The Cost of Consent: Can we afford it? Policy considerations based on the cost analysis of an "opt-in" consent system for Immunization Information System (IIS) participation

Learning Objectives for this Presentation:
By the end of this presentation, participants will be able to understand the cost associated with an opt-in system of consent and the policy considerations associated with operating such systems.

Background:
Currently, Texas law requires consent from parents for children to participate in the statewide IIS, ImmTrac. In addition, a law passed in 2005 now requires the State to verify and maintain proof of consent. Texas Children's Hospital, supported by other statewide stakeholders, led an effort to quantify the cost of consent to the public and private sectors in Texas.

Setting:
Project staff measured the time spent gathering consent for one child by conducting time studies at 5 private and 3 public birthing hospitals and 10 private and 10 public provider offices in the Greater Houston area. Time studies were also conducted at ImmTrac to record the time required to complete procedures for receiving, verifying and maintaining proof of consent.

Population:
Children consented at birthing hospitals and primary care clinics.

Project Description:
Total cost for the consent process was computed using direct expenses and time costs associated with obtaining and documenting consent. Preliminary analysis of data from the public sector showed an annual cost of $1.7million for the current consent process or $4.81 per child. It is estimated that 96% of parents approached agree to safeguard their child's records in an IIS. The cost of voluntarily excluding 4% of the population that does not want to participate in an IIS is estimated to be less than $20,000 per year or $1.30 per child.

Results/Lessons Learned:
Obtaining and verifying consent on 96% of the population is expensive and leads to a less robust database. State law and administrative procedures should be amended to eliminate the consent process and institute a voluntary exclusion system.