Regulatory Knowledge and Support

Meharry Medical College, Nashville TN

Investigators

Linked publications & trials

Abstract

Investigators are often expected to be knowledgeable in areas outside of science, including facility with the increasing complexity of federal, state, and local regulations that govern the conduct of human subject research. Coupled with, and adding to this obligation, is the difficult task of having to navigate the sometimes confusing and non-intuitive institutional administrative processes designed to assure compliance with these rules and regulations. To facilitate investigator and institutional compliance, as well as ensure the highest integrity of research and health and welfare of research subjects, we propose to expand our Research Support Services (RSS) unit which consists of expert personnel who provide research-related just-in-time information, assistance and educational support to investigators. These efforts translate into enhanced compliance and a reduced burden on investigators' already limited time and resources. Accordingly, the aims of this Key Activity are to: 1. Provide a responsive one-stop shop with easy access to personnel experienced in responding to a wide range of regulatory inquiries. This is achieved by a research administration technical support team, conceived of as a concierge help desk and branded Meharry Research Concierge Services (MeRCury) 2. Enhance the oversight of human subjects' research by expanding the role of the Reseach Subject Advocate (RSA), who will now also serve as the Director of Regulatory Affairs (DRA). As a DRA, this Director will create standardized polices including data safety monitoring plans (DSMPs), provide training and ensure that investigators adhere to a wide range of compliance regulations. 3. Enhance investigator and staff education related to ethics and the Responsible Conduct of Research (RCR). The overarching goal of this activity is reduce, remove and or reconfigure those administrative processes that are considered barriers to the ethical conduct of research which may jeopardize the protection of human subjects, and to expand a culture of compliance by providing responsive assistance to investigators and research teams in meeting the administrative and regulatory processes associated with research. This will enhance the safety of human subjects and will support investigators and research teams.