(1)  Risks to subjects are minimized:

(i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk;

(ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) 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 form 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 (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Categorize potential risk level:
no more than minimal risk*
minor increase over minimal risk
more than minor increase over minimal risk

Categorize potential benefits:
no prospect of direct benefit to individuals, but is likely to yield generalizable knowledge
prospect of direct benefit to individuals

* Minimal risk:  the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

(3) 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.  The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

(4) 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 §___.116.

The Informed Consent contains the appropriate required elements:

(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.  This part of the informed consent must be organized and presented in a way that facilitates comprehension.

(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.

(5)  Documentation of Informed Consent.  Informed Consent will be appropriately documented or appropriately waived in accordance with §___.117.

(6)  Data Monitoring.  When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7)  Privacy and Confidentiality.  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, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.