Overview

1. What is the NINDS Repository for Human Gene Discovery?
2. What disease categories are being collected?
3. What are the benefits for the investigator to participate?
4. Language for acknowledging the NINDS Repository

1. What kind of samples can be sent to the repository?
2. Who is eligible to send samples to the repository?
3. What must be done in order to submit?
4. What are the costs of submission?
5. How must samples be collected (volume, tubes, etc)?
6. What is required in terms of accompanying clinical data?
7. What is the grace (or embargo) period for which samples will be stored before withdrawal is allowed?

1. What assurances are in place to protect subject privacy?
2. What is the effect of the Health Insurance Portability and Accountability Act (HIPAA) on the NINDS Repository?
3. Does the Repository have a Certificate of Confidentiality?

1. Who is eligible to withdraw samples from the repository?
2. What are the costs of withdrawal?

Overview

1. What is the NINDS Repository for Human Gene Discovery?
   The National Institute of Neurological Disorders and Stroke (NINDS) Repository for Human Gene Discovery is funded by NINDS as a contract at Coriell Cell Repositories (CCR). The repository receives, stores, and standardizes the collection of clinical data and DNA for genetics research in neurological diseases.

2. What disease categories are being collected?
   The diseases to be collected into the repository currently include Parkinson's disease, Stroke, and Epilepsy, Motor Neuron diseases, as well as Tourette syndrome. In future years, additional diseases may be included.

3. What are the benefits for the investigator to participate?
   • The repository banks and collates clinical data in a downloadable excel format allowing researchers to more easily manage the clinical data they collect.
   • The repository maintains a searchable database of clinical data for each submitter, which allows web-based or paper based submission of data.
   • The repository prepares DNA and automatically returns a 20 µg aliquot of DNA for each sample to the submitter (or their designee) at either no cost or for a nominal fee (depending on the nature of the project under which samples are collected).
   • The repository prepares additional DNA or cell lines from samples submitted on request for submitters/their designees.
   • The submitter can access samples submitted by others at a nominal fee.
   • The submitter will be assisted with sample collection by Coriell.
     • Coriell will provide sample collection kits (tubes, packing material)
     • Coriell will pay for shipping of blood samples after collection to the repository within the United States.
   • By utilizing the repository, the submitter meets NIH guidelines regarding sharing of research resources and data.

   Please contact the NINDS Project Manager (ninds@coriell.org) or visit here regarding how to become a submitter.

4. Language for acknowledging the NINDS Repository
   If you use NINDS Repository samples and/or data and publish the results, NINDS expects acknowledgement of this publicly funded resource.
   1. Model Language for Acknowledging DNA panels
      DNA panels from the NINDS Human Genetics Resource Center DNA and Cell Line Repository (http://ccr.coriell.org/ninds) were used in this study, as well as clinical data (if applicable). The submitters that contributed samples are acknowledged in detailed descriptions of each panel: (list catalog numbers here; these serve as direct links to detailed panel information, including submitter names).

   2. Model Language for Acknowledging Repository Samples Purchased Separate From Panels
      This study used samples from the NINDS Human Genetics Resource Center DNA and Cell Line Repository (http://ccr.coriell.org/ninds), as well as clinical data (if applicable). NINDS Repository sample numbers corresponding to the samples used are: (list catalog numbers here; these serve as direct links to the sample in the catalog).

   3. Model Language for Acknowledging Repository SNP Database
      This study used data from the SNP Database at the NINDS Human Genetics Resource Center DNA and Cell Line Repository (http://ccr.coriell.org/ninds), as well as clinical data (if applicable). The original genotyping was performed in the laboratory of Dr.________, at city, state, country.

1. What kind of samples can be sent to the NINDS repository?
   Currently, the repository is accepting only blood samples. These are used to prepare DNA and immortalized lymphoblastoid cell lines. Clinical data must be submitter for each sample.
   • Samples from individuals with a neurological disorder being collected (Stroke, Parkinson's, ALS, Epilepsy, Tourette) and of spousal, population, and convenience controls are accepted as long as complete clinical data is also submitted.
   • Unaffected blood relatives will only be accepted from families being collected in which there are three or more living affected individuals, or, if these are from families with a known causal gene. Others will only be accepted with expressed approval of the project officer for a given project. These must have Clinical data elements for the disorder, and ideally, for controls as well, completed.
   • Unaffected married-in relatives must have the control data elements completed.

2. Who is eligible to send samples to the repository?
   Any investigator who collects samples under an IRB approved protocol in the area of disease interest currently banked will be able to submit samples (pending Project Officer approval). Those willing to share immediately rather than after an embargo (grace period) may be considered preferentially.

3. What must be done in order to submit?
   A tracking form must be completed by each investigator prior to submission; please submit and send to the NINDS Project Manager (ninds@coriell.org). Note that if a tracking form is completed but no samples are submitted within six months, a new tracking form must be completed. The Repository retains the right to revoke submitter status at any time, should submitters not be compliant with Repository operating procedure and regulations. Please see here for further details on how to become a submitter.

4. What are the costs of submission?
   There are currently no costs for submission for NINDS grantees. A nominal fee may be required for some non-NINDS submitters.

5. How must samples be collected?
   • Draw at least two 10 ml tubes (8.5 ml draw) of blood from each study subject.
   • Use yellow topped Vacutainer tubes containing ACD Solution A for blood collection (the repository can provide these to you, as well as shipping materials).
   • KEEP BLOOD AT ROOM TEMPERATURE AT ALL TIMES. DO NOT REFRIGERATE.
   • Assign a subject identification number to each tube for your records. Coriell will assign a new, unique ID to it upon arrival to allow masking but you can still use your ID number to assist your tracking of the sample.
   • Write the date the sample was collected on the label of the tube.
   • Place tubes in shipping container. These are provided in advance by the repository.
   • Be sure to include Clinical Data Elements for each subject either at the time of shipment, shipped separately or as data download format arranged prior to shipping.
     • Note that there are separate Clinical Data Elements (CDEs) for each diagnostic category, and a separate CDE for control subjects. Please click here for more details.
     • Samples which do not have completed clinical data will not be accepted for processing or storage into the repository.
   • Ship samples Priority Overnight (next business morning) to arrive at Coriell on Monday through Friday. The Repository will pay shipping costs.
   • Contact the Project Manager (ninds@coriell.org) via email the day samples are sent. Please provide her with the number of samples to be shipped and the FedEx or other shipper's tracking number.

6. What is required in terms of accompanying clinical data?
   Each disorder has a minimum data set which must be included as a part of sample submission. This includes patient demographics (age, diagnosis, family history, gender) and diagnostic details (which differ for each disorder collected, designed to be simple but useful). Forms for collection of these data are available online or in hard copy (email ninds@coriell.org) for copies.

   If your project has an existing database and you would like to submit data to Coriell directly from that, this might be possible and should be coordinated with Scott Megill (smegill@coriell.org).

7. What is the grace (or embargo) period for which samples will be stored before withdrawal is allowed?
   The grace period is the interval between sample submission to the repository and release by the repository of the sample publicly. Immediate sharing is encouraged: there is a maximum grace period of two years after the sample is submitted. Different fee schedules may apply when an embargo period is chosen, in order to encourage timely sharing of resources.

   In certain cases there will be samples collected for the repository under initiatives which will differ in terms of the grace period allowed as specified as well as in terms of fees applied.

8. What is required in terms of consent forms?
   All samples must be collected with informed consent (under IRB approval). The investigator needs to submit a single, blank consent form per project prior to submission to assure that language regarding inclusion in a repository is appropriate.

   As a minimum, the consent form should state:

   • That the blood sample will be submitted to the Coriell Cell Repositories, a research resource supported by the National Institutes of Health/ National Institute of Neurological Disorders and Stroke
   • The sample will be stored indefinitely.
   • No personal identifiers will be sent to the Repository, the sample will be identified by a number assigned by the Dr. 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 only, and as such the Repository does not return results to donors.
   • The sample could be used for research in any type of disease and other genetic factors, not just _______________.
   • The sample and unidentified data will be available to researchers at hospitals, universities, and commercial organizations.
   • 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.
   • Optional: The NINDS Repository has a Certificate of Confidentiality.

   The following CAN NOT be on the consent:

   • A longer embargo time than allowed by the Repository (2 yrs max as of 5/22/08)
   • Any indication that the institution where the sample is collected will own the sample even after it is submitted to the NINDS Repository. Once submitted, samples are owned by NINDS.

   Privacy and Investigator and Subject Rights

   1. What assurances are in place to protect subject privacy?
      The NINDS Repository will take measures to protect subject privacy. Each blood specimen will be given a code number upon arrival at Coriell and all names will be removed. Identifiable information will not be used or retained by Coriell Repositories for any samples distributed. Some patient identification, such as age, gender, diagnosis, and race, will be made available to the Repository and scientists; however, these data will not be traceable to any individuals and will be HIPAA compliant.

   2. What is the effect of the Health Insurance Portability and Accountability Act (HIPAA) on the NINDS Repository?
      The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. The Repository does not accept or store any personally identifying information on samples submitted, and therefore, both submitters and withdrawers of samples are HIPAA compliant during repository usage. Note that Coriell and the NINDS Repository are not covered entities, and therefore, are not subject to HIPAA regulations.

   3. Does the Repository have a Certificate of Confidentiality?
      A Certificate of Confidentiality protecting the identity of research subjects has been issued by the National Institutes of Health to the repository to protect the privacy of research subjects by withholding their identities from all persons not connected with this research.

   SAMPLE WITHDRAWAL/PLACING AN ORDER

   For instructions on ordering please see here. To place an order, please contact Coriell Customer Service (customerservice@coriell.org).
   

   1. Who is eligible to withdraw samples from the repository?
      All samples in the repository, which have completed the requisite grace period, will be available publicly. Those who have submitted samples will have access at markedly reduced costs. Samples which are publicly available can be found in the NINDS Repository Catalog.

   2. What are the costs of withdrawal?
      There will be a nominal fee for submitting investigators to withdraw samples. For all other withdrawers, a fee scale will exist which will vary depending on the affiliation of the withdrawer (academic institution versus industry user, NIH funded grantee versus other, sample series type to be withdrawn, etc). This fee scale may be subject to change: fees will be applied based on what is posted at the catalog site. See the price list for more information.
   Contact Information

   For any assistance or issues please contact the NINDS Team at the Coriell Repository at NINDS@Coriell.org.

   To place an order, please contact Coriell Customer Service (customerservice@coriell.org).

   Updated: 31 August 2011