Ancillary studies to REGARDS are welcomed and encouraged. The ancillary study process Ancillary Study Key Stages is for the protection of REGARDS participants, staff, and other ancillary study investigators and is designed to ensure project aims do not overlap with previously approved ancillary study aims. The process also protects the biorepository, minimizes participant burden to promote retention, and verifies that methods are a logical use the cohort given that REGARDS does not have in person clinics. Ancillary studies are reviewed by the Steering Committee. Additional review by the NINDS-appointed Observational Studies Monitoring Board (OSMB) is required if participants are being recontacted.
Definition: An ancillary study is defined as a project that will be submitted for funding that utilizes participant data, biosamples, and/or medical records for aims that are separate from the aims of the parent study. An ancillary study may also include new data to be collected from participants or linkages to other datasets using confidential participant identifying information. An ancillary study is different from work done in pursuit of a manuscript in that ancillary studies have funding attached to completion of the work, e.g., grants, internal pilot studies, industry sponsorship, fellowships, or other funding opportunities.
Process:
- Investigators are encouraged to submit a REGARDS Ancillary Study Concept Sheet to receive support and guidance from REGARDS Investigators and/or REGARDS Working Groups before starting the process of the Ancillary Study Proposal. While this is optional, it can save time for the investigators and provides an opportunity for important feedback before beginning the grant writing process.
- The completed Ancillary Study Proposal Form is submitted online here: https://dcsapps.ad.uab.edu/Regards .
- All ancillary studies must adhere to data sharing and publication requirements for the parent study found here
Timing: The REGARDS Steering Committee needs to review the ancillary study proposal before the proposal is developed into a grant application. The Ancillary Study Proposal Form must be submitted to REGARDS at least 8 weeks prior to submission to the funding agency.
Components of the Ancillary Proposal
1.) Participant burden - Any contact with participants that lasts longer than 5 minutes or any contact that involves in-person data collection will require review by both the REGARDS Steering Committee and the NINDS OSMB.
2.) Biosamples - Total volume should be as low as possible. Your proposal will be given full consideration, alongside our ongoing commitment to maintain adequate biospecimen reserves for future REGARDS investigations. Investigators must contact the REGARDS Central Blood Laboratory to discuss considerations related to biological samples before preparing their proposals and must also fill out the biospecimen form here: REGARDS Ancillary Study Proposal Form for Studies Proposing to use the Biorepository
3.) Methods - A clear concise ancillary study proposal should describe the funding mechanism, the aims of the work, the number of participants needed and inclusion/criteria, and the reasoning for why REGARDS over other studies or datasets. Incomplete methodology may result in delays reviewing your proposal.
4.) Coordinating center resources – Some ancillary studies require parent study (coordinating center at UAB) infrastructure to complete the aims. Investigators should describe how the proposed ancillary study will impact the coordinating center. Coordinating center involvement must be described in detail as well as plans in place to cover coordinating center costs (i.e., sufficient budget to cover costs to the coordinating center). Typical items that require coordinating center resources are: adding questions to the computer assisted telephone interview (CATI), requesting additional participant visits, pulling medical records for new outcomes, linking external datasets to REGARDS datasets, data management, and statistical analyses.
IRB Considerations: NIH studies now fall under the single IRB mandate.
Option A (studies that obtain new consent): If the investigator is planning to collect primary data that requires additional consenting of the participant, UAB will need advance notice to confirm that the UAB IRB is able to serve as the IRB of record. Adequate funding is needed to support single IRB activities at UAB. These funds range between $8,000 and $16,000 per year depending on the number of sites that will be included in the single IRB application. If an investigator has questions about the process for the single IRB, the best way to get started is by filling out the Ancillary Study Concept Sheet to begin discussions with REGARDS study investigators and Working Group chairs. As noted in the Ancillary Study Key Stages process webpage, discussions about the IRB process immediately.
Option B (studies that do not involve obtaining new consent): Investigators conducting secondary data analysis, measuring new biomarkers, or collecting data that does not require consent need to complete a single IRB at their home institution and list UAB as a reliant site. Investigators will need to provide approval from their local IRB to confirm that their local IRB is willing to serve as the IRB of record and confirmation that associated fees are included in the budget.