Subject: Protection of Human Research Subjects

Responsible Office: Office of the Chief Health & Medical Officer

Chapter 3. Criteria for NASA IRB Approval

3.1 Criteria for all Research

3.1.1 In addition to complying with the Common Rule, to ensure human subject welfare and minimal health risk, research will be conducted:

a. Using procedures already being performed on the subjects for other experiments, so as to minimize the collective impact of multiple protocols on the subject, where possible.

b. Only if risk/benefit analysis shows risks to subjects are reasonable in relation to anticipated benefits and the importance of the new knowledge is reasonably expected to result. This analysis should consider the collective impact of multiple protocols that may result from the research. Possible long-range effects of new knowledge gained in the research (e.g., the possible effects of the research on public policy) are not considered.

3.1.2 Research complies with NASA’s Information Technology (IT) security and privacy policies to protect the privacy of subjects and the confidentiality of data, especially electronically stored data. Biomedical data, if held by NASA and maintained by contractors on our behalf and if it is retrievable by a personal identifier or is otherwise identifiable, are subject to 5 U.S.C. § 552a. Such data held by other institutions will have similar safeguards.

3.1.2.1 PIs report any inadvertent data release, breach of data security, or other data management incidents to the NASA IRB and in accordance with NPR 2810.1.

3.1.2.2 All results approved, by the appropriate authority, for public release are limited to the minimum data necessary to support the research conclusions.

3.2 Additional Criteria for Human Research Genetic Testing

3.2.1 Research involving Human Research Genetic Testing adheres to 5 U.S.C. § 552a, 42 U.S.C. § 2000ff et seq., and this NPR.

3.2.2 All human research genetic testing data are considered protected data. NASA will protect the privacy of genetic information to the full extent of the law, including after death of the subject to avoid unwarranted invasion of personal privacy of surviving family members.

3.2.3 All studies that generate or utilize identifiable genetic information are categorized as “greater than minimal risk.”

3.2.4 Genetic counseling, by a qualified counselor who is not the PI or co-investigator on the protocol, or through appropriate education as determined by the NASA IRB, will include discussion of the potential importance of genetic testing information for the individual and their biological family. This counseling will also indicate which findings were generated in a non-Clinical Laboratory Improvement Amendments-certified lab and the analytical validity, clinical validity, clinical utility, and the ethical, legal, and social implications of genetic testing results to the subject.

3.2.5 Research protocols involving human research genetic testing will clearly state:

a. Human Research Genetic Testing is performed.

b. Whether or not human research genetic data is extracted from biospecimens or sharing of such data is requested from other sources.

c. Identifiable human research genetic data is not released outside the study team without the prior approval of the individual research subject (or descendants, as applicable) and other subjects whose anonymity might be affected by the release, as well as the NASA IRB and/or other applicable authorities such as the Lifetime Surveillance of Astronaut Health Advisory Board or the Astronaut Occupational Health Management Group. (This policy should not restrict the IRB-approved re-use or release of research data which may include aggregate datasets, summary results, and analyses derived from genetic testing).

d. That PIs using human research genetic information offer genetic counseling to research subjects, both before and after obtaining genetic information, whenever subjects are informed or could become aware of their genetic testing results.

3.2.6 That PIs adhere to IT security and privacy policy practices to ensure only authorized individuals can gain access to data files.

3.2.6.1 Results from human research genetic testing are not to be data-mined or cross-referenced with other databases of any kind unless approved in advance by the NASA IRB.

3.2.6.2 Research team members do not attempt to identify or contact individual participants from whom data was collected without approval from the NASA IRB.

3.2.6.3 In accordance with the research protocol and policies of the funding program, PIs will archive raw and analyzed original study data and biospecimens at NASA or elsewhere at NASA’s direction and will destroy all copies of the original study data and biospecimens following completion of the study unless approved by NASA.

3.2.6.4 Because it may be possible to reidentify de-identified genomic and exomic data, access to de-identified research subject genomic and exomic data is controlled. No whole genomic or exomic sequence data will be released outside the study team without written consent from the subject or their direct family members who may be impacted by the release of the data.

3.2.6.5 Human research genetic data is stored in a database separately from data containing personally identifiable information (e.g., sex, age, name, address, phone number, or social security number), unless it has been included in the research subject’s Electronic Medical Record at the request of the subject or treating physician.

3.2.7 Consistent with 42 U.S.C. § 2000ff et seq., NASA may utilize the results of human research genetic testing for occupational surveillance, tailoring of individual countermeasures, and informing clinical care. Results will not be used for employment decisions including, but not limited to, hiring/selection, training, and mission/project selection (e.g., for astronauts, flight analog crew).

3.2.8 Human research genetic information and analyses will not be placed in a system that is accessible to managers or supervisors who make employment or, for astronauts, mission selection decisions, related to the individuals whose data is contained in the system.

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