If issues of concern arise in the process of full or expedited review, the researcher will be provided the opportunity to respond to those concerns prior to any action on that review. A full review by the IRB will be conducted for research that involves greater than minimal risk. A full review must be conducted at a meeting of the IRB under the procedures established below. Selection of subjects is equitable, taking into account the purposes of the research. Privacy of the subjects and confidentiality of data are protected.
Informed consent is obtained and documented.
In order to involve a human subject in research, a researcher must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. Exclude language waiving legal rights. Be stated in language that minimizes the possibility of coercion or undue influence. Describe any benefits. State conditions of participation and circumstances for termination of subject's participation by the investigator.