This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Regulatory Knowledge and Support (RKS): There are many regulatory challenges facing clinical and translational research efforts. To be clinically proven, treatment innovations will require """"""""phase 1"""""""" testing of novel """"""""high risk"""""""" interventions in human subjects. Some study designs will be associated with ethical controversy (e.g. sham procedures, gene transfer, and xenotransplantation). It is critical that patients who participate in high-risk translational research are fully informed, understand, and voluntarily agree to participate through the informed consent process and that investigators comply with both the letter and the spirit of the human subject protection regulations. Regulatory compliance will help foster public support and trust in the clinical and translational research enterprise. The overall goal of the Regulatory Knowledge and Support key function is to assure that all research activities are in compliance with federal policies, rules, and guidelines for research involving animals and/or human subjects. The goal of the key function is to enhance the model support services already in place at collaborating institutions by providing """"""""research-focused"""""""" and """"""""translational research specific"""""""" support for regulatory compliance and management.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54RR026139-02
Application #
8359928
Study Section
Special Emphasis Panel (ZRR1-RI-1 (02))
Project Start
2011-07-01
Project End
2012-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
2
Fiscal Year
2011
Total Cost
$267,775
Indirect Cost
Name
University of Puerto Rico Med Sciences
Department
Type
Schools of Medicine
DUNS #
948108063
City
San Juan
State
PR
Country
United States
Zip Code
00936
Ortiz, A P; Tortolero-Luna, G; Romaguera, J et al. (2018) Seroprevalence of HPV 6, 11, 16 and 18 and correlates of exposure in unvaccinated women aged 16-64 years in Puerto Rico. Papillomavirus Res 5:109-113
Andriankaja, Oelisoa M; Muñoz-Torres, Francisco J; Vivaldi-Oliver, José et al. (2018) Insulin resistance predicts the risk of gingival/periodontal inflammation. J Periodontol 89:549-557
Anderson, Julia; Seol, Haeri; Gordish-Dressman, Heather et al. (2017) Interleukin 1 Receptor-Like 1 Protein (ST2) is a Potential Biomarker for Cardiomyopathy in Duchenne Muscular Dystrophy. Pediatr Cardiol 38:1606-1612
Jimenez-Torres, Gladys J; Wojna, Valerie; Rosario, Ernesto et al. (2017) Assessing health-related resiliency in HIV+ Latin women: Preliminary psychometric findings. PLoS One 12:e0181253
Zhang, Yong; Sun, Jie; Li, Feng et al. (2017) Salivary extracellular RNA biomarkers for insulin resistance detection in hispanics. Diabetes Res Clin Pract 132:85-94
Joshipura, Kaumudi J; Muñoz-Torres, Francisco J; Campos, Maribel et al. (2017) Association between within-visit systolic blood pressure variability and development of pre-diabetes and diabetes among overweight/obese individuals. J Hum Hypertens 32:26-33
Ortiz, A P; Tamayo, V; Scorsone, A et al. (2017) Prevalence and correlates of cervical HPV infection in a clinic-based sample of HIV-positive Hispanic women. Papillomavirus Res 4:39-44
Estape, Estela S; Mays, Mary Helen; Sternke, Elizabeth A (2016) Translation in Data Mining to Advance Personalized Medicine for Health Equity. Intell Inf Manag 8:9-16
Santiago-Rolón, Amarilys; Purcell, Dagmary; Grigg, Nicole et al. (2016) Chronic Hepatitis C: Treatment, Complications, and Long-term Outcomes in a Population of Latino Veterans. P R Health Sci J 35:30-4
Maldonado-Martínez, Gerónimo; Hunter-Mellado, Robert F; Fernández-Santos, Diana et al. (2016) Persistent HIV Viremia: Description of a Cohort of HIV Infected Individuals with ART Failure in Puerto Rico. Int J Environ Res Public Health 13:ijerph13010050

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