November 2004

Human Subjects

New Release of IUPUI/Clarian SOPs Available for Public Comment until Dec 22 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. The SOPs roll out plan calls for the SOPs to be released to the IUPUI/Clarian research community via this Web site. For a limited time, the SOPs will be open to the IUPUI/Clarian research community for review and comment. 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 (http://www.iupui.edu/~respoly/human-sop/human-sop-menu.htm). 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. IUPUI/Clarian IRB Announces Fee increase for Studies Funded by For-Profit Companies October 28, 2004 Dear Investigator: As you know, research is one of our most important priorities at IUPUI and moreover, research with human subjects is extensively regulated. With new regulations and recent interpretations by the Office for Human Research Protections (OHRP) and others, we are all, investigators and Institutional Review Boards (IRBs) alike, faced with the challenge of complying with these rules. In order to ensure compliance for our University and Clarian to continue in our research endeavor, increased demands upon the IRB, staff, and investigators must be met. In recent years, the institution has worked to develop and expand its human research protection program (HRPP) such that it will continue to operate in a highly principled way. However, costs have increased for the institution relative to ensuring the HRPP’s ethical and compliant functioning. The IRB plays an integral part in this program and the IRBs’ responsibilities continue to increase. For example, the average number of study actions requiring IRB review per study (e.g., including all new study submissions, continuing reviews, amendments, adverse event reports, etc.) has increased approximately 18% between 2002 to 2003. As a result, additional IRB members have been recruited for service on the IRBs in response to an ever-increasing IRB workload, necessary additional support staff have been hired to facilitate the IRBs’ functioning, and new standard operating procedures (SOPs) for investigators are being continually implemented. An audit program (based upon these SOPs) has been instituted, as well. An electronic research application (ERA) submission system (which will allow for the electronic submission, processing, routing, and management of IRB protocols) is also being developed “in-house” and is anticipated for release in 2005. Institutions around the nation are facing similar rising costs and have already established comparable IRB charges or are redefining them to ensure their appropriateness to adequately recover their institutional costs. Effective January 1, 2005, the fee schedule for IUPUI/Clarian IRB Review is as follows: Type of Review Fee Initial, Full Board $2,000 Initial, Expedited $1,000 Exempt N/A Continuing Review N/A Amendment N/A The following applies to the IUPUI/Clarian IRB Review Fee: This fee applies to the IRB review of any new for-profit-sponsored project (not just clinical trials) involving human subjects as of the effective date. This fee encompasses the initial and continuing reviews, as well as reviews of amendments and adverse event reports for the duration of the study. Note: Contracts that were negotiated prior to January 1, 2005 will be subject to the previous IRB Fee Policy (effective January 1, 2003). The fee is a one-time upfront fee incurred at the time of initial IRB review. It is not based on the size of the study budget, the number of subjects enrolled, or whether or not the project is initiated, but rather on the level of IRB review the project receives. Indirect cost will not be calculated on the IRB Review Fee. The fee does not apply if the project recovers full indirect costs at the federally negotiated rate. Investigators and/or departments are responsible for payment of the IRB fee if the sponsor does not ultimately reimburse this fee. There are no anticipated exceptions to the applicability of this fee, however, in rare occasions and under exceptional circumstances, a request for a fee waiver/reduction may be made in writing directly to the Vice Chancellor for Research and Graduate Education. Any decision reached by the Vice Chancellor is final and is not subject to appeal. Sincerely, Mark L. Brenner, Ph.D. Vice Chancellor for Research and Graduate Education, IUPUI IRB Instruction Packet Undergoes Update for 2005  Summary of additions and revisions to the IRB Instruction Packet include: Centralization of IRB policies: All policies and procedures are now located on the IUPUI/Clarian Standard Operating Procedures (SOPs) web site located at: http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm Section III: Collaborations, Multicenter Studies, Offsite Research and Non-affiliated Investigators Section IV: 2005 IRB deadlines Section: VI: Appendix A - Guidelines and Eligibility for Research Protocol Submission Appendix B - IU Protocol Review Procedures for Human Subjects Appendix C - Does Your Proposed Activity Meet the Definition of Human Subjects Research? Section VII: Summary Safeguard Statement - Section II: Additional Methodist and IUPUI campus sites Section III: Additional rationale information for involving minors in research Section X: Additional clarification and justification requirements for compensation arrangements Section XII: Additional clarification on waivers of IC for demonstration projects conducted by or subject to the approval of state or local government officials Section XVII: Revised conflict of interest; now FINANCIAL COI Informed Consent Checklist – Additional clarification added to items 3., 7., 14., and 15 Protocol Deviation Form – Now for “Unanticipated Problems Involving Risks to Subjects and Protocol Deviations or Violations.” Click here to access the downloadable IRB Human Subjects Instruction Packet and Forms.

Proposals and Awards

Revised NIH Forms Now Available Revised PHS 2590 (Non-Competing Grant Progress Report Notable changes include: A refined definition of key personnel. A new category termed ‘Other Significant Contributors’ has been added which allows the PI to identify those individuals who are contributing to the scientific development but are not committing any measurable effort. SNAP questions #1 and #2 have been updated. SNAP instructions have been rewritten for clarification. Effective Date: Progress reports using the newly revised PHS 2590 form will be accepted immediately. All progress reports received on or after May 1, 2005 must use the new form. Revised PHS 398 (DHHS Public Health Service Grant Application Notable changes include: This edition has been extensively rewritten with a focus on clarity and special emphasis on simplicity and plain language. Thus, it is important that the instructions be reviewed before completion. Title field has been increased to accommodate 81 characters. A new category termed ‘Other Significant Contributors’ has been added. Budget pages have been modified to move the ‘Consortium/Contractual Direct Costs’ budget row to above the ‘Subtotal Direct Costs’ line in order to implement the new policy on direct cost limitations. This applies to both full and modular budgets. Font size requirement: NIH now requires the use of Arial-11 or Helvetica-11 point font. Instructions have been updated to reflect the changes to the forms. Effective Date: The revised PHS 398 application will be accepted for submission/receipt dates on or after December 1, 2004. All applications received on or after May 10, 2005 must use the new instructions and forms. During the transition period, however, both the previous and new version will be accepted. Revised PHS 2271 (Statement of Appointment) Notable changes include: Trainees are now requested to provide only the last four digits of their social security number though providing this information still remains voluntary. Effective Date: The new Statement of Appointment Form may be used immediately and must be used for all trainee appointments made on/after May 1, 2005. Revised PHS 3734 (Relinquishing Statement) No notable changes with regards to the completion of the form. Effective Date: The 9/2004 version of the relinquishing statement is available immediately. Revised HHS 568 (Final Invention Statement and Certification No notable changes with regards to the completion of the form. Effective Date: The 9/2004 version of the final invention statement is available immediately. NIH will continue to provide the information in two electronic formats – MS Word and PDF-fillable. In addition, the bottom left corner of each revised form will include the notation ‘Rev 09/04’. If you have additional questions or need assistance, please contact Research & Sponsored Programs at 317.274.8285. NIH Announces Revised Policy: Applications that Include Consortium/Contractual F&A Costs Specifically, the policy revision states the following: While consortium F&A costs will continue to be requested and awarded, applicants will now separate these costs when determining if a budget exceeds a direct cost limit. This policy impacts eligibility to submit a modular budget. The modular budget format continues to be used for applications requesting $250,000 or less in direct costs per year; however, consortium/contractual F&A costs are no longer factored into this direct cost limit. They may be requested in addition to the $250,000. The policy also effects applications requesting a budget of $500,000 direct costs or more for any year. These applications continue to require prior approval from Institute/Center staff; however, this limit is now exclusive of any consortium F&A costs. This change is effective for applications that have submission/receipt dates on or after December 1, 2004. The revised notice as outlined above can be found in its entirety at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html. If you have additional questions or need assistance, please contact Research & Sponsored Programs at 317.274.8285.

What's New

Grants.gov: Find Federal Dollars for Sponsored Projects Mark Your Calendar for Grants.gov at IUPUI Nov 30 Grants.gov is the single secure Web site portal that unifies all federal grants. Through Grants.gov, state, local, and tribal governments, colleges and universities, nonprofits, research institutions, and other organizations can access, find, and apply for grants from more than 900 grant programs representing more than $360 billion in annual funds offered by the 26 Federal granting agencies. DATE: Tuesday, November 30, 2004 TIME: 10 am-12 noon (for Research Administrators)   1 pm-3 pm (for Faculty and Researchers) PLACE: Lilly Auditorium, University Library, Indianapolis, IN SPEAKER: Katie Root, Grants.gov Program Management Office REGISTRATION: http://opd.iupui.edu/events.asp?unit=opd Register Now for the Sixth Annual Scientists and Subjects Online Seminar The seminar is open to junior and senior researchers, members of Institutional Review Boards and other administrators, and college and university faculty members who teach future researchers. Five years of experience offering the SAS seminar has allowed us to develop an intensive, focused curriculum addressing core issues in human subjects research. To maximize interaction and attention to each seminar member's concerns, each cohort will be limited to 17 members on a first-come, first-served basis. The seminar fee is $200. Continuing Medical Education credits are available for an additional processing fee of $50 (16 credits). Prospective participants must submit a check or purchase order to cover the registration fee and complete an application form, available on the Web at http://poynter.indiana.edu/sas/, no later than Friday, December 10, 2004. For more information, contact: Kenneth D. Pimple, SAS Project Director, Poynter Center, Indiana University, 618 East Third Street, Bloomington, IN 47405-3602; (812) 856-4986; FAX 855-3315; pimple@indiana.edu; http://poynter.indiana.edu/sas/. Holiday Closing Information for Research and Graduate Education Additional holiday closing information is provided for the following Research and Sponsored Programs offices: Research Compliance Administration (IRB/IBC) If there is a life-threatening emergency which necessitates the use of an investigational agent, please call University Hospital Pharmacy at (317) 274-0362. Sponsored Program Administration Proposals with a postmark or receipt date between December 23, 2004 and January 3, 2005 must be received by R&SP no later than noon on December 20, 2004. Proposals will not be processed during the holiday period. The staff of R&SP wishes everyone a happy, peaceful, and safe Holiday Season!

Submissions

Submit Your News to the R&SP Communicator Send us your news...... Deadline for R&SP Communicator news article submission: 5:00 PM on the 25th day of each month R&SP Communicator readers: IUPUI faculty, staff, and students interested in or involved with the conduct of research or other sponsored programs Submit news articles to: Shannon Walden Coordinator of Educational Programs for Responsible Conduct in Research UN 618 620 Union Drive, Room 618 Indianapolis, IN 46202-5167 Phone - (317) 274-8285 Fax - (317) 274-8744 E-mail: sfwalden@iupui.edu

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Research and Sponsored Programs UN 618 General - 317 274-8285 Research Compliance - 317 274-8289 Sponsored Program Development - 317 278-0249