Regulatory Considerations in Human Subjects Research
 1. The voluntary consent of the human subject is absolutely essential. The person involved should have legal capacity to give consent; should be so situated as to be able to…
 1. The voluntary consent of the human subject is absolutely essential. The person involved should have legal capacity to give consent; should be so situated as to be able to…
Died Survived Drug A 27 498 525 Placebo 75 500 575 102 998 1,100 The row totals are the total number of patients receiving Drug A and placebo, whereas…
Fig. 1.1 Members of the clinical trial research team (IRB institutional review board, Co–PI coprincipal investigator) 1.2 Key Members of the Clinical Trial Research Team 1.2.1 Principal Investigator The principal…
Fig. 7.1 Steps for submitting the NIH budget 7.3 Complying with Federal Cost Principles For a grant to be accepted by the NIH, not only should it be scientifically sound…