NASA Procedural Requirements

NPR 7100.1 Effective Date: March 28, 2003 Expiration Date: September 07, 2013

Subject: Protection of Human Research Subjects (Revalidated 7/7/08)

Responsible Office: Office of the Chief Health & Medical Officer

CHAPTER 11. Reports on Injuries, Illness, or Disease and Medical Care

11.1 PI Responsibility for Reporting

The PI shall immediately inform the IRB Chairperson and initiate appropriate investigations in the event of the following:

11.1.1 Any injury, illness, disease, or death, whether expected or not, incurred by the subject as a possible result of a research protocol.

11.1.2 Any change in the experimental environment or in the subject that could forecast medical problems.

11.2 PI Responsibility for Recordkeeping

The occurrence of any instance requiring medical attention. The PI shall note any such occurrences in the subject's research records and make them available to the subject's physician.

11.3 Determination of Suspension of Research

The IRB Chairperson or designate shall determine whether the research should be immediately suspended with subsequent IRB concurrence.

11.4 Reporting to NASA Headquarters

The PI shall report all such events immediately to the IRB. If appropriate, the PI shall report all such events additionally to NASA. A non-NASA PI shall notify all institutional IRB's that approved his or her proposal. It shall be the responsibility of said IRB's holding approved MPA's from other Federal agencies to communicate such incidents to that Agency directly.

11.4.1 When the injury results in a loss of life, a permanent disability, or when a person requires hospitalization, and/or a person requires extensive first aid or lost workday(s), the mishap must be reported to NASA HQ immediately (within 1 hour) in accordance with NPD 8621.1, NASA Mishap and Close-Call Reporting, Investigating, and Recordkeeping Policy, and NPR 8621.1, NASA Procedures and Guidelines for Mishap Reporting, Investigating, and Recordkeeping.

11.4.2 The IRB Chairperson shall notify the NASA Center Safety Officer; the ANO; and the Crew Medical Officer especially in the case of crew involvement in the event of a reportable incident. The IRB Chair shall initiate an investigation as soon as possible per NPR 8621.1, NASA Procedures and Guidelines for Mishap Reporting, Investigating, and Recordkeeping.

11.4.3 When NASA conducts a mishap investigation to investigate an injury or illness resulting from the research, all researchers shall cooperate with the NASA mishap investigators, grant interviews, and provide data as requested.

11.5 Review by IRB Required to Resume Research

Once a research protocol involving human subjects is suspended, IRB review and approval are required before the experiment can resume.

11.6 Health Care Provisions for Research Subjects

11.6.1 The NASA IRB shall review the health care provisions provided to the research subject, and/or available for possible injury or illness that could occur during the research.

11.6.2 The provisions for access to medical care shall be included in the consent form as appropriate.

11.6.3 The medical care for astronaut research subjects shall include the assigned NASA flight surgeon. The flight surgeon shall have access to all research data that pertains to the health of the astronaut research subject. The flight surgeon may use this data for the ongoing health monitoring of the astronaut.

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