When sharing samples with BioSEND prospectively, we recommend the following components be included in the informed consent to ensure samples can be shared. The wording listed below is only a suggestion and will need to be tailored to institution and study specific requirements.
The language listed below references “biological samples”. Depending on your study and institution’s requirements, this may need to be more specific (for example: DNA, plasma, etc.).
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Language to allow sharing of samples and data with BioSEND and other researchers (including for profit and not for profit)
Your biological samples will be sent to the NINDS Biomarkers Biospecimen and Data Repository, the Biospecimen Exchange for Neurological Disorders at Indiana University or another biospecimen and data repository NINDS selects for this project. Only your unique subject identifier will be used to identify your information and biological sample. The biological samples* may be provided to researchers at academic institutions, hospitals, and biotechnology/pharmaceutical companies. De-identified (all identifying information has been removed) clinical and genetic data may be provided to the researchers requesting biological samples*. These researchers may perform analysis of the biological samples you have provided. As this is done for research purposes, you will not be given the results of this analysis.
When samples and information about you and your family are sent to the Biospecimen Exchange for Neurological Disorders (BioSEND) or another biospecimen repository selected by NINDS, a unique subject identifier is assigned to this information. A unique subject identifier is a combination of numbers and/or letters that do not correspond to any information you have provided to us (i.e. birth date, age, name) and which is different for each person who participates in this study. BioSEND uses a secure computer system. There is a slight risk that there could be a breach of the security of this computer system resulting in the access of information about your family or medical history. Safeguards are in place to minimize this risk.
Results/data may be provided to a government health database
Results of the analysis of the biological samples* you have provided may be submitted along with the de-identified clinical data to a government health research database that will assist other researchers investigating various diseases. This government health research database will have access limited to approved researchers. Your data may be withdrawn at any time, upon your request. However, data that has already been distributed for approved research will not be retrieved.
Some de-identified data may be provided to a government health research database for broad sharing to approved investigators. This information will be de-identified and will not contain any traditional identifiers (i.e. name, date of birth, address, telephone number). There is a slight risk that there could be a breach in the security of this database system resulting in the access of information. Safeguards are in place to minimize this risk.
Any type of disease vs. disease-specific
The biological samples* provide the genetic material, which could be used for studies designed to identify the genes contributing to diseases, such as [PD, HD, FTLD, etc]. In addition, the data and samples may also be used to study other diseases.
For Profit vs. Not for Profit research sharing
The biological samples* may be provided to researchers at academic institutions, hospitals, and biotechnology/pharmaceutical companies.
Successful research using your samples could result in a commercial or therapeutic project with significant value, such as a product for the medical treatment of [PD, HD, FTLD] or for diagnosing a mutation responsible for the disease. You will not share in any financial benefits of these uses.
Samples will be used to generate genomic data (do not limit to GWAS)
A possible risk from your participation in this phase of study involves loss of privacy as a result of providing biological samples* for research. Although your genetic information is unique to you, you do share some genetic information with your children, parents, brothers, sisters, other blood relatives, and other members of your ethnic group. Consequently, it may be possible that genetic information from them could be used to help identify you. Similarly, it may be possible that genetic information from you could be used to help identify them. While information traditionally used to identify you will not be released (i.e. name, date of birth, address, telephone number), people may develop ways in the future that would allow someone to link your genetic or medical information back to you.
Samples will be stored indefinitely
Your biological samples will be maintained in the laboratory for many years. These samples will be coded and not identified by your name. The samples are necessary for long-term research and will be stored indefinitely.
Withdrawal of Consent
Taking part in this study is voluntary. You may choose to take part or may refuse to participate in the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are otherwise entitled. If you do withdraw from the study, then you may request that your demographic and clinical data and any unused sample be destroyed. However, data and samples that have already been distributed to approved researchers will not be retrieved.
A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or an individual’s family members. These health insurers or health plan providers also are prohibited from using such information for decisions regarding coverage, rates, or preexisting conditions. GINA also prohibits employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment. Furthermore, the researchers have adopted strict privacy and confidentiality procedures for maintaining your genetic information as described in this consent form. You should be aware, though, that if your genetic information were accidentally released to the wrong source, federal law does not protect against genetic discrimination by companies that sell life insurance, disability insurance, long-term care insurance, or by adoption agencies.
When possible, it is best to not include check boxes. Tracking of the various responses possible when check boxes are present can be challenging and lead to potential errors.
All studies and all institutions will have different requirements but the more broad the consent can be written initially, the more flexibility you will have in the future.
We also recommend visiting the NIH website for additional information.