Institutional Review Board

Conducting Research  |  Guidance on Space Flight, Reduced Gravity Aircraft, Ground Studies, Human-In-The-Loop Studies, and Multi-Experiment Projects

A.Space Flight Studies

1.Overview

Space flight protocols require additional information on training, equipment, and specialized hardware submitted to the IRB;

Expected outcomes for pre- and post-flight training/baseline data collections and in-flight experiments;

Dates/Duration: Expected study duration, pre-flight training schedules, in-flight experiments, and post-flight data collection;

Location(s) of Training/Test/Baseline Data Collection;

Hardware descriptions and hazard analyses;

Detailed procedures for each training session;

Biological specimens: Methods for collection, processing, and disposal of biological samples;

Proposed flight studies should be routed through the designated mission/increment scientist before IRB review to facilitate the process;

Space flight research protocols should be submitted for initial approval 12 months before the mission.

Minimal risk protocols and previously approved reasonable risk protocols with only minor changes may be submitted for expedited review at any time;

Training/baseline data collection protocols must be submitted to the IRB 6 weeks before crew training begins.

Crew physical examination requirements

The annual physical examination for flight personnel is sufficient in most cases;

Specialized testing must include an indication and description;

The need for a flight surgeon and/or medical facilities for preflight, in-flight, or postflight testing must be addressed in the protocol;

Review results of ground-based research to ensure feasibility of the protocol and adequate risk/benefit assessment before proposing a space-flight research protocol;

Include an integrated mission plan for pre-, in, and post- space-flight studies to minimize the risk of an adverse event during the experiments. This plan must include the proposed study, medical requirements (such as blood draws), and crew scheduling requirements.

2.Data Collection Protocols

Pre-flight Training/Baseline Data Collection Protocol must include the following:

Study Title

PI and Technical Personnel; include contact information

Date and location of training

Session Objectives, including background and relevant information

Daily schedule of the training procedures and equipment

Detailed procedures

Protocol modifications (if any) due to previous training sessions and baseline data collections

Hazard and Safety Analyses for equipment, (hardware configuration inspection records, and functional test and checkout) and equipment safety certification

S&MA office inspection and approval of all equipment, whether commercial, modified commercial, or custom designed

Consent Form and Layman's Summary

Additional Attachments

Safety certificates (equipment inspection and certification)

Equipment calibration records

IRB approval letters from host institutions

In-Flight Experiments: Provide detailed procedures and equipment needed, approximate duration of the testing, how many crew subjects are necessary, and number of times the experiment will be performed;

Postflight Testing: Note number of times the test will be done, when, where, and what procedures and equipment will be used.

3.Verbal On-Orbit Consent

The IRB acknowledges that potential scientific experiments may not be identified or offered to crewmembers before flight. Under these circumstances, it is acceptable for a crewmember to be contacted while on orbit. The International Space Station Medical Projects (ISSMP) together with the Principal Investigator of the proposed research study will provide the investigation requirements/informed consent briefing to the crewmember. Questions regarding the investigation may be addressed directly to the ISSMP and the Principal Investigator.

The Flight Surgeon may participate in the informed consent briefing and at a minimum will be provided the technical and operational requirements of the study. The Flight Surgeon will be prepared to discuss the investigation with the on-orbit crewmember just as they would preflight. Medical questions or concerns from the crewmember may be resolved directly with the Flight Surgeon. Crewmember consent via e-mail or verbal consent in such a situation will stand in place of the usual signed informed consent. The crewmember's flight surgeon may serve as witness and may sign the informed consent as his/her proxy, if requested by the crewmember. It is understood that all programmatic approvals for adding the experiment/activity will be in place prior to approaching a crewmember, as well as IRB/HRMRB approval of the addition to a crewmember's complement.

On-Orbit Consent Memo

B.Reduced Gravity Aircraft Studies

1.General Information

General information about the Reduced Gravity Program and Aircraft Operations is available by contacting the JSC Reduced Gravity Office at 281-244-9809 or online at:

NASA Reduced Gravity Research Program

Digitized images from previous flights may be accessed online (password-protected)

Reduced Gravity Program Photographs

2.Special Notes

Indicate the required level of medical monitoring in the protocol;

Include the following statement in the consent document:

"Since the C-9 or other NASA sponsored aircraft are considered to be a public aircraft within the meaning of the Federal Aviation Act of 1958, as amended, and as such do not hold a current airworthiness certificate issued by the Federal Aviation Administration, any individual manifested to board the C-9 or other NASA sponsored aircraft should determine before boarding whether their personal life or accident insurance provides coverage under such condition.".

A Test Equipment Data Package (TEDP) must be submitted to the JSC Reduced Gravity Office at least 6-weeks prior to flight. This package must include the test plan, engineering drawings and schematics, structural analysis, electrical load analysis, and hazard analysis. The test plan should contain the following:

Test Equipment Data Package Requirement and Guidelines NASA JSC RGO

3.Human Test Subject Clearance

Test subjects must obtain a “Human Test Subject Clearance” to fly as a test subject onboard the Reduced Gravity Aircraft. This clearance is a separate requirement outside from receiving a JSC Institutional Review Board (IRB) approval letter. To meet the necessary requirements, please coordinate and communicate with Test Subject Screening personnel.

Dr. Mark Sheehan 281-483-7498 mark.d.sheehan@nasa.gov

Linda Byrd 281-483-7284 linda.m.byrd@nasa.gov

and/or Wanda Thompson 281-483-3252 wanda.thompson-1@nasa.gov

C.Ground-Based Studies

1.Human-in-the-Loop Studies

a.Overview

Human-in-the-loop testing refers to hardware tests and evaluations where human test subjects are required to interface in some manner with the hardware being tested. These tests do not involve human research of the type normally reviewed by the IRB but have the potential of exposing test subjects to some amount of risk to their safety and well-being.

The guidelines below were developed by a sub-committee of the IRB for application to human-in-the-loop hardware tests and evaluations at JSC. The guidelines are intended to ensure the safety and well-being of the test subjects, and to ensure that subjects are informed about all of their rights as defined by Federal and NASA regulations that govern human subject protections in such data collection activities. These guidelines are in addition to requirements that must be met for Test Readiness Reviews.

The guidelines address test subject medical qualification, informed consent, and medical monitoring. A new informed consent form approved by the JSC Legal Office representative to the IRB and an outline for preparing a Layman's Summary description of the test are included with the guidelines.

It is important for users of these guidelines to recognize that hardware tests and evaluations may expose test subjects to risks that range from those that are very minimal to those that are potentially severe.

Minimal risk: In cases where it has been determined that the hardware test involves minimal risk, the test protocol can be reviewed and approved in an expedited manner by the IRB Chair provided that the enclosed IRB guidelines have been met.

Reasonable risk: In cases where greater than minimal risk is involved (i.e., "reasonable risk") the test protocol may be reviewed and approved in an expedited manner by a sub-committee of the IRB.

Reasonable-high risk: In cases where the hardware test requires that test subjects be exposed to a high level of physiological stress to achieve the objectives of the test, a review by the full committee will be required.

The IRB will make every reasonable effort to review and approve hardware test protocols in a timely manner in order to accommodate hardware test schedules. However, principal investigators and project managers of hardware tests must likewise submit review materials, including documentation regarding test subject medical qualification, to the IRB in a timely manner.

General questions about these guidelines may be addressed to the IRB Chair or Deputy Chair. Questions concerning test subject medical qualification should be addressed to the NASA Manager of the JSC Test Subject Screening Facility.

b.IRB Guidelines on Subject Protections Requirements for Human-in-the Loop Hardware Tests and Evaluations

The following requirements are for the conduct of tests and evaluations where the primary focus of the project is to gather data on the performance of the hardware and not the human subject. These are tests where human subjects are required because the hardware cannot be evaluated without a human using or donning the hardware.

The primary intent of IRB involvement in tests and evaluations of this type is to ensure that appropriate measures have been taken to properly medically qualify the human subjects involved, that the subject's informed consent to participate has been obtained, and that appropriate medical monitoring of the activity is implemented.

IRB requirements are in three primary areas:

c.Test Subject Medical Qualification

All test subjects are required to annually complete a NASA-modified Air Force Class III physical examination or equivalent, preferably at the Building 8 Test Subject Screening Facility (TSS). Test subjects who have received a physical examination clearance from the Building 8 Occupational Health Clinic must provide a copy of the exam findings and laboratory reports to the TSS for TSS physician review prior to the subject being cleared for participation in a hardware test. For any exam completed in the Building 8 clinic, the TSS will require that an updated medical history and other forms be filled out by the test subject. Any subsequent changes in the test subject's medical history must be reported to the TSS prior to participation in a hardware test. The TSS physician may require additional medical evaluations based on his or her review of the Building 8 records. Although test subjects must keep their TSS physical exam clearances current on an annual basis, clearances to participate in any given hardware test must also be obtained on a individual case-by-case basis.

Exceptions to the requirement for an annual Air Force Class III equivalent medical clearance may be made for tests or evaluations where very minimal risk to the test subject is involved and the activity would be defined by the IRB as requiring only Level 4 medical monitoring. In these cases, other types of physical examinations performed in the Building 8 Clinic may suffice as long as copies of the medical records are provided to the TSS physicians for review. However, investigators must realize that such exams will typically not be sufficient for any of their other hardware tests involving higher levels of risk.

The TSS does not need to recruit test subjects from the TSS-qualified pool if the investigators already have their own qualified test subjects. However, in all cases, the investigators will need to submit a test subject request form, a copy of the IRB approval letter, and a copy of the Layman's Summary to the TSS.

Medical Monitoring

Preparing for Research | Medical Monitoring

The Principal Investigator shall propose the required level(s) of Medical Monitoring for the hardware evaluation protocol. The IRB will evaluate the proposed level(s) and guide any necessary changes.

Test Subject Informed Consent

The individual who is designated as the Principal Investigator for the hardware test or evaluation is required to give each subject an informed consent briefing that describes the procedures and conditions to which the subject will be exposed. This briefing must include a complete description of all potential hazards or discomforts associated with the test or evaluation and the measures that will be taken to mitigate the hazards and discomforts. In addition to a verbal briefing, the Principal Investigator must provide to the subject an informed consent form for his or her signature, and a Layman's Summary.

Informed Consent Form

An informed consent form specific to studies where the primary purpose is to test or evaluate hardware performance and not collect data on the human has been developed by the IRB with guidance from the JSC Legal Office. The IRB requires that after receiving an informed consent briefing, this consent form be read and signed by all human subjects who volunteer to participate in hardware test and evaluation projects.

Human-in-the-Loop or Engineering Consent and Lay Summary Template

Layman's Summary

The consent form and the Layman's Summary that must accompany the consent form will ensure that the subjects are properly informed about all of the protections to which they are entitled as defined by Federal regulations. The Layman's Summary may be limited to 2-3 pages of carefully worded text. An outline of the information that must be included in the Layman's Summary follows.

d.Layman's Summary Outline

Please use the Engineering Subject Information Handout Elements for your Layman's Summary / Informed Consent, found at the following location:

Engineering Subject Information Handout Elements (Human-in-the-Loop or Engineering Consent and Lay Summary Template)

2.Biohazardous Materials in Ground-Based Studies

The JSC Biosafety Review Board (BRB) requires completion of a Biohazardous Material Approval Form (JSC Form 712) for review and approval prior to the start of any ground-based experiment that utilizes biological agent(s). Biological agents include, but are not limited to: bacteria, fungi, protozoa, viruses, mammalian cell lines, recomginant DNA, and biological toxins. The review process ensures that appropriate practices, safety equipment, and facility safeguards are in place to protect laboratory workers and non-laboratory occupants of the building. The form can be accessed through the BRB website:

Biosafety Review Board Website

All human blood, blood components, products made from human blood, and body fluids that are used for diagnostic or research purposes at JSC must be handled according to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030). BRB approvals are not required for the use of blood and body fluids.

The IRB and BRB will coordinate resolution of any concerns raised by either committee before issuing final authorization and approval. A link will be maintained between the approved IRB application and the JSC Form 712 for the life of the study.

D.Multi-Experiment Projects

1.Overview, Process, and Example of Increment 27-28 HRMRB Package

a.Overview

Institutional Review Boards (IRB) have developed well established processes and requirements for managing and approving research involving human experiments where an individual subject participates in a single experiment. Generally these processes and requirements are consistent across settings such as universities, government entities, research institutes, etc., which are based on compliance with federal regulations. However, currently there are no guidelines or established processes for managing projects or programs that involve subjects participating in multiple experiments simultaneously, such as bed rest campaigns and space flight missions and expeditions. It would be a daunting job for members of an IRB to review, in a single submission, all of the master protocols and plans for integrating the protocols for every campaign, mission or expedition. In order to simplify the IRB task of approving such research projects and programs a process developed and tested for space flight missions by the International Space Station Medical Program (ISSMP) is outlined below for application to, or implementation with, other projects involving multiple investigations:

b.Process

Each principal investigator (PI) must individually submit their protocol to IRB for initial approval and must maintain current approval status.

A separate package should be submitted to IRB by the responsible program lead that essentially summarizes the upcoming project and should include the following components:

Complete list of all experiments to be included in the project (Titles, PIs, and Sponsoring Institutions).

One or more scenarios that participating subjects will likely be assigned to following informed consent procedures, and which represent the maximum number of experiments in which a subject assigned to that scenarios of experiments would participate.

A table showing "Institutional Review Board Status." This should include a list of all experiments planned for the upcoming project and the latest approval date from IRB and IRBs of sponsoring institutions.

A set of 3 tables summarizing the experiment activities before, during and following the project: Each table should include the experiment title, PI, and session activity and their time requirements (familiarization, training, BDC, etc.)

A summary table of blood volume requirements for all experiments in a given complement of experiments. The table should show the total amount of blood to be drawn (for a given scenario of experiments) during each phase of the project (before, during and following). The table should also include a column indicating the blood volume limits set by the IRB for each time period.

Each PI must complete an annual Test Readiness Review (TRR) as required by the IRB. Information about the TRR requirements are available on the IRB website.

c.Example

An example IRB package for an ISS expedition is posted on the IRB website. There are two items in the example that are NOT required for the multi-experiment ground-based projects: 1) the table entitled "Target Matrix," and 2) the set of tables detailing the blood volume requirements by experiment before, during and following the project ("Blood Volume by Activity").

Example HRMRB Package for ISS Expedition 27-28 (1.9 MB; PPT)