From IRB Approval to Implementation: Evaluating Medication Therapy Management (MTM) Services on medication adherence in Children with Special Healthcare Needs (CSHN)

Suwanee, GA

Institutional Review Board (IRB) reviews and approves research studies involving human subjects to ensure compliance with ethical standards set by the US government. Our research team is preparing to investigate whether Medication Therapy Management (MTM) services improve medication adherence in children with special healthcare needs (CSHN) aged 5-17, many of whom require complex medication regimens. Prior studies show that a caregiver’s socioeconomic status significantly impacts a child’s medication adherence due to financial constraints and limited healthcare literacy. MTM services could address these barriers and enhance adherence through caregiver education on medication administration and by reducing prescription burden. Before conducting our study, we must obtain IRB approval. This poster outlines the steps we have taken to secure approval, including required documentation, ethical considerations, and data security measures.

To initiate the IRB application process, one must first develop a comprehensive research plan detailing the study's purpose, objectives, and methodology. Our study will evaluate the current utilization of MTM services, if present, and their impact on medication adherence in CSHN by surveying 40 caregivers and collecting information on their demographics, the child’s medical history, and adherence patterns. The insights collected may help us better understand the challenges facing caregivers of CSHN, highlight the role of MTM services, and confirm its necessity in improving medication adherence.

A key component of our IRB submission is crafting an informed consent form that clearly communicates participants’ rights, including voluntary participation, the option to skip any question, and the ability to withdraw at any time without consequences. Since our study involves minimal risk, we outline that participation requires only survey completion, with any potential emotional discomfort addressed by allowing caregivers to skip sensitive questions. Additionally, to encourage participation while avoiding coercion, we will offer a $40 Target gift card to caregivers who complete the survey.

Another important aspect of IRB approval is outlining our data security measures. We specify that data collection will occur through PCOM’s REDCap platform, which provides encryption protocols and automatically assigns unique ID numbers to de-identify participant responses. We will also implement additional safeguards, including password-protected computers and encrypted STATA18 files for data analysis, to ensure compliance with data protection regulations.

The IRB application also requires a thorough explanation of our recruitment strategy. We plan to collaborate with local community healthcare co-ops and providers in Georgia to identify and recruit eligible caregivers. To minimize bias and ensure voluntary participation, we will distribute informational flyers and rely on healthcare professionals for referrals rather than direct solicitation.

Once IRB approval is obtained, our next steps will involve implementing the survey and analyzing collected data using advanced statistical methods to identify risk factors associated with poor medication adherence. We anticipate that our findings will highlight key challenges caregivers face and contribute to the design of targeted MTM interventions to enhance pediatric health outcomes. By addressing ethical considerations and adhering to rigorous IRB standards, we aim to conduct meaningful research that contributes to advancements in pediatric medication management.