Criteria for Approval of Research

In order to approve research, the IRB shall determine that all of the following requirements are satisfied:

-Risks to subjects are minimized: (1) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (2) 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 in relation to 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).

-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.

-Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.

-Informed consent will be appropriately documented or appropriately waived.

-When appropriate, the research plan makes adequate provision for monitoring 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.

-For purposes of conducting the limited IRB review, the IRB need not make the determinations above, and shall make the following determinations: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained; (ii) Broad consent is appropriately documented or waiver of documentation is appropriate; and (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, 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.