Policy on Investigator’s Conflicts of Interest:Q & A for Investigators regarding disclosure requirements

Prior to October 31, 2003, what research activities were covered by the disclosure requirements of the Policy?

Prior to October 31, 2003, the Policy required Investigators to make disclosures covering all human subject research and for all research proposed to be funded by NSF or NIH.

On and after October 31, 2003, what research activities are covered by the disclosure requirements of the Policy?

Effective October 31, 2003, the Policy has been revised to

Expand the Policy to cover the following “Covered Research”: On the Medical Campus all research and on the Charles River Campus all externally-funded research and all human subject research (regardless of funding).

Expand the Policy to define “Significant Financial Interest” as: Anything of monetary value, including a salary, consulting fee, honorarium or other payment for service; equity interests, including stocks, stock options or other ownership interests; and intellectual property rights, including patent rights owned by the investigator or on which a clinical investigator is a named inventor (whether licensed or not), copyrights and royalties.

This Policy on Investigators’ Conflicts of Interest, however, excludes from consideration the following items:

  1. salary, or other remuneration (not including royalties) from Boston University;
  2. income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
  3. income from service on advisory committees or review panels sponsored by public or non-profit entities;
  4. salary, royalties or other payments from a single entity (or group of affiliated entities) that, when aggregated for the investigator and members of his immediate family over the next twelve months, are not expected to exceed $10,000.

Who must make disclosures under the revised Policy?

The term “Investigator” includes all principal investigators and co- investigators, and may include others (e.g., graduate students, post-doctoral fellows, and technicians) who are responsible for designing, conducting or reporting Covered Research.

Individuals whose independent responsibilities will significantly affect the integrity of these functions in Covered Research should be identified by the PI as “investigators” for purposes of the disclosure requirements of the Policy.

All Investigators who are responsible for designing, conducting or reporting Covered Research (as defined above) in the course of Boston University work must make disclosures under the Policy

What information do Investigators need to review and disclose?

Investigators must review their on-going research activities to determine whether they are engaged in proposing, conducting or reporting Covered Research. If so, they will need to disclose the answer, yes or no, to the question below and provide relevant information that will enable the Provost, advised by the Conflicts of Interest Advisory Committee, to determine whether a conflict of interest exists, and, if so, what if any conditions or restrictions should be imposed under the Policy to manage, reduce or eliminate a conflict of interest. Investigators will answer the question:

Do you, your spouse, or dependent children have a Significant Financial Interest that would reasonably appear to be affected by your Covered Research?

When do Investigators need to make disclosure?

Investigators must make disclosure:

  1. whenever the Principal Investigator files a new, continuation or renewal application or other non-federal proposal with ORA(Medical Campus) or OSP(CRC) for Covered Research. These disclosures must be supplemented whenever there is a material change in the information previously disclosed.
  2. whenever the Principal Investigator files an application with the BUMC- IRB or CRC-IRB for initial review. These disclosures must be supplemented whenever there is a material change in the information previously disclosed. If both 1 and 2. apply to the research, disclosure need be made only under 1.
  3. On the Medical Campus, on or before December 31, 2003 (or, thereafter, December 31 of an Investigator’s first year at the University), Investigators must submit a comprehensive disclosure relating to all of their Covered Research, whether or not funded. These disclosures must be supplemented whenever there is a material change in the information previously disclosed. If the comprehensive disclosure indicates that the Investigator has no Significant Financial Interests as to which disclosure is required, then no further filings need be made, except filings under 1. and 2. above and filings of supplemental disclosures in the event of material change in information previously submitted.

What forms should Investigators use to disclose and supplement disclosure?

All required disclosures and supplemental disclosures must be made by Investigators using the attached Project Specific Disclosure Form, except for the one-time comprehensive disclosures made on or before on December 31 by Medical Campus Investigators.

The one-time comprehensive disclosure on or before December 31 by Medical Campus Investigators will be made using the attached Comprehensive Disclosure Form. Thereafter, Investigators will be required to supplement their comprehensive disclosure only if there is a material change in information previously disclosed. So long as Investigators have no Significant Financial Interests that are required to be reported, they will have no need to file a supplement. Those Investigators who do have Significant Financial Interests requiring disclosure will be expected to file supplements to their comprehensive disclosure to indicate material changes affecting the information previously disclosed. The initial mailing of this Q&A is the only notification that will be sent to all Medical Campus Investigators that they must submit their Comprehensive Disclosure forms not later than December 31, 2003.

Where do Investigators file Disclosure Forms?

Forms filed under 1. above:

Investigators submit all Project Specific Disclosure Forms relating to externally-funded research to ORA (Medical Campus) or OSP (CRC).

Forms filed under 2. and 3. above:

All Project Specific Disclosure Forms under 2. and Comprehensive Disclosure Forms under 3. above are to be filed as follows:

Medical Campus Disclosure Forms submitted to Office of Clinical Research, 715 Albany St; A-206.

Charles River Campus Disclosure Forms submitted to Office of the Provost, One Sherborn Street, Room 835.

Disclosure Forms are available on-line at Office of Sponsored Programs (Charles River Campus) and at (Medical Campus).