IRB Submission Guidance
The NASA IRB has the responsibility to review all human subject research that involve astronaut subjects or research that occurs on the ISS, just to name a few examples. During the review process, the IRB can approve, require modifications to secure approval, or disapprove a submission. Regardless of the review, the roadmap to submit a study or modifying it is similar.
View the NASA IRB Submission Roadmap about IRB Submission Guidance
The Key Question:
Is the study human subjects research?
All activities that meet the Common Rule definition of human subject research must be reviewed and approved by the IRB. The type of review depends on several factors but it will fall under one of three methods: Expedited, Exempt, or Convened Board. If NASA is engaged in research, the research must remain in compliance with, at a minimum:
- NASA 14CFR1230
- NASA NPD 7100.8, and
- NASA NPR 7100.1
The first and key step is determining if a study meets the definition of research.
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge.”
If the definition of “research” is satisfied, then the study qualifies as research. The second step is to determine if the study involves human subjects.
Human subjects are defined as “a living individual about whom an investigator conducting research
- (1) Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens OR
- (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
If the definition of “human subjects” is satisfied, then the study meets the definition of human subjects research and needs IRB review! Click on the tabbed sections to gain more information about the different submission pathways, such as starting a new study or reporting new information.
If the study does not meet the definition of human subjects research at any step, it is considered Not Human Subjects Research (NHSR). Investigators can submit a NHSR questionnaire to the NASA IRB for concurrence and acknowledgement.
New Study
Before submitting a new study, determine the Principal Investigator and identify the study team. All members of the study will have completed human subjects protections training and conflict of interest requirements. Develop the study protocol, informed consent, and gather supporting documents such as advertisements and questionnaires/surveys. Review all documents thoroughly for consistency before submission.
Learn how to submit a new study
Modifications to Approved Studies
Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the NASA IRB for any modifications of the previously approved research before implementing the proposed modification.
Learn how to submit a modification
Continuing Review/Continuing Review with Modifications
Continuing Review (CR) is required for all studies determined to be greater than minimal risk and FDA-regulated research; it may be required for minimal risk studies.
When required, CR occurs at least annually until all research-related activities are completed. Conflict of interest disclosures must be updated at least annually for all key personnel.
Reportable New Information (RNI)
If investigators change the research in order to eliminate apparent immediate hazards without prior IRB approval or if a hazard occurs, it would need to be reported promptly. The NASA IRB uses a special submission in the eIRB for researchers to submit such events.
Learn how to report new information
Study Closure
All IRB approved research protocols require a study closure when research activities are completed. Research activities include, but not limited to, participant enrollment, recruitment, data collection, storage of identifiable data, and sharing identifiable data. The study cannot be closed if any research activities are occurring and NASA IRB approval must be maintained through a continuing review, where appropriate.
Learn how to close out a study
Reliance Acknowledgment and Individual Investigator Acknowledgment
The NASA IRB can serve as the IRB of record or cede review to an external IRB, depending on how the research is being conducted. It holds a Federal-wide Assurance (FWA), FWA00019876, that can help facilitate cooperative research between institutions.
If a collaborating investigator is not affiliated with an institution or organization holding an FWA, an Individual Investigator Acknowledgement can be obtained.
