Effective Date: March 28, 2003
Expiration Date: September 07, 2013
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The following information shall be included with the proposal submitted for IRB review:
1. Name of the organization conducting the research or for which the research is being conducted.
2. Name and qualifications of persons who shall conduct the research involving human subjects.
3. The reasons for the use of human subjects and a plan to ensure equitable selection of research subjects with reference to race and gender.
4. Possible inconveniences, discomforts, illnesses, diseases, injuries, pain, and risks to the subject.
5. A description of the hazard controls and safety precautions to be applied.
6. Expected duration of the study, including approximate beginning and ending dates.
7. The extent of any physical examinations to be given by medical personnel:
a. Initially, to ascertain the subject's health status and to certify that the subject is capable of undertaking the proposed research,
b. During the course of the research, and
c. At the completion of the research.
8. Wage, salary, or other payment, if any, to be paid to the subject for participating in the research.
9. Source (Federal or State compensation acts and insurance) and general description of compensation, if any, to be received by a subject or the subject's legally authorized representative in the event of injury or death. Assistance in the preparation of this information may be obtained from the appropriate NASA Center OGC or, if the subject is or shall be a Government employee, from the NASA Center Personnel Office.
10. Availability of medical personnel, if applicable, and an adequate medical facility within a reasonable distance of the location where research is performed. Indicate whether a physician shall be present at all times or on call; if on call, the physician's location during the research.
11. Information about the research involving human subjects that shall be given to the subject while obtaining the subject's informed consent.
12. The research involving human subjects consent form, including the provision that subjects concerned about protocol violations may request a meeting with the relevant IRB.
13. Evidence of review and approval by the sponsoring organization's IRB.
14. A plan for ensuring privacy and protecting the confidentiality of data with particular attention to data contained in an electronic database.
15. Data Safety Monitoring plan, where applicable.
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