Appendix E: Implementation of the Final Rule on Conflicts of Interest in Public Health Service Funded Research
Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
The following policy sets forth Worcester Polytechnic Institute’s (WPI) implementation of the above referenced Final Rule and is applicable to each WPI Investigator, as defined by the regulation, who is planning to participate in or is participating in Public Health Service (PHS) funded research. Relevant sections of the WPI Conflict of Interest Policy to which this Appendix relates will remain in effect unless superseded by the requirements, as stated in this Appendix.
The policy, which is primarily intended to cover financial assistance awards (grants and cooperative agreements), also shall be used in cases in which the University submits a proposal to or receives Public Health Service (PHS) funding by means of a contracting action. Regulatory citations incorporating appropriate parts of 45 CFR Part 94 relating to contracting actions are provided throughout the policy, as needed.
- Disclosure, Review, and Monitoring
- Reporting to NIH
- Enforcement Mechanisms
- Public Accessibility
- Subrecipient Requirements
- Training Requirements
- Records Maintenance
Contractor means an entity that provides property or services under contract for the direct benefit or use of the federal government.
Disclosure of significant financial interests means an Investigator’s disclosure of significant financial interests to an Institution.
Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report means an Institution’s report of a financial conflict of interest to a PHS Awarding Component that provides sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict and to assess the appropriateness of the Institution’s management plan. Elements of FCOI reports include, but are not limited to, the following information:
- Project number,
- PI/PD or Contact PI/PD if a multiple PI/PD model is used,
- Name of the Investigator or Key Person with the financial conflict of interest,
- Name of the entity with which the Investigator has a financial conflict of interest,
- Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium),
- Value of the financial interest (dollar ranges are permissible: $0 - $4,999, $5,000 - $9,999, $10,000 - $19,999, amounts between $20,000 - $100,000 by increments of $20,000, amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value,
- A description of how the financial interest relates to the PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research, and
- A description of the key elements of the Institution’s management plan, including
- Role and principal duties of the conflicted Investigator in the research project,
- Conditions of the management plan,
- How the management plan is designed to safeguard objectivity in the research project,
- Confirmation of the Investigator’s agreement to the management plan,
- How the management plan will be monitored to ensure Investigator compliance, and
- Other information, as needed.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS means the United States Department of Health and Human Services and any components of the Department to which the authority involved may be delegated.
Institution means any domestic or foreign, public or private, entity or organization (excluding a federal agency) that submits a proposal for, or that receives, PHS research funding.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the university including, but not limited to, customary activities such as research, teaching, academic activities, community service under the auspices or on behalf of the university, scholarly events, and service on University committees, such as the Institutional Review Board or the Institutional Animal Care and Use Committee.
Investigator means the Project Director or Principal Investigator and any other person, including a Key Person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Key personnel includes the Project Director/Principal Investigator and any other personnel considered to be essential to work performance in accordance with the Health and Human Services Acquisition Regulation (HHSAR) subpart 352.242-70 and identified as key personnel in the contract proposal and contract.
Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
Mitigation report means a report submitted to the PHS Awarding Component on a research project as a result of having discovered bias while conducting a retrospective review. Each mitigation report must include, at a minimum, the key elements documented in the retrospective review (see definition of retrospective review) as well as a description of the impact of the bias on the research project and the institution’s plan for taking action(s) to eliminate or mitigate the effect of the bias (e.g., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm, analysis of whether the research project is salvageable).
PD/PI means a Project Director or Principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Research means a systematic investigation, study or experiment 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 (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Retrospective review means a review that is undertaken after learning that a significant financial interest was not disclosed on a timely basis by an Investigator or was not reviewed by the institution during an ongoing PHS-funded research project. The minimum required information that must be included in a retrospective review includes:
- award number,
- project title,
- Project Director/Principal Investigator (PD/PI) or contact PD/PI for multiple PI models,
- name of the Investigator/Key Person with the financial conflict of interest,
- name of the entity with which the Investigator has a financial conflict of interest,
- reason(s) for the retrospective review,
- detailed methodology used for the retrospective review (e.g., review process, composition of the review panel, documents reviewed),
- findings of the review, and
- conclusions of the review.
Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
Significant financial interest means:
- A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities: (i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; (ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or (iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel. Please see section 2.A.2) of this policy for a complete discussion of instances requiring Investigator disclosure of travel and exceptions under which such disclosure is not required.
- The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97–219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102–564.
University means Worcester Polytechnic Institute (WPI).
2. Disclosure, Review, and Monitoring
Significant financial interests (SFI) that are subject to disclosure by an Investigator to the University are those that reasonably appear to be related to the Investigator’s “Institutional Responsibilities,” as defined by WPI and in Section 1 of this Appendix. Such disclosure shall take place, a) concurrent with and no later than the submission of an application for a PHS-funded research activity, b) in the absence of an application for a PHS-funded research activity, at least annually during the period of any current PHS-funded award, and/or c) within 30 days of discovering or acquiring a new SFI.
In the case of a) above, disclosure of an SFI shall be made to the Director, Office of Sponsored Programs via the completion of a WPI Proposal Coordination Form (PCF), which must be provided no later than the day on which an application for a PHS-funded research is to be submitted.
For b) above, on or before October 1 annually or within sixty (60) days of appointment, each faculty member and other individual(s) identified in Appendix D shall complete and submit a disclosure of SFI to his/her Department Head.
And in the instance when c) above applies, a new disclosure must be completed and submitted within 30 days of discovering or acquiring a new SFI during the period of any current PHS-funded award. It should be noted as well that any previously submitted disclosures, whether submitted in satisfaction of the PHS proposal submission requirement or in fulfillment of the WPI annual disclosure requirement or IRB disclosure requirement, must be updated when a new reportable Significant Financial Interest or potential financial conflict of interest exists.
In addition to the disclosure of significant financial interests as specified above, investigators must disclose within thirty (30) days from completion of a trip the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Please note that no de minimus has been prescribed under the PHS Final Rule; thus, all qualifying reimbursed or sponsored travel must be disclosed.
Each Investigator travel disclosure must include, at a minimum, the following key elements:
- an explanation of the purpose of the trip,
- the identity of the sponsor/organizer paying for the trip,
- the destination(s), and
- the dates/duration.
Upon receipt of each travel disclosure, (see Apppendix F) the WPI designated institutional official (described below) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
Guidelines for institutional official
WPI will provide guidelines in accordance with the relevant regulatory citations in the Code of Federal Regulations (CFR) for the use of the Investigator’s department head and WPI’s designated institutional official in reviewing SFI disclosures. WPI has designated the Director of Sponsored Programs as the University’s institutional official for PHS-related FCOI matters.
All qualifying individuals participating in the submission of a PHS application shall be required to disclose whether or not such participation is affected by a significant financial interest (SFI). Each disclosure of a SFI by a WPI faculty member participating as a Principal Investigator or Key Person on a PHS application shall be reviewed by the Investigator’s department head before forwarding to the Director of Sponsored Programs.
The review will focus primarily on the nature of the disclosure(s) to determine a) whether the SFI constitutes a financial conflict of interest of the Investigator or other Key Person, as well as the Investigator/Key Person’s spouse and dependent children, and b) whether the SFI could be affected by the PHS-funded research or is in an entity external to WPI whose financial interest may be affected by the research. In the event a determination reveals that a SFI is, in fact, a financial conflict of interest, the Director of Sponsored Programs will inform the Vice Provost for Research and the University Compliance Officer, who, together with the Director of Sponsored Programs, shall review the documentation leading to such determination and take action to develop a management plan specifying any actions that have been, or will be, take in order to appropriately oversee the financial conflict of interest. The management plan will be reviewed and approved by the Conflict Management Committee prior to implementation.
It is possible that a disclosure of a SFI that could be affected by a PHS-funded research program originates outside of the Office of Sponsored Programs disclosure process. In such cases, the disclosure recipient should inform the Director of Sponsored Programs to determine, in consultation with the Investigator’s department head, whether a review equivalent to the foregoing is needed.
- Mid-Project Review
In the event that an Investigator who is new to an ongoing PHS-funded project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest, the Director of Sponsored Programs, in cooperation with the Investigator’s department head, shall, within sixty (60) days of such disclosure, review the disclosure of SFI, determine whether it is related to the PHS-funded research and determine whether a financial conflict of interest exists. If so, the Director of Sponsored Programs shall inform the Vice Provost for Research and the University Compliance Officer, who together with the Director of Sponsored Programs, shall develop, at least on an interim basis, a management plan specifying the actions that have been, and will be, taken to manage the financial conflict of interest. The management plan will be reviewed and approved by the Conflict Management Committee prior to implementation.
If warranted by virtue of the results obtained in the Mid-Project Review, the Conflict Management Committee will consider additional interim measures that may be taken regarding the Investigator’s participation in the PHS-funded research between the date of disclosure and completion of the University’s review.
- Retrospective Review
In the event the University identifies a significant financial interest that was not disclosed on a timely basis by an Investigator or Key Person or was not previously reviewed by WPI during the timeframe of an ongoing PHS-funded project, the Director of Sponsored Programs, in cooperation with the Investigator’s department head, shall, within sixty (60) days of learning of the SFI, review the SFI, determine whether the SFI is related to the PHS-funded research project, and determine whether a financial conflict of interest exists. If such determination is positive, the Director of Sponsored Programs shall inform the Vice Provost for Research and the University Compliance Officer, who together with the Director of Sponsored Programs, shall develop, at least on an interim basis, a management plan specifying the actions that have been, and will be, taken to manage the financial conflict of interest. The management plan will be reviewed and approved by the Conflict Management Committee prior to implementation
In addition, whenever a financial conflict of interest is not identified or managed in a timely manner, including a) failure by the Investigator to disclose a significant financial interest that is determined by WPI to be a financial conflict of interest, b) failure by WPI to review or manage such a financial conflict of interest, or c) failure by the Investigator to comply with a financial conflict of interest management plan developed by the University, WPI shall complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research. The University shall complete the retrospective review within 120 days of the University’s determination of non-compliance.
Based on the results of the retrospective review, if appropriate, the University, through its Conflict Management Committee, will update the previously submitted financial conflict of interest report by specifying the actions that will be taken to manage the financial conflict of interest. If, as a result of the retrospective review, bias is found, WPI will notify the PHS Awarding Component promptly and submit a mitigation report (see definition for mitigation report and what it must include) to the PHS Awarding Component.
Following submission of a mitigation report, WPI is required to submit financial conflict of interest reports annually (see section 3). It should be noted that, depending on the nature of the financial conflict of interest, WPI, through its Conflict Management Committee, may determine that additional interim measures are warranted with regard to the Investigator’s participation in the PHS-funded research project between the mitigation report submission date and the expiration of the PHS-funded research project.
In all instances in which the disclosure of a financial conflict of interest has necessitated the development and implementation of a management plan, the University shall monitor compliance with the plan by the affected Investigator on a continuing basis throughout the life of the PHS-funded research project. Actual monitoring activities shall be determined on a case by case basis by the WPI Conflict Management Committee as part of the management plan review process, prior to implementation.
3. Reporting to NIH
Whenever a significant financial interest (SFI) has been identified and found to be conflicting, the University shall, prior to the expenditure of any funds under a PHS-funded research project, submit to the PHS Awarding Component a financial conflict of interest (FCOI) report and provide assurance that a management plan has been developed, approved by the WPI Conflict Management Committee, and implemented. Conversely, if a financial conflict of interest is identified, but eliminated prior to the expenditure of PHS funds, a report is not required. After an initial FCOI report is submitted during an ongoing PHS-funded research project, if the University identifies a conflicting significant financial interest (e.g., upon the participation of an Investigator or other Key Person who is new to a PHS-funded research project), it will, within sixty (60) days of such discovery, submit a second FCOI report regarding the financial conflict of interest and provide assurance that the University, through its Conflict Management Committee, has implemented a management plan.
Another instance in which WPI is required to submit a FCOI report is when a significant financial interest is discovered that was not disclosed on a timely basis by an Investigator or other Key Person or, for whatever reason, was not previously reviewed or managed by the University (e.g., was not timely reviewed or reported by a subrecipient). In such cases, the University will undertake a retrospective review, as specified in section 2.B.3) of this policy, to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of the research. If bias is discovered, the University, through its Conflict Management Committee, will notify the PHS Awarding Component promptly by submission of a mitigation report (see definition of mitigation report in section 1 for required contents).
For instances when a financial conflict of interest was previously reported by the University on an ongoing PHS-funded research project, WPI will provide to the PHS Awarding Component an annual FCOI report, as approved by the Conflict Management Committee, that addresses the status of the FCOI and any changes to the management plan. Such reporting shall continue for the duration of the PHS-funded research project, including any extension periods, in the time and manner specified by the PHS Awarding Component. As part of the annual FCOI reporting process, the University will specify whether the financial conflict is still being managed or explain why the FCOI no longer exists.
4. Enforcement Mechanisms
The WPI Conflict Management Committee shall determine an appropriate enforcement mechanism and, if necessary, sanctions in the event of non-compliance by an Investigator or Key Person with either the University’s financial conflict of interest policy or financial conflict of interest management plan in cases in which the non-compliant activities appear to have biased the design, conduct, or reporting of the results of PHS-funded research. In addition, the University, through its Conflict Management Committee, shall promptly report to the PHS Awarding Component each instance of such non-compliance, provide notification of the corrective action that was or is to be taken, and forward upon request (or permit HHS on site review of) all records developed during and relating to the University’s review, monitoring, and enforcement activities.
In the event that HHS reviews FCOI-related materials provided by the University and makes a determination of additional corrective actions that should be taken, the University, through its Conflict Management Committee, will enforce such corrective actions, which may include imposition of special award conditions or suspension of funding. Should HHS determine that a PHS-funded project involving clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, of treatment, has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the University, WPI shall require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
5. Public Accessibility
The University shall maintain and update, prior to the expenditure of funds under a PHS-funded research project and at least annually thereafter, a publicly accessible website on which is posted this policy and related forms and procedures. In addition, the University will respond within five (5) business days to requests for information concerning any significant financial interest disclosed to the University that meets the criteria specified in the PHS Final Rule.
6. Subrecipient Requirements
The University is responsible for taking reasonable steps to ensure that any subrecipients (i.e., subcontractors or consortium members) performing work under a PHS-funded research project comply with the PHS Financial Conflict of Interest regulations, as revised, and shall do so, as follows:
In connection with any proposal to be submitted for PHS funding that includes research to be conducted by a subrecipient organization (e.g., subcontractor, subawardee, consortium member), the University will require an advance understanding of which institution’s conflict of interest policy will apply to each subrecipient’s Investigator(s) in the event of an award.
Upon receipt and acceptance of a PHS-funded research award, the University shall draft a subrecipient agreement based upon the advance understanding(s) in A. above, for each collaborating organization. The subrecipient agreement shall specify which institution’s financial conflict of interest policy shall apply, as follows:
- If the subrecipient’s Investigator(s) must comply with the subrecipient’s financial conflict of interest policy, the subrecipient shall certify as part of the subrecipient agreement that its policy complies with the PHS regulation. In the event the subrecipient is unable to provide this certification, the subrecipient agreement shall state that subrecipient Investigators are subject to this WPI Conflict of Interest Policy for disclosing significant financial interests that are directly related to the subrecipient’s work for the University.
- If the Subrecipient’s Investigator(s) must comply with the subrecipient’s financial conflict of interest policy, the subrecipient agreement shall specify time periods for the subrecipient to report all identified financial conflicts of interest to the University. The specified time period shall be sufficient to enable WPI to provide timely FCOI reports, as necessary and required by the PHS regulation and the WPI Conflict of Interest Policy.
- If the subrecipient’s Investigator(s) are required to comply with the WPI Conflict of Interest Policy, the subrecipient agreement shall specify time periods for the subrecipient to submit all Investigator disclosures of significant financial interests to the University, which time periods shall be sufficient to enable WPI to comply with its timely review, management, and reporting obligations under the PHS regulation.
Further, the subrecipient agreement shall require any subrecipient organization(s) receiving funding under a prime PHS-funded research award to the University to provide financial conflict of interest reports to the PHS Awarding Component (with a copy to the Director of Sponsored Programs) regarding financial conflicts of interest of all subrecipient Investigators prior to the expenditure of funds and within sixty (60) days of any subsequently identified financial conflict of interest.
7. Training Requirements
Training in the requirements of the PHS regulation and the WPI Conflict of Interest Policy is required of each Investigator prior to engaging in research relating to any PHS-funded project. It is to be repeated every four (4) years. Training also is required immediately whenever any of the following circumstances are known to occur:
- A. The University revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
- An Investigator who is to be engaged in PHS-funded research is new to the University; or
- The University discovers that an Investigator is not in compliance with either this policy or any specifically developed and implemented management plan.
WPI will provide an on-line training program, e.g., the Collaborative Institutional Training Initiative (CITI) online Financial Conflict of Interest (FCOI) module, which will be supplemented by case studies and/or other instructional materials through the Vice Provost for Research office, as appropriate.
The Director of Sponsored Programs, as designated institutional official, shall be responsible for maintaining and updating the University’s registry of qualifying WPI and subrecipient Investigators and for scheduling training, as required above.
8. Records Maintenance
The University shall maintain all records of faculty member (Investigator) disclosures of financial interests and its subsequent review of, and/or response to, such disclosures (whether or not a disclosure resulted in the University’s determination of a financial conflict of interest), and all actions taken under the University’s policy or retrospective review for a period of at least three (3) years from the date of submission of the final expenditure report or, where applicable, from other dates specified in 45 CFR 74.53(b) and 45 CFR 92.42(b) for differing situations. Such records shall be maintained for each competitive segment of an award for PHS-funded research, as follows:
45 CFR 74.53(b) - Financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained for a period of three years from the date of submission of the final expenditure report or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report. The only exceptions are the following: (1) If any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken. (2) Records for real property and equipment acquired with Federal funds shall be retained for 3 years after final disposition. (3) When records are transferred to or maintained by the HHS awarding agency, the 3-year retention requirement is not applicable to the recipient.
45 CFR 92.42(b) - Length of retention period. (1) Except as otherwise provided, records must be retained for three years from the starting date specified in paragraph (c) of this section. (2) If any litigation, claim, negotiation, audit or other action involving the records has been started before the expiration of the 3-year period, the records must be retained until completion of the action and resolution of all issues which arise from it, or until the end of the regular 3-year period, whichever is later. (3) To avoid duplicate recordkeeping, awarding agencies may make special arrangements with grantees and subgrantees to retain any records which are continuously needed for joint use. The awarding agency will request transfer of records to its custody when it determines that the records possess long-term retention value. When the records are transferred to or maintained by the Federal agency, the 3- year retention requirement is not applicable to the grantee or subgrantee.
45 CFR 92.42(c) - Starting date of retention period—(1) General. When grant support is continued or renewed at annual or other intervals, the retention period for the records of each funding period starts on the day the grantee or subgrantee submits to the awarding agency its single or last expenditure report for that period. However, if grant support is continued or renewed quarterly, the retention period for each year's records starts on the day the grantee submits its expenditure report for the last quarter of the Federal fiscal year. In all other cases, the retention period starts on the day the grantee submits its final expenditure report. If an expenditure report has been waived, the retention period starts on the day the report would have been due.
(2) Real property and equipment records. The retention period for real property and equipment records starts from the date of the disposition or replacement or transfer at the direction of the awarding agency.
(3) Records for income transactions after grant or subgrant support. In some cases grantees must report income after the period of grant support. Where there is such a requirement, the retention period for the records pertaining to the earning of the income starts from the end of the grantee's fiscal year in which the income is earned.
(4) Indirect cost rate proposals, cost allocations plans, etc. This paragraph applies to the following types of documents, and their supporting records: indirect cost rate computations or proposals, cost allocation plans, and any similar accounting computations of the rate at which a particular group of costs is chargeable (such as computer usage chargeback rates or composite fringe benefit rates).
(i) If submitted for negotiation. If the proposal, plan, or other computation is required to be submitted to the Federal Government (or to the grantee) to form the basis for negotiation of the rate, then the 3-year retention period for its supporting records starts from the date of such submission.
(ii) If not submitted for negotiation. If the proposal, plan, or other computation is not required to be submitted to the Federal Government (or to the grantee) for negotiation purposes, then the 3-year retention period for the proposal plan, or computation and its supporting records starts from end of the fiscal year (or other accounting period) covered by the proposal, plan, or other computation.