Human Subjects Core Services
Karla McGregor, Ph.D., is director of the Human Subjects Core at Boys Town National Research Hospital. The HSC's mission is to enhance measurement quality, promote the efficiency of data collection and sharing, streamline recruitment of participants and assist with quality assurance. Centralized services and expertise in clinical measurement, recruitment, and compliance are available to Boys Town Hospital investigators and their collaborators at other institutions. The HSC was developed in response to the challenges research programs face related to standardized testing, recruitment of special populations and regulatory compliance, with the understanding that for individual labs to independently overcome these barriers, they would have to use their limited time, effort and resources in ways that could negatively affect the lab's productivity. Consequently, many labs, and especially those of junior scientists, are faced with difficult decisions about whether to implement processes that ensure their research studies are of the highest possible quality. The inability of labs to dedicate extensive resources to such quality issues has contributed to the current replication crisis in research. Specifically, the overall quality and applicability of research findings are often impeded due to small sample sizes, lack of expertise in a wide variety of measures and lack of control of confounds. To address these issues, the HSC provides centralization of services and expertise that support investigators in clinical measurement, recruitment and compliance. The HSC supports investigators through two integrated programs that have led to increased efficiency, collaboration and productivity in the research program: the Recruitment and Quality Assurance Program (RQP) and the Clinical Measurement Program (CMP).
Click here to view the HSC team members.
The CMP, which is coordinated by Dr. Sophie Ambrose, was designed to provide administration and interpretation of evidence-based clinical assessments to COBRE investigators, along with training and services related to clinical measures from a centralized team of clinical experts.
The RQP, which is coordinated by Judy Kopun, has two primary purposes:
- to streamline the participant-recruitment program and database, while increasing its representation of minority groups and individuals with developmental language disorders
- to assist investigators with quality-assurance evaluation and training, ensure compliance with regulations, and support the preparation of IRB and NIH reports.
Meet Our Human Subjects Core Staff
Funding for the Human Subjects Core comes from a Centers of Biomedical Research Excellence (COBRE) grant from the National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH) under award number P20GM109023.