July, 2002
Research and Sponsored Programs

Special Edition

Task Force Rolls Out First Three SOPs on Research with Human Subjects

The new Indiana University-Purdue University Indianapolis (IUPUI) and Clarian Health Partners Standard Operating Procedures (SOPs) for Research with Human Subjects Web site is now available! Go to http://www.iupui.edu/~respoly/human-sop/human-sop-menu.htm to view this central resource for researchers to find information on what will become the required IUPUI/Clarian SOPs pertaining to research with human subjects.

As reported in SOP Communication #1 (see http://www.iupui.edu/~respoly/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, with human tissues, it is imperative that you review the following information on the Standard Operating Procedures (SOPs) for Research with Human Subjects Web site:

The Standard Operating Procedures (SOPs) for Research with Human Subjects Web site also includes the following additional features:

The roll out plan for the SOPs 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. 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.

The online reading guide is provided as a tool to help the user understand how the SOPs are formatted and provide a guide that will allow for easier reading and interpretation of the content. To access the guide, go to http://www.iupui.edu/~respoly/human-sop/human-sop-readinguide.htm. All future communications, introducing each SOP and inviting comment from the IUPUI/Clarian research community, will be published in future issues of the R&SP Communicator.

The first three SOPs being released can be viewed now on this Web site, go to http://www.iupui.edu/~respoly/human-sop/human-sop-menu.htm.

PLEASE NOTE:
The review and comment date is listed after the title of the following first three SOPs being released at this time:

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

All comments must be received prior to the close of the comment date posted.


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


Research and Sponsored Programs
UN 618
General - 274-8285
Research Compliance - 274-8289
Sponsored Program Development - 278-0249