Mark Hess Headquarters, Washington, DC (Phone: 202/358-1778) Jeffrey Carr Johnson Space Center, Houston (Phone

: 713/483-3671) RELEASE: 95-74

May 19, 1995

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. -endNote 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). NASA press releases and other information are available automatically by sending an Internet electronic mail message to domo@hq.nasa.gov. In the body of the message (not the subject line) users should type the words "subscribe pressrelease" (no quotes). The system will reply with a confirmation via E-mail of each subscription. A second automatic message will include additional information on the service. Questions should be directed to (202) 358-4043.