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 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 retrievable by a personal identifier, are subject to The Privacy Act of 1974, as amended, 5 U.S.C. § 552a and such Privacy Act system of records is noticed in the Federal Register as Human Experimental and Research Data Records (10HERD), 80 FR 68569 (Nov. 5, 2015). 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, NASA Information Security Policy.

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 and The Genetic Information Nondiscrimination Act of 2008, 42 U.S.C § 2000ff et seq. and NPD 7170.1.

3.2.2 All studies involving human genomic testing is categorized as “greater than minimal risk.”

3.2.3 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.

3.2.4 Research protocols involving human research genetic testing clearly state:

a. Human Research Genetic Testing is performed.

b. Whether or not human research genetic data is extracted from biospecimens.

c. Attributable or identifiable human research genetic data is not publicly released without the prior approval of the individual research subject and other subjects whose anonymity might be affected by the release as well as the NASA IRB and/or the Lifetime Surveillance of Astronaut Health Advisory Board.

d. PIs using human research genetic information offer genetic counseling to research subjects, both before and after obtaining genetic information.

3.2.5 All human research genetic testing data is considered protected data.

3.2.6 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 PIs archive original study data at NASA or elsewhere at NASA’s direction and destroy all copies of the original study data after the study is complete. PIs return biospecimens to NASA or destroy the biospecimens following completion of the study in accordance with the protocol research.

3.2.6.3 PIs do not attempt to identify or contact individual participants from whom data was collected without approval from the NASA IRB.

3.2.6.4 Because it may be possible to reidentify deidentified genomic data, access to deidentified research subject data is controlled.

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, and social security number), unless it has been included in the research subject’s Electronic Medical Record.

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