Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

Subject Selection, Recruitment and Compensation

Investigator Responsibilities for Selection of Subjects

UVa recognizes its responsibility to create an environment in which the equitable selection of research participants is fostered. Therefore, Principal Investigators must provide the IRB the details on the proposed involvement of humans in the research. Principal Investigators must describe the number of subjects and observations necessary to obtain statistically valid results. The type of study design and the procedures for randomization, blinding, crossover, controls (positive and negative), and, washout, as applicable, must all be explained. Principal Investigators must specify the

Methods for subject screening and eligibility should be described in detail. Screening for enrollment into a study entails careful evaluation of the potential subject on the basis of the criteria that are stated in the protocol.

If a potential subject conforms to those preliminary criteria, more specific screening evaluations can be performed, such as the taking of a medical history, a physical examination, and clinical laboratory tests, such as a complete blood count with differential; blood chemistry analysis ( e.g. , electrolytes, cholesterol, and triglycerides), urinalysis, an electrocardiogram, and blood pressure.

The protocol should state the limits of acceptability for the aforementioned evaluations; for example, it should define a normal range for the clinical laboratory tests and include appropriate statements about the interpretation of those tests ( e.g. statements on borderline values).

If the proposed study may include a vulnerable or special subject population, investigators shall refer to the additional requirements for these subject populations.