Ancillary Studies
| Definitions | |
| “Parent Study” | An NHLBI-funded parent study is a grant, contract, or other transaction (OT) award in which NHLBI is the sole or primary funder and the NIH Institute issuing the award. |
| “Ancillary Study” | A project that is funded by a grant, contract, OT, Industry, Foundation, or other award would be ancillary to an NHLBI-funded parent study if the investigator collects new information beyond what has been proposed under the parent study or derives new information from existing resources by leveraging data, biospecimens, images, interaction with participants, or other resources directly from the NHLBI administered parent study. |
Q: What are the responsibilities of the NHLBI parent study in sharing data collected or derived from ancillary studies?
A: The parent study coordinating center or data management center will deposit ancillary study data into an approved NIH repository. This includes data from ancillary studies and data collected from parent study activities such as clinical/home/remote visits, follow-up contacts, adjudicated or derived outcomes, or assays directly funded under the main award. If an ancillary study award extends past the project period for the parent study AND the parent study does not receive renewal funding, then the ancillary study investigator will submit the data collected from the ancillary study directly to the repository the parent study was using.
The parent study will develop ancillary study and publications and presentations (P&P) policies that conform with the approved Data Management and Sharing Plan and clearly communicate to internal and external investigators the expectations for complying with NIH/NHLBI data sharing policies. These ancillary and P&P policies will define timelines for the submission by ancillary studies of scientific data and appropriate documentation to the parent study so the parent study can ensure their integration into its database for deposition into the approved repository according to its approved Data Management and Sharing Plan.
NHLBI-administered parent studies must comply with the data management and sharing policies and supplements effective when the funding application was submitted and the data management and sharing terms and conditions included in their awards unless directed otherwise by NHLBI.
- For parent studies with new or renewal applications submitted prior to January 25, 2023, refer to the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies.
- For parent studies with new or renewal applications submitted between January 25, 2023, and May 24, 2023, refer to the NIH Data Management and Sharing Policy.
- For parent studies with new or renewal applications submitted on or after May 25, 2023, refer to the NHLBI Supplement to the NIH Policy for Data Management and Data Sharing.
Q: What are the responsibilities of the ancillary study investigator in sharing data derived from ancillary studies?
A: NHLBI expects ancillary studies to adhere to NIH and NHLBI data-sharing policies regardless of funding source, as outlined in the agreement between the parent and ancillary study. Any limitation on sharing must be communicated to the parent study and strongly justified (for example, Tribal sovereignty, consent restrictions). Ancillary studies funded through an NIH application submitted on or after January 25, 2023, are subject to the NIH DMS Policy and require a Data Management and Sharing (DMS) Plan. DMS plans will be reviewed by the NIH. Ancillary study DMS Plans must clearly reference the relevant parent study approved repository and parent study policies, as well as the ancillary study investigator’s planned adherence to those policies. Changes to an NIH DMS Plan for an ancillary study must be discussed with the parent study before NIH submission and approval.
Ancillary studies that are subject to the NIH DMS Policy prior to the parent study are not expected to share scientific data if it would conflict with the sharing policies or plans of the parent study or agreements entered into with the parent study, as noted in the ancillary study FAQ for the NIH DMS Policy.