Real or predicted costs associated with different return of participant-level data to clinical trial participants
| Current model | Model 2 | Model 3 | Model 4 | |
| Sponsor-managed, centralised return of participant-level data to participants | New IRB+ contract at each trial site for the return of data, inclusive of on-site visit of family (standalone study) | New IRB+ contract at each site to return data to participants, with remote delivery of information (standalone study) | Return of data included in original clinical trial contract (part of original IRB); extend site contract by 2 years for return of data, on-site visit. (included in initial protocol) | |
| Sponsor costs (US$) | ||||
| Fixed costs of data management for return of results | $78 585 | $78 585 | $78 585 | $78 585 |
| Central IRB/ethics (sponsor) | $7586 | |||
| Clinical site costs | ||||
| Site IRB/ethics | 0 | $36 900 | $36 900 | 0 |
| Annual IRB renewal Models 2,3: 4 years Model 4: 2 years* | 0 | $33 580 | $33 580 | $18 190 |
| Scheduling/coordinating date entry/query | 0 | $2070 | 0 | $2070 |
| Investigator time | 0 | $4830 | $4830 | $4830 |
| Travel | 0 | $11 323 | 0 | $11 323 |
| Overhead | 0 | $24 762 | $21 040 | $9825 |
| Total | $86 171.00 | $192 050.00 | $174 935.00 | $124 823.00 |
*The reduced number of years (2 years) in model 4 is assuming that the IRB costs of the parent clinical trial would be borne by the parent study (not the return of results portion of the study), but the parent study would need to be kept open an additional 2 years.