Consent-to-Contact Registry: A New Tool for Accelerating Clinical Research Recruitment at UCI

C-2-C, UCI MIND, and ICTS Translational Science Research Day 2017, University of California Irvine Introduction: The most consistent barrier to improved medical care is slow recruitment to clinical research. To help clinical investigators at UCI overcome this barrier, we developed a potential participant registry. The UCI Consent-to-Contact Registry (C2C, c2c.uci.edu) is an online repository of individuals who have given permission to be contacted about studies for which they may be eligible. The objective of the registry is to enhance clinical research recruitment at UCI. Investigators from all departments and schools have the opportunity to recruit through the registry, provided that they have IRB approval to do so and complete the necessary components to access the registry with the organizers. The C2C is supported by HCP, Inc; NIA AG106573; and UL1 TR000153

Preclinical Alzheimer Disease and the Electronic Health Record

Because information technologies are increasingly used to improve clinical research and care, personal health information (PHI) has wider dissemination than ever before. The 21st Century Cures Act in the United States now requires patient access to many components of the electronic health record (EHR). Although these changes promise to enhance communication and information sharing, they also bring higher risks of unwanted disclosure, both within and outside of health systems. Having preclinical Alzheimer disease (AD), where biological markers of AD are identified before the onset of any symptoms, is sensitive PHI. Because of the melding of ideas between preclinical and "clinical" (symptomatic) AD, unwanted disclosure of preclinical AD status can lead to personal harms of stigma, discrimination, and changes to insurability. At present, preclinical AD is identified mainly in research settings, although the consensus criteria for a clinical diagnosis may soon be established. There is not yet adequate legal protection for the growing number of individuals with preclinical AD. Some PHI generated in preclinical AD trials has clinical significance, necessitating urgent evaluations and longitudinal monitoring in care settings. AD researchers are obligated to both respect the confidentiality of participants' sensitive PHI and facilitate providers' access to necessary information, often requiring disclosure of preclinical AD status. The AD research community must continue to develop ethical, participant-centered practices related to confidentiality and disclosure, with attention to sensitive information in the EHR. These practices will be essential for translation into the clinic and across health systems and society at large