Becoming a Submitter
There are two ways to be approved to submit samples to the NINDS Repository. One way is to become an "Investigator" by submitting completed Investigator Approval and Tracking Data, together with an IRB approved consent that contains the necessary language for the Repository. A second way is to become a "Collaborator" by identifying an approved Investigator that would like Collaborators on their project. Collaborators must submit an IRB approved consent, but do not submit Tracking Data; rather, Collaborators submit under their corresponding Investigator"s Approval and Tracking Data.
Neither NIH/NINDS nor Coriell make a profit from the distribution of samples from the NINDS Repository.
Forms
Minimum Requirements Specific for NINDS Repository Consent (updated 10/6/08)
- The blood will be submitted to the NINDS Human Genetics Resource Center (also called the NINDS Repository) at the Coriell Institute for Medical Research, a research resource supported by the NIH/NINDS.
- The sample will be stored indefinitely
- No personal identifiers will be sent to the NINDS Repository, the sample will be identified by a number assigned by the doctor or researcher.
- The blood sample will be used for preparation of DNA, and may be used for cell culture from which DNA will be prepared.
- The DNA and cell culture will be distributed to scientists for use in research and teaching.
- The sample and unidentified data will be available to researchers at hospitals, universities, and commercial organizations.
- The sample could be used for research in any type of disease and other genetic factors, not just _____________.
- There is a risk that someone could use information from the sample you submitted, via DNA, to identify you if it were matched with another DNA sample provided by you. However, any user of this sample must agree not to use it for that purpose, and the risk, while real, is small.
- You have the right to withdraw from this research project at any time. If possible, any samples you have contributed will be discarded if you request this; however, because of the sample masking, we may not always be able to identify which samples were donated by you. Your withdrawal from the study will in no way affect access to medical care for which you are otherwise eligible.
- Certificate of Confidentiality language requirements:
Certificate of Confidentiality
The NINDS Repository will do everything possible to keep others from learning about your participation. To further help protect your privacy, the Repository has obtained a Certificate of Confidentiality from the Department of Health and Human Services (DHHS). With this certificate, the NINDS Repository cannot be forced (for example, by court subpoena) to disclose information that may identify you in a federal, state, or local civil, criminal, administrative, or other proceedings. Disclosure will be necessary, however, upon request of DHHS for the purpose of audit or evaluation.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. Note, however, that if an insurer or employer learns about your participation, and obtains your consent to receive research information, the NINDS Repository may not use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your own privacy.
Finally, you should understand that the NINDS Repository is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.
A copy of the consent form for each subject should be kept on file by the investigator but does not need to be sent for each sample.
- The following CANNOT appear on the consent:
- a longer embargo time than allowed by the NINDS Repository (2 yrs max as of 5/22/08)
- any indication that the submitter or the submitter’s institution will own the sample after it is submitted to the NINDS Repository
A copy of the consent form for each subject should be kept on file by the investigator but does not need to be sent for each sample.
Guidelines and Policies
Privacy Rule
General Information
|
|