As mentioned in recent issues of the Nexus, the NIH is engaged in a system-wide review of policies, procedures and guidance on financial conflicts of interests (FCOI). The results of the review are still being analyzed but we noted a number of issues related to compliance with the regulation governing Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart F). We are concerned that these issues were also identified during previous compliance efforts conducted by the Office of Extramural Research (including Targeted Site Reviews in 2006 and the Review of Institutional Conflict of Interest Policies in 2002) and continue to be compliance issues.

The three major recurring concerns are:

• Definition of Investigator
  Typically, Institutions define “Investigator” too narrowly by qualifying the individuals covered by the term (e.g., senior faculty, key personnel, co-investigators), which is inconsistent with the regulation. The FCOI regulation defines “Investigator” as the “principal investigator and any other person who is responsible for the design, conduct, or reporting of” funded research, and the definition includes the Investigator’s spouse and dependent children. The regulation is thus very broad in its definition. An Institution that limits the definition of “Investigator” by titles or other designations increases the risk that an unidentified FCOI may compromise the research enterprise.
  
  
• Reporting
  Institutions are required to report identified FCOIs to NIH prior to the expenditure of any funds under the grant award, and assure that the conflict has been managed, reduced or eliminated. Further, Institutions must report any FCOI identified subsequent to the initial report under the award within 60 days of that identification. We observed that Institutions seldom include a provision in their policies that require a report be sent to NIH when a new FCOI has been identified.
  
  
• Subrecipients
  The regulation provides that if the Institution carries out NIH-funded research through subrecipients (i.e., subawardees, contractors, or collaborators); the Institution must take reasonable steps to ensure that Investigators working for such entities comply with the regulation. Subrecipient Investigators must be required to comply with the Institution’s policy or the entities must provide assurances to the Institution that will enable it to comply with the regulation. We found that Institutional FCOI policies do not generally address this requirement. In addition, the institution is responsible for reporting to the NIH any conflicting interests it has identified, including those of its subrecipients, and assuring that the interest has been managed, reduced, or eliminated in accordance with the regulation.
  

Given the importance of the promoting objectivity in research and maintaining the public’s trust in our endeavors, it is essential that extramural Institutions and Investigators alike are aware of and fully comply with the provisions of the regulation.

For more information on this important topic, consult the new Frequently Asked Questions document on the OER Web site or contact FCOICompliance@mail.nih.gov.

Effective May 15, 2008, a new safeguard was put in place to password-protect data on the compact disks (CDs) that are sent to peer reviewers prior to study section meetings (see Guide notice). The following types of information will be password protected on reviewers’ CDs:

• Grant application information,
• Previous summary statements,
• Appendix materials, and
• Additional materials (“eAdditions”) in the grant folder.

The password-protection, and specific reviewer instructions (Accessing a Password-Protected CD: Instructions for Reviewers) will be incorporated on each CD.

NIH recognizes that these protective measures will involve additional tasks for review staff and peer reviewers, as well as enhanced security for information contained on NIH-generated CDs. Future enhancements and refinements to this approach are planned. Feedback to your Scientific Review Officer will aid us in improving your use of CDs as you engage in NIH peer review processes.

The conversion from PureEdge to Adobe versions of the SF424 (R&R) grant application forms is planned for December 2008. NIH is mindful of the impact caused by multiple forms changes on the applicant community, and this timing will allow us to combine the following changes:

• NIH’s recently OMB-approved PHS 398 form changes
• FFATA changes to the SF424 (R&R)
• Changes to the SF424 (R&R) as part of the renewal process

NIH expects to pilot the Adobe forms with a couple single receipt date Funding Opportunity Announcements with October receipt dates.

Once NIH transitions to Adobe forms, it will focus on making progress towards its goal of electronic submission of all grant applications. While 80 percent of grant applications are already electronic, the agency is working closely with Grants.gov to transition the remaining 20 percent on the following schedule:

• Research Career Development (all Ks except K12) - February 12, 2009
  
• Individual National Research Service Awards (F) - April 8, 2009
  
• Institutional National Research Service Awards and Other Training Grants (T, D), D43, D71/U2R and K12 - September 25, 2009
  

The timing for electronic submission for NIH’s complex, multi-project grant programs has not been set, although NIH is exploring ways to receive this cohort of applications.

Clearly there is much activity in the world of eSubmission and we look forward to sharing updates in future issues of the Nexus. In the meantime, information may be found on the eSubmission Web site and questions may be directed to NIHElectronicSubmiss@mail.nih.gov.

FAQ Updates

On May 2, 2008, NIH made the following changes to the NIH Public Access Policy Frequently Asked Questions (FAQ):

• Questions C7, C9 and C10 are new, and reflect improvements to PubMed. They clarify and simplify how awardees can comply with the fifth specification of the NIH Public Access Policy, which states: “Beginning May 25, 2008, anyone submitting an application, proposal or progress report to the NIH must include the PMC or NIH Manuscript Submission reference number when citing applicable articles that arise from their NIH funded research. This policy includes applications submitted to the NIH for the May 25, 2008 due date and subsequent due dates.”
  
• Questions A4, B10-B12, C8, C11, D5, E4, E5, F5 and F6 were developed based on questions received by NIH. These questions do not signify any changes in policy or procedure.
  
• NIH has responded to a number of questions about issues already addressed by the January 11 version of the FAQs, and we have made a number small changes to many of these FAQ questions to improve their clarity. The biggest changes we have made is to the wording of FAQs B1-B5. These clarifications to the existing FAQ do not signify any changes in policy or procedure.
  
• The January 11, 2008 FAQ uses the term “article” as a generic word for a peer-reviewed scientific publication and all its versions. At the March 20 Open Meeting, some stakeholders commented that ‘article’ could be confused with the term “final published article”. Therefore, this FAQ uses the term ‘paper’ instead of ‘article’. We will be updating the website to reflect this change as well.
  

NIH Public Access Request for Information ends May 31. Please send us your comments and suggestions for the NIH Public Access Policy. You may also view previously submitted comments.

NIH requires applicants to submit public health relevance statements in grant applications to ensure the description of the projects’ potential to improve public health is clearly articulated. The public health relevance statement should be written in plain language that can be understood by a general, lay audience, as well as your reviewers and colleagues. NIH uses these public health relevance statements for portfolio analyses, to identify research highlights to Congress and to make the importance of the research clear to the public.

Applicants should enter a brief statement of public health relevance in field 7, Project Narrative, on the Other Project Information component of the SF 424 (R&R) application. If using the PHS398 application, enter this information into the Relevance field of Form Page 2.

Statements of public health relevance are highlighted in a new field, separate from the project abstract, on the CRISP (Computer Retrieval of Information Scientific Projects) tool found on the new NIH Report Web site.

NIH seeks candidates for two positions to provide expert advice to the Director, OER Office of Extramural Programs, the NIH Deputy Director for Extramural Research NIH and other senior NIH officials on overall administration of Human Subjects Protection issues related to NIH extramural programs.

The application deadline is June 4, 2008, so apply today!

This vacancy announcement is open to all U.S. citizens

This vacancy announcement is for current Federal employees

Check out http://www.jobs.nih.gov/ for other job opportunities at NIH.

NIH has been developing a new tool that utilizes knowledge management to provide consistent and transparent information to the public about NIH research. With this new computer-based tool, the public will see NIH's research activities broken down into nearly 360 categories covering research areas, diseases and conditions each fiscal year.

The Research, Condition, and Disease Categorization (RCDC) Project recently launched its public website to keep the public informed about the way RCDC categorization will change the way NIH develops reports starting in 2009 on research funding for fiscal year 2008 and beyond.

A webinar will be held on June 11, 2008 to introduce the system to the public. The webinar will provide an overview to the RCDC system followed by a question-and-answer session.

The NIH Program on Clinical Research Policy Analysis and Coordination (NIH CRpac program) maintains a compendium of ethics resources that are available over the Internet. These may be found on the NIH site titled, "Bioethics Resources on the Web." Recently, the NIH CRpac Program augmented the site through the addition of a compilation of international guidelines, codes, regulations, policies and declarations. These materials will be of interest to researchers, IRB members, administrators and others involved in international research activities. For more information contact Allan C. Shipp, NIH Program on Clinical Research Policy Analysis and Coordination at 301-435-2152 or shippa@od.nih.gov.

The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) recently released a report exploring the potential for pharmacogenomics (PGx) to advance the development of diagnostic, therapeutic, and preventive strategies to improve the safety, effectiveness, and quality of health care; identify opportunities and critical barriers in need of the Federal Government’s attention; and make 35 policy recommendations aimed at enhancing the development and integration of PGx applications.

PGx has drawn great attention in the United States and abroad for its potential to improve drug research and development (R&D), health care delivery, and ultimately, patient health. SACGHS was established in 2002 to deliberate and provide advice to the Department of Health and Human Services (HHS) on the broad range of policy issues raised by the development and use of genetic and genomic technologies. In writing and distributing this report, it is SACGHS’s intent to provide policy-relevant information about PGx to inform the decisions of clinicians, policymakers, and other stakeholders. More information about SACGHS is available at http://www4.od.nih.gov/oba/SACGHS.htm.