Important Update:

NIH has just released a policy clarification statement with regard to the disclosure of travel information as required under the final rule regarding financial conflicts of interest in federally funded research (42 CFR Part 50, Subpart F).  NIH has announced that institutions have the discretion to apply the $5,000 de minimis threshold for disclosure to reimbursed or sponsored travel (when aggregated per entity).  HMS is applying the de minimis.  NIH also confirmed that the initial disclosure, which must be made no later than the time of application for PHS funding, must include all significant financial interests related to the investigators institutional responsibilities from the previous 12 months, including sponsored or reimbursed travel. 

The text of the notice is available here: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-004.html.

Implementation of PHS Conflict of Interest Regulations

The Public Health Service (PHS) issued new regulations covering the obligations of its awardee institutions to identify and address investigator financial conflicts of interest (fCOI) in PHS-sponsored research.  These new regulations have an effective date of August 24, 2012 and apply to anyone responsible for the design, conduct and reporting of PHS-supported research.  As a result of its broad application, the new regulation will likely impact the vast majority of HMS/HSDM researchers.

Instructions for Investigators who submit grants through HMS Sponsored Programs Administration.

1.  Completion of Your HMS Outside Activities Report:  As an HMS/HSDM faculty appointee, you are required to report all outside activities that may be relevant to your institutional role to HMS through the HMS Annual Outside Activities reporting system (AOA system).  If you have not previously completed your 2011 outside activities report, the report MUST be completed and updated prior to your participation in research under a sponsored award (regardless of funder) with an award date after August 24, 2012.  The 2011 reporting cycle was announced by Dean Flier in April 2012 with a due date of June 15, 2012.  The system can be accessed at the following link:

                           http://ecommons.med.harvard.edu/gopage.asp?aoa.asp

Additional information about the reporting process, including answers to frequently asked questions can be found at the following location:

http://hms.harvard.edu/content/outside-activity-reporting.

AFTER AUGUST 24, 2012, PROPOSALS CANNOT BE SUBMITTED OR AWARDS RELEASED WITHOUT AN UPDATED HMS OUTSIDE ACTIVITIES REPORT ON FILE.

2.  Updating Your Outside Activities Report: If you have completed your 2011 report, you will have to update your report in the AOA system to reflect any new financial interests that have arisen since December 31, 2011.  The AOA system now allows an investigator to indicate when a financial relationship has terminated and to update relevant information about a previously disclosed relationship.

In addition, Investigators are required to update the AOA system within thirty (30) days of identifying or acquiring a new financial interest that meets the reporting requirements.  Failure to update your financial interests may require HMS to engage in an institutional retrospective review, and, potentially, mitigation procedures required by the regualtions.  This required review is could be time-consuming, costly and encumbering to ongoing work under a PHS award.

3.  Reporting your Sponsored/Reimbursed Travel:   If you are a PHS-supported investigator, you must also report your travel sponsored and/or reimbursed by industry through the AOA system link entitled, “PHS Sponsored/Reimbursed Travel”.  This functionality is now available on the AOA system and you are strongly encouraged to enter this information immediately and on an ongoing basis.  The 2012 PHS regulations require investigators to report the occurrence of any reimbursed travel or sponsored travel by an entity (other than excluded entities) including the purpose of the trip, the identity of the sponsor/organizer and the destination.

4.  Complete your supplementary Disclosure Statement with each proposal submission after August 24, 2012.  The Disclosure Statement provides HMS with additional information pertinent to an institutional assessment regarding whether reported financial interests may be (i) relevant to the proposed research and (ii) directly and significantly affect the design, conduct and reporting of the research and, therefore, pose a fCOI.  The supplemental disclosure statement will be in a fillable pdf form.  This form will fully replace the paper forms previously utilized.

• For Principal Investigators: If you are a principal investigator on a grant awarded after August 24th, you are also responsible for identifying any individual that meets the definition of “investigator” for the award (Any individual responsible for the design, conduct and reporting of the research) and for notifying your SPA administrator of changes to your investigator team during the term of the award.

5.  Complete your Required Training Through Citi: Any Investigator working under a PHS award is required to complete the HMS Citi training every four years.  This training is a regulatory requirement and will cover the 2012 PHS regulations and implementation of these regulations at HMS.  The training is now available for completion and can be accessed immediately at the following link:

https://www.citiprogram.org/default.asp?language=english

Instructions:

1)    Log-in:
A CITI account is required to access the training, and you should use your existing account.  If you do not have an account, this link will also allow you to create an account.   Please register with your HMS email address and provide your HUID.

When registering, please select Harvard Medical School and Harvard School of Dental Medicine from the list of participating institutions.

2)  You will need to enroll in the CITI Conflict of Interest Course. To enroll:
•         Please select “Conflicts of Interest” when it asks which category or categories of courses you need to take

3)  The “Conflict of Interest – Stage 1” Course will be displayed in the “My Courses” section. Click on “Enter” to begin.

4)  To access the course content, you will need to sign the Integrity Assurance Statement. Once acknowledged, you’re now able to begin the Conflict of Interest Training modules.

5)  Complete all three COI Training modules:
a) Financial Conflicts of Interests
b) Institutional Responsibilities
c) Mandatory PHS Required Training on Research Conflicts of Interest at Harvard Medical School
 
You will need a score of 80% or higher on Modules 1 and 2, to successfully complete the training and receive credit. If you do not score 80% or higher, you will need to re-take the quiz portion of the relevant module until you reach 80%. There is no quiz for module 3.

To confirm you have completed each module, you can find your results by clicking on “See a list of all modules completed” located in the main menu.

Why This Training is Important:
Individuals who are currently participating in PHS-funded projects or cooperative agreements, and who do not complete the mandatory training by August 24, will become ineligible to work on those projects at the next progress report. Individuals who have submitted a new application for funding will not be able to participate, or receive any funds, until the training is completed. Individuals who are not currently participating in a PHS-funded project will be ineligible to join such a project until the training is completed.

OPSI is willing to make additional live education on this topic available to any departments, faculty members, administrators and managers who desire live instruction and an opportunity to ask specific questions in an open forum.  If you are interested in scheduling a session, please contact Cindi Hirst, Conflict of Interest Coordinator in OPSI at 617-432-1343 or Cindi-Ann_Hirst@hms.harvard.edu. 

If you have questions about the online disclosure form, the HMS policy, the 2012 PHS regulations, the HMS reporting process or the Citi Training requirement, please send an email to outside_activities@hms.harvard.edu or call 617-432-1343.