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NASA Procedures and Guidelines |
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This Document is Obsolete and Is No Longer Used.
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| | TOC | ChangeHistory | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | Chapter6 | Chapter7 | Chapter8 | Chapter9 | Chapter10 | AppendixA | AppendixB | AppendixC | AppendixD | AppendixE | AppendixF | ALL | | |||||
5.1 Approval Requirements
5.1.1 The following requirements will be satisfied for the IRB to approve the research involving human subjects covered by this NPR:
a. The PI shall always protect the safety and minimize health risk to subjects by:
(1) Selecting methodologies and procedures which are consistent with sound research design and conduct and which do not unnecessarily expose subjects to undue risk; and
(2) Using procedures already being performed on the subjects for other experiments, so as to minimize the collective impact of multiple protocols on the subject.
b. In evaluating safety risks and benefits, the IRB ensures risk to subjects be reasonable in relation to anticipated benefits, if any, and the importance of the new knowledge may reasonably be expected to result. The IRB considers only those risks and benefits, taking into account the collective impact of multiple protocols that may result from the research. The IRB should not consider possible long-range effects of new knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks or benefits that are its responsibility.
c. The PI shall obtain and document the voluntary informed consent of each prospective subject or the subject's legally authorized representative. The human research consent form will contain at least all elements listed in section 4.2 and 4.5. The PI shall inform the subject that not all risks are readily identifiable.
d. The PI may ensure the subject or the subject's beneficiaries receive compensation by means of insurance, worker's compensation, or the like in the event that the subject suffers illness, disease, injury, loss, or death as a direct result of the research. The lack of this provision may serve as a basis for disapproval of the research. Such provisions for compensation will be required for all studies performed at a NASA Center, uses NASA equipment or facilities, or for which a NASA employee or onsite contractor is the principal investigator.
e. The research proposal contains provisions for monitoring the data collected to ensure the safety of the subjects. Appendix C includes other informational items that should be included in a human research proposal.
f. The PI shall comply with NASA's 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 retrievable by personal identifier, are subject to 5 U.S.C. 552(a) and are maintained under the NASA Privacy Act System of Records, Human Experimental and Research Data (HERD) Records. Such data held by other institutions will have similar safeguards. The PI maintains the records relating to the conducted research and will retain these records for at least three years after completion of the research.
g. No human subject will participate in any portion of the research until the IRB approves the protocol.
h. The PI shall ensure selection of subjects is equitable and representative of the population that its biomedical research intends to represent. The IRB should assess the purposes and setting of the research. In the case of space flight, considerations should be given to the habitability conditions and the level of medical care available in the event of illness or injury.
i. Research involving Human Research Genetic Testing will adhere to 5 U.S.C. § 552(a) and 42 U.S.C § 2000ff et seq.
(1) All studies involving human genomic testing will be categorized as "greater than minimal risk."
(2) Genetic counseling by a qualified counselor who is not the PI or co-investigator on the protocol 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) Research Protocols will clearly state:
(a) Human Research Genetic Testing will be performed.
(b) Whether or not human research genetic data will be extracted from biospecimens.
(c) Attributable or identifiable human research genetic data will not be 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 appropriate NASA IRB or the Lifetime Surveillance of Astronaut Health Advisory Board.
(d) Investigators using human research genetic information will offer genetic counseling by a qualified genetic counselor to research subjects, both before and after obtaining genetic information.
(4) All human research genetic testing data will be considered protected data for the purposes of safeguards; electronic and policy.
(a) Investigators will adhere to IT security and privacy policy practices to ensure only authorized individuals can gain access to data files.
(b) Investigators will report any inadvertent data release, breach of data security, or other data management incidents contrary to the terms of data access in accordance with the terms in the NASA IRB approved protocol and informed consent.
(c) All results approved for public release will be limited to the minimum data necessary to support the research conclusions.
(d) Results from human research genetic testing will not be data-mined or cross-referenced with other databases of any kind unless approved in advance by the appropriate NASA IRB.
(e) Per 2 CFR pt. 215, Investigators will 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. Investigators will return biospecimens to NASA or destroy the biospecimens following completion of the study in accordance with the protocol research.
(f) Investigators will not attempt to identify or contact individual participants from whom data was collected without approval from the appropriate NASA IRB.
(g) Because it may be possible to reidentify deidentified genomic data, access to deidentified research subject data will be controlled.
(h) Human research genetic data will be stored in a database separately from data containing personally identifiable information (e.g., sex, age, name, address, phone number, social security number), unless it has been included in the research subject's Electronic Medical Record (EMR).
| TOC | ChangeHistory | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | Chapter5 | Chapter6 | Chapter7 | Chapter8 | Chapter9 | Chapter10 | AppendixA | AppendixB | AppendixC | AppendixD | AppendixE | AppendixF | ALL | |
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