Ripple Effect provided three full-time onsite support staff to fill the Human Subjects Specialist and Administrative Coordinator positions to support all the activities of the Human Subjects Team at NIH. This team provides expert advice and leadership in the areas of policy development, evaluation, and implementation for human subjects protection issues related to the NIH extramural research programs; helps ensure the compliance of NIH grantees with federal regulations regarding the protection of human subjects in research; and assesses and approves resolution of human subjects concerns noted by NIH review groups for fundable applications. The Human Subject Specialist position was a senior staff position, while the Human Subjects Administrative Coordinator position was for a junior staff member. Ripple Effect provided multiple staff in this role, and three were such good fits that they became federal employees.
The Human Subjects Specialist’s duties included the following: assessment of human subjects code change submissions; oversight of the administrative process for submissions of code change requests and questions on human subjects protection; to have a thorough understanding of the use and capacity of the system; to serve as liaison between program officers and SharePoint developers; to continually examine the work processes and identify areas for improvement in order to better fulfill OEP-HS functions; oversee the update and development of work manuals and SOPs; support literature reviews in relevant bioethical topics; and review policy updates.
The Human Subjects Administrative Coordinator was responsible for administrative processing of submissions for code change requests and questions on human subjects protection; general communications with NIH extramural staff; generation of team statistics for general administrative purpose; creation of annual IC statistical report; and assessment of simple human subjects code change submissions.