An IRB takes into account a number of factors when reviewing proposed
research projects and ongoing research efforts. The number of factors
examined depends on the specific nature of the research study or
the statistical procedures and analyses under review. Common factors
include risks and benefits, subject selection, informed consent,
confidentiality and privacy, and vulnerable populations.
The IRB verifies that:
to research subjects are minimized.
to the subjects are reasonable in relation to the potential
benefit and the importance of knowledge that may be reasonably
expected to be gained from the research.
those risks and benefits that may result from
the research are considered by the IRB; these risks and benefits
are distinguished from any benefit or risk of interventions subjects
would receive if not participating in research.
selection of subjects is equitable when subject selection
is integral to the proposed research study.
consent is obtained from each research subject (or from the
subject’s legally authorized representative) and appropriately
documented. Consent must be solicited in language that is understandable
to the subject and in a manner that gives the subject sufficient
opportunity to decide whether or not to participate. Consent may
not be secured through coercion or undue influence, and no attempts
should be made to induce subjects to waive rights in connection
with the granting of consent.
confidentiality and privacy of all subjects are
appropriate, the Principal Investigator has adequate provisions
to monitor and collect data to ensure the safety of all subjects.
populations are provided adequate protection with regard to
coercion or undue influence.
Principal Investigator has documented IRB approval and consent
forms from other institutions, if so required.
Principal Investigator and/or the research team has the essential
qualifications and experience to carry out the proposed research
relative to the complexity of the research design and methodology,
the degree of potential risk to human subjects, and the research
team’s past record of IRB approved research.