Resource Sharing Expectations in NIH-Funded Research Bruce Elliott Executive Director

1. Resource Sharing Expectations in NIH-Funded Research Bruce Elliott Executive Director OSR – Chicago June 7, 2011

2. What is the Basis of NIH’s Policies and Expectations? • Reinforces open scientific inquiry, encourages diversity of analysis and opinion, promotes new research, facilitates education of new researchers, enables exploration of new topics not initially envisioned, permits creation of new datasets when data combined them, allows review by other scientists, giving them the opportunity to verify results by attempting to reproduce them; and then extend them(scientific method; creation of new knowledge) • NIH policy that PIs and universities are expected to make the results and accomplishments of their activities available to the research community and to the public at large

3. NIH Expectations Consistent with NU’s Position on Openness in Research • NU committed to openness in research - principle of freedom of access by all interested parties to underlying data, processes, and final results of research • NU does not conduct secret / classified research or work-for-hire projects • NU won’t accept projects that restrain its freedom to disclose: • Existence of grant or contract • General nature of inquiry to be conducted • Identity of sponsor • The research results • NU doesn’t accept publication restrictions • NU owns intellectual property developed with NU resources • Reasonable best efforts

4. What Kinds of Data are Candidates for Sharing? • Data • Unique research resources • Model organisms • Genome-wide association studies • IP (inventions and patents) • Publications

5. Resource Sharing Plans • Data Sharing Plan • All data should be considered for data sharing: Data sharing requirement of all NIH-funded grants • Proposals requesting >500K DC in any year expected to include data sharing plan or explanation of why one isn’t feasible • Some PAs may request data sharing plan regardless of amount of direct cost • Sharing Model Organisms • Not subject to 500K threshold • All applications proposing to develop model organisms must have plan or explain why sharing is restricted or not possible • Genome-Wide Association Studies • All applications proposing to develop model organisms must have plan or explain why sharing is restricted or not possible • Reviewers comment on whether plans are reasonable but does not affect overall impact score • Becomes a term and condition of the award

6. What Are Final Research Data? • Recorded information, regardless of form or media on which it may be recorded (data files, writings, recordings, drawings, designs, graphic representations, diagrams, flow charts, computer software)commonly accepted in the scientific community as necessary to document and support research findings. • Data from human subjects (e.g., surveys, clinical studies) also can be shared if the identity and privacy of research participants can be protected.

7. What Are Final Research Data? • Preliminary or raw data without analysis is not included for access by the general public. • Does not include laboratory notebooks, partial datasets, preliminary analyses, or physical objects, such as gels or lab specimens. • Data does not mean summary statistics or tables. It means the data on which summary statistics and tables are based.

8. Unique Data • Data that can’t be readily replicated • Large surveys • Studies of unique populations, e.g., centenarians • Rare metabolic diseases • Studies conducted at unique times, e.g., disasters

9. Model Organisms • All applications in which development of model eukaryotic organisms is anticipated need to have specific plan for sharing and distributing, or state why sharing is restricted or not possible • Required for all applications: Not subject to cost threshold of 500K

10. Genome-Wide Association Studies (GWAS) • Any study of genetic variation across the entire human genome that is designed to study associations with observable traits (e.g., blood pressure, weight), or presence or absence of a disease • Data sets valuable not only for addressing questions the grant was designed to answer but have added value when combined with other large data sets • All applications regardless of requested cost expected to include plan for submission of data to GWAS repository or explanation as to why this is not possible

11. GWAS and Privacy Concerns • Potential for public benefit of GWAS data significant but concern about sensitive nature of data • Risk of developing particular disease • Information that might be socially stigmatizing • Information regarding paternity and ancestry • Implications for other family members • Non-use of research data • Freedom of Information Act (FOIA) requests

12. GWAS and Privacy Concerns • Role of Informed Consent • Importance of Informed consent for safeguarding interests of research participants essential component of any data sharing policy • Disclose to subjects that data will be shared • Subjects can opt to withdraw at any time • Sensitive data can be shared as long as safeguards are in place • De-identification of submitted data • Institution has no knowledge that information used alone or together with other data can be used to identify subject (deductive disclosure) • Certificate of Confidentiality recommended

13. When Must You Share Data? • NIH continues to expect that the initial investigators may benefit from the first and continuing use, but not from prolonged exclusive use • When the research findings have been accepted for publication or after they have been provided to NIH

14. Data Retention • Investigators must retain raw data in laboratory notebooks or records for purposes of validating research findings. The raw data serves other purposes such as patent applications and misconduct investigations. • NIH policy to retain data 3 years • University Compliance Committee presently determining policy for retention of data • NU must have access to data for PIs that leave NU • NIH has royalty free, non-exclusive license to reproduce, publish, or otherwise use material and to authorize others to do so • Caution: might be a problem for a project co-funded by industry with constraints on public disclosure • Delays of 30-60 days for IP generally considered reasonable

15. Methods for Data Sharing • Depends on nature of work and type of data • PI can send data on CD • Material transfer agreements (MTAs) • Data archives • Data sharing agreements

16. Material Transfer Agreements (MTAs) • Contracts that govern the transfer of research materials between two organizations. • Defines the rights of the provider and the recipient with respect to the materials and any derivatives. • Three types of MTAs are most common. Each calls for different terms and conditions • Transfer between academic or research institutions • Transfer from academia to industry • Transfer from industry to academia • More on MTAs and CDAs at an upcoming

17. Data Repositories • NIH GWAS data repository • PI has exclusive rights for 12 months • All data and conclusions derived will remain freely available without licensing requirements • Other repositories • Other unique resources such as DNA protein sequences, and crystallographic coordinates required to be stored in repositories such as ATCC, GenBank, Protein Data Bank, Open Crystallographic database.

18. Elements of Data Sharing Plan • IP will be administered in accordance with university and NIH policies • Ownership of sole inventions will be owned by institution • Joint inventions based on mutual consent • Institutions will disclose inventions to NIH • No warranties offered • Restrictions against attempting to identify subjects • Destruction of data after analyses completed • Restrictions on redistributing data to third parties • Proper acknowledgment • Contact OSR for examples

19. Example 1 • This application requests support to collect public-use data from a survey of more than 22,000 Americans over the age of 50 every 2 years. Data products from this study will be made available without cost to researchers and analysts. https://ssl.isr.umich.edu/hrs/ • User registration is required in order to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Registered users will receive user support, as well as information related to errors in the data, future releases, workshops, and publication lists. The information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.

20. Example 2 The proposed research will involve a small sample (less than 20 subjects) recruited from clinical facilities in the NYC area with Williams syndrome. This rare craniofacial disorder is associated with distinguishing facial features, as well as mental retardation. Even with the removal of all identifiers, we believe that it would be difficult if not impossible to protect the identities of subjects given the physical characteristics of subjects, the type of clinical data we will be collecting, and the relatively restricted area from which we are recruiting subjects. Therefore, we are not planning to share the data.

21. Publications and NIH Public Access Policy • All investigators funded by the NIH must submit to the NLM’s PubMed Central an electronic version of their final peer-reviewed manuscripts upon acceptance for publication no later than 12 months after the official date of publication

22. Discussion Bruce Elliott 3-1780 b-elliott@northwestern.edu