What is a screening consent and what am I agreeing to?
In order to participate in the Brain Gene Registry, a member of our team will need to confirm that you have an eligible gene variant by reviewing a copy of your genetic testing results. This is called “screening” and it is entirely voluntary. We would like to provide you with some information about the study so that you can decide if you want to participate in the screening process. If you agree to be screened, you will be notified if you are eligible to participate or not. If you are eligible and would like to enroll, a member of our team will help you do that step later. If you complete the screening process and are not eligible or decide not to enroll, your personal information will not be included in the Brain Gene Registry.
This study is funded by a branch of the National Institute of Health called NCATS which stands for the National Center for the Acceleration of Translational Sciences. It is a collaboration between 13 academic medical centers that are recognized as being Intellectual and Developmental Disabilities Research Centers (IDDRC’s) and is being led by Washington University School of Medicine. We are recruiting participants who have received genetic testing that shows they have variant in a gene that is suspected to affect brain development or behavior. You do not have to receive care at one of these IDDRC’s in order to enroll in this study, but you must have a copy of your genetic test results that show you have a variant in one of the genes we are studying. If you choose to participate in this study, you will be asked to provide a copy of your genetic testing results, complete questionnaires and a Telehealth visit with a study team member at one of our sites. You will be asked if you or your child has received healthcare at one of our 13 IDDRC sites, so that we can connect you with a study team at that site who can help you to enroll. If decide to enroll, you will also be asked to share certain information contained within you or your child’s electronic health record. You can complete the study entirely from home, and it does not require any medical procedures or treatments. As part of your participation in this study, you also be asked to join Genome Connect which is part of the NIH’s Clinical Genomics Resource (ClinGen). Genome Connect is a way for participants to find other families who have variants in the same gene, and to help accelerate our understanding of the relationship between genes and diseases. Altogether, we estimate that your participation in this study should take 2-3 hours to complete all parts of the study and you will be compensated for your participation.
The National Institute of Health is funding this research study.
In order to determine if you are eligible for this research study you will need to provide us with a copy of your genetic testing results to review.
Your data collected as part of this screening will NOT be used for future research studies or shared with other researchers, even if we remove identifiers.
A risk of participating in this screening is that confidential information about you may be accidentally disclosed. To minimize this risk as much as possible, we will email you a link to share your genetic test results to a HIPAA secure folder that we will create for you. The folder will be labeled with a 9-digit study ID number and will not contain any information that could personally identify you. If you decide not to participate or are not eligible to participate, you will be notified and the file you shared and the folder we created will be deleted. Any report or article that we write will not include information that can directly identify you. However, 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 activity.
You will not benefit from participating in the screen.
To further protect your privacy, this research is covered by a Certificate of Confidentiality from the federal government. This means that the researchers can refuse to disclose information that may identify you in any legal or court proceeding or to anyone who is not connected with the research except if:
- there is a law that requires disclosure, such as to report child abuse and neglect, or harm to self or others
- you give permission to disclose your information, including as described in this consent form; or
- it is used for other scientific research allowed by federal law.
This Certificate may not be effective for information held in foreign countries.
You have the right to share your information or involvement in this study with anyone at any time. You may also give the research team permission to disclose your information to a third party or any other person not connected with the research.
If you decide to share information gained from this study with your healthcare provider, they may choose to include this information in your medical record. You do not have to share information gained from this study with your healthcare provider.
If information about you or your involvement in this research is placed in your medical record the information may no longer be protected under the Certificate. However, information in your medical records is protected in other ways.
Your participation in this screening is completely voluntary. You may choose not to take part at all. If you decide to participate in the screening, you may stop participating at any time. Any data that was collected as part of this screening will remain as part of the study records and cannot be removed. If you decide not to take part in the screening, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you otherwise qualify.
If, after completing this screening, you are eligible for the research study you will be asked at a later date to sign a separate consent form that includes more detailed information about the study.
Your answers to the screening questions will create Protected Health Information (PHI) that identifies you. Your health information is protected by law under HIPAA (the Health Insurance Portability and Accountability Act). Because of this law, you will need to give the research team permission to use and share your protected health information from the phone screen for this research.
When possible, the research team will make sure information cannot be linked to you. Once information doesn’t identify you, it may be used and shared for other purposes not discussed during this phone screen.
The information collected today during the screening may be seen by people making sure the research is being done right. This may be people at people at Washington University, the National Institute of Health (the funder of this study), from the federal Office for Human Research Protections, or Boston Children’s Hospital.
- If you agree, you are giving permission for us to use of your PHI for this research, and your permission will not expire.
- If you do not agree to allow 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 phone screen for this study.
- Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.
- If you change your mind and do not want the research team use or share your information, you will need to provide a written letter to the research team cancelling your permission. 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 do this, the research team may only use and share information already collected for the study. You will not be allowed to continue to participate in the study.
- If you have questions or concerns about your privacy and the use of your protected health information, please contact us by email email@example.com.
We encourage you to ask questions. If you have any questions about the research study itself, please indicate that below and a member of our team will reach out to you using the contact preferences you provided on the previous form. 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 firstname.lastname@example.org. General information about being a research participant can be found on the Human Research Protection Office web site, 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.