Q. Do the Genomic Data Sharing (GDS) Policy and/or the NIH Data Management and Sharing (DMS) Policy apply to my NHLBI grant application or NHLBI-funded project?
A. NHLBI is part of the National Institutes of Health (NIH), so research funded by the NHLBI is subject to the NIH GDS Policy and the NIH DMS Policy.
To determine if the NIH GDS policy applies to your NHLBI application or funded project, see When does the NIH GDS Policy Apply to My Research. NHLBI also developed a decision tree to help NHLBI investigators determine whether the DMS or GDS policy applies to their research.
For DMS policy applicable datasets below the GDS policy threshold, please contact your program officer or NHLBI’s Genomic Program Administrator at nhlbigeneticdata@nhlbi.nih.gov to discuss appropriate protection, possibly through controlled access.
When is an institutional certification needed?
If GDS Policy applies to your application, NHLBI will collect an Institutional Certification during the Just-in-Time (JIT) process. NHLBI collects these certifications when data to be submitted are generated from human samples so that the sharing arrangement aligns with participants’ informed consent and to mitigate other risks associated with genomic data sharing.
To ensure that parent studies’ consent structure is appropriately reflected for ancillary studies that are likely to be linked with genomic data in dbGaP, NHLBI may discuss controlled access data registration strategies and appropriate documentation for data protection. Please contact NHLBI’s Genomic Program Administrator at nhlbigeneticdata@nhlbi.nih.gov or your program officer if you have questions about the applicability of the GDS policy.
What happens if my NHLBI grant application did not or will not meet NIH’s consent expectation and the data generated will be GDS policy applicable?
When an investigator submits an application that does not meet NIH’s consent expectation and the data will be GDS policy applicable, the investigator may apply for approval for Compelling Scientific Reason for not having consented data. However, the Compelling Scientific Reason approval request is very rarely considered and approved, It will require a dedicated institutional certification form. If approved, investigators must provide an appropriate data management and sharing plan outlining appropriate limitations on sharing under that condition by Just-In-Time.
Should I submit my small-scale rare diseases and special population data?
Yes, NHLBI expects submission of genomic data from smaller scale research projects for rare diseases and special populations. NHLBI acknowledges the high value of rare diseases or special population data. Submission of such valuable NHLBI-funded data to BioData Catalyst (See 5.1 Data Repositories) is encouraged. Examples of such small-scale datasets include:
- Any NHLBI-funded genomics dataset with fewer than 100 participants in the sample from a special population (e.g., either as a subsample of a larger study or a study focused on patients in the special population category). Special populations include, but are not limited to, women (non-pregnant and pregnant), pediatric patients, and elderly persons.
- Any NHLBI-funded rare disease-focused genomics dataset (see above for the list) with five or more individuals.
- For data with fewer than 10 participants, posting genomic summary results should be registered as “not allowed.”
- For datasets with special or rare disease population samples, add IC-specific terms and conditions shown below:
- “Use for research that promotes discriminatory treatment of the special or rare disease population is not allowed.”
The National Center for Advancing Translational Sciences’ Genetic and Rare Diseases Information Center offers a browsable list of many rare diseases. The following links go to lists of rare disease examples in categories related to NHLBI’s research areas.
Blood: https://rarediseases.info.nih.gov/diseases?category=Blood%20diseases&page=1&letter=&search=
Heart: https://rarediseases.info.nih.gov/diseases?category=&page=1&letter=&search=heart
Respiratory: https://rarediseases.info.nih.gov/diseases?category=Respiratory%20diseases&page=1&letter=&search=lung
Sleep: https://rarediseases.info.nih.gov/diseases?category=&page=1&letter=&search=sleep