Commercial Sponsor Agreements

Accordingly, we have taken the following actions:

• In the late fall, ORA proposed revisions to our policy on sponsor responsibilities where we were at a stalemate with sponsors. With the General Counsels, we agreed to revise our contractual requirements regarding HIPAA, intellectual property, interim notification of adverse information, and indemnification.
  
• On a regular basis, ORA will advise us and the General Counsels of Johns Hopkins Health System and Johns Hopkins University of any additional Hopkins policies that are impeding negotiation.
  
• When ORA needs access to a higher corporate sponsor authority to resolve a negotiation issue, the General Counsels have agreed to contact their counterpart at the sponsor to resolve the issue. Three model/master agreements were resolved by this process in the last several months.
  
• Our ORA in-house contract attorney is concentrating on establishing new and revised model and master agreements with our most active corporate sponsors or to at least assure consistent negotiation of individual agreements with the most active corporate sponsors. The recently revised Hopkins policy on sponsor responsibilities has greatly improved this process.
  
• While use of outside attorneys has provided some assistance in the past, their use has generally proven not to be an effective long-term solution. By re-budgeting current funds, we have renovated the ORA workspace and are immediately adding two additional personnel to the ORA staff devoted to contracting.
  
• We are adding a clinical trials specialist office, initially consisting of four staff members who will advise, review and approve the budget assumptions on clinical trials regarding which parts of patient care costs are standard. To avoid duplications of effort, they will also be authorized to approve study agreements that use established Master or Model agreements.
  
• We have requested space and financial resources for three new ORA staff to be added by July 1st.
  
• ORA and JH Technology Transfer are working to revise the process of negotiating incoming material transfer agreements to provide one-stop processing for both sponsors and faculty.
  
• This spring, ORA will establish a faculty advisory committee to assist us with the contract process, and with electronic grants transition.
  
• To fund these changes the indirect cost rate for fee based commercial sponsors will increase to the Federal rates of 26% and 63.5%.

We believe that these changes will enable us to meet the goal of reviewing and commenting on proposed agreements within ten (10) working days, to advise and approve research patient care budgets, and to complete negotiations as quickly as the sponsor will let us. Staff will work to keep faculty appraised of the status of their agreements and when appropriate will ask faculty to contact their corporate counterparts to expedite the corporate response. Renewed efforts to establish model or master agreements for both pre-clinical and clinical studies appear to be consistent with most corporate sponsors' current desires, resulting in less redundant negotiation. Please remember to parallel process your contract and IRB submissions. You will not be charged for commercial study IRB review until a contract is awarded. We look forward to working with the advisory committee to continue to refine our processes.

Indirect Cost Rate Increasing

The indirect cost rate for fee-based commercial sponsors will increase to the Federal rates of 26% and 63.5%. This change will go into effect for all commercial studies that are proposed (complete and signed eIS is received in ORA), on or after May 1.

Updated Instructions from NIH Regarding Publications as Appendix Materials

The NIH standard policy regarding the inclusion of publications as acceptable Appendix material in grant applications has changed effective for applications intended for the May 10, 2006 submission date. Publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project may be included. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant mechanisms allow the inclusion of publications. For complete details, click here: http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-06-051.html

R03, R21, R33, and R34 Grant Mechanisms Transitioning to Electronic Submission

Effective June 1, 2006, R03 and R21 paper applications will no longer be accepted by the NIH, AHRQ or CDC. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html. The NIH is transitioning to electronic submission on the SF424 Research and Research Related (R&R) application form through Grants.gov by mechanism, which requires that they expire and/or issue separate funding opportunity announcements (FOAs) for each mechanism to accommodate the new process. The use of "parent" FOAs will provide a means for standardizing the R03 and R21 application characteristics, requirements, preparation, and review procedures. These parent announcements accommodate investigator-initiated (unsolicited) applications and allow Institutes/Centers (ICs)/Agencies to describe how they use each mechanism and highlight their specific areas of scientific interest within a single FOA. Note, currently, there is not a Parent R34 FOA; each IC plans to issue separate R34 announcements. For complete details, click here: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-046.html

New and Improved NIH Awards Success Rates Page

The NIH's page detailing award success rates has been updated and has a new format. Please review this page and the new data by clicking here: http://grants.nih.gov/grants/
award/success.htm

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