Supplement to The UMBC Procedures on Conflict of Interest For Faculty

Interest in Sponsored Research And Economic Development

PROCEDURES REQUIRED FOR NSF/PHS SPONSORED ACTIVITY

1. General

Effective October 1, 1995 all proposals being submitted to the National Science Foundation (NSF) or the Public Health Service (PHS) by UMBC and all current grants from NSF and PHS are required to include a certification by the UMBC authorizing official that UMBC has implemented and is enforcing a written policy on conflicts of interest. In addition to existing University of Maryland System and UMBC policies on Professional Commitment of Faculty, Outside Consultancy and Conflict of Interest, the following requirements apply to actual or potential conflicts of interest arising from activities sponsored by NSF and PHS. These federal agencies have promulgated regulations which require:

(1) investigators to disclose certain financial interests;

(2) institutional review of those disclosures;

(3) designation of a person(s) to review the disclosures and resolve actual or potential conflicts revealed;

(4) arrangements for informing (a) the NSF of conflicts that are not resolved to the satisfaction of UMBC, and (b) the PHS of all conflicts reported, resolved or not; and

(5) record retention procedures.

Subcontractors and collaborators must either comply with UMBC's policy or provide assurances to UMBC that they comply with their own policies that meet the PHS and/or NSF requirements as applicable.

II. Definitions

A. "Investigator(s)", means the Principal Investigator and any other person employed by or working under the auspices of UNMC who has independent responsibility for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF or PHS (this may include persons working under the PI) . These individuals are those who have independent responsibility for accomplishing project objectives. For purposes of the requirements relating to financial interests, "investigator" includes the investigator's spouse and dependent children.

B. "Significant Financial Interest" means anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g. stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

(1) salary, royalties or other remuneration from the UMBC;

(2) income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

(3) income from service on advisory committees or review panels for public or nonprofit entities;

(4) an equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, meets both of the following tests: (a) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and (b) does not represent more than a 5% ownership interest in any single entity; or

(5) salary, royalties, or other payments that, when aggregated for the investigator and the investigator's spouse and dependent children, are not expected to exceed $10,000 during the next twelve month period.

C. "Conflict of interest" means, for the purpose of these regulations:

  1. any significant financial interest of the investigator and the investigator's spouse and dependent children that could directly and significantly affect the design, conduct, or reporting of research; and/or

(2) any significant financial interests of the investigator (including those of the investigator's spouse and dependent children):

  1. that would reasonably appear to be directly and significantly affected by

the research and educational activities funded or proposed for funding by NSF; or

(ii) in entities whose financial interests would reasonably appear to be directly and significantly affected by such activities.

D. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in these Procedures, the term includes any such activity for which research funding is available from a component of the PHS through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, and any such activity for which research funding is available from the NSF.

III. Disclosure Requirements

A. An investigator seeking PHS or NSF funding who has no real or potential conflict of interest to disclose must so indicate by checking the appropriate statement and signing the Proposal Routing and Approval Form which accompanies the proposal.

B. An investigator seeking PHS or NSF funding who has a real or potential conflict of interest to disclose must so indicate on the Proposal Routing and Approval Form and complete the "Investigator Financial Disclosure Statement for PHS/NSF Proposals" (Appendix 1). This form and any supporting documentation (such as the Conflict Exemption Disclosure Form) must be submitted with or, preferably, in advance of the proposal.

C. All disclosures must be updated during the period of the award on an annual basis or as new reportable significant financial interests are obtained by completing and routing the Update/Annual Certification Form for PHS/NSF Sponsored Activities (Appendix 2). Each investigator with a current PHS or NSF grant must complete this form.

D. Financial disclosures related to activities proposed to NSF or PHS for funding must be routed within UMBC in accordance with the procedures set forth below prior to submission of the proposal to NSF or PHS.

IV. Institutional Review Process

A. The investigator's academic supervisor (generally the department chair) is responsible for conducting the initial review of financial disclosures submitted by investigator(s) within that supervisor's academic unit. The supervisor, subject to UMBC's review and final decision, will determine what mechanisms are appropriate for managing, reducing, or eliminating real or potential conflicts of interest. Examples of conditions or restrictions that might be imposed include:

B.(1) Disclosure of conflicts and the resolution or plan for resolution shall be forwarded from the academic supervisor, through any intermediate supervisors as required, to the academic dean. Following action by the dean, the disclosure and resolution or plan for resolution shall be forwarded to UMBC's senior research officer, the Associate Vice President for Research and Dean of Graduate Studies ("Research Officer" or "RO") for review and approval.

B.(2) Should a potential conflict which was unrecognized through the proposal routing processes be discovered (e.g. a potential conflict is recognized by the OSPA ), the office that discovers the conflict will contact the RO. The RO will contact the investigator for additional information regarding the potential conflict. The RO will then take whatever action is deemed appropriate.

C. If the RO finds that a disclosure of real or potential conflict of interest is unresolved or unrecognized after the initial reviews, or if the Research Officer finds that a recommended plan for resolution is inconsistent with UMBC guidelines and experience; the Research Officer may take immediate action to resolve the matter or delay resolution pending further review. The RO may also forward the matter to UMBC's Conflict of Interest Committee for consideration. The committee will consist of. the RO, the Dean of the College of Engineering, the Dean of Arts and Sciences, the Associate Vice President for academic Affairs and the University Counsel. The committee will examine the matter and make its recommendations to the Research Officer, who will make a decision on the case. The decision of the RO will be final.

D. Proposals will not be forwarded to NSF or PHS by UMBC until the conflict of interest review process has reached the level of the RO. The RO will include an Acknowledgment of Potential Conflict Disclosure in the proposal file prior to release of the proposal for submission to the NSF or PHS. A proposal may be forwarded to NSF or PHS by UMBC before the review process is completed, however, no ftmds can be spent for the project until the process is completed. For all PHS grant proposals for which a potential conflict has been disclosed, the OSPA will prepare a letter of notification for signature by the RO which informs the PHS of the disclosed potential. Letters of conflict notification are not required by the NSF.

E. If a proposal has been forwarded on the expectation that an approved plan for resolution of conflict of interest will be implemented, the identified conflict of interest must be satisfactorily managed, reduced or eliminated prior to the UMBC's expenditure of any funds under the award for the project affected. If the conflict cannot be satisfactorily resolved, UMBC reserves the right to withdraw the grant proposal or refuse the award.

F. For on-going projects, conflicts under an award that are disclosed subsequent to

UMBC's initial report to NSF or PHS must be resolved, at least on an interim basis, within sixty (60) days after identification to UMBC of the potential conflict.

V. Reporting Procedures and Record Retention

A. In the case of PHS proposals, notice must be given to the agency by UMBC for all conflicts of interest. The RO is responsible for providing the appropriate written notice to the PHS through a letter prepared by the OSPA. Conflicts which cannot be satisfactorily resolved must be disclosed to NSF or PHS, as appropriate. In the circumstance where a conflict could not be resolved, the RO will directly report the case to the awarding agency.

B. The RO will maintain records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest for at least three (3) years after termination or completion of the sponsored project or after resolution of any government action involving those records, whichever is longer.

C. As required by federal agency regulations, information regarding all PHS/NSF grant related conflicts of interest identified to or by UMBC will be made available to the Federal government upon request.

VI. Compliance

Failure to comply with this policy and the underlying Federal regulations may result in the termination of the sponsored activity and/or restrictions on the individual with respect to proposal submissions as well as other appropriate sanctions auhtorized and available under University of Maryland System and UMBC policies and procedures, the Maryland Public Ethics Law, and federal laws and regulations.

VII. Confidentiality

Information submitted by faculty with respect to conflicts of interest shall be treated as personal information under the Maryland Access to Public Records Law, and shall be disclosed by UMBC only as permitted by State law or otherwise required by law or court order. This limitation shall not apply to information which must be disclosed to manage a potential or actual conflict of interest.


APPENDIX I

Investigator Financial Statement for PHS/NSF Proposals

Name:

Dept:

Proposal Title:

Sponsor: NSF-or PHS-

Proposal No.:

Submission of this form is required before a proposal can be signed and submitted to NSF

or PHS by UMBC

Administrative review and resolution and/or notification to NSF and PHS must occur prior

to UMBC's expenditure of any funds under the award.

NSF and PHS regulations require that an investigator disclose his or her significant financial interests and those of the investigator's spouse and dependent children that (i) would reasonably appear to be affected by, or reasonably might affect, the research or educational activities proposed for funding by NSF and PHS; or (ii) that are held in entities whose financial interests would reasonably appear to be affected by such activities.

Significant Financial Interest is defined in the "Supplement to the UMBC Procedures on Conflict of Interest for Faculty Interest in Sponsored Research and Economic Development@.

Based upon the definition contained in the Policy and in accord with the attached Disclosure Form, if any, I make the following representation:

1 . No conflict or appearance of conflict exists (no disclosure form required).

2. A conflict exists or may exist. Please identify any significant financial interests that would reasonably appear to constitute a conflict of interest with respect to the conduct or reporting of the proposed research (Attach Disclosure Form if necessary).

3. An appearance of conflict exists or may exist. Please identify below anything which in your opinion would not compromise your objectivity in the conduct or reporting of the proposed research but might have the appearance of doing so (Attach Disclosure Form if necessary).

Certification

I certify that the above information (including any attached disclosure forms) is complete and true to the best of my knowledge and that I have read the University's policies related to investigator financial disclosures as described in the BOR Policy 11-3.30, UMBC Conflict of Interest Policy and the Supplement to the UMBC Procedures on Conflict of interest for Faculty Interest in Sponsored Research and Economic Development. I supply this information for review by UMBC and do not authorize release of any of it for any use other than compliance with the university's policies and related State and federal laws and regulations, and as required by law or court order.

Name and Signature

Date:

Administrative Review

The academic unit head is responsible for conducting the initial review of this disclosure and making findings.

Based on the activity reported, to the best of my knowledge and in my judgment:

1. No real or potential conflict of interest exists;

2. A real or potential conflict of interest exists. The conflict and steps taken to manage, reduce, or eliminate the real or potential conflict are described below: (Attach additional sheets if necessary.)

3. A real or potential conflict of interest exists which has not been resolved. This conflict and the situation preventing the development of a resolution plan is described in detail below: (Attach additional sheets if necessary.)

Signatures:


Department Chair

Date:

I do do not concur in the chair's recommendation. Attach explanatory statement if disagreeing with recommendation of chair or with chair's reasoning.

Dean

Date:

This form and any supporting material must be forwarded directly to the RO.

APPENDIX 2

UPDATE/ANNUAL CERTIFICATION FORM FOR PHS/NSF SPONSORED

ACTIVITIES

Name:

Dept:

Proposal Title:

Sponsor: NSF PHS Grant Number

FAS or SAI#

NSF and PHS regulations require that an investigator disclose his or her significant financial interests and those of the investigator's spouse and dependent children that (i) would reasonably appear to be affected by, or reasonably might affect, the research or educational activities proposed for funding by NSF and PHS; or (ii) that are held in entities whose financial interests would reasonably appear to be affected by such activities.

The initial annual certification covers the period from the award date through June 30. Thereafter NSF and PHS require annual certifications. This annual certification will cover the period of July I through June 30 of each year. This form must be submitted through the department chair and dean and received by the RO by October I of each year.

"Significant Financial Interest" is defined in Supplement to the UMBC Procedures on Conflict of Interest for Faculty Interest in Sponsored Research and Economic Development. Please review the definition to ensure complete compliance with Federal disclosure requirements.

Based upon the definition contained in the Policy Supplement and any additional disclosure

forms attached, I make the following representation:

No changes have occurred in the information disclosed since award or in the past 12 months, whichever is less, which would affect my research or educational activities supported by NSF or PHS.

Changes have occurred in the information disclosed since award or in the past 12 months, whichever is less, which might affect my research or educational activities supported by NSF or PHS. If checked, please fill out and attach the Conflict Exemption Disclosure Form, taking particular care to disclose:


1. Any significant financial interests that might constitute a conflict of interest in the conduct or reporting of the research proposed.

2. Anything in your opinion that would not compromise your objectivity in the conduct or reporting of the research but might have the appearance of doing so.

3. If you are the principal investigator of this project, please list any new "investigators", as defined in the UMBC Conflict of Interest Policy and its Supplement who were not identified on the original UMBC proposal routing form and Conflict Disclosure Forms.

Certification

I certify that the above information is complete and true to the best of my knowledge and that I have read the University's policies related to investigator financial disclosures as described in the BOR Policy II-3.30 and UMBC Conflict of Interest Policy and its Supplement. I supply this information for review by UMBC and do not authorize release of any of it for any use other than compliance with the University's policies and related State and federal laws and regulations, and as required by law or court order.

Name and Signature

Date:

Administrative Review

The academic unit head is responsible for conducting the initial review of this disclosure and making findings.

Based on the activity reported, to the best of my knowledge and in my judgment:

1. No real or potential conflict of interest exists;

2. A real or potential conflict of interest exists. The conflict and steps taken to manage, reduce, or eliminate the real or potential conflict are described below: (Attach additional sheets if necessary.)

3. A real or potential conflict of interest exists which has not been resolved. This conflict and the situation preventing the development of a resolution plan is described in detail below: (Attach additional sheets if necessary.)

Signatures:


Department Chair

Date:

I do do not concur in the Chair's recommendation. Attach explanatory statement if disagreeing with the recommendation of the chair or with chair's reasoning.

Dean

Date:

This form and any supporting material must be forwarded directly to the RO.

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