Institutional Review Board

Preparing for Research  |  Standardized Wording for Submission Templates and Mishap Corrective Action Summaries

A.Treatment and Compensation for Injury

"I understand that in the event of injury resulting from my participation in this test and calling for immediate action or attention, NASA will provide or cause to be provided, the necessary treatment. I understand that NASA will pay for any claims of injury, loss of life or property damage to the extent required by the Federal Employees Compensation Act or the Federal Tort Claims Act. My agreement to participate shall not be construed as a release of NASA, or any third party, from any future liability, which may arise from, or connected with, the above procedures."

B.Identify Plan for Addressing Pregnancy

If pregnant subjects are excluded from participation, use the following statement:

"Female subjects will model the astronaut population: a pregnancy test will be required prior to inclusion in the study and prior to each experimental session"

C.Maximum Strength Protocols and Functional Fitness Tests (FFTs)

Mishap Investigation Board Corrective Action Plan SA42-07-009

PI's and medical monitors must define a rationale for and utility of using any form of maximum strength testing in their protocols, and if a defensible rationale is provided, include a well defined upper limit for maximum physical exertion that will minimize the likelihood of injury.

The Test Subject Screening Facility (TSS) has implemented procedures to identify subjects with greater than average strength during the test subject screening process. These are subjects who are visibly more muscular than the average individual and/or who acknowledge a history of body building or weight training. PIs who elect to use such subjects will be responsible for adjusting test protocols (e.g. placing upper limits on maximum strength exertion allowed) to address differences between subjects of average strength and greater than average strength.

The TSS medical screening forms and screening exams record specific information about the amount, type (brand name), and frequency of use of performance enhancing nutritional supplements that contain substances that are intended to increase strength. Individuals who test positive for urine steroids will be disqualified. The TSS will inform PIs of subject use of other nutritional supplements and PIs must factor this information into their test protocols, especially where strength testing is involved.

Informed consent documents, lay summaries, and hazard analyses for the use of FFT and other protocols that require bench pressing with extreme weights must include discussion of potential severe muscle and/or tendon injuries that could require surgical repair or rehabilitation.

Before a protocol developed to assess astronaut flexibility and strength is adapted for use with non-astronaut test subjects, the PI must identify differences in physical and psychological characteristics and in the research outcome and document the rationale for adapting the protocol to non-astronaut volunteers.

When test protocols include multiple test procedures, the PI must identify the hazards of all procedures.

D.Mishaps Investigation Board and Corrective Action Plan IRIS S-2011-277-00003

The Office of the NASA Chief Health and Medical Officer (OCHMO) and the JSC Space Life Sciences Directorate (SLSD) should establish scientifically based criteria for the use and non-use of inertially loaded exercise equipment in ground studies and during space flight. These criteria should be publicized for use by the Institutional Review Board in evaluating research proposals and for use by the Flight Surgeons and Astronaut Strength, Conditioning, and Rehabilitation Group during crew operations.

The Office of the NASA Chief Health and Medical Officer, JSC Space Life Sciences Directorate, and the NASA Institutional Review Board should implement procedures to ensure that physicians that monitor medical safety and protocol compliance have unimpeded and timely access to all baseline research data and medical records for test subjects enrolled in NASA based research studies.

The NASA Institutional Review Board should implement procedures to ensure that baseline data that may provide exclusionary criteria for research subjects is reviewed by physicians qualified in the interpretation of that data as it pertains to the safe and successful completion of the research testing.

The JSC Institutional Review Board (IRB) should implement procedures to ensure appropriate medical screening studies are performed and reviewed by qualified physicians prior to a research subject entering the testing phase of a research protocol. These screening studies should be tailored for each research proposal in an attempt to detect exclusionary criteria in candidate research subjects.

The iRATS principle investigator should modify the subject screening criteria to include an assessment of creatine kinase prior to the first exercise session.

The Test Subject Screening Facility should add research protocol appropriate detailed range of motion exams to their physical examination guidelines.

The NASA OCHMO and JSC SLSD should implement administrative and fiscal policies that guarantee independent authority of action for physicians that screen test subjects and monitor medical safety and protocol compliance, and that will prevent any conflict of interest with those that they are expected to monitor.

The JSC SLSD should assess the potential risk to longitudinal data comparability between DXA studies performed at JSC and those performed at UTMB and, if a risk is found, develop a means to mitigate that risk.

E.Subject Privacy and Data Confidentiality

1.Background

JSC Procedural Requirement (Management Instruction) 1382.5B, "Maintaining the Privacy of Biomedical Research Data" has been referenced in past studies. This document was cancelled effective April, 1, 2009.

In addition to narrative required to describe the extent to which confidentiality of records identifying the subjects shall be maintained; the following statements, one for the Research Protocol and one for the Lay Summary, are offered for consideration as being required for studies coming before both the Ground and the Flight IRBs.

2.Privacy/Confidentiality (for Research Protocol)

Subject privacy and data confidentiality will be maintained in accordance with 1) NASA Policy Directive (NPD) 7100.8, "Protection of Human Research Subjects"; 2) NASA Procedural Requirements (NPR) 7100.1, "Protection of Human Research Subjects"; and 3) to the extent allowed by Federal law.

3.Statement of Privacy/Confidentiality (for Lay Summary)

My/Your privacy as a research subject and the confidentiality of any research data about me/you associated with this study will be maintained in accordance with 1) NASA Policy Directive (NPD) 7100.8, "Protection of Human Research Subjects"; 2) NASA Procedural Requirements (NPR) 7100.1, "Protection of Human Research Subjects"; and 3) to the extent allowed by Federal law.