What kinds of ethical issues does the IRB consider?
Criteria for IRB approval of research: risks to subjects are minimized; risks are reasonable in relation to anticipated benefits; selection of subjects is equitable; informed consent is sought from each subject; informed consent is appropriately documented. Additional criteria where appropriate: data collection is monitored to ensure subject safety; privacy and confidentiality of subjects is protected; additional safeguards are included for vulnerable populations. A complete list of criteria are given at the following link: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.
