UC Davis

Objective

We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control).

Study design

This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.

Results

Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).

Conclusion

A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.