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Case Research Weekly  
January 28, 2008  
Compliance News
OIG Reports on NIH Financial COI Oversight at Grantee Institutions
The Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) issued its report on the number and nature of financial conflicts of interest reported to the National Institutes of Health (NIH) and the extent of NIH’s oversight of those reported financial conflicts of interest. The report entitled “National Institutes of Health: Conflicts of Interest in Extramural Research,” is available under “What’s New” on the OIG website at: http://www.oig.hhs.gov/ (Posted January 17, 2008, OEI-03-06-00460).

The OIG noted the following findings:
  1. NIH could not provide an accurate count of the financial conflicts of interest reports submitted by grantees during the period 2004-2006;
  2. NIH did not know the types of conflicts because the policy does not require detailed reporting of the nature of the conflicts; and
  3. that NIH and its institutes and centers (ICs) primarily rely on the grantee assurance of compliance with the regulations, as stated in the policy.
To address NIH management of financial conflicts of interest or Objectivity in Research in the extramural research community, the OIG recommends greater oversight by NIH by amending the regulations to require grantees to submit more detailed reports on the nature of the conflict, the individuals involved and how the conflict is being managed, reduced or eliminated by the institution. In addition, the OIG recommends that ICs be required to submit the reports they receive concerning conflicts of interest to the NIH Office of Extramural Research (OER) for posting to a OER database to ensure an accurate count of the reports received by the agency.

In responding to the OIG report, NIH Director Elias Zerhouni agreed with the findings and supports two of the recommendations: providing greater oversight through targeted site visits and expanded informational outreach; and the need for accurate counting to be achieved through a new web-based reporting system for NIH staff that will help track reports received by each IC. NIH looks forward to developing a reporting mechanism in NIH’s electronic portal, eRA Commons, to allow grantee institutions to report conflicts of interest online.

NIH does not concur with the recommendation to change the regulations to require more detailed reports from grantee institutions concerning financial conflicts of interest. In his response, Zerhouni argues that the authority for managing financial conflicts of interest resides in and should remain with the grantee institution. He notes that this authority needs to be exercised with the complete knowledge of an individual and his/her activities to make it effective. The grantee institution can view the financial disclosure in the context of the investigator’s entire research enterprise and make a better assessment of how to manage, reduce or eliminate the financial conflict. More importantly, the grantee institution has the authority and responsibility to monitor and enforce regulatory requirements with its employees. Zerhouni notes that the collection of detailed information as proposed by the OIG would “effectively, if not legally, transfer the locus of that authority …to the Federal Government.” He does not believe this authority should pass to NIH.

NIH’s policy on Objectivity in Research can be found at 42CFR Part 50, Subpart F. The policy, NIH’s report on its targeted site visits and from its Proactive Compliance Site Visits as well as Frequently Asked Questions (FAQ) concerning financial conflicts of interest are available on NIH’s Conflicts of Interest web site at: http://grants.nih.gov/grants/policy/coi/index.htm.

 

As some of you may have heard, Case is losing a great asset and leader. Our Associate Vice President for Research, Dr. Eric Cottington, has accepted a position in New York City. Eric will become the Vice President for Research and Technology at Memorial Sloan-Kettering Cancer Center in mid-February.

While all of us in Research Administration are happy for Eric and his family, we will miss his ease of communication and excellent style in managing and mentoring. Good Luck, Eric!

 
Compliance News
January Issue of Research Regulator Available

In keeping with our increased effort to focus on Responsible Conduct in Research (RCR), the new issue of Research Regulator is available. You will find some changes to the content. Instead of concentrating soley on human subjects research, we have expanded the scope to include RCR. This issue discusses RCR in general, and gives more in depth information about conflict of interest, peer review and collaborative science.

For those of you who have enjoyed the convenience of taking the quiz for CREC each quarter, don't worry! Once a year, we will offer an expanded, human subjects edition. That issue will be the only one with a quiz, which will be 4 credits!

Check out the new issue at: http://ora.ra.cwru.edu/research/orc/education/ResearchRegulatorPage.cfm.

 
Sponsored Projects News and Updates
NIH Announces New Salary Limitation on Grants, Cooperative Agreements, and Contracts
Every year since 1990 Congress has legislatively mandated a provision limiting the direct salary that an individual may receive under an NIH grant. For FY 2008, Public Law 110-161: Consolidated Appropriations Act, 2008 restricts the amount of direct salary to Executive Level I of the Federal Executive Pay scale. The Executive Level I annual salary rate was $186,600 for the period January 1 through December 31, 2007. Effective January 1, 2008, the Executive Level I salary level increased to $191,300. Guidance on other legislative mandates contained in P.L. 110-161 will be issued in the near future.

For the purposes of the salary limitation, the terms "direct salary," "salary," and "institutional base salary" have the same meaning and are exclusive of fringe benefits and facilities and administrative (F&A) expenses, also referred to as indirect costs. An individual's institutional base salary is the annual compensation that the applicant organization pays for an individual's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual may be permitted to earn outside of the duties to the applicant organization.

NIH grant/contract awards for applications/proposals that request direct salaries of individuals in excess of the applicable RATE per year will be adjusted in accordance with the legislative salary limitation and will include a notification such as the following: None of the funds in this award shall be used to pay the salary of an individual at a rate in excess of the current salary cap.

This is the eighth year that the limitation has been linked to Executive Level I of the Federal Pay Scale. Please see the salary cap summary and the time frames associated with salary caps at http://grants.nih.gov/grants/policy/salcap_summary.htm.

The complete NIH notice can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html.

 
NIH Public Access Policy Is Now Mandatory
In accordance with Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008), the NIH voluntary Public Access Policy (NOT-OD-05-022) is now mandatory. The law states:
"The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law."
Specifics

  1. The NIH Public Access Policy applies to all peer-reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7, 2008.
  2. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.
  3. PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases (see: http://www.pubmedcentral.nih.gov/).
  4. The final, peer-reviewed manuscript includes all graphics and supplemental materials that are associated with the article.
  5. 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.
Compliance

Compliance with this Policy is a statutory requirement and a term and condition of the grant award and cooperative agreement, in accordance with the NIH Grants Policy Statement For Contracts, NIH includes this requirement in all R&D solicitations and awards under Section H, Special Contract Requirements, in accordance with the Uniform Contract Format.

 
Compliance News
Ethical Challenges in Surgical Innovation - CCF Symposium
May 8-9, 2008
InterContinental Hotel

This dynamic program presented by Cleveland Clinic will be a unique opportunity to listen to and discuss key issues regarding innovation in contemporary surgical procedures, device development, and organ transplantation. Outstanding speakers and moderators including recognized leaders in surgery, academic medicine, research, industry, government and bioethics, will participate in interactive discussions.

Summit Objectives
  • To educate participants about the moral dilemmas that often arise in the conduct of device development and other surgical innovations.
  • To suggest potential solutions to these challenges, balancing the need for progress and creativity with the imperative of protecting patients from undue risk.
  • To create a forum for exchange of ideas between surgical innovators and bioethicists with expertise in surgical ethics.
This course is recommended for surgeons, nurses, bioethicists, physicians and students.

For more information and to register, please go to: http://www.clevelandclinicmeded.com/live/courses/2008/ethicalsurgery08/overview.htm.

 

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