Project 13

Human Subjects Core: Protocols, Statistics, Collaborative Method Development and Tools

Rajita Sinha, PhD

Rajita Sinha, PhD

Project Leader: Rajita Sinha
Team of Investigators: Heping Zhang, Rachel Lampert, Carlos Grilo, Cynthia Brandt, Jeremy Gray, Roy Baumeister, Nallakkandi Rajeevan, Jody Sindelar, Sandra Talley, Robert Sherwin, R. Todd Constable, Perry Miller, & Fei Wang

The conduct of interdisciplinary and translational clinical research is complex and can be optimized through coordination of specialized resources across projects. This P30 will provide core Human Subjects resources for coordinated and efficient data collection and statistical analysis across the clinical studies and pilot projects included in this consortium.

Among the overall goals of the IRCSSA, is the need to study well characterized clinical and non-clinical participants in all human projects so as to achieve both economics of scale and more importantly to synthesize findings on stress, self control and addiction across multiple response systems. This may be achieved by a coordinated and centralized participant recruitment process and by the use of analogous measures to understand the key concepts of stress, self control and addiction across research projects.

Furthermore, as multi-system assessments (e.g., genetics, neurochemical, physiological, behavioral, social factors) are being conducted across studies, we plan to create large datasets of common measures across clinical and non-clinical participant groups so as to evaluate the key constructs from multiple perspectives. In this way a Human Subjects P30 that incorporates these services will enhance the synergy between human projects in the IRCSSA.

Therefore, the overall aims of this Core are the following:

(1) To provide centralized coordination of subject recruitment for clinical studies;

(2) To provide a central assessment resource on stress, self control, physical health screening measures and for specific addictive behaviors of smoking, drinking, overeating; 

(3) To provide central data collection and management resources;

(4) To provide centralized and coordinated data analysis and statistics expertise; and

(5) To provide scientific support and consultation to ongoing and pilot study investigators.  Through these aims the P30 will provide critical support to the human studies and facilitate integration of data across projects in the IRCSSA. Such integration will permit pooled analysis across studies that will lead to a more comprehensive understanding of the stress mechanisms that affect self control processes in addiction.