Research Participant Information Provide information about the subject population (e.g., including age, gender, inclusion/exclusion criteria, and disease state). Total Sample Size Total number of N = subject records or samples Provide justification for the sample size and it is adequate for answering the research question(s). Sample size rationale Waiver or Alteration of Informed Consent To approve a waiver of informed consent, all of the following criteria must be justified by the research. Provide a protocol specific justification for each. The research involves no Provide a protocol specific rational. more than minimal risk to the subjects. The waiver or alteration will Provide a protocol specific rational. not adversely affect the rights and welfare of the subjects. The research could not Provide a protocol specific rational. practicably be carried out without the waiver or alteration (it is impracticable to perform the research if obtaining informed consent is required and not just impracticable to obtain consent).
Research Participant Information Provide information about the subject population (e.g., including age, gender, inclusion/exclusion criteria, and disease state). Total Sample Size Total number of subject records or samples N = Sample size rationale Provide justification for the sample size and it is adequate for answering the research question(s). Waiver or Alteration of Informed Consent To approve a waiver of informed consent, all of the following criteria must be justified by the research. Provide a protocol specific justification for each. The research involves no more than minimal risk to the subjects. Provide a protocol specific rational. The waiver or alteration will not adversely affect the rights and welfare of the subjects. Provide a protocol specific rational. The research could not practicably be carried out without the waiver or alteration (it is impracticable to perform the research if obtaining informed consent is required and not just impracticable to obtain consent). Provide a protocol specific rational.
IRB-Proposal-Secondary-Use-Submission-Form.docx