FAQs Related to the NIDA Genetics Consortium, Human Genetic Studies, and Data and Biospecimen Submission and Access
Revised October 2015
In September 1998, NIDA issued a Request for Applications (RFA) entitled "RFA DA-99-003: Genetics of Drug Addiction Vulnerability" to identify human chromosomal regions containing genes that confer susceptibility to drug abuse and addiction and related behaviors. The principal investigators of the studies funded under this RFA formed the initial membership of the NGC, and other investigators have subsequently joined. The NGC investigators represent multiple institutions, use diverse approaches and study designs, and are required to meet twice yearly to discuss issues related to the collection and analyses of data from human genetic studies on drug addiction.
The overarching goals of the NGC are to identify genetic factors involved in drug addiction and addiction vulnerability, and to share data among members and the broader scientific community. Toward this end, NGC members collect anonymized phenotypic data as well as biospecimens. These data, plus all data derived from genotyping and other genetic analyses are stored in the NIDA Center for Genetic Studies (NCGS). In addition, many of the Genome-Wide Association Studies (GWAS) conducted by the NGC membership are also stored in the NIH Database of Genotypes and Phenotypes (dbGaP). To learn more about the NGC please see section B of this FAQ document and for information about each study in the NGC, please see https://nidagenetics.org.
The NCGS is a NIDA-funded scientific resource for informing the human molecular genetics of drug addiction. The NCGS stores clinical data, diagnostic data, pedigree information, other phenotypic information and biospecimens from human subjects participating in studies that form the NIDA Genetics Consortium (NGC). The resource is for all investigators who have fulfilled the requirements for membership and agree to become members of the NGC.
Data stored at the NCGS will be made available for sharing to the scientific community. Membership in the NGC is not required to access phenotypic data and DNA from the NCGS. The data will be made available to researchers other than the Principal Investigator either 6 months after the completion of the funding period for which the samples were obtained initially, upon publication, or through early release as defined by the principal investigator. Those researchers requesting access to data stored in the NCGS will go through an application procedure to assure appropriate use and reporting of the data. The sharing of data in the NCGS is done in strict accordance with the informed consent provided on each research subject.
The NCGS creates high-quality DNA, plasma (if consented), and cryopreserved lymphocytes (CPLs) on all whole blood samples submitted by NGC members. If samples do not have sufficient lymphocytes for cryopreservation, the sample will be made into an Epstein-Barr virus transformed cell line (from which DNA is extracted and stored). If DNA quantities become low, the CPLs are thawed and transformed into cell lines. The NCGS also provides a mechanism by which all databases containing phenotypic information and biospecimens (DNA) can be widely searched or distributed to qualified investigators in the scientific community. The NIDA contract allows for cell lines to be made from the cryopreserved lymphocytes that are stored upon receipt of blood samples if the initial DNA stored from that sample has been depleted. If the DNA has not been depleted, but you would like to request that a cell line be made, you may do so directly through the Repository. This service will not be covered by the NIDA contract, but the Repository can invoice you directly. Further, the NIDA contract does not cover cell line distribution. Rutgers will invoice you directly if you request that cell lines be sent to you.
NIDA Genetics Consortium and All Human Genetics Studies at NIDA
Q1. How can I find out what studies are participating in the NGC?
A1. Information about the investigators and studies of the NGC can be found at the NCGS website, which is maintained at Washington University (https://nidagenetics.org).
Q2. Who can join the NGC?
A2. Only investigators conducting the human genetics of drug addiction research are eligible for NGC membership. Such studies aim to identify gene variants and chromosomal regions associated with drug addiction and are collecting biospecimens containing DNA. NGC meetings, however, are open to any researcher interested in attending. Please contact NIDA staff for a schedule of upcoming NGC meetings.
Q3. Do the members of the NGC meet to discuss progress, scientific advancements, etc?
A3. Yes. Members of the NGC are required to meet twice a year to discuss issues related to the collection and analyses of data from human genetic studies on drug addiction. These meetings are also designed to facilitate collaborations among NGC investigators. Cost for travel to these meetings is to be included in the PI's grant award.
Q4. Are all principal investigators of NIDA-funded grants studying the human genetics of addiction encouraged to join the NGC?
A4. Yes. Because of economies of scale and the need to facilitate sharing through the centralized resource, all principal investigators of NIDA-funded grants studying the human molecular genetics of drug addiction are encouraged to contribute to and use the resources of the NCGS. By joining the NGC the applicant will:
- Increase statistical power of the studies using samples being collected;
- Enhance quality control of the data collected;
- Facilitate and enhance opportunities for collaboration;
- Have access to a data management facility to create extensively documented files at no cost;
- Produce high quality cryopreserved PBMCs;
- Have aliquots of high quality DNA extracted from the cell lines;
- Have the opportunity to meet, on a regular basis, colleagues engaged in similar genetics studies, thereby facilitating information sharing, problem solving, and collaborations.
Q5. Does NIDA require membership in the NGC for all principal investigators of NIDA-funded grants studying the human molecular genetics of drug addiction?
A5. No. NIDA strongly encourages, but does not require, membership in the NGC for investigators principal investigators of NIDA-funded grants studying the human molecular genetics of drug addiction. Investigators who choose not to join the NGC, however, will have to use resources from their grant to meet NIH and NIDA's expectations for data sharing for human molecular genetic studies of addiction (see Q13).
Q6. What is the application process for becoming a member of the NGC?
A6. Effective Sept. 1, 2004, the process for acquiring membership is:
- Submission of requests for membership. Written requests for membership will be received three times per year (April 1, August 1, and December 1) by the NGC Chair with a copy to your project officer:
Mark S. Caulder, M.S., M.P.H.
NIDA Genetic Data Access Request Committee
Genetics, Epigenetics, and Developmental Neuroscience Research Branch
Division of Neuroscience and Behavior
6001 Executive Blvd.
Rm 4271, MSC 9555
Bethesda, MD 20892-9555
Rockville, Maryland 20852 (for courier/overnight mail service)
- Review of requests for membership. The NIDA access committee, a panel of experts comprised of NIH staff who serve to review the applications and advise the NGC Steering Committee, will convene by phone conference to discuss the merit of each request in the context of the existing studies with the NGC. This committee does not replace or supersede the IRG. In the situation where NIDA is unable to provide membership or access to all requests at a given time, the Access Committee will advise the NGC Steering Committee on prioritization of the proposals.
The merit of the request will be determined by:
- Purpose and scope of the funded grant (only NIDA-funded grants will be considered for membership)
- Written plan to contribute biospecimens and phenotypic data
- Data sharing agreement
- Design of study
- Need for the study (overlap with other studies in the NGC)
- Likelihood of finding genetic loci
- Adequacy of power to detect the hypothesized effect(s)
- Operationalization of phenotype
- Operationalization of environmental risk factors
- Notification of decision. Notification will be approximately two months after submission of the request.
- Confirmation of acceptance of membership. Investigators whose request for membership has been approved must confirm acceptance of membership by sending a letter of acceptance to join the NGC, countersigned by the appropriate business official at the investigator's sponsoring institution, to the NGC secretary.
- Submission of grant and site information. New members to the NGC must send a copy of their grant abstract and their site information to the NGC Secretary and to the NCGS (email@example.com).
Q7. Are data sharing plans expected for all human genetic studies of addiction funded by NIDA? (If I am not approved for membership, am I still required to comply to the sharing policies outlined in this FAQ)?
A7. Yes. These sharing plans must describe how data and resources generated by NIDA-funded research will be made available to other qualified individuals in a timely manner. If membership is not approved, NIDA will help guide the investigator to other potential resources or ways in which compliance to NIH and NIDA sharing policies can be maintained.
Q8. What are the data covered under this sharing plan?
A8. Phenotypic and genotypic data is covered and NIDA expects all studies to comply with the NIH Genomic Data Sharing (GDS) Policy (https://gds.nih.gov/).
Q9. What are points to consider for a data sharing plan for membership in the NGC?
A9. An appropriate data sharing plan includes all elements of the NGC Model Data Sharing Plan. * Also see:
NIH Genomic Data Sharing Policy (https://gds.nih.gov/PDF/NIH_GDS_Policy.pdf)
Standard Data Use Limitations (https://gds.nih.gov/pdf/standard_data_use_limitations.pdf)
IRB and Institutions Points to Consider in their Review of Data Submission Plans (https://gds.nih.gov/pdf/PTC_for_IRBs_and_Institutions.pdf)
NIH Genomic Data Sharing FAQs (especially G, H, K, L) (https://gds.nih.gov/13faqs_gds.html)
Central Institutional Review Boards (http://osp.od.nih.gov/sites/default/files/resources/revisedlocalconstext.pdf)
Example Consent Form (https://www.framinghamheartstudy.org/researchers/consent-forms.php)
NIDA Genetics Consortium Model Data Sharing Plan
- Whole blood, blood products or other biospecimens from each subject will be sent to the NIDA Center for Genetic Studies (NCGS). The NCGS will extract DNA and plasma and cryopreserve the lymphocytes where appropriate. If the lymphocyte cell count is low, the NCGS will attempt to create a cell line immediately.
- The NCGS will distribute DNA and plasma only to the principal investigator until the biospecimens are available for sharing. If the principal investigator pays for and receives a copy of a cell line, they may prepare and distribute DNA from these cell lines for himself/herself and his/her collaborators. However, resolving any discrepancies associated with DNA samples that were not prepared by the NCGS will be the responsibility of the principal investigator and at the principal investigator's expense.
- The data provided for each subject will be:
- Subject ID #
- Family ID #
- Site ID #
- Parental ID #s
- Death status
- Ethnicity or geographic origin of ancestry
- Age and/or year of birth
- Twin status
- DSM IIIR-V diagnoses
- PhenX Toolkit addiction assessment
- Instrument used to establish diagnoses
- Answers to all of the questions in the structured interview or, minimally, the answers to those questions from which the addiction diagnoses were established.
- Other descriptive information collected about the drug abuse/addiction phenotypes, such as age of onset, quantity and frequency of peak lifetime use of addictive substances, etc.
- Genotyping data, including the DNA marker names, description of SNPs (single nucleotide polymorphisms) or allele sizes in base pairs and corresponding frequencies, and relative map distances.
- We encourage the inclusion of quantitative measures of substance abuse.
- Data will be verified and regular updates will be provided to the NCGS throughout the project.
- Verified genotyping data will be submitted to the NCGS at the time that the data will be made available for sharing.
- The approved informed consent(s) for this study are consistent with this sharing plan. Annual updates and modifications will be sent as approved by the IRB.
- A statement in the data sharing plan acknowledging that the PI has read and agrees to the term set forth in the FAQ documents.
- A statement describing a timetable specifying when various elements of the database (e.g., diagnostic assessments or genetic data) and DNA will be available for distribution. In general, 6 months after the termination of the grant period, including extensions, or immediately upon first publication of the data, whichever comes first, the NCGS will distribute DNA and data to qualified investigators who have been approved by the NIDA Genetic Data Access Request Committee and who have signed the Distribution Agreement.
- The NCGS will not provide pedigree structures online; instead, a printed copy of the pedigrees will be sent to approved investigators at the time that the investigator is given access to the biospecimens and database.
- The PI will participate in NGC meetings, which are held 2 times per year. Cost for travel to the NGC is included in the PI's grant award.
Q10. What are the important elements to include in my data sharing plan?
A10. See: Data Sharing Plan Checklist (PDF, 103KB).
Q11. What is NIDA's process for approval of data sharing plans and will this be part of the terms and conditions of the Notice of Grant Award?
A11. The process for approval of the data sharing plans is separate from the process for requests for membership, but should be done in parallel to the membership request. The NIDA Genetics Steering Committee will review all data sharing plans for human genetic studies of addiction. The committee will review the adequacy of the data sharing plan and will ask the Institutions to certify that the informed consent is consistent with the data sharing plan. Data sharing plans for non-competing applications will only be re-reviewed if there are proposed modifications to the original plan. The NIDA program official assigned to your application will mediate the review with the NIDA Genetics Steering Committee and will provide final approval of the data sharing plan and determine adequacy and consistency of the informed consent with the data sharing plan. The program official will also be responsible for monitoring your compliance with the plan.
Q12. How will applicants be informed of NIDA's expectations of dissemination of data and biospecimens (DNA)?
A12. As part of the Data Sharing Plan, the applicant shall include a statement indicating that they have read and agree to the terms in the FAQ documents. The applicant is encouraged to speak to their program official or a member of the NGC Steering Committee prior to submission of their application.
Q13. Is NGC membership open to investigators funded by other NIH institutes or funding agencies?
A13. Yes, provided that the application is co-funded by NIDA.
Q14. May investigators apply for administrative or competitive supplements so they can join the NGC?
A14. Yes. Investigators may apply for supplemental funds to join the NGC. Supplemental funds might be requested, for example, to re-contact subjects, hire a phlebotomist, or for other purposes that would make joining the NGC possible.
Q15. Will progress on my grant be reviewed differently if I do or do not become a member of the NGC?
A15. No. Your NIDA Program Official will review and evaluate your scientific progress each year and will make recommendations for continued funding based solely on such scientific progress. Membership in the NGC will have no bearing on this evaluation process.
Q16. If I join the NGC may I decide to withdraw later?
A16. Yes. You may withdraw from the NGC after joining by making such a request when submitting your non-competing renewal (i.e., progress report). However, investigators may not withdraw data and biospecimens already deposited in the NCGS and will continue to have access to their data. Furthermore, you will need to use extant funds to ensure that NIDA's requirements about dissemination of phenotypic data and biospecimens (DNA) resulting from NIDA-funded studies on the human molecular genetics of drug addiction are met. You should not expect that NIDA will provide supplemental funds for this purpose. You must submit a revised data sharing plan. Your revised data sharing plan must be consistent with NIH and NIDA's requirements for sharing phenotypic information and biospecimens (DNA). Finally, biospecimens can be withdrawn and destroyed if the research participant wishes to withdraw from the study, however data that has already been used in published manuscripts cannot be destroyed.
Q17. What is the role of the NGC Steering Committee?
A17. The NGC Steering Committee comprises extramural staff from various divisions and offices within NIDA and other NIH Institutes that co-fund human molecular genetics research on drug addiction. The NGC Steering Committee coordinates meetings and agenda of the NGC (see above) and is actively involved in working with program staff in developing procedures and policies directly related to issues concerning human molecular genetics research at NIDA. The NGC Steering Committee's other major functions are to coordinate other NGC-related matters including requests for NGC membership (see above) and requests for access to data stored at the NCGS (see section B). The NGC Steering Committee reviews and facilitates the process of membership approval and access by ensuring that NIH and NIDA data sharing practices are met and that other application procedures have been completed.
Biospecimen and Data Submission and Access through the NIDA Center for Genetic Studies (NCGS)
Q1. How may investigators gain access to submit samples to the NCGS?
A1. The purpose of the NIDA contract that supports the NCGS is to provide funds for the processing of samples and storing them in the Repository for a variety of drug addiction research. The Repository has a limited budget and a maximum capacity, therefore some proposals may not be accepted into the Repository. If, for budgetary or capacity reasons the contract cannot cover samples to be place in the Repository, it is advised that the PI plan to include the addition of their samples into the Repository as if it were a sub-contract to Rutgers. If the PI includes this alternative method in the grant application, then the samples will be covered either by the contract or the grant if it is awarded. If the NIDA contract can cover the costs and has the capacity, then the budget allocated for that activity in the grant application will be administratively cut.
In the grant application, appropriate language could be, "We plan to request access to the NIDA Center for Genetic Studies for submitting our samples. If the study and the samples are approved, the NIDA contract will provide funds for receiving, processing, storing, and distributing the samples. If the study and samples are not approved, we provide budgetary justification for submitting the samples to the NIDA Repository using funds received through this grant application."
For CTN investigators, ideally the concept for a genetics protocol should be discussed in the very early stages of the parent protocol development so that there is more opportunity for genetics issues to be resolved (i.e. statistical power for low effect sizes, population stratification, etc). Once a concept has been established, the process proceeds in two stages (See attached flow diagram for process). Stage I is the genetics protocol concept approval process and Stage II is the dataset request.
The process may take 2-3 months. Investigators must submit a concept to the Executive Committee for initial comment and approval for proceeding to obtain funding. The proposal should include a detailed budget (for CTN costs), and documentation that the CTN Lead Investigator of the parent study has discussed the plan and is in concurrence with the proposal. In the event that the NGC Repository is unable to accept submission of samples due to budgetary limitations, the budget should also include a contingency to pay for the samples to be submitted to the Repository. If there are sufficient funds, this item in the budget will be administratively deleted, and the NIDA Center for Genetic Studies will pay for those costs. The PI must then obtain funding through regular mechanisms (eg. R01 or other grant mechanism, or administrative supplement). Once funding has been secured, submit the request to the NGC Steering Committee, where it will be sent for review to the NIDA Genetic Data Access Request Committee to request sample and data storage.
Q2. How may investigators gain access to data stored at the NCGS?
A2. Investigators must submit a NIDA Genetic Data Access Request to the NIDA Genetic Data Access Request Committee. Requests should consist of one original plus one copy of the following:
- Cover Letter. A cover letter containing the name, mailing address, e-mail address, fax number, and telephone number of the applicant principal investigator. This letter should be written on the letterhead of the sponsoring institution at which the research is or will be conducted.
- Biographical Sketches. The biographical sketches of the applicant principal investigator and all co-investigators (NIH format).
- Resources and Environment (NIH format).
- Full Disclosure of Funding. Declaration of all sources of public and private funding, periods of support, active/pending status, and relationships with any public or private agency conducting work related to the proposed research. In lieu of the above information, the "Other Support" pages from a NIH format application may be attached.
- Study Description. A description of the study design that includes the following sections:
- Abstract. Summarize the study in no longer than one-half page.
- Specific Aims. Clearly state the hypotheses to be tested.
- Background and Significance. Justify that the hypotheses are of interest to the scientific community and that the resources of the NCGS are essential to the study.
- Method. Provide a clear description, justification, and timetable of the research to be conducted including the DNA (number and amount) and data requirements, the markers to be used and the general methods of analysis. In addition, present evidence of a clear understanding of the limitations, strengths, and feasibility of using the dataset to address the proposed study aim(s).
- Statistical Analysis. Indicate which analytical techniques will be applied, including, when relevant, power calculations to justify the amount of DNA requested.
- Statement of Public Health Good. Identify the public health benefits and risks of the proposed research, and describe how the findings from the proposed research would be used to promote public health.
- Dissemination of Research Findings. Clearly specify the plans to disseminate findings from the proposed research.
- Human Subject Approval. Applicants should provide documentation of IRB review and either approval of the proposed project or exemption of the proposed project from the need for further IRB review, according to the requirements of the Department of Health & Human Services Office for Human Research Protections (OHRP). Although IRB approval will not be required at the time the Access Request is submitted, neither data nor DNA can be released until evidence of IRB approval has been received. Applicants should indicate to their IRB that all data and biospecimens in the repository were stripped of all personal identifiers before they were submitted to the repository, such that no identifying information is associated with the samples.
- A completed Distribution Agreement.
- A completed List of Requested DNA and Associated Data.
The following is the procedure for obtaining approval for a genetics sub-study for a planned CTN protocol:
- Genetics sub-study PI submits proposal to Lead Investigator early on in the conceptual design of the clinical trial. The LI with the development team reviews for feasibility in context of the parent study and assurance that the genetic sub-study will not interfere with completing the parent protocol (i.e. it does not impose undue burden on subjects, staff, etc.; it will not interfere with enrollment, etc).
- PI sends full proposal (see Q5) and letter of support from LI to the Executive Committee (EC) for review of feasibility and resources in the CTN and in context of comments and recommendations from LI makes approval/disapproval recommendation from the CTN perspective. EC can request additional information before the final determination is made. EC sends proposal and review comments to the NIDA Genetics Consortium Steering Committee/NIDA Access Committee for review (*This is done only if PI requests that samples collected are stored in the NIDA Genetics Repository).
- NIDA Access Committee reviews for scientific merit and for feasibility and resources in the NGC and makes final approval/disapproval for samples to be placed in the Repository. The NIDA Access Committee review and decision will be sent to the EC and PI.
Full approval for studies with samples going to the Repository requires both EC and NGC concurrence. Studies with samples collected and stored elsewhere require EC approval only.
If you are a member of the NGC and would like to gain access to either your own data and biospecimens or others data and biospecimens within the consortium, you will need to submit a NIDA Genetic Data Access Request form to Mr. Mark Caulder (firstname.lastname@example.org) for expedited review.
Q3. Where should NIDA Genetic Data Access Requests be sent?
A3. Requests should be sent to:
Mark S. Caulder, M.S., M.P.H.
NIDA Genetic Data Access Request Committee
Genetics, Epigenetics, and Developmental Neuroscience Research Branch
Division of Neuroscience and Behavior
6001 Executive Blvd.
Rm 4271, MSC 9555
Bethesda, MD 20892-9555
Rockville, Maryland 20852 (for courier/overnight mail service)
Q4. What is the NIDA Genetic Data Access Request Committee?
A4. The NIDA Genetic Data Access Request Committee, selected by NIDA staff, is a panel composed of one bioethicist and four other individuals with expertise in one or more areas including human genetics, genetics of complex traits, statistical analysis, molecular genetics and drug addiction research. NIH Program and Review staff members are excluded from membership on the Committee. The Committee has several charges:
For requests to join the NGC and submit samples to the NCGS:
- Does the investigator have a funded grant to cover the sample collection?
- Does the study fill a scientific gap area?
- Is there sufficient power within the sample for the research question to be addressed?
- Is the NIDA contract for the Repository able to cover the costs to add the samples?
- Should the samples/study be granted access to the Repository resource? If yes, should this study take high priority?
For requests to access samples/data:
- Is investigator qualified? (see below)
- Does the investigator have funding for the work proposed?
- Is there an appropriate plan for depositing the data obtained back into the Repository? Can investigator address research question with samples requested?
The following criteria will be used to determine whether an investigator is qualified:
- Experience and qualifications of the applicant principal investigator and co-investigator(s)
- Adequacy of the research environment(s)
- Ethical considerations
- Applicant principal investigator's familiarity with the characteristics, limitations, and strengths of the dataset
- Adequacy of proposed research design, statistical methods, and timetable of proposed project
- Adequacy of the applicant principal investigator's funding resources to support the proposed study
- Benefit to public health
Q5. What happens after Access Requests are approved?
A5. After the NIDA Genetic Data Access Request has been granted approval, an electronic data file, documentation, and pedigree drawings will be sent to the applicant principal investigator. Based upon the information on these forms, the principal investigator must e-mail or fax a list comprised of the identification number for each subject for which DNA is requested. This list must be submitted to the Secretary of the NIDA Genetics Access Request Committee. This list will be forwarded to the NCGS, which will contact the applicant principal investigator regarding shipping and logistics.
Q6. How can I find out what studies are participating in the NGC and contributing phenotypic data and biospecimens to the NCGS?
A6. This information can be found at the NCGS website, which is maintained at Washington University (https://nidagenetics.org).
Q7. I have been told that investigators belonging to the NGC used nested informed consents in which research participants agreed to different levels of access to data stored at the NCGS. Is this true and how does this affect access to data stored at the NCGS?
A7. NIDA and the NCGS must abide by and implement the wishes of research participants as indicated in their nested informed consents. These nested consent forms vary from study to study, but typically include three levels of consent. These levels of consent may restrict access to data to the scope of the original study, to addiction and related medical disorders, or to any genetics study. NIDA will provide the data use limitations of the samples on the NCGS website (https://nidagenetics.org).
Q8. How soon can qualified scientists from around the world gain access to data stored at the NCGS?
A8. Access to DNA and anonymized phenotypic data is dependent upon the data sharing plan of the submitting PI. In general, access can occur if one of the following conditions are met: either 18 months after the ending date of the grant period for the first competitive award (the proprietary period), upon initial publication of the sample set, or upon early release as defined by the investigator. Requests for access will start sometime in 2006. For information on availability of samples, the NCGS website (https://nidagenetics.org).
If you are a member of an active CTN node and you have submitted an access request that has been approved, you can access samples from the Repository as soon as the data are locked. The locking of a database is when all data points are considered to be valid and final. The database is considered final when all cleaning is completed, and no further changes to the database are expected. Only completed studies with a locked database are eligible for data sharing. It is the responsibility of the Lead Investigator of the original study to verify data lock, to carefully review the research project protocol and agree to release the requested data set for the study. No individual study site analyses or publications are permitted prior to publication of the main study findings. Once the acceptance for publication of the main findings from the final dataset occurs, the timely release and sharing of final research data from CTN studies for use by other researchers can occur.
If you are not a member of a CTN node, but have been approved for access, you can access the samples as soon as the main study findings have been published. Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken in the CTN is required. It is expected that the Lead Investigator will have an initial outcome paper completed and submitted to an appropriate peer-reviewed scientific journal within 180 days of data lock for the protocol. Once this occurs, NIH (and therefore NIDA) expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. Any CTN investigator, as well as those outside the CTN structure, will no longer need to follow the procedures outlined in this document but can request the final dataset from NIDA. Procedures for such requests are under development.
Q9. How can I get access sooner than the end of the proprietary period?
A9. You can access the data stored in the NCGS sooner than the end of the proprietary period through collaboration or agreement with the PI by obtaining written approval from the principal investigator who originally submitted the data to the NCGS. This letter must be countersigned by the business official at the principal investigator's institution. The requester must have IRB approval or a waiver of IRB approval from the local IRB to analyze the data. Once written approval has been obtained, a NIDA Access Data Request must be submitted as described above.
Q10. To gain access to data stored at the NCGS, must the Recipient have IRB approval?
A10. Yes. As stated above, applicants should provide documentation of IRB review and either approval of the proposed project or exemption of the proposed project from the need for further IRB review. The IRB approval will not be required at the time the Access Request is submitted. However, no data can be released from the NCGS until evidence of IRB approval has been received.
Q11. Must the Recipient follow the conditions for use of Biospecimens, Phenotypic Data, and Genetic Analysis Data as approved by the Institutional Review Board (IRB) of their own institution and the IRB of the NIDA contractor and subcontractor that operate the NCGS?
A11. The Recipient must follow the conditions for use of Biospecimens, Phenotypic Data, and Genetic Analysis as approved by the Institutional Review Board of their own institution and of the IRB of the NIDA contractor and subcontractor that operate the NCGS in accordance with the United States Department of Health and Human Services regulation at 45 CFR Part 46. Some IRBs may waive IRB approval for studies concerned with secondary analysis of data.
Q12. How soon must the Recipient provide NIDA with any Genetic Analysis Data derived from data stored at the NCGS and received under the conditions of the Distribution Agreement?
A12. The Recipient agrees to provide NIDA, through the NCGS, with any and all Genetic Analysis Data derived from data stored at the NCGS and received under the conditions of the Distribution Agreement within 6-12 months after receipt of such data or upon publication of the research, whichever comes first.
NIDA Distribution Agreement
Q13. When must the Recipient destroy Biospecimens, Phenotypic Data, and Genetic Analysis Data received from the NCGS?
A13. The Recipient must notify NIDA and provide written certification of the destruction of Biospecimens, Phenotypic Data, and Genetic Analysis Data received from the NCGS in accordance with any applicable laws and/or accepted safety procedures upon completion of the project or within 3 years after receipt of phenotypic data and DNA.
Q14. What happens if the Recipient fails to comply with the terms in the distribution agreement?
A14. Failure to comply with any of the terms may result in disqualification of the Recipient from receiving additional Biospecimens, Phenotypic Data, and Genetic Analysis from NIDA, as provided by the NCGS. This disqualification may be posted on the NIDA web site and in the NIH Guide.
Q15. Is there any obligation by the Recipient to collaborate with investigators that contributed data and -biospecimens to the NCGS?
A15. There is no obligation by the Recipient to collaborate with the investigators that contributed phenotypic data and biospecimens to the NCGS. However, the Recipient or Principal Investigator will acknowledge the contribution of scientists who generated Genetic Analysis Data received from the NCGS, in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of these Genetic Analyses of Data.
Q16. Who is liable for demands, damages, expenses, and losses arising out of the Recipient's use for any purpose of Biospecimens, Phenotypic Data, and Genetic Analysis Data received from the NCGS?
A16. The Recipient is liable. Under the Distribution Agreement the Recipient agrees to hold the United States Government, its contractor and subcontractor that operate the NCGS, Submitters, and other Recipients providing Genetic Analysis Data to the NCGS harmless and to indemnify all such parties for all liabilities, demands, damages, expenses, and losses arising out of the Recipient's use for any purpose of Biospecimens, Phenotypic Data, and Genetic Analysis Data received from the NCGS.
Q17. Is the Recipient forbidden from any effort to discover the identity of anonymized subjects from Phenotypic Data and DNA received from the NCGS?
A17. Yes. Under the Distribution Agreement the Recipient will not make any effort to discover the identity of anonymized subjects from Phenotypic Data and DNA received from the NCGS.
Q18. What safeguards are in place to prevent disclosure of subject identities whose biospecimens and phenotypic data are sent and stored at the NCGS?
A18. Several safeguards are in place to protect subject confidentiality. First, biospecimens and phenotypic data sent to the NCGS are stripped of all subject identifiers and given a code by the Principal Investigator sending the samples. The NCGS then provides a new identifier number for the sample and informs the Principal Investigator of the new identifier number that corresponds to the code given by the Principal Investigator. Any samples containing subject identifiers submitted to the NCGS are returned immediately to the investigator. Second, a Certificate of Confidentiality also covers the NCGS. This protects the NCGS from court orders and subpoena to release information from the NCGS in most cases. Third, the NCGS must operate in accordance with the United States Department of Health and Human Services regulation at 45 CFR Part 46 concerning human subjects and its local institutional review board. Fourth, anyone given access to phenotypic data and DNA is forbidden to attempt to discover the identity of the research participants from DNA and biospecimens obtained from the NCGS. This is stipulated as a term and condition in the Distribution Agreement.
Q19. What assurance to the investigator and their subjects is there that NIDA will handle the phenotypic data and biospecimens (DNA) as indicated in the data-sharing plan?
A19. The data-sharing plan becomes part of the notice of grant award (NGA). The NGA is a contractual agreement between the investigator's institution and NIDA. The NGA cannot be changed except by mutual agreement between the investigator's institution and NIDA. NIDA is also legally bound to follow the United States Department of Health and Human Services policy regarding protection of human subjects.
Q20. Has there ever been a breach of confidentiality by the NCGS?
A20. No. There has never been a breach of identity of research participants in over 50,000 samples for all projects collected as of Jan 1, 2005.
NIH and NIDA Data Sharing Policies
Q1. Where can I find NIH and NIDA Data Sharing Policies?
A1. NIH and NIDA Data Sharing Policies can be found at the links below.