76 - Ethical and Procedural Interplay between Ongoing Research Programs and Ancillary Studies

Background:  Although the development of ancillary studies from ongoing research programs is common, ethical and procedural problems may arise affecting both the parent and the ancillary study. Currently, the interplay required for the successful conduct of such studies will be considered, with particular emphasis on the impact to parent studies.

Methods:  Experiences drawn from the operation of a pre-existing multi-site longitudinal observational study and its ancillary intervention trial inform the current analysis. Close collaboration between the operations teams for the parent study and ancillary study, and regulatory/compliance teams at the single-IRB site occurred throughout the duration of the ancillary study start-up period.

Conclusion:  Ancillary studies are often viewed as a sign of a successful research program. However, unless plans for expansion were incorporated into the parent study at initiation, an ancillary study may negatively impact the parent study. Needs for data sharing with the ancillary study for recruitment or data analysis may run counter to data sharing agreements developed by the parent study across sites. Findings generated by the ancillary study may alter inclusion/exclusion criteria or group classification for the parent study, or require the creation of new database variables to account for the presence of the ancillary study. Confusion may exist about situations in which adverse events observed in the ancillary study should be reported to the parent study team, and vice versa. Participants may also be confused about which team members belong to which study, or may feel pressure to take part in the ancillary study to subjectively remain in “good standing” with the parent study. For each of these possibilities, increased time demands are placed on both study teams for the alignment of projects, though the parent study’s team carries the higher burden. For multi-site parent studies under single IRB review and single-site ancillary studies, navigating differing institutional agreements can prove particularly challenging even when IRBs are in alignment. IRB alignment may not solve practical limitations for parent and ancillary studies.

Limitations: These conclusions are drawn from experiences between a multi-site longitudinal trial subject to single IRB that started before the New Common Rule and an intervention trial being conducted at one site, but enrolling participants from all participating sites from the parent study. Interplay between studies may look different for single-site or single-time-point studies, studies started after the New Common Rule, or for ancillary studies that do not include an interventional component.

Discussion:  Research programs should incorporate some flexibility to allow for easier implementation of future ancillary studies in their initial development, or through amendment. This flexibility written into protocols, procedure manuals, consent forms, data collection instruments and systems, etc., will aid the interplay between parent and ancillary studies – especially as they pertain to data sharing agreements. Future work is encouraged to qualitatively and quantitatively investigate the impact of ancillary studies on pre-existing research programs, particularly those involving single IRB studies and items that extend beyond IRB issue – such as data use agreements, data sharing, and protected health information.