Data Use Certification
(An Appendix to the Data Access Request)
Introduction and Statement of Policy
The Medical Sequencing Program (MSP) was implemented by the National Human Genome Research Institute (NHGRI) with the goal of identifying genetic variants that contribute to diseases of major public health importance by sequencing samples from existing studies that include large numbers of affected and unaffected individuals. Implicit in the MSP is the view that scientific progress in this area will be greatly enhanced if the data that are produced by the program are readily available to all investigators in the research community.
MSP Project Datasets (See: Medical Sequencing Project and Current Initiatives) to be distributed under this certification process will be coded. However, due to the nature of the sequence data, and in some cases, the phenotype data, it may be possible, in principle, to use the data to identify an individual research participant. Thus, these data will only be provided to investigators who, along with their institutions, have certified their agreement with the requirements and terms of access detailed below. It is the intent of the NHGRI that Approved Users of MSP Project Datasets should recognize the restrictions on data use imposed by the original informed consent agreements of Contributing Studies.
To promote the responsible use of the MSP Project Datasets all investigators and their institutions seeking access shall acknowledge their agreement with the MSP Policies and Procedures described on the NHGRI Web site, which are articulated within this Data Use Certification. For collaborative projects, any independent collaborating investigator shall complete a separate Data Access Request (DAR) if that collaborating investigator is from a separate institution. If investigators are from the same institutions, multiple Data Use Certifications may be submitted under a single DAR.
Definitions of terminology used in these documents are found in the MSP Glossary.
Terms of Access
1. Requesting Investigator ("Requester")
The Requester has reviewed and understands the guiding principles for responsible research use and data handling of the data included within MSP Project Datasets as described in the on-line material provided through the NHGRI Web site.
2. Research Use
The Requester agrees that he/she shall use the MSP Project Dataset solely in connection with the research project described in the Data Access Request submitted through the MSP website, which includes the project title, the Requester’s name and institution, the names of any Major Collaborators and their institutions, and a brief description of the research objectives. New uses of these data outside those described above will require submission of a new DAR; substantive modifications to the research project will require submission of an amendment to this application. The Requester further agrees that he/she shall use the MSP Project Dataset(s) only in accordance with the parameters described on the MSP website for appropriate research uses, and any limitations on such use, of this dataset. The Requester and his/her institution further acknowledge that they are responsible for ensuring that all uses of the data are consistent with federal, state, and local laws and regulations and any relevant institutional policies.
It is anticipated that, at least in some cases, the MSP Project Datasets will be updated with additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of the MSP Project Datasets.
The Requester agrees not to use MSP Project Datasets, or any other information, to identify or contact individual participants from whom phenotype data and DNA samples were collected.
The Requester agrees to retain control over the data, and further agrees not to distribute the individual data in any form to any entity or individual other than his/her research staff, who also agree to the terms within this Data Use Certification, subject to applicable laws and regulations.
The Requester agrees that if he/she changes institutions then a new Data Access Request and appended Data Use Certification will be submitted and approved before data use resumes. Any versions of data stored at the prior institution will be destroyed.
5. Computer Security
The Requester agrees to store MSP data only on computers with adequate security controls, to adhere to practices that ensure that only authorized individuals can gain access, and to maintain appropriate control over any copies of the data.
In the event of a breach of confidentiality, Approved Users are required to report the breach on the same day it is discovered. Reports should be made by contacting the NHGRI Data Access Committee by e-mail (NHGRIDAC@mail.nih.gov). The report must include all known information regarding the breach as well as a description of plans for further investigation and immediate remediation.
The NHGRI or other entity designated by the NHGRI may also investigate such breaches. Approved Users and their associates will be required to support such investigations and provide information, within the limits of applicable local, state and federal laws and regulations.
6. Intellectual Property
By requesting access to MSP Project Dataset(s), the Requester and his/her home organization (Requesting Institution) acknowledge the intent of the NHGRI to see that Approved Users follow the NHGRI/MSP intellectual property policy as summarized below:
- Achieving maximum public benefit is the ultimate goal of NHGRI/MSP. NHGRI believes that MSP data should be considered as pre-competitive, and urges users to avoid making IP claims on the data. However, NHGRI also recognizes the importance of the later development of IP on downstream discoveries, especially in therapeutics, which will be necessary to support full investment in products that the public needs.
- It is expected that MSP data and conclusions derived therefrom will remain freely available, without requirement for licensing. While NHGRI recognizes the value of patents in developing downstream products that benefit the public, the intent of the NHGRI is to discourage the use of patents in a manner that would prevent use of or block access to any fundamental data that are developed with NHGRI support. The NHGRI encourages broad use of MSP Datasets in a manner consistent with a responsible approach to management of intellectual property derived from downstream discoveries as outlined in NIH's Best Practices for the Licensing of Genomic Inventions [ott.nih.gov] and in the NIH Research Tools Policy [grants.nih.gov].
While NHGRI/MSP seeks to accelerate the rapid advancement of scientific knowledge through publication, it recognizes the effort that the Contributing Investigators and their institutions have made in obtaining the Submitted Samples and the associated Submitted Data that were the basis for the MSP Project Datasets. NHGRI considers that the MSP data are unpublished data until the Contributing Investigator publishes a paper describing the results of a particular MSP project, specifically in this case, results describing the association of a variation with a phenotype. Approved Users are asked to apply the normal standards of scientific etiquette when deciding to publish results (association of a variation with phenotype) based substantially on unpublished data. Contributing Investigators are asked to keep in mind that they have a reciprocal responsibility to publish significant results rapidly.
8. Research Use Reporting
In order to ensure that NHGRI/MSP policies and procedures for participant protection and data use are adhered to, Approved Users agree to provide annual feedback on how the MSP data have been used and any results such as publications and patents that have been generated as a result of access to the data. This information will be used by the NHGRI Data Use Review Board (DURB) (See Page 17 in PDF, section titled Data Use Review Board) provide ongoing, independent oversight of all MSP Project Dataset use and by NHGRI staff as required for program oversight and management activities.
Approved Users thus agree to provide a brief report on the research specified within this DAR. Requesters that were previously Approved Users (that is, those seeking renewal) will be asked to provide specific information in the renewal DAR. Those not seeking renewal will be asked to complete only a specific reporting section of the DAR. The report will be in an automated format, and will ask questions regarding publications that resulted from the use of MSP data, potentially adverse events for research participants, breaches in security of data (for example, accidental distribution of data beyond Approved Users), information on any intellectual property generated as a result of the data, and any return of research results to research participants (in cases where the Approved User is also a Contributing Investigator). Approved Users may be asked to provide general comments regarding the effectiveness of MSP, such as ease of access and use, appropriateness of data format, challenges in complying with MSP policies, and suggestions for improving MSP data access or the program in general.
9. Dissemination of Research Results and Acknowledgments
It is the intent of NHGRI to promote the dissemination of analyses of MSP Project Dataset(s) as widely as possible. Requesters are strongly encouraged to publish their results in peer-reviewed journals.
The Requester agrees to acknowledge NHGRI, the Contributing Investigator(s) who contributed the phenotype data and DNA samples from his/her original study, the Sequencing Center, and the primary funding organization that supported the contributing study in all oral and written presentations, disclosures, and publications resulting from any analyses of the data. The Requester further agrees that the acknowledgment shall include a reference to the specific version of the MSP Data analyzed.
The Requester also acknowledges that the Contributing Investigator(s) have made a significant contribution to the research project, and that scientific etiquette calls for that contribution to be respected. Thus, not only should that contribution be acknowledged in any manuscript submitted for publication by the requester, the requester should also consider whether the Contributing Investigator should be afforded the opportunity to publish her/his work first, if that is done within a reasonable period of time.
10. Non-Endorsement, Indemnification
The Requester and his/her institution acknowledge that although all reasonable efforts have been taken to ensure the accuracy and reliability of the MSP data, NIH, NHGRI, Sequencing Centers, and Contributing Investigators do not and cannot warrant the results that may be obtained by using any data included therein. NIH, NHGRI and all contributors to the MSP dataset disclaim all warranties as to performance or fitness of the data for any particular purpose.
No indemnification for any loss, claim, damage or liability is intended or provided by any party under this agreement. Each party shall be liable for any loss, claim, damage, or liability that said party incurs as a result of its activities under this agreement, except that the NIH, as an agency of the United States, assumes liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. 2671 et seq.
11. Termination and Violations
This Data Use Certification will be in effect for a period of one year from the date the data were made accessible to the Approved User. At the end of this time period, the Approved User agrees to destroy all copies of MSP Project Datasets.
Consideration will be given to a renewal of this agreement upon submission of a new DAR.
NHGRI may terminate this agreement and immediately revoke access to all MSP Project Datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of MSP.
Contributing Investigators who provided the Submitted Data and Submitted Samples used to generate a particular MSP Project Dataset are exempt from certain provisions of this Data Use Certification, as follows:
- Contributing Investigators are exempt from Terms of Access, provision 2 (Research Use) for the original phenotype data (the Submitted Data), but this provision will apply to any portion of the dataset that contains sequence data or sequence-phenotype association data.
- Contributing Investigators are exempt from Terms of Access, provision 3 (Non-Identification), if they have appropriate institutional approval to retain the participant identities and to re-contact participants, and only for those subjects from whom that investigator originally supplied samples.
- Contributing Investigators are exempt from Terms of Access, provision 6 (Publication).
The statements below summarize the terms and conditions of data use for the reader's convenience and under no circumstance substitute for the specific certifications described.
The Principal Investigator and this Institution make the following assurances:
- The MSP dataset will be used solely in connection with the research project as described in the statement of intent for this request.
- The Institution has considered any participant protection issues and agrees that the research can go forward.
- No efforts will be made to attempt to re-identify the participants in this Research.
- There will be no transfer of restricted MSP data to any other investigators/institutions (except between collaborating investigators in the applicant institution as listed in Appendix 2 and research assistants, students, post-doctoral fellows, etc. who answer directly to the PI).
- To prevent accidental transfer of restricted MSP data, adequate security controls are in place (e.g. secure lap tops and mass storage devices; no download to unsecured network drives or servers).
- To respect the precompetitive nature of MSP datasets in considering claims of intellectual property derived from use of these data and to adhere to the tenets of NIH’s Best Practices for the Licensing of Genomic Inventions.
- To provide to NHGRI a report on uses of the data, e.g., publications, on an annual basis.
- To acknowledge the MSP dataset, the NHGRI, the large-scale Sequencing Centers, and the Contributing Investigator in any publication or presentation resulting from the use of the dataset.
- That all collaborating investigators in the applicant institution, as listed in the Data Request form, agree to the conditions specified in the Data Use Certification (DUC).
By submission of a Data Access Request form, the Requester and Authorized Institutional Official represent and warrant the Requester’s qualifications for access to and use of MSP Project Dataset(s) and certify their agreement to the NHGRI principles, policies and procedures for the use of MSP Project Datasets as articulated in this document. Requesters further acknowledge that they have shared this document and the MSP policies and procedures with any research staff who will participate in their use. Authorized Institutional Officials also acknowledge that they have considered the relevant MSP policies and procedures and have assured compliance with local institutional policies related to technology transfer and human subjects research.
Last Reviewed: October 19, 2011