Test Subject Screening at Johnson Space Center

A.Overview

Test Subjects participating in ground-based studies at Johnson Space Center are generally qualified through the Test Subject Screening (TSS). Following the study protocol approval from the IRB, the Principal Investigator (PI) or designee submits the following items to the TSS:

A Completed "Request for Human Test Subject Recruiting Form"

Copy of the IRB approval letter

Copy of the Layman's Summary of the study

Information to include: location of testing site, specific requirements/exclusion factors for test subjects, payroll charge number, and requirements for advertising if needed

Recruitment requests should allow sufficient time for processing. Six weeks is the usual timeline, but often can occur sooner due to the active test subject pool. If advertising is needed, more time should be allowed before scheduling the testing times.

Subject eligibility will be determined based on physical and biological characteristics comparable to those astronauts currently involved in NASA's human space flight program.

B.Test Subject Information

Healthy volunteers are chosen for test subject participation. To determine eligibility, healthy volunteers must have an annual visit with evaluation of general health status, physical examination, and laboratory testing, including HIV, hepatitis B and hepatitis C. Certain physical findings identified during the examination may or may not be relevant to a particular study. For this reason, a TSS physician will review the subject chart as a screen for inclusion and provide clearance for each subject entering a study.

If the potential test subject is new to the TSS, a screening medical evaluation is scheduled at no charge to the individual.

The TSS personnel will usually recruit subjects from an active test subject roster for short term studies and from the general public for long term studies.

If scientific data is being collected, test subjects, with the exception of NASA test subjects, must pass a drug screen prior to participation in the study. No drug screen is required for hardware testing.

Test Subjects, who are not employed by NASA or KBR, will become temporary employees of a sub-contractor and must pass a background check and complete paperwork in order to be eligible to participate in studies.

C.Subject Qualifications

1.Allergy or Allergic Reaction, Ground-Based or Reduced Gravity Aircraft

No subject who has had an allergic diathesis (predisposition) or any anaphylactoid or frank anaphylactic reaction, including, but not limited to, a reaction to a medication, diagnostic agent, food, or insect venom, will be selected for research involving intravenous/intramuscular administration of any drug. Using the results of the physical exam and a review of the medical history, the examining physician will certify that each subject meets the medical standards for participation and that the procedures in the given study present no apparent additional risk of an allergic reaction for that subject.

2.Allergy or Allergic Reaction, Space Flight

Space flight personnel with history of any above reactions will not be selected for research involving intravenous/intramuscular administration of any drug. If at any time the crew surgeon believes, on the basis of his/her specific knowledge of the crew member's medical history, a crew member's participation presents an unacceptable risk, the crew surgeon can prohibit the crew member from participation in a study. The crew member may request consideration of a waiver for participation from the Aerospace Medical Board (AMB).

3.Exercise Protocols

The risk of injury is inherent in any physical activity. All research and/or engineering evaluations utilizing exercise in the protocol must make every effort to prevent exercise-related injuries and identify modifiable risk factors.

Principal Investigators (PI) must provide screening physicians with type, intensity, frequency and duration of exercise that will be required of participating subjects.

Screening physicians will evaluate subject eligibility for exercise protocols based on age, fitness level, and history of pre-existing medical conditions or other pertinent medical history.

If the screening physicians have any concerns about prior injuries, a specialist consultation may be necessary. The PI will be consulted prior to any specialist referral as the consulting fee is the financial responsibility of the study project.

The consent form should notify prospective subjects that failure to disclose pre-existing medical conditions may place them at greater risk for injury or other adverse events resulting from participation in the study.

The consent form should notify prospective subjects of the incidence of previous injuries in current study or in similar studies. (e.g. During this exercise program, x out of xx participants have experienced a significant muscle strain, resulting in release from the study.)

Inclusion/exclusion criteria for exercise-related protocols should be specific and precise to keep subjects safe. Examples include:

BMI greater than 30

BMI less than 19

Recent smoking history

History of lower back pain

History of Achilles tendinitis

D.Following TSS Clearance

Upon medical clearance of a subject for a study, any additional study requirements are scheduled. (i.e., treadmill, cycle ergometer, physiological training, etc.)

The PI or designee will receive a roster of qualified subjects which includes subject's name, phone number, payroll status and universal code number, if needed.

E.Investigator Responsibilities

Contacting, briefing, and scheduling the subjects for testing or notifying subject of any schedule change

Obtaining test subject consent form for study protocol

Submission of badging request to TSS

Submission of pregnancy screen testing to the TSS, if needed

Submission of subject timesheets and payroll information to TSS on a weekly basis, which include paid and non-paid subject hours (The designee should contact the TSS secretary for instructions regarding payroll.)

Submission of blood volume levels and radiation exposure reports to TSS for data entry, if part of the study

Maintain contact with the test subjects if study is delayed

Provide TSS with IRB renewal approval letter as needed and IRB approval of any protocol changes

Arrange Medical monitoring for study testing as required

Provide an adverse event form copy to TSS for subject's chart, if an event occurs

Maintain communication with TSS, if study is of long duration, to make sure test subject physical exam and HIV/HEP status are current

Enter documentation into the subject's chart if a notation is pertinent to subject's compliance during study testing.

F.Payments to Subjects

Describe the schedule and amounts of payments, and specify any bonuses. Include the total subjects can receive for completing the study.

If deviating from the recommendations in the Test Subject Screening Subject Payment Guides, include specific justification.

Use the term "payment" when discussing money given to a subject to offset time and inconvenience and/or to provide incentive to participate. The IRB reserves the term "compensation" for discussions of NASA Treatment and Compensation for Injury policies. The term "reimbursement" suggests that subjects must provide receipts for particular out of pocket expenses (for instance, parking and transportation), which they often cannot.

The consent form should explain how subjects will be paid (i.e., in cash or by check) and how long they will have to wait for payment (i.e., whether they are paid immediately or after a delay of four to six weeks).

For studies with more than two or three visits, payment should be prorated, that is, based on the amount of time subjects have spent participating so far.

It is acceptable to offer a small bonus for completing all study procedures, but the bonus should be no more than 30% of the total available payment.

G.TSS Contact Information

Recruitment Department:

Yvonne Parsons (Analog studies): 281.244.1447

Rori Yager, RN (Ground studies): 281.483.7240