Subject Assessment, Sample Procurement and Clinical Operations

National Institute On Aging

Investigators

Abstract

In order to conduct clinical research in a safe, efficient and effective manner, an established infrastructure attendant to all aspects of subject safety, emergent medical care, and data acquisition and managment is essential. The Subject Assessment, Sample Procurement and Clnical Operations Core addresses these needs and assists investigators and research subjects conducted within the NIA Clinical Research Unit. The need to obtain human tissue for methods development and disease correlation is frequent in Biomedical Research Center laboratories. This protocol is designed to create the opportunity to obtain such tissue samples including: blood, urine, saliva, sweat, feces, hair and nail clippings, nasal scraping, muscle, fat and skin. It may also include samples taken during a surgical procedure, including: fluid from around the spinal column, heart, lungs and abdomen; fat, muscle, connective tissue and organs (liver, bladder, heart, kidney and skin). Information derived from such studies is for research purposes only and is not provided to the participants or their health care provider. Samples will be coded (no names) and identifying information linking the participant to the sample will be maintained in a secure location by the P.I. and Study Coordinator. Participants will be 18 years or older and have been identified by the investigator and/or physician to have a condition of interest for exploratory studies related to the participants illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies. Participants could also be healthy volunteers, willing to provide their samples. These samples could be requested by an investigator to be used as age, gender, race and/or ethnicity-matched controls or to calibrate or compare and contrast across lab equipment. Participants will be excluded if obtaining the sample would be over and above usual clinical care, would result in excessive blood loss, or the individual is unable to provide informed consent. The expected outcome is to provide investigators with the opportunity to obtain tissues of interest for laboratory evaluation.