Regulatory Knowledge and Ethics (RKE)

The Delaware Valley Resources Unit for Regulatory Knowledge and Ethics (RKE) will develop systems to serve both researchers and the beneficiaries of DVICTS research by properly educating our scientists, administrators, staff and students about regulatory and ethical standards and by providing tools and resources that will enable them to follow these standards more completely, quickly and efficiently. Agreements are either in place or under active negotiation among the four DVICTS partners – University of Delaware (UD), Thomas Jefferson University (TJU) and its hospital network, the Christiana Care Health System (CCHS), and Nemours (most particularly the Alfred I. duPont Hospital for Children, [Nemours/AIDHC]) that arrive at a common set of ethical standards and administrative procedures for conducting lawful, responsible research at DVICTS. Working with the DVICTS Bioinformatics Unit (BMI), RKE will develop computer-based resources to simplify compliance of both DVICTS and government protocols, primarily by improving the sharing of data tracking of progress and entry of compliance information. Further, RKE will work with BMI and all other units to optimize the research innovations provided through the Delaware Health Information Network (DHIN), the nation’s first state-wide Regional Health Information Organization, described in detail in the BMI unit.

To help DVICTS investigators meet the obligations of applying for and administering multi-institutional grant funding, common sets of standards will be developed among the institutions, and computer-based access to tools that guide the researchers to follow the regulatory protocols will be provided. RKE will accomplish this mission through collaboration, negotiation, and a single public interface using the DVICTS Research Commons website. The Biomedical Informatics Unit (BMI) will work with RKE to develop this one-stop shopping access to research regulatory processes to minimize the administrative hurdles inherent in conducting multi-institutional research. Further, RKE will work with several other DVICTS units, most notably Community Engagement and Research (CER), Participants in Clinical Interactions and Research (PCIR) and Research, Education, Training and Career Development (RETCD) to ensure that a clear, accurate message is delivered both internally and to the public. Building on the cooperative agreements among the DVICTS partners that are already in place (and described below), the CTSA will allow us to complete these programs.

The challenge for the RKE and BMI staff will be to design these intermediate data processing systems to efficiently move the required information to and from the individual institutions. The record of excellence in designing and using web-based interfaces, the documented record of collaboration, and a DVICTS-wide recognition of the benefits of such collaborations will ensure success. Further, researchers, staff, and the public will be educated about the ethical and regulatory requirements of translational and clinical research. RKE’s ethics support mission is to ensure that all staff, student and faculty researchers receive excellent education in biomedical ethics and have access to expert consultants for help with ethical dilemmas. RKE will also provide appropriate education to the public on issues relating to the clinical and translational research that is being done. Strategies to be developed will demonstrate that multiple institutions, working across state and cultural boundaries, can successfully conduct collaborative translational and clinical research when they share a common, well-defined mission and set of goals.

To accomplish this mission, the following set of aims is proposed:

  • Aim 1. Expand and improve the inter-institutional regulatory resources and opportunities for researchers, students, staff, and the public. This will be accomplished by building on the considerable and varied expertise available in regulatory affairs and clinical/translational ethics across the DVICTS />
  • Aim 2. Innovate, simplify, enhance, and improve the administrative processes for researchers, students, staff, and the public in all phases of translational research from the initiatial project design to completion, including regulatory, ethical, and business activities and decisions.

  • Aim 3. Provide a forum for public and investigator advocacy for issues arising in regulatory and ethical arenas in clinical and translational research within DVICTS.