If you have any questions about the research study itself, please contact: Sarah Cole or Emily Furtado, at 314-273-8430 or at LCBD@wustl.edu. If you feel you have been harmed from being in the study, please contact: Dr. Susan Perlman, at 314-362-5184. If you have questions, concerns, or complaints about your rights as a research participant, please contact the Human Research Protection Office at 1-(800)-438-0445 or email hrpo@wustl.edu. General information about being a research participant can be found on the Human Research Protection Office web site, http://hrpo.wustl.edu. To offer input about your experiences as a research participant or to speak to someone other than the research staff, call the Human Research Protection Office at the number above.
Thank you very much for your consideration of this research study.
Please click "Continue" to consent to join the registry.