![[NASA Logo]](../Images/nasaball.gif)
| |
NASA Procedures and Guidelines |
This Document is Obsolete and Is No Longer Used.
|
|
P.1 Purpose
P.2 Applicability
P.3 Authority
P.4 Applicable Documents and Forms
P.5 Measurement/Verification
P.6 Cancellation
1.1 Human Subject Research at NASA
1.2 Common Rule Implementation
2.1 Criteria for all Research
2.2 Additional Criteria for Human Research Genetic Testing
3.1 Research Modifications
3.2 Medical Data
3.3 Withdrawal from Research
3.4 Adverse Events
3.5 Sanctions and Disciplinary Action
This directive outlines the implementing procedures and requirements for the Agency to conduct and support research involving human subjects. These guidelines follow the provisions in 14 CFR pt. 1230 (Common Rule).
a. This NPR is applicable to NASA Headquarters and NASA Centers, including Component Facilities and Technical and Service Support Centers. This language applies to the Jet Propulsion Laboratory (a Federally Funded Research and Development Center), other contractors, recipients of grants, cooperative agreements, or other agreements only to the extent specified or referenced in the applicable contracts, grants, or agreements.
b. This NPR is applicable to all research involving human subjects conducted, sponsored, or supported by NASA.
c. In this directive, all mandatory actions (i.e., requirements) are denoted by statements containing the term "shall." The terms: "may" or "can" denote discretionary privilege or permission, "should" denotes a good practice and is recommended, but not required, "will" denotes expected outcome, and "are/is" denotes descriptive material.
d. In this directive, all document citations are assumed to be the latest version unless otherwise noted.
a. The National Aeronautics and Space Act, 51 U.S.C. § 20113 (a).
b. NPD 7100.8, Protection of Human Research Subjects.
c. NPD 7170.1, Use of Human Research Genetic Testing.
a. The Privacy Act of 1974, as amended, 5 U.S.C. § 552(a).
b. The Genetic Information Nondiscrimination Act of 2008, 42 U.S.C § 2000ff et seq.
c. Protection of Human Subjects (Common Rule), 14 CFR pt. 1230.
d. NPD 8621.1, NASA Mishap and Close-Call Reporting, Investigating, and Recordkeeping Policy.
a. The Chief Health and Medical Officer (CHMO) will measure compliance with this directive by:
(1) Monitoring the number and type of research proposals reviewed and approved by the IRBs.
(2) Monitoring the number and type of protocol non-compliances, corrective actions taken, and sanctions imposed.
(3) Monitoring audit findings and corrective measures adopted.
NPR 7100.1A, Protection of Human Research Subjects, dated February 22, 2018.
1.1.1 Research designed to understand and overcome the effects of aerospace-relevant conditions, contributing factors, and environments on the health and performance of flight and ground crews often requires Principal Investigators (PI) to rely on human subjects. In some cases, basic and applied research is conducted to understand and predict the ability and successfulness of human performance in simulated or actual ground and flight tasks. In other cases, interventional studies may be conducted to study the efficacy of interventions to mitigate the adverse health effects of these environments. Studies may be conducted by scientists, test engineers, and/or clinicians in laboratories (e.g., human-computer interaction, cardiovascular, neuroscience, musculoskeletal, suit design, exercise, nutrition, immunology labs), work environments (e.g., air traffic and mission control centers, as well as on aircraft and spacecraft), and simulated environments (e.g., the Human Exploration Research Analog, the Vertical Motion Simulator, Flight Simulation Facility).
1.1.2 An IRB is a committee operating under the Common Rule that reviews research involving human subjects to ensure the ethical, safe, and equitable treatment of the subjects. There are five NASA IRBs. Four of these IRBs address ground and aircraft research: the Johnson Space Center (JSC) IRB, Langley Research Center IRB, Ames Research Center IRB, and Kennedy Space Center IRB. In addition, there is one IRB that addresses space flight and aircraft research: the Flight IRB which is located at JSC. The JSC IRB is the IRB of record for Glenn Research Center and Marshall Space Flight Center.
The Common Rule applies to all research involving human subjects conducted and supported by NASA. NPD 7100.8, NPD 7170.1, and this NPR are consistent with, but not duplicative, of the common rule. All four documents taken together form NASA’s policy for research involving human subjects. NPD 7100.8 and NPD 7170.1 detail the policy and responsibilities of Headquarters and the Centers, while this NPR defines procedures and requirements in addition to the Common Rule. The five NASA IRBs implement these requirements through charters and/or other Center documentation and report annually to the CHMO.
2.1.1 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.
b. Only if risk/benefit analysis shows reasonable anticipated benefits and the importance of the new knowledge is reasonably expected to result. This analysis should take into account 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.
2.1.2 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 personal identifier, are subject to 5 U.S.C. § 552(a) and are maintained under the NASA Privacy Act System of Records and Human Experimental and Research Data Records. Such data held by other institutions will have similar safeguards.
2.1.2.1 PIs 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.
2.1.2.2 All results approved for public release are limited to the minimum data necessary to support the research conclusions.
2.2.1 Research involving Human Research Genetic Testing adheres to 5 U.S.C. § 552(a) and 42 U.S.C § 2000ff et seq.
2.2.2 All studies involving human genomic testing is categorized as "greater than minimal risk."
2.2.3 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 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.
2.2.4 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 appropriate NASA IRB 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.
2.2.5 All human research genetic testing data is considered protected data.
2.2.6 PIs adhere to IT security and privacy policy practices to ensure only authorized individuals can gain access to data files.
2.2.6.1 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 appropriate NASA IRB.
2.2.6.2 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.
2.2.6.3 PIs do not attempt to identify or contact individual participants from whom data was collected without approval from the appropriate NASA IRB.
2.2.6.4 Because it may be possible to reidentify deidentified genomic data, access to deidentified research subject data is controlled.
2.2.6.5 Human research genetic data is stored in a database separately from data containing personally identifiable information (e.g., sex, age, name, address, phone number, social security number), unless it has been included in the research subject's Electronic Medical Record.
The Flight Surgeon lead for the mission may temporarily suspend research until substantive changes to spaceflight protocol are reviewed by the Flight IRB.
Medical data recorded during research for medical monitoring purpose will be available to appropriate medical personnel and will be included as part of the Informed Consent agreements. Research data will be available to the medical personnel (including flight surgeons) for issues involving safety of flight, safety of mission, medical emergencies,
contingencies, and as required in the care of the patient.3.3.1 Research subjects may withdraw from participation at any time without explanation, penalty, or loss of benefits to which they are otherwise entitled.
3.3.2 In the event a subject withdraws from participation, NASA reserves the right to replace that individual with another test subject.
Upon occurrence of an Adverse Event, the IRB Chair shall notify the NASA Center Safety Officer, the Authorized NASA Official (ANO), the NASA Center Chief Medical Officer (where applicable), the relevant NASA research funding program, and the Flight Surgeon (in the case of astronaut involvement).
Note: Human research mishaps are reported and controlled per NPR 8621.1.
3.5.1 If PIs do not comply with this NPR or with the IRB approved protocol, the appropriate IRB or Institutional Official may suspend or terminate the research. Such noncompliance may be cause for revocation of funding or other appropriate remedies including disciplinary action against the PI.
3.5.2. If a Federalwide Assurance for a NASA Center or any institution is suspended or terminated for cause, the ANO with the concurrence of the Office of the General Counsel and the Office of Procurement may recommend to the NASA Administrator that all NASA funding for human research to that institution be suspended or terminated.
3.5.3. Any evidence of alleged criminal wrongdoing at any level related to information obtained from IRB activities and oversight by the CHMO will be reported to the NASA Office of the Inspector General.
Adverse Event – Any untoward or unfavorable medical occurrence involving a human research subject occurring while associated with the subject's participation in the research. An adverse event is not necessarily a mishap if the protocol-related documents or informed consent documents identify the potential for the medical occurrence.
Human Genetic Testing – An analysis of human Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal and biochemical changes. These tests can include the following:
a. Molecular genetic tests that study single genes or short lengths of DNA or RNA to identify variations or mutations.
b. Chromosomal genetic tests that analyze the entire genome or whole chromosomes or long lengths of DNA or RNA.
c. Biochemical genetic tests that study the amount or activity of proteins or metabolites and wherein any noted changes can indicate changes in (or characteristics of) DNA or RNA.
d. Microbiome testing from human subjects (gut, skin, etc.).
Institutional Official – an individual who has administrative and operational authority to commit institutional resources to ensure compliance with Federal laws, regulations, and guidelines.
Principal Investigator – A civil servant or non-civil servant (e.g., contractors and parties to agreements) researcher who has overall responsibility for all aspects of the funded and/or sponsored research project. Responsibilities for non-civil servant researchers are implemented through a contract or agreement.
ANO – Authorized NASA Official
CHMO – Chief Health and Medical Officer
DNA – Deoxyribonucleic Acid
IRB – Institutional Review Board
JSC – Johnson Space Center
PI – Principal Investigator
RNA – Ribonucleic Acid
C.1 NASA Privacy Act Regulations, 14 CFR pt. 1212.
C.2 Genetic Information Nondiscrimination Act, 29 CFR pt. 1635.
C.3 NPR 1382.1, NASA Privacy Procedural Requirements.
C.4 NPR 1441.1, NASA Records Management Procedural Requirements.
C.5 NRRS 1441.1, NASA Records Retention Schedules.
C.6 World Medical Association Declaration of Helsinki, 18th World Medical Assembly, Helsinki, Finland, June 1964, and amended by the 29th World Assembly, Tokyo, Japan, October 1975; 35th World Medical Assembly, Venice, Italy, October 1983; 41st World Medical Assembly, Hong Kong, September 1989; and 64th World Medical Association, Fortaleza, Brazil, October 2013.
C.7 Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants, World Health Organization, 2011.