Human Subjects Research Protection

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Across
  1. 4. Last name of the person who establishes the mechanisms and framework for the Human Research Protection Program (HRPP)
  2. 5. One of the "Big 3" IRB findings that are reportable to federal and regulatory agencies. Not continuing noncompliance but __________ noncompliance
  3. 7. One of the "Big 3" IRB findings that are reportable to federal and regulatory agencies. Not suspension but __________
  4. 10. One-time enrollment of a research subject in a protocol that fails to meet current IRB approval
  5. 11. Subpart D pertains to this vulnerable population
  6. 12. Ethical principle that maximizes benefits and minimizes risk
Down
  1. 1. Subpart C pertains to the vulnerable population
  2. 2. NIH funded clinical trials require a Data & __________ Monitoring Plan
  3. 3. Ethical principle that requires research benefits and burdens to be distributed fairly
  4. 6. Not undue influence but __________
  5. 8. Risk defined as "the probability and magnitude of harm or discomfort anticipated in research are not greater in and of themselves than ordinarily encountered in daily life"
  6. 9. One-time departure from an IRB approved protocol with enrolled subjects