- What is an Ancillary Study?
An ancillary study (AS) is any study that may request additional new data or biosample collection from RURAL Cohort Study participants or any previously collected data (of any kind) from RURAL participants. AS include those with the goal of secondary data analyses if funding is sought, and analysis of collected data for hypotheses related and unrelated to the central goals and aims of the RURAL Cohort Study.
All AS must be reviewed and approved by RURAL’s Ancillary Studies Subcommittee and Steering Committee. AS requiring the use of a third-party data and/or materials transfer agreement requires approval from the National Heart, Lung, and Blood Institute (NHLBI). AS that are not funded by the current RURAL U01 grant and AS investigator(s) must often seek additional funding. The AS approval process will institute extra layers of review if an AS seeks funding from a non-peer reviewed source (such as industry-based grants). The RURAL Cohort Study Observational Study Monitoring Board (OSMB) may contribute an additional perspective and must approve AS that involve any participant burden. Approval from the RURAL Laboratory Committee will be required for those AS that seek the use of existing biosamples.
- What types of Ancillary Studies are permissible by the RURAL Cohort Study?
RURAL Investigators are encouraged to consider AS and to use other investigators, within and outside of RURAL in this process. Please read the below information provided here if interested in submitting a study proposal:
- AS that require additional questionnaires for collection of data at the time of initial mobile examination unit (MEU) visit that were not originally outlined (to be posted on the RURAL Cohort Study website) in the initial funded RURAL Cohort Study U01 grant application
- AS that require additional visits to the MEU for additional tests, including additional phenotyping, imaging, and/or questionnaires
- AS that require access to stored biospecimens collected from the RURAL Cohort Study participants
- AS that require additional mHealth measures and equipment
- AS that perform secondary analyses of the RURAL Cohort Study data, whose research questions are not a part of the main/central RURAL Cohort Study aims and for which funding is sought1
- AS that require the use of the RURAL Cohort Study data in pooling projects or consortia
- AS that involve relatives of the RURAL Cohort Study participants2
1AS that perform secondary analyses but seek no funding are reviewed by the RURAL Cohort Study Publications and Presentations committee
2AS that involve relatives of RURAL Cohort Study participants will be assessed on an individual basis
- Can non-RURAL Investigators apply?
Yes. Applications from non-RURAL Cohort Study Investigators will be considered by RURAL’s Ancillary Studies Subcommittee and Steering Committee. Non-RURAL Cohort Study investigator applications must involve sponsorship of their AS by a RURAL Cohort Study Investigator(s) to ensure compliance with RURAL Study policies and procedures. Non-RURAL Investigators have access to RURAL data either through National Institutes of Health (NIH) repositories or through collaboration with a RURAL sponsor. All AS will have the same review process regardless of the status of affiliation to the RURAL Cohort Study. Please see our Ancillary Studies Policy for a contact list of liaisons from RURAL’s respective cores.
- Process for submitting an Ancillary Study to the RURAL Cohort Study
Applicants who propose an AS should refer to the RURAL Ancillary Study Review Process document and Ancillary Study Processes and Procedures Flowchart for detailed instructions on submitting a Concept Proposal and Full Proposal.
If you are interested in submitting a proposal for an AS, please contact one of our study PIs or email us at email@example.com.
- Review of Ancillary Study proposals
Please see the RURAL Ancillary Study Review Process document and Ancillary Study Processes and Procedures Flowchart for detailed information on the review and approval processes.
- OSMB review of participant burden
The RURAL Observational Studies Monitoring Board (OSMB), convened annually by the National Heart, Lung, and Blood Institute (NHLBI), provides oversight of the RURAL Cohort Study and AS. Please note that the OSMB must review and approve, on a rolling basis, all proposals that involve participant burden.
- How frequently are the reviewing RURAL Cohort Study Committees convened?
Multi-PIs and Ancillary Studies Subcommittee Chairs: Rolling
Lab Committee: Rolling
DNA Committee: Rolling
Ancillary Studies Subcommittee: First Monday of every month
Steering Committee: Third Friday of every month
Observational Study Monitoring Board: Rolling
- Data and Materials Distribution Agreement
A formal agreement, signed by you, a representative of your institution, and Boston University is required to permit the distribution of RURAL Cohort Study data sets or both data and materials. This agreement precludes individuals or organizations from redistributing distribution of RURAL Cohort Study data to a third party. The details of the data distribution can be found in our DMDA Policy and Agreement.
- Return of data
Data collected from your project or derived from assays, or measures from images, irrespective of funding source, must be shared with the RURAL Cohort Study, the National Heart, Lung, and Blood Institute (NHLBI), the RURAL Cohort Study Statistical Data Coordinating Center at the University of Pennsylvania, and the RURAL Cohort Study Coordinating Center at Boston University. The derived data must be delivered to Lisa Wesby, RURAL Cohort Study Data Manager, the RURAL Cohort Study Statistical Data Coordinating Center, within one year of compiling a clean and complete dataset for inclusion in RURAL data repositories. Please note that all data will also be deposited in NHLBI repositories (BioLINCC, dbGaP and BioData Catalyst).
- Ancillary Study costs
Providing data, materials (including DNA), or other research and administrative services for an ancillary study involves costs, which vary based on the scope of the work. None of these costs are covered within the RURAL Cohort Study U01 parent grant.
The cost to RURAL for servicing ancillary studies needs to be reimbursed by the Principal Investigator(s) of the ancillary study. Therefore, it is necessary for you to include RURAL Cohort Study fees in your proposal budget.
- Publications derived from Ancillary Studies
An AS manuscript will analyze additional data collected as part of an AS of the RURAL Cohort Study. Manuscripts and abstracts from the AS must be submitted to the RURAL Cohort Study Publications and Presentations Subcommittee for review and approval. Publications based upon data from the RURAL Cohort Study must follow the guidelines as set in the Publications and Presentations Policy.
- RURAL Ancillary Study resources
For additional information or assistance, please contact firstname.lastname@example.org.