Mark Hess
Headquarters, Washington, DC           May 19, 1995
(Phone:  202/358-1778)

Jeffrey Carr
Johnson Space Center, Houston
(Phone:  713/483-3671)

RELEASE:  95-74

NASA TAKES ACTION TO IMPROVE SAFETY IN HUMAN RESEARCH

     NASA today announced immediate actions to improve the 
safety of human subjects in Agency research efforts.  The 
actions are being taken in response to the formal review of a 
mishap that occurred last year during a life sciences 
experiment at the Johnson Space Center, Houston, TX.

     A Mishap Investigation Board was chartered by NASA's 
Office of Safety and Mission Assurance and charged with 
investigating the mishap, reviewing the policy and procedures 
regarding the approval and conduct of life sciences research, 
and making recommendations for optimizing the safety of human 
subjects in scientific research. 

     On October 16, 1994, one of six planned human subjects 
participating in a metabolic experiment experienced a reaction 
to the ingestion and infusion of two chemicals, Inutest and 
Indocyanine Green as prescribed in the experiment protocol.  
The attending physician monitoring the activity administered 
emergency medical care and the subject was taken to a local 
hospital for observation.  The subject was later released and 
returned to work.  The other five experiment subjects had no 
reaction to the chemicals.

     The Board identified the primary cause of the mishap as 
an individually specific, yet unpredictable, hypersensitivity 
reaction ("idiosyncratic anaphylactoid reaction") to the 
administration of the Inutest and/or Indocyanine Green.  The 
Board determined that there is no standard protocol available 
to pre-screen subjects for this reaction, and consequently the 
reaction was unpredictable.  The Board concluded the response 
of the attending medical personnel during the mishap was 
timely and appropriate.

     A number of observations and recommendations were made by 
the Board regarding emergency equipment and supplies inventory 
and configurations, test team training in the use of emergency 
equipment and life support procedures, procedures for communicating
information regarding known prior adverse reactions to a protocol
in a prior subject, and emergency services notifications.  The
report notes that a number of recommendations have already been
acted on and completed.

     In addition, the Mishap Board reviewed policies and 
procedures of the Human Research Policy and Procedures 
Committee (HRPPC) at the Johnson Space Center regarding the 
review, approval and conduct of life sciences research.  The 
Board recommended changes that would further improve the 
safety of life science research on human subjects, and advised 
that the membership of the HRPPC be reviewed with the intent 
of increasing the participation of medically trained members, 
providing representation for subject participants in 
experiments, providing bioethics training for members, and 
broadening participation by non-NASA personnel.  

     As a result of an internal study ordered by JSC Director 
Carolyn L. Huntoon, an Institutional Review Board (IRB) has 
been formed in place of the HRPPC.  Many of the Mishap Board's 
other recommendations coincide with the already proposed 
changes in NASA-wide policy for protection of human research 
subjects.

      An action plan has been developed by NASA's Office of 
Life and Microgravity Sciences detailing steps, many of which 
have already been taken, in response to the Mishap Board's 
findings and recommendations. 

     JSC is charged with the responsibility to develop an 
implementation plan by mid-June addressing all the remaining 
recommendations in both reports and describing any other 
management changes being made to further minimize the 
occurrence of medical mishaps.  NASA's Office of Life & 
Microgravity Sciences will review and certify the 
implementation plan.

     In addition, the Office of Life and Microgravity Sciences 
is coordinating with the Office for Protection from Research 
Risk to assure that NASA remains in full compliance with 
federal regulations and guidelines, and has accelerated 
completion of the revised NASA Management Instruction dealing 
with protection of human research subjects.  

	The IRB will conduct an immediate evaluation of the risk 
to astronauts associated with proposed research for any future 
flight missions.
                         -end-

Note to Editors:  Copies of the Mishap Board reports can be 
obtained by contacting the Newsroom at either NASA 
Headquarters (202/358-1600) or the Johnson Space Center 
(713/483-5111).

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