D. Criteria for Acceptance of Proposals

The IRB will approve projects that meet all of the following criteria (46.111a, b):

1. Risks to participants: risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate using procedures already being performed on the subjects for diagnostic or treatment purposes
2. Anticipated benefit: risks to subjects are deemed reasonable in relation to the anticipated benefits and the importance of the knowledge that may be expected to result.
3. Subject selection: selection of subjects is equitable and has been made considering the purposes of the research, the setting in which the research will be conducted and the special problems of research involving vulnerable populations.
4. Safeguards of vulnerable populations: care has been taken to minimize the likelihood that subjects are vulnerable to coercion or undue influence, especially if they are members of vulnerable populations. Additional safeguards are included to protect the rights of these subjects.
5. Informed consent process: appropriate methods are in place to obtain informed consent from subjects and parental permission if necessary, and to document such consent as required. Section documents informed consent procedures in detail.
6. Protection of privacy and data: the research plan makes adequate provision for monitoring data to ensure safety and to protect the privacy of subjects, and when appropriate to maintain the confidentiality of the data. Section documents protection procedures in detail.