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.
Collaborative Institute Training Initiative (CITI) Training
All key research personnel on the submission are required to complete the Collaborative Institute Training Initiative (CITI) human subjects research curriculum before the study can be approved by the NASA IRB.
CITI training certificates must be attached to the submission.
CITI training certificates are valid for 3 years. The NASA IRB will not accept expired CITI training certificates (even if the outside institution has an expiration date of more than three years from the initial pass date).
CITI offers a Refresher Course that may be used to renew Human Subjects Training requirements. Training may be renewed through completion of the Refresher Course three times. After three renewals, CITI requires completion of the Basic Course.
If the investigator is not associated with NASA and submits an alternative human participants protection training certificate, the NASA IRB Office reserves the right to require the investigator complete some or all elements of the NASA CITI training module.
The NASA IRB must ensure that conflicts of interest “do not adversely affect the protection of participants, the integrity of the research, or the credibility of the Human Research Protection Program” (AAHRPP).
All key research personnel must disclose financial and non-financial interests. Key personnel should select the appropriate disclosure form depending on whether they are civil servants or non-civil servants .
The probability and magnitude of harms or discomforts anticipated in the research protocol are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests.
Greater than Minimal Risk
The probability and magnitude of harm or discomfort anticipated in the research protocol are greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests, but these risks are considered to be acceptable when weighed against the anticipated benefits and the importance of the knowledge to be gained from the research.
A scientific merit review should be conducted prior to submission of the research protocol to the NASA IRB. Protocols that have not previously received a scientific merit review may be rejected for IRB review, depending on the particular circumstances, and at the discretion of the NASA IRB chair or other IRB members as assigned by the chair. Scientific merit reviews help assure the quality of the IRB submission and processes (including IRB members’ decisions about “risk versus benefit”), and reduce turnaround time for review and approval. Because the results of scientific merit reviews need to be communicated to the IRB, it is necessary that one copy of any related documentation be included with the IRB application.
The regulatory rationale for requiring scientific merit reviews emanates from NASA 14CFR1230.111(a)(1)as follows:
Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.
Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
When reviewing human subjects research, the IRB must be able to determine that risks to subjects are minimized and reasonable in relation to anticipated benefits (14CFR1230.111). Hazard/Risk Assessment (HRA) is an essential component of minimizing the risks associated with human research. The goal of an HRA is to document the hazards and associated risks involved and the controls in place to mitigate these conditions.
While a safety professional may review and assist in the development of an HRA, it is the principal investigator and others directly involved with the research that are best suited to defining the hazards and risks associated with the proposed research.
When completing the HRA within the IRB protocol, only include those hazards/risks associated with the research. While a separate HA document is not required when submitting to the IRB, the information should be added to the table in section I1 of the protocol.
Please contact the NASA IRB or the Safety Representative with questions.
Blood sample collection should minimize the number of needle sticks and catheter insertions, grouping data collections as much as possible for all studies. The number of proposed venipunctures and finger sticks must be part of the NASA IRB review package for the individual proposal as well as for the final plan in which all the studies for a mission or ground-based study are combined.
The allowable experiment blood volume may be reduced by a crew surgeon. Crew members who weigh less than 110 pounds may be limited in the maximum blood volumes permitted.
Medical Operations requires blood analyses as part of the crewmember standard health care. With crewmember consent, data from medical analyses may be made available to investigators when outlined in a Data-Sharing Plan.
The NASA IRB has established standards for the total amount of blood (including the blood volumes required for medical care).
Note: Expedited Review Category 2 states that the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture may not exceed 550 mL in an 8-week period and collection may not occur more frequently than 2 times per week for healthy, non-pregnant adults who weigh at least 110 pounds. If blood volumes exceed these limitations, the protocol must be reviewed by the convened board.
Spaceflight Less than 30 Days
Total pre-, in-, and post-flight blood volume
Maximum 450 mL per mission (6 weeks before launch to 6 weeks after landing)
In-flight blood draws
Maximum 50 mL per week
Blood volumes outside of this timeline
Federal guidelines of 450 mL per 56 days
Spaceflight 30 Days and Longer
Up to 6 months before launch (L-6 months)
Maximum 450 mL per 56 days
L-6 months to L-20 days
250 mL per month, not to exceed a maximum volume of 500 mL
L-20 days to launch
Maximum 100 mL
In-flight blood draws
150 mL per month, except for the last 30 days of a mission, which will remain at 100 mL, with a maximum total in-flight volume of 450 mL
No later than the end of crew day R-1
No blood may be drawn
Landing day
Maximum 120 mL
Post-landing (R+1) to R+45
Maximum 300 mL
After R+45 days
Maximum 450 mL per 56 days
Spaceflight 1-Year Mission
For 1 year mission and the increased number of research investigations with a greater number of in-flight sessions requiring blood samples. There are no changes to the current monthly blood volume standard. The proposed change affects only the total allowable blood to be collected from each crew member. There will not be any changes to the current pre-fight and post-flight blood volume guidelines.
The In-Flight Blood Volume Standard is:
For missions of 6 months or less:
150 mL per month, maximum total in-flight blood volume of 450 mL
For missions greater than 6 months:
150 mL per month, maximum total in-flight blood volume of 900 mL per year
Small Modifications to In-flight Blood Draw Limit Onboard ISS
The NASA IRB and HRMRB maintain an in-flight blood draw limit of 150 mL per 30 days. In rare cases, rapid contingency on-orbit rescheduling may result in rolling 30-day blood draw totals slightly exceeding that limit. The NASA IRB grants the crew surgeon the authority to approve a waiver to the 150 mL limit to allow the scheduled activity to proceed, provided that the crewmember concurs and the additional blood drawn will not raise the total to greater than 130 mL. In any such cases, ISSMP will notify the NASA IRB within 3 days of the occurrence.
All ISS Human Research Missions are planned with strict adherence to the NASA IRB and HRMRB in-flight blood draw limits, specifically no more than 150 mL of blood drawn per 30 days in-flight. ISS planners develop a comprehensive Increment schedule prior to the start of the mission, but detailed weekly schedules are finalized in 15-minute blocks three weeks prior as the mission proceeds. Weekly schedules are further adjusted as in-flight events or other logistical issues necessitate. These real or near real time adjustments can sometimes shift planned blood draws into time frames that may result in somewhat more than 150 mL being drawn during a 30-day period. Often this occurs following a period of intensive schedule re-planning that requires schedule changes on short notice. For example, this may mean a 20 mL blood draw planned on Flight Day 32 must now occur on day 28, and what would have been a 30-day period involving only 90 mL of blood now involves 110 mL.
There are two types of scenarios that are the most likely to require a rapid waiver to the 150 mL/30 day blood draw limit:
1. Vehicle Traffic:
Unexpected launch, docking, or undocking delays can lead to rapid and significant changes to crew schedules, sometimes resulting in shifting of previously planned blood draws and breaking what had been satisfactory 30-day windows. A recent undocking delay nearly resulted in the need for a repeat blood draw within 24 hours, which would have violated the 100 mL constraint while not providing enough time for formal IRB approval.
2. Technical issues during blood draws:
In some cases, a blood tube with a faulty vacuum or an operator technical issue results in the incomplete filling of blood tubes, which must be supplemented with one or more additional tubes.
In some cases rapid schedule changes proposed by the flight controllers require ISSMP concurrence within 12-24 hours. Currently, if such a schedule change results in a 30-day blood draw total in excess of 150 mL, ISSMP must secure an approval from the NASA IRB Chair. The process of securing even this expedited formal approval can exceed the response time required by the Flight Director and could result in a significant loss of science. This in turn can jeopardize the time a willing crewmember has already invested in the experiment. The risk is particularly great if such decisions are required after normal business hours or on weekends. Since the crew surgeon assigned to the mission has the greatest insight regarding the crewmember’s health and his or her ability to provide blood beyond the IRB limit, the crew surgeon may serve as a IRB proxy for real-time waivers to blood draw limits.
Indwelling Venous Catheters
Investigators must provide a rationale for such frequent sample collection.
When reviewing human subjects research, the IRB must be able to determine that risks to subjects are minimized and reasonable in relation to anticipated benefits(14CFR1230.111). Hazard/Risk Assessment (HRA) is an essential component of minimizing the risks associated with human research. The goal of an HRA is to document the hazards and associated risks involved and the controls in place to mitigate these conditions.
While a safety professional may review and assist in the development of an HRA, it is the principal investigator and others directly involved with the research that are best suited to defining the hazards and risks associated with the proposed research.
When completing the HRA within the IRB protocol, only include those hazards/risks associated with the research. While a separate HA document is not required when submitting to the IRB, the information should be added to the table in section I1 of the protocol.
For questions, contact theNASA IRB Officeor theSafety Representative. Please allow two to three business days for a response.
