A comparative effectiveness study of eSource used for data capture for a clinical research registry.

Objective: This pilot study compared eSource-enabled versus traditional manual data transcription (non-eSource methods) for the collection of clinical registry information. The primary study objective was to compare the time spent completing registry forms using eSource versus non-eSource methods The secondary objectives were to compare data quality associated with these two data capture methods and the flexibility of the workflows. This study directly addressed fundamental questions relating to eSource adoption: what time-savings can be realized, and to what extent does eSource improve data quality.

Leveraging a Statewide Clinical Data Warehouse to Expand Boundaries of the Learning Health System.

Learning Health Systems (LHS) require accessible, usable health data and a culture of collaboration-a challenge for any single system, let alone disparate organizations, with macro- and micro-systems. Recently, the National Science Foundation described this important setting as a cyber-social ecosystem. In 2004, in an effort to create a platform for transforming health in South Carolina, Health Sciences South Carolina (HSSC) was established as a research collaboration of the largest health systems, academic medical centers and research intensive universities in South Carolina.

Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents.

Background: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically.

An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting.

Purpose: Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS).

A Biomedical Research Permissions Ontology: Cognitive and Knowledge Representation Considerations.

In designing a comprehensive mechanism for managing informed consents and permissions for biomedical research involving human participants, a significant effort is dedicated to the development of standardized classification of these consents and permissions. In this paper, we describe the considerations and implications of this effort that should be addressed during the development of a Biomedical Research Permissions Ontology (RPO). It is hoped that this standardization will allow disparate research institutions to pool research data and associated consents and permissions in order to facilitate collaborative translational research projects across multiple institutions and subsequent new breakthroughs in medicine while providing: 1) essential built in protections for privacy and confidentiality of research participants and 2) a mechanism for insuring that researchers adhere to patient's intent whether to participate in research or not.

Challenges that limit meaningful use of health information technology.

Purpose: Health information technology (HIT) is perceived as an essential component for addressing inefficiencies in healthcare. Without understanding the challenges that limit meaningful use of HIT, there is a high chance that institutions will convert complex paper-based systems to expensive digital chaos.

Recent Findings: Clinical information systems do not communicate with each other automatically because integration of existing data standards is lacking.