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Procedure for Determination of Exemption from Human
Subjects
- IRB PRO105
This procedure documents the requirements for determining an exemption from Human Subjects research regulations, including the responsibilities of the Investigator, OIRB and IRB. An attachment that details federal criteria for determining exemption is also included in the document.
Procedure for Not Human
Subjects
Research Designation - IRB PRO117
This procedure describes how human materials or data not involving human subjects may be classified as Not Human Subjects Research.
Procedure for Compliance Issues with Human
Subjects
Regulations or IRB Requirements or Determinations - IRB PRO128
This procedure outlines responsibilities for dealing with compliance issues with Human Subjects regulations or IRB requirements or determinations.
Procedure for Conducting and Evaluating Activities Designed to Educate the Public about Human
Subjects
Research - IRB PRO130
This procedure outlines the responsibilities of the investigator, OIRB and IRB for conducting and evaluating activities designed to educate the public about Human Subjects research.
Procedure to Ensure Prompt Reporting Of Unanticipated Problems Involving Risks to
Subjects
or Others to the IRB - IRB PRO106
This procedure delegates responsibilities of the Investigator, OIRB and IRB for ensuring prompt reporting of unanticipated problems encountered in research.
Procedure for Review of Decisionally Impaired Adults Involved in Human
Subjects
Research Including Assent - IRB PRO125
This procedure outlines responsibilities of the investigator, IRB and OIRB for review of decisionally impaired adults involved in human subjects research including assent
Procedure for Determination that Research Risks to
Subjects
Are Minimized - IRB PRO127
This procedure outlines the responsibilities of the investigator, OIRB and IRB for determining that research risks to subjects are minimized.
Procedure for Data and Safety Monitoring for Human
Subjects
Research - IRB PRO116
This procedure lists the responsibilities of the investigator, IRB and OIRB for conducting data and safety monitoring for Human Subjects research.
Procedure for Selection and Recruitment of
Subjects
in Research - IRB PRO139
This procedure outlines the responsibilities of the investigator, OIRB and IRB for the selection and recruitment of subjects in research.
Procedure on Maintaining the Privacy of Research
Subjects
- IRB PRO155
This procedure outlines the responsibilities of the investigator, IRB, and OIRB for maintaining the privacy of research subjects.
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