Policy for Sharing Resources and Data From Studies on the Genetics of Alzheimer's Disease
Background
NIH advocates publicizing the results and accomplishments of its activities. NIH assures research resources developed with public funds become readily available to the broader research community in a timely manner for further research, development, application, and secondary data analysis for the development of products and knowledge of benefit to the public health. Shared resources include data, collected biological materials, and pertinent methods of analysis. Whenever possible, research resources should be made available to qualified investigators. Compliance with these policies is an important requirement of an NIH award.
Although NIH policy (http://www.grants.nih.gov/grants/policy/data_sharing/) is applicable to awards exceeding $500,000 in any one year, NIA has instituted a sharing policy in human Alzheimer's disease genetics that applies to all NIA-funded research in Alzheimer's disease genetics, regardless of cost.
- Principal investigators (PIs) should discuss their data sharing plan (possible reasons why they cannot share final research data prior to application or proposal submission) with their program official.
- Program officials will be responsible for assessing the appropriateness and adequacy of any proposed data sharing plan prior to award and may allow a study to waive a data sharing plan under exceptional circumstances.
- Documentation of agreement to comply with the terms and conditions for this award must be sent to the NIA program official within 15 calendar days of receipt from the NIA of the Guidance for Sharing in Studies on the Genetics of Alzheimer's Disease document.
Implementation
NIA has a Genetics Initiative to assist in the identification of the risk factor genes for Alzheimer's disease. Investigators are encouraged to use the NIA-supported the National Cell Repository for Alzheimer's Disease (NCRAD) at Indiana University (http://ncrad.iu.edu). NCRAD is a national repository that facilitates access by qualified investigators to samples and associated phenotypic data for studying the genetics of late onset Alzheimer's disease. More information can be obtained from the Web site or through an NIA Neuroscience and Neuropsychology of Aging program official.
A Cell Bank Advisory Committee to NCRAD, NCRAD staff, and NIA staff collaborated to establish:
- Eligibility criteria
- Guidance on protection of human subjects, confidentiality, and compliance with relevant laws and regulations
- Operating procedures for the sharing of biological samples and associated phenotypic data.
NIA Policy
Useful specimens and associated phenotypic data for the genetics of late onset Alzheimer's disease be deposited at NCRAD whenever possible.
- Qualified investigators can use biological samples and associated phenotypic data supplied by NCRAD.
- Application for use will be made directly to NCRAD.
- Genetic data derived from the use of these samples and associated phenotypic data will be deposited in an NIA-supported genetics data repository.
- Exemptions to providing a sharing plan will be considered by NIA staff with proper justification.
- Reason(s) for requesting that samples not be deposited at NCRAD must be clearly stated in writing.
Sharing Biological Samples
Sharing biological samples and associated phenotypic data between the PI and other qualified investigators (other than through NCRAD), including sharing with for-profit entities, should be accomplished via a simple letter of agreement (SLA). See: http://ott.od.nih.gov/NewPages/RTguide_final.html for more information.
- NIA requests a copy of any pre-existing SLAs that apply to the samples associated with this award.
- Existing SLAs should be mailed to the NIA program official with a signed sharing plan agreement.
- Sharing biological samples, associated phenotypic data, and resources through NCRAD should be accomplished through the NIH-approved Material Transfer Agreement (MTA) for transferring biological samples to NCRAD.
- The NIH-approved MTA template is available from the program official responsible for the award.
What Should Study Subjects Be Aware of?
Subjects participating in a specific study must: (1) be informed of the study's purpose, including the measures developed for protecting confidentiality; (2) give appropriate consent to participate in the study; and (3) provide authorization for the sharing and archiving of deidentified samples and associated phenotypic and genetic data for qualified investigators' use.
How Should DNA Samples and Phenotypic Information Be Treated?
For DNA samples and phenotypic information stored at the parent institution, the consent process should document permission for sharing of samples and selected associated phenotypic data with qualified investigators, as determined by a local advisory board. A copy of the Institutional Review Board-approved consent form must be sent to the program official responsible for this award within 15 calendar days of approval.
When Should Biological Samples Be Released to Investigators?
Biological samples—with relevant subsets of associated phenotypic data and genetic data resulting from the research—should be released to qualified investigators no later than within 1 year of the completion of the funded project period for the parent award, immediately upon publication of a subset of data, or upon public disclosure of a submitted patent.
What Needs To Be Documented?
For biological samples and for associated phenotypic data, a record of requests for data and biological specimens including relevant names and institutions must be documented and retained by the investigator. This record also should be reported with the annual progress report for the noncompetitive renewal of the funded award. Investigators will be asked to place genetic outcome data in an NIA-supported genetic data repository.
Where Can I Find More Information on Sharing Policies and Patent Issues?
Consult the following Web sites and links for information related to sharing policies and patent issues:
The following links define the terms, parties, responsibilities for sharing; prescribe the order of disposition of rights; prescribe a chronology of reporting requirements; and delineate the basis for and extent of government actions to retain rights (1999):
