Regulatory & Ethics Support

The ICTR offers education, expert advice and resources to better equip study teams to conduct research that is ethical, relevant and responsive to the interests of patients and research participants.

Clinical Research Billing Compliance (CRBC) – Assures adherence to research billing regulations and policies at the federal, state and health system level.

Clinical Research Support Services (CRSS) – Provides centralized support and ongoing instruction to clinical research teams regarding Prospective Reimbursement Analysis (PRA), budget development, budget negotiation with commercial sponsors.

ClinicalTrials.gov Program – Provides investigators with instructions to stay in compliance through our ClinicalTrials.gov program.

Drug and Device Resource Service (DDRS) – Provides tools needed to help manage the development and use of investigational drugs and devices in research.

Office of Human Subjects Research (OHSR) & Johns Hopkins Medicine Institutional Review Boards (IRB) – Supports the activities of the Johns Hopkins Medicine (JHM) IRB.

Office of Research Administration (ORA) – Reviews and negotiates all grant and contract proposals and awards for the School of Medicine, including commercially‐sponsored clinical research agreements.

Research Participant Advocacy Program – Provides consulting on human subjects and regulatory issues, including IRB applications, the informed consent process, study feasibility and good clinical practices.

Research Ethics Consultation – Helps raise awareness of, and assists investigators in resolving ethical issues throughout the entire research process.