Research Support
Social & Scientific Systems staff supports investigators and agencies with a variety of research support activities, such as scientific and advisory meetings, literature reviews and research summaries, protocol development, pretests and pilot studies, and preparation of Institutional Review Board (IRB) or Office of Management and Budget (OMB) submissions. We identify agencies, institutions, subcontractors, vendors, and consultants to assist in studies, such as laboratories, clinical settings, and technical specialists. Two major projects that characterize these capabilities are the Sister Study: Genetic and Environmental Risk Factors for Breast Cancer, and the Study of Estrogen and Development (SEAD).
The Sister Study is a national longitudinal study of breast cancer that is targeted to enroll 50,000 women. For this National Institute of Environmental Health Sciences (NIEHS) project, we coordinated recruitment and scientific advisory panels, conducted a 2-year pilot study in four states, developed national subcontracts with vendors to conduct clinical home visits, created collaborative agreements with national breast cancer organizations, identified laboratories and pretested specimen collection protocols, created a network of lay and advocacy study supporters and volunteer recruiters, designed and conducted outreach including media campaigns, contributed to all research design protocols including questionnaire content, and recruited and collected data and specimens on more than 35,000 women as of January 2008. The study is now in the fourth year of national recruitment. See the Sister Study: Genetic and Environmental Risk Factors for Breast Cancer for more information.
SEAD is a series of pilot studies we conducted for NIEHS to assess how to measure the effects of soy feeding in infants. Currently, we are assisting investigators in designing a study based on these findings. For the pilot studies, we identified three clinical settings that were capable of recruiting sufficient numbers of infants from birth to 12 months who were fed soy formulas, other formulas, or were breastfed. Our staff organized expert panels with the investigators. With the collaborating clinical scientists, we tested all infant measurement protocols, including specimen collection, body measurements, and clinical examinations including infant sonography. We designed and maintained a Web application for the sites to track enrollment by specified age and feeding type and supervised the subcontracts.