January 27, 2009
The Office of Human Subjects Research Monitoring Program began in 2004. I believe the Program has served as a resource to investigators and research personnel, and I want to take this opportunity to update you about the activities associated with it.
The primary function of the program has been to is examine IRB approved protocols from two approaches: first, is the Routine Monitoring Visit; second, is the Directed Audit.
A routine monitoring visit involves a planned examination of a JHM IRB approved protocol to assess and assure overall compliance with regulatory requirements and terms of IRB approval. Routine monitoring visits are scheduled to accommodate the PI and study team schedules. Although all IRB approved research is eligible for a routine monitoring visit, I have asked the Compliance Monitoring Specialists to give priority to the following types of research activities:
- Research for which a Hopkins’ study team member holds the IND or IDE number. In these cases, the FDA considers the Hopkins’ faculty member to be the sponsor/investigator and he/she must fulfill all of the associated FDA regulations. All projects for which a Hopkins study team member is the sponsor/investigator must have a monitoring visit before the IND or IDE is used in the project.
- Research that involves recombinant DNA, infectious agents and/or pathogens, biological toxins, or gene transfer or pathogens introduced into human participants.
- Research projects that are more than five years old and for which there is a recent change in the principal investigator.
Directed audits are requested either by a JHM IRB or by me. The IRB may require an audit in cases where the IRB believes non-compliance with conduct of human subjects research has occurred. A directed audit may be required as a result of problems during or after FDA or other regulatory agency inspections, or in association with an investigation of a problem reported to JHU. All members of the Compliance Monitoring Team are involved in a directed audit. A directed audit must be completed as soon as possible.
The monitoring program includes an education component. The IRB website section on the Compliance Monitoring Program includes information and tools that research teams may use to promote regulatory compliance in the conduct of the research. The Compliance Monitors conduct a seminar twice each year to cover topics that arise during compliance visits and further explain the program goals.
With the ever increasing demand on researchers to keep up with compliance standards and regulations, I encourage you to use the Monitoring Program resources as tools to facilitate the conduct of human subjects research. Concerns or comments regarding the monitoring activities may be directed to me, the Assistant Dean for Human Subjects Research Compliance, or the monitors. Thank you for cooperating with the OHSR Compliance Monitoring Program.
Daniel E. Ford, M.D., MPH
Vice Dean for Clinical Investigation