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
- characteristics of the subject population,
- numbers of subjects ( i.e. , the number of subjects required to obtain statistically valid results),
- age ranges of subjects,
- health statuses of subjects, and
- the gender composition and racial/ethnic composition of the subject population. If ethnic, racial and gender estimates are not specified, the Principal Investigator must provide a clear rationale for exclusion of this information.
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.