JSC 20483 Revision C JSC Committee for the Protection of Human Subjects Guidelines for Investigators Proposing Human Research for Space Flight and Related Investigations Space and Life Sciences Directorate Before use, verify that this is the correct version (Verification on JSC ISO-9000 Internet Site http://stic.jsc.nasa.gov/dbase/iso9000/master/master.cgi) February 2004 National Aeronautics and Space Administration Lyndon B. Johnson Space Center Houston, TX 1 JSC 20483 Revision C Johnson Space Center (JSC) Committee for the Protection of Human Subjects (CPHS) Guidelines for Investigators Proposing Human Research for Space Flight and Related Investigations Approved by:___Original signature on file_________________ ________ C. F. Sawin, Ph.D. Date Chairperson, JSC Committee for the Protection of Human Subjects (CPHS) Concurrence:__Original signature on file__________________ _______ J. R. Davis, M.D. Date Director, Space and Life Sciences Concurrence:__Original signature on file_________________ _______ R. Cabana Date Director, Flight Crew Operations 2 JSC 20483 Revision C JSC Work Instruction Title: JSC CPHS Handbook 20483 Revision: Revision C Date: February 2004 Handbook Revision Process This Handbook has been reviewed by each major organizational element involved (denoted by Handbook signature page). Requests for changes shall be submitted in writing to the Director for Space and Life Sciences. The quality record for this review and update process will be the current document with the appropriate updated revision number and date, signed by the Director, Space and Life Sciences. The Director, Space and Life Sciences, can update the document within any fiscal year as required, and will provide notification that a new version is available. This Handbook shall remain in effect until the Director, Space and Life Sciences, cancels it through such notification. Once a change, revision, or cancellation of this document has been approved, the appropriate information will be provided to the Master List Custodian for placing the change on the Space and Life Sciences Master List. Revision Record Revision # Date Originator/Phone Description March 1988 L. Dietlein Basic Revision A February 1993 L. Dietlein Update Revision B July 1996 L. Dietlein Update Revision C February 2004 C. Sawin/281-483-7202 Update Approved by: _Original signature on file__ Charles F. Sawin, Ph.D. Before use, verify that this is the correct version 3 JSC 20483 Revision C Table of Contents Section Page HANDBOOK REVISION PROCESS ....................................................................... ii ACRONYMS AND ABBREVIATIONS ................................................................... viii GLOSSARY ............................................................................................... xii POINTS OF CONTACT ................................................................................. xiv INTRA- AND INTERNET ACCESS ...................................................................... xvi INTRODUCTION .......................................................................................... 1 1.0 OVERVIEW OF THE JSC CPHS .................................................................. 1 1.1 Guiding Principles of the JSC CPHS .................................................... 1 1.2 Charter of the JSC CPHS ................................................................. 1 1.3 Composition of the JSC CPHS ........................................................... 2 1.4 Working Principles of the JSC CPHS ................................................... 3 1.5 Purpose of JSC CPHS Review ........................................................... 4 1.5.1 Definitions of Risk Levels. ....................................................... 4 1.6 Authority and Responsibility of the JSC CPHS ........................................ 5 1.6.1 Actions ............................................................................ 5 1.6.2 Sanctions for Violations ......................................................... 5 2.0 APPLICATION: SUBMISSION OF A RESEARCH PROTOCOL .................................... 5 2.1 Types of Research Protocols Reviewed by the JSC CPHS ........................... 5 2.2 Submission Process for JSC CPHS Approval. ........................................... 6 2.3 Renewal of a Training/Baseline Data Collection Protocol .......................... 7 3.0 BOARD DECISION AND NOTIFICATION .......................................................... 8 3.1 Disposition of a Research Protocol ..................................................... 8 4.0 CONDUCT OF THE RESEARCH PROTOCOL ..................................................... 8 4.1 Normal Process ........................................................................... 8 4.2 Informed Consent ....................................................................... 11 4.3 Privacy of Biomedical Research Data ................................................. 11 4.4 Government Access to and Use of Human Research Data ......................... 11 4.5 Test Readiness Review .................................................................. 11 4.6 Appropriate Medical Monitoring ....................................................... 12 4.7 Corrective Action ........................................................................ 13 4.7.1 Corrective Action Plan ......................................................... 13 4.8 Reporting of Adverse Events and Anomalous Data .................................. 13 4.9 Withdrawal of Flight Crew Subjects from Human Research ....................... 15 4.10 Studies Involving Animals .............................................................. 15 5.0 MISCELLANEOUS GUIDELINES AND STANDARDS .............................................. 15 5.1 Recommended JSC CPHS Electrical Standards for In-flight Instrumentation ... 15 5.2 Crew Venipuncture and Blood Volume Constraints ................................. 16 5.2.1 Specific Guidelines .............................................................. 16 5.2.2 Responsibilities .................................................................. 17 5.3 Practice Guidelines for Anesthetic Procedures Immediately After Landing ..... 17 5.3.1 Anesthetic Concerns Unique to Post-flight Patients ....................... 18 5.3.2 Conduct of Anesthesia ......................................................... 19 5.4 Safety Reporting Requirements for Investigations .................................. 20 Performed at Off-site Locations ....................................................... 20 4 JSC 20483 Revision C APPENDICES Appendix A Current Ethics Policies and Research Oversight Practices for Federally Sponsored Research Appendix B Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979 Appendix C Section 4.8 - JSC Committee for the Protection of Human Subjects (CPHS) (in: The JSC Organization JPG 1107.1A) Appendix D NASA Policy Directive (NPD 7100.8D ) and NASA Procedures and Guidelines (NPG) 7100.1 ―Protection of Human Research Subjects‖ Appendix E Memorandum of Understanding (MOU), JSC Committee for the Protection of Human Subjects (CPHS) and JSC Payload Safety Review Panel (PSRP) Appendix F Examples of Research Activities Involving No More Than ―Minimal Risk‖ Protocols or Previously Approved ―Reasonable Risk‖ Protocols With Only Minor Changes Appendix G Life Sciences Research Protocol Format Appendix H Training/Baseline Data Collection Appendix I Guidelines for Radionuclide Use in Space-flight Payloads Useful Radiation Exposure Comparisons Ionizing Radiation Source Data Sheet - Space-flight Hardware and Applications (JSC Form 44) Radio Frequency/Microwave Hazard Evaluation Data (JSC Form 44A) Laser/Optical Device Hazard Evaluation Data (JSC Form 44B) Worksheet for Tissue Doses from Radiopharmaceuticals (JSC Form 44C) Worksheet for Tissue Doses from Diagnostic X-Ray Examinations (JSC Form 44D) Radiopharmaceutical Human Use Information Form (JSC Form 44E) Radiopharmaceutical Unit Dosage Receipt and Use Log (JSC Form 44F) Radiopharmaceutical Multidose Vial Preparation and Use Log (JSC Form 44G) Radioactive Material Use Authorization (JSC Form 1942) Radiation User Approval (JSC Form 1944) Appendix J NASA-JSC Committee for the Protection of Human Subjects (CPHS) Principal Investigator Request to Renew Approval of Human Research Protocol Appendix K NASA/JSC Human Research Informed Consent (JSC Form 1416) Multinational Space Station Human Research Informed Consent (JSC Form 1418) NASA/JSC Human Research Informed Consent for Grants/Other Agreements Where Research is Conducted at Locations Other Than JSC (JSC Form 1419) Appendix L JSC CPHS Letter of Disposition Appendix M Food and Drug Administration (FDA) Forms 1571 and 1572 5 JSC 20483 Revision C Appendix N Request for Human Test Subject Recruiting Appendix O Scientific Misconduct with Regard to Human Research (JMI 7170.2B) Appendix P Maintaining the Privacy of Biomedical Research Data (JMI 1382.5B) Appendix Q Guidelines for Test Readiness Review Appendix R NASA Mishap Report (NASA Form 1627) Appendix S Guidelines Relative to Use of Experimental Animals During Preflight Crew Training Activities Appendix T Guidelines Relative to Use of Experimental Animals During Crew Training Simulations, Chamber Simulations (Closed Environments), and Actual Space Flight Appendix U CPHS Guidelines Regarding In-Flight