If you have questions that are not answered using the information on this page, contact the NASA IRB office via email at NASA-IRB@nasa.gov. Please allow two to three business days for a response.
Basic Folder Information
Medical Monitoring Level
Medical Monitor
The Medical Monitor Level (MML) for a research protocol is assigned by the clinical staff at JSC (not the NASA IRB). A medical monitor attends ground-based tests and training sessions as specified in the MML definitions and approved by the NASA IRB. The medical monitor may approve minor equipment and procedural changes during the session for the safety of the subject.
If the change to the equipment or procedure is subject-specific, the medical monitor shall alert the PI and the NASA IRB and an RNI shall be submitted to the NASA IRB.
If the change results in a modification to the NASA IRB approved protocol, the modification shall be submitted to the NASA IRB.
Studies conducted at remote locations wherein procedural or other telemedicine consultations may be required or recommended, or studies wherein none of the above medical monitoring levels apply, may have unique, study-specific medical monitoring plans assigned to them by the IRB in consultation with the NASA IRB physician representative (e.g. studies occurring in Antarctica).
Medical Monitoring levels are specific to the NASA Center where the research is conducted.
Johnson Space Center (JSC) and Flight
For questions pertaining to Medical Monitoring requirements, please contact William Tarver, MD.
The Principal Investigator shall propose the required level(s) of Medical Monitoring for all protocols submitted to the NASA IRB. The NASA IRB will evaluate the proposed level(s) and guide necessary changes.
The PI will also recommend a medical monitoring level for procedures conducted in-flight.
When necessary, the medical operations community and crew office will be involved in the review of medical monitoring plans for in-flight procedures and provide feedback to the PI on operational constraints and existing procedures.
For flight protocols, the PI shall recommend medical monitoring levels that apply to those aspects of the flight protocol that are conducted for pre- and post-flight procedures.
Ames Research Center (ARC)
For questions pertaining to ARC Medical Monitoring requirements, please contact Ralph Pelligra, MD.
At the Ames Research Center (ARC), the medical monitoring lead individually evaluates all research performed at ARC that is greater than minimal risk and works with the investigator to determine the appropriate medical monitoring. Dr. Pelligra will also work with the investigator as needed to determine the protocol’s level of risk.
Kennedy Space Center (KSC)
For questions pertaining to KSC Medical Monitoring requirements, please contact Philip Scarpa, MD or Dave Tipton, MD.
The Protocol Compliance Officer (PCO) is a physician who ensures reports involving protocol compliance, risks, incidental findings, or other information relevant to research in astronaut subjects and/or research occurring at JSC. The PCO may serve as a medical liaison to the NASA IRB and is a voting member of the IRB.
The PCO is authorized to:
Be present to monitor any research procedure carried out under a NASA IRB-approved protocol.
Review research data when necessary to ensure research subject safety after an Adverse Event is reported the NASA IRB, or to investigate subject complaints.
The PCO may aid the NASA IRB Chair in the investigation of Reportable New Information (RNIs) reported to the NASA IRB.
Receive information from investigators related to any injury, illness, disease, or death, whether expected or not, incurred by a subject as a possible result of participation in a research protocol.
The role of the PCO may be modified for a particular protocol as deemed appropriate by the IRB Chair or by a vote of the NASA IRB.
The PCO is expected to bring any safety or compliance issues to the attention of the IRB Chair or the full committee in a timely manner.
