Institutional Review Board

Preparing for Research  |  Medical Monitoring

Medical Monitoring

The Principal Investigator shall propose the required level(s) of Medical Monitoring for the protocol. The JSC IRB will thereafter evaluate the proposed level(s) and guide any necessary changes. The medical monitoring levels only apply to those aspects of the protocol that are not conducted in space flight.

Aspects of the protocol that are conducted during space flight will often not have equivalent monitoring because of programmatic constraints, but appropriate level of medical monitoring is still required. For aspects of a study occurring during space flight, the medical monitoring plan will be proposed by the investigator. The medical operations community and crew office will be involved in the review of such medical monitoring plans and provide feedback to the PI on operational constraints and existing procedures. Importantly, investigators are responsible for submitting a well-developed initial plan to the IRB to initiate the medical monitoring review process.

A medical monitor attends ground-based tests and training sessions under the direction of the IRB. The medical monitor may approve minor equipment and procedural changes during the session. Other changes are referred to the IRB, and the part of the study affected will be placed on-hold until the IRB has ruled on the changes.

The following levels of medical monitoring are recognized by the IRB:

1.Level 1

Typically for invasive or highly provocative procedures or for protocols that require maximal aerobic exertion.

A physician with current BLS-AED and ACLS training is required to be present at the time of the test and is actively monitoring the test subject.

Two other personnel with current BLS-AED training are present during testing.

Appropriate resuscitation equipment, including an AED, is available in the immediate vicinity of the test.

Advanced life support equipment and personnel (e.g., ambulance/EMT, hospital code team, etc.) are available and within 5-10 min of the testing area if summoned for an emergency.

Quarterly emergency drills are conducted by the investigator team as supervised by the medical monitor.

Protocol Compliance Officer is made aware of the test and emergency drill schedules.

2.Level 2

Typically for modestly provocative procedures carrying greater than minimal risk such as those that require sub-maximal aerobic exertion of >85% of maximum predicted heart rate or oxygen consumption (VO2).

Physician with current BLS-AED training is able to reach the testing area within two minutes.

Two other personnel with current BLS-AED training are present during testing.

Appropriate resuscitation equipment, including an AED, is available in the immediate vicinity of the test.

Advanced life support equipment and personnel (e.g., ambulance/EMT, hospital code team, etc.) are available and within 5-10 min of the testing area if summoned for an emergency.

Quarterly emergency drills are conducted by the investigator team as supervised by the medical monitor.

Protocol Compliance Officer is made aware of the test and emergency drill schedules.

3.Level 3

Typically for procedures that carry less risk than Level 2 procedures, for example those that require sub-maximal aerobic exertion of <85% of maximum predicted heart rate or VO2.

Physician with current BLS-AED training is available within 15 minutes of notification.

Two other BLS-AED certified personnel can respond to the test site within two minutes.

An AED is located nearby and available for use within two minutes.

4.Level 4

Typically for minimal risk procedures.

Physician is aware of the specific testing and is available for telephone consultation.

5.Other Medical Monitoring Plans

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, will typically have unique, study-specific medical monitoring plans assigned to them by the IRB.

6.Definitions

a.Advanced Cardiac Life Support (ACLS)

Advanced Cardiac Life Support (ACLS) refers to a set of clinical interventions for the urgent treatment of cardiac arrest and other life threatening medical emergencies, as well as the knowledge and skills to deploy those interventions. The American Heart Association ACLS certification is good for two years.

b.Automated External Defibrillator (AED)

Automated External Defibrillator (AED) refers to a portable electronic device that automatically diagnoses the potentially life threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia, and is able to treat them through defibrillation, the application of electrical therapy which stops the arrhythmia, allowing the heart to re-establish an effective rhythm.

c.Basic Life Support (BLS)

Basic Life Support (BLS) is a basic level of pre-hospital medical care provided by trained responders, including in the absence of advanced medical care. The American Heart Association BLS certification is good for two years.

d.Crash Cart

Crash Cart refers to a collection of medical equipment, medications, and supplies used to provide resuscitation to an individual. While traditionally a "crash cart" is a wheeled storage chest, the more important feature is that all material necessary to perform resuscitation are readily available to the advanced clinician. Maintenance of JSC crash carts and training medical personnel in the use of equipment falls within the Space Medicine Division.

Effective April, 2014, decommissioning of crash carts will be instituted with the exception for one at the JSC Clinic and one at the Sonny Carter Neutral Buoyancy Laboratory (NBL JSC ambulance service will provide dedicated support during “on-site” Level I testing with a supplemental second ambulance (including ambulance crew) available to respond to emergencies during those periods whereby the JSC ambulance is unavailable.

Physicians monitoring Level I tests take with them bags with an AED, an epi pen, and IV administration kits and solutions.

Protocol Compliance Officer

The Protocol Compliance Officer (PCO) is a physician who serves as medical monitor for the IRB and ensures that all experiments are conducted in accordance with IRB requirements. The PCO routinely monitors tests as a representative of the IRB and is a voting member of the IRB. In this role, the PCO is fully authorized to halt any research or test activity that is judged to be in violation of IRB recommendations, accepted medical practice, or accepted safety guidelines.

To fulfill these duties, the protocol compliance officer is authorized to:

Be present to monitor any research test or procedure carried out under a IRB-approved protocol.

Review research data when necessary to ensure test subject safety or adherence to IRB recommendations.

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.

Review investigators' plans for implementation of IRB recommendations in general, including those for medical monitoring and care of test subjects.

Review plans and procedures for recruitment and medical screening of potential test subjects.

Directly contact any current or previous test subjects to request information relevant to protocol compliance, safety, or medical issues that may have been related to participation in a protocol.

Directly contact any personnel involved in a human subject research protocol to obtain information related to protocol compliance or safety.

Perform additional duties as assigned by the IRB chair or by a vote of the full committee.

Because the protocol compliance officer is a representative of the IRB, these duties may be modified for particular protocols as deemed appropriate by the IRB chair or by a vote of the committee.

If the PCO requires an investigator to halt a research activity, it is the duty of the PCO to inform the IRB chair of this action as soon as possible. The specific activity may only be resumed when authorized by the IRB chair or a vote of the committee.

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.