Mission

The mission of the University of Iowa Institutional Review Boards is to assure that the rights and welfare of the human subjects are adequately protected in research.

Criteria for IRB approval of research

In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

Risks to subjects are minimized:

• By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
• whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable

in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

• In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).
• The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Selection of subjects is equitable.

In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

Informed consent will be sought

from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116 (See Consent Elements).

Informed consent will be appropriately documented

in accordance with, and to the extent required by §46.117.

When appropriate, the research plan makes adequate provision

for monitoring the data collected to ensure the safety of subjects.

When appropriate, there are adequate provisions to protect the privacy of subjects

and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable

to coercion or undue influence, such as:

• children
• prisoners
• pregnant women
• mentally disabled persons
• economically or educationally disadvantaged persons

additional safeguards have been included in the study to protect the rights and welfare of these subjects.