Abstract
Background
In biomedical research, the consent form must comply with regulatory requirements. Checking for compliance typically has been performed on-site and most frequently after a participant’s final enrollment. We use a procedure for remote preenrollment checking of consent forms that protects participant identities. This procedure requires a copy of the consent form that partially masks the fields for participant’s name and signature; this copy is faxed to the clinical trials unit for checking.
Purpose
To describe our efforts to identify an appropriate printed masking pattern. We tried several patterns that permit ascertainment of the presence of signatures and names and evaluated each one with respect to degree of masking participant identities.
Methods
We assessed the efficiency of a satisfactory pattern through an experiment. We created forms with variants of the masking pattern on the copy to be faxed. We completed the forms with fictitious identities before copies were faxed and checked by clinical research associates. We measured the rate of empty and filled fields detected and the rate of letters and names correctly read. The target was defined as 100% for the rate of empty and filled fields detected and 0% for the rate of letters and names correctly read.
Results
The best masking pattern allowed the detection of 100% empty and filled fields and the reading of 0% names and 19% letters. Consequently, the consent form with the selected masking pattern has been used routinely in our clinical trials unit.
Limitations
We tested only five fictitious identities, five individuals who completed forms, and three who checked forms. Also, we initially considered only four patterns and variations in them.
Conclusions
We defined a masking pattern that satisfactorily fulfilled our needs for confidentiality. This and other procedures for remote preenrollment checking of consent form can be a key component of a risk-based monitoring strategy.
Get full access to this article
View all access options for this article.