Adverse Events, Student Research, and Emergency Use SOPs Available for Public Comment; Comment Period Closed on First Three SOPs
The second release of the Standard Operating Procedures (SOPs) governing the policies and procedures for all human subjects research being conducted by researchers whose work is subject to review and approval by the IUPUI/Clarian Institutional Review Boards (IRBs) is available online for public comment. The comment period will close October 18, 2002.

Reporting Adverse Events to the IRB	HTML format	PDF format
Student Research Involving Human Subjects	HTML format	PDF format
Emergency Use of Investigational Agents or Devices	HTML format	PDF format

The comment period on the first three SOPs listed below was closed on September 1, 2002.

Auditing of Research Involving Human Subjects
IRB Operations and Study Approval Process
Policies and Procedures for the Standard Operating Procedures

As reported in the SOP Communication #1 (http://www.iupui.edu/~res-poly/human-sop/communication-1.htm), IUPUI/Clarian developed Standard Operating Procedures (SOPs) governing the policies and procedures for all human subjects research being conducted by researchers whose work is subject to review and approval by the IUPUI/Clarian Institutional Review Boards (IRBs). These SOPs will become the minimum required standards for conducting human subjects research and will be the framework against which all applications are evaluated and audited by the IRBs. If you do research with or about human subjects or their records, identifiable information contained in databases, or with human tissues, it is imperative that you review information provided in the Standard Operating Procedures (SOPs) for Research with Human Subjects Web site. Go to http://www.iupui.edu/~res-poly/human-sop/human-sop-menu.htm.

The SOPs roll out plan calls for the SOPs to be released to the IUPUI/Clarian research community via this Web site in groupings of two or three SOPs at a time. For a limited time, the SOPs will be open to the IUPUI/Clarian research community for review and comment. The SOPs Table of Contents identifies each SOP and the timeline status for review and comment prior to the official release of the SOP and required compliance date for all IUPUI/Clarian organizations. All comments must be received prior to the close of the comment date posted in the SOPs Table of Contents. Approved revisions to a SOP will be made in a timely manner and displayed on this Web site. Only comments that are appropriate, constructive and objective will be considered. Due to resource limitations, we can only accept comments transmitted electronically to the Research Compliance Administration mailbox at resrisk@iupui.edu. Comments received by other media (e.g., by telephone, fax, mail and to other e-mail addresses) will not be considered.

Send COMMENTS, QUESTIONS to:
RSPCOMMU@iupui.edu.