Overview of talk: a) Content of Human Life Science data; b) Data archive structure; c) Applicable legal documents and policies; and d) Methods for data access. Life Science Data Archive (LSDA) contains research data from NASA-funded experiments, primarily data from flight experiments and ground analog data collected at NASA facilities. Longitudinal Study of Astronaut Health (LSAH) contains electronic health records (medical data) of all astronauts, including mission data. Data are collected for clinical purposes. Clinical data are analyzed by LSAH epidemiologists to identify trends in crew health and implement changes in pre-, in-, or post-flight medical care

Sams, Clarence

NASA Technical Reports Server

Human Research Program
HRP Data Accessibility 
Current Status
Investigators Workshop
3 February 2009
Clarence Sams
https://ntrs.nasa.gov/search.jsp?R=20090010022 2019-08-30T06:26:08+00:00Z
Human Research Program
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Perception of science community
regarding the “stealth” medical data…
I know it’s there…I just can’t see it!!
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• Content of Human Life Science data
• Data archive structure
• Applicable legal documents and policies
• Methods for data access
Overview of talk
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50 Years of Spaceflight Data
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What Data Does NASA Have?
• Life Science Data Archive
• (LSDA)
• Contains research data from 
NASA-funded experiments, 
primarily data from flight 
experiments and ground 
analog data collected at 
NASA facilities
• http://lsda.jsc.nasa.gov
Longitudinal Study of 
Astronaut Health (LSAH)
• Contains electronic health 
records (medical data) of all 
astronauts, including mission 
data
• Data are collected for clinical 
purposes
• Clinical data are analyzed by 
LSAH epidemiologists to identify 
trends in crew health and 
implement changes in pre-, in-, or 
post-flight medical care
• Repository more than study
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Data Access: LSDA
http://lsda.jsc.nasa.gov
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Data Access: LSDA
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Data Access: LSDA
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Data Access: LSDA
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Data Access: LSDA
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Data Access: LSDA
                      Flight Crew-Intervertebral Disc Cross-Sectional Area,
                    Percent Change From Baseline
T12-L1 L1-L2 L2-L3 L3-L4 L4-L5 Average P
L-(50/51) 1 1 -1 -1 -1 0
L-(29/31) -1 -1 1 1 1 0
R+0 -4 -2 -3 -5 -1 -2 NS
R+2 -4 -2 -2 -0 1 -2 NS
R+10 -9 -5 -7 -9 -6 -6 <0.01
R+30 -1 -1 -3 -4 -2 -1 NS
Each data points represents the average from four subjects.
Preflight measurements (L-50/51 and L-29/31) were combined and were the baseline the 
postflight measurements were compared with.
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Data Access: LSDA
• Key Points and limitations about LSDA
– Contains research data from NASA-funded experiments, 
primarily data from flight experiments and ground analog 
data collected at NASA facilities
– Collected under specific informed consent
– Each dataset collected under different circumstances 
defined by the original investigation
– Data on main web site is from published reports
– http://lsda.jsc.nasa.gov
NOTE:  Quality of data in = quality of data out.  PIs 
are responsible to populate this database at the end 
of their NASA sponsored research
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Data Access: LSAH
Longitudinal Study of Astronaut Health (LSAH)
• Irrespective of the title, this is an ongoing data repository 
not a specific study
• Contains electronic health records (medical data) of all 
astronauts, including mission data
• Data are collected for clinical purposes
• Clinical data are analyzed by LSAH epidemiologists to 
identify trends in crew health and implement changes in 
pre-, in-, or post-flight medical care
• Task makes available information from the medical 
requirements (MRIDs) – descriptions available at 
http://lsda.jsc.nasa.gov/docs/MRID/MRIDhome.cfm
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Data Access: LSAH
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Data Access: LSAH
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Data Access: LSAH
• Limitations of the Data
– Taken for clinical purposes
– Flight Surgeons assess health of crew members using 
numerous inputs
• Data may not always be taken for each crew member
– Data taken on crew members may be taken in different 
circumstances
• Example: Soyuz vs. Shuttle crew returns change times and tests
– Much of data content is driven by crew surgeon need
• Data may list outcome (e.g.,  “normal”) not the detailed measures
– Raw data may be recoverable, but will require deeper 
retrieval
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Privacy Law
– Privacy Act of 1974 prohibits disclosure of records 
contained in a system of records maintained by a federal 
agency (or its contractors) without the written request or 
consent of the individual to whom the record pertains. 
• Privacy Act permits agencies to disclose information for other 
purposes defined as “routine uses” which are defined and 
published in the Federal Register Systems of Record Notice.
– 10HIMS – Health Information Management System
– 10HERD – Human Experimental and Research Data
• Access on a need-to-know basis. 
– Subjects have the right to decide the extent to which their 
data is used, i.e. Informed Consent.  Reviewed and 
enforced by JSC Committee for the Protection of Human 
Subjects (CPHS).
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Methods for Access to Data
• Data can be given under these circumstances
– Informed Consent has been obtained from each crew 
member, specifying the purpose for which the data are to 
be used
• Based on Informed Consent, limitations may be placed on 
publication of data
– Review by LSAH Executive Committee to ensure data submitted for 
publication are properly de-identified
OR
– Data are “De-Identified” prior to delivery to the researcher
• Data have identifiers such as mission length, gender, etc removed 
or “binned” to preclude individuals from determining the crew 
member’s identity
– e.g. Mission length is one of 12, 13, 14, etc. days vs specification of 
mission length to days, hours and minutes
• Data are reported in pooled manner to preclude any specific 
individual from being identified
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NRA Proposals
• Proposers to an NRA could include the use of 
biomedical data as part of their research plan
– Researcher reviews the MRIDs and defines the 
requirement for access to data in their proposal
– If proposal is selected
• Review by the Committee for the Protection of Human Subjects
• Brief subjects on use of data
• Obtain informed consent
• Use data
• Publication may be subject to LSAH Executive Committee review 
to ensure data are properly de-identified prior to publication
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Obtaining De-Identified Data
• The most expedient way to obtain access to data is 
to obtain de-identified pooled or grouped data 
• NASA has a staff of epidemiologists that work to 
provide de-identified datasets that address the 
researcher’s specific need
• Since the data were taken in varied circumstances, 
it usually takes some iteration to determine the best 
way to provide the data to the researcher
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De-Identified Data - Individual
BMD Absolute Loss from Preflight 
Expeditions 1-14 (n=18)
-0.200
-0.150
-0.100
-0.050
0.000
0.050
Lumbar
Spine
F. Neck Trochanter Whole
Body
Heel Pelvis
BM
D 
ab
so
lut
e l
os
s (
g/c
m
2)
Average
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De-Identified Data - Pooled
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Obtaining De-Identified Data
• Researcher 
– Searches the MRIDs
– Formulate data request per format posted at 
http://lsda.jsc.nasa.gov/docs/MRID/MRIDhome.cfm
• Purpose/Description
• Information on peer review 
• Data requested
• Contact information
– Email form to jsc-lsah@mail.nasa.gov
or mail to address on form
– Epidemiologist contacts the researcher to further 
understand request
– Epidemiologist provides de-identified data
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Obtaining identified or
crewmember specific data
• Possible to obtain identified data
• Normally the requirement is defined during 
experiment development and is part of the data 
sharing plan
• Requests can be accommodated for approved 
studies
• Requires that individual approval be obtained from 
each crewmember via informed consent
• LSAH team can handle this with appropriate 
information from requesting PI
• Adds processing time to the data release
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0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
0-1
0
11
-20
21
-30
31
-40
41
-50
51
-60
61
-70
71
-80
81
-90
91
-10
0
10
1-1
10
11
1-1
20
12
1-1
30
13
1-1
40
14
1-1
50
36
1-4
70
47
1-4
80
78
1-7
90
Break in Time Line
Average - 68.1 days
• If the requests > 200 days are 
excluded, the average drops 
to 24.9 days
Response Time for Requests Jan-Oct 2008
Days to Completion of Request
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Evidence Reports
• Evidence Reports are a scientific survey of all the 
evidence associated with a particular risk
• Experimental and Biomedical data from LSAH were 
used extensively to write these reports
• Specific discipline  reports are submitted for 
publication in relevant journals
• Reports, publications and references are available 
on the HRP website 
http://humanresearch.jsc.nasa.gov/elements/smo/hr
p_evidence_book.asp
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Data Accessibility Summary
• MRIDs posted on web and pointed to by the NRA
– http://lsda.jsc.nasa.gov/docs/MRID/MRIDhome.cfm
• Evidence Reports available to community
– http://humanresearch.jsc.nasa.gov/elements/smo/hrp_evi
dence_book.asp
• Information regarding process for obtaining data on 
web
– Email jsc-lsah@mail.nasa.gov with any questions
• Survey results will provide a baseline
– The HRP will conduct the survey annually to monitor 
areas to improve


HRP Data Accessibility Current Status

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