43 - Improving Efficiencies in Single Institutional Review Board Reliance Processes Related to Informed Consent Development

Background:  Incorporating local context into consent forms for studies under single IRB (sIRB) review is often a challenging process. It is difficult for institutions to combine required local context into varying consent form templates. This task often results in lengthy reliance processes and delayed study approvals.

Program

Description:  To improve the efficiency in sIRB processes related to consent form development, a two part consent form was implemented. Part one of the consent form is considered the main study consent section containing key study information describing the required study activities. Part one of the consent is not modifiable with the exception for the local PI’s contact information. Part two of the consent form contains site specific information including required local context and describes any differences in study activities discussed in part one of the consent. Part one and two are combined to create one seamless document. To assess if the implementation of a two-part consent form improved efficiency in sIRB processes, pre- and post-implementation data were collected and compared. The post-implementation data of utilizing a two-part consent document indicated a decrease from an average of 88 days to an average of 46 days for sIRB process completion.

Program

Assessment:  Data collected in 2022 & 2023 showed that it took an average of 88 days to complete sIRB processes, which involved receiving approval from the IRB of record. This process included multiple rounds of communication between the sIRB team, study team, and IRB of record to ensure that the consent form reflected the local requirements of the institution. In 2023, the process of developing the consent form involved adding information to the body of the main consent form provided by the IRB of record. Due to the different templates used by different IRBs, it was time-consuming to make sure that the necessary local context was included in the appropriate sections of the consent form.

After the introduction of a two-part consent form, data from 2024 showed that the average time to complete the sIRB processes had decreased to 46 days. This represented a significant improvement of 42 days compared to the pre-implementation period. The use of a two-part consent form led to quicker completion of sIRB processes, resulting in faster activation of studies within the institution.

Limitations: The institutional sIRB team is a small team consisting of three individuals which only serve study teams with ceded studies. This team is able to dedicate one-on-one support to study teams during consent development processes and initiates communication with IRB of Records to further facilitate consent form development. This sIRB team currently works with 40 IRB of Records.

Discussion:  Institutionally initiated multisite research studies in which the local IRB will serve as the IRB of record, will continue to utilize the two-part consent model explained above. Collaborating sites will receive a template for the two-part consent form to aid in developing their own consent documents. By adopting the two-part consent model, other sIRBs can streamline the process of developing site-specific consent documents in local languages, ultimately expediting study approvals and site activations.