The Kathmandu Research Institute for Biological Sciences (KRIBS) is a non-profit research organization located in Lalitpur, Nepal. The institute is dedicated to conducting research in the field of biological sciences with a particular focus on public health.

KRIBS was established with the aim of promoting scientific research in Nepal and addressing the challenges faced by the country in the field of public health. The institute focuses on research areas such as infectious diseases and immunology, and anti-microbial. It is registered in District Administration Office, Lalitpur, Nepal with registration no. 4512/073 and Social Welfare Council Nepal with affiliation no. 45260.

The researchers at KRIBS conduct both basic and applied research, including laboratory-based research and field studies. The institute has state-of-the-art research facilities, including a biosafety level 2 (BSL-2) laboratory. One of the key objectives of KRIBS is to build research capacity in Nepal by providing training opportunities for young researchers and collaborating with other research institutions both in Nepal and internationally. The institute also works closely with government agencies, non-governmental organizations, and other stakeholders to translate research findings into policy and practice.

Founding members

Amina Baniya

Anurag Adhikari

Ashmita Timilsina

Binod G.C

Binod Rayamajhee

Daisy Awale

Manjula Bhattarai

Minu Singh

Nardip Ghimire

Nim Raj Sapkota

Sagar Aryal

Sushma Singh

Financial Conflict of Interest Policy

PURPOSE

1.1. This Financial Conflict of Interest Policy (“Policy”) outlines the legal obligations for Investigators to disclose potential Financial Conflicts of Interest (FCOI). The purpose of this Policy is to comply with relevant laws and to ensure the integrity of research conducted by KRIBS and its subsidiaries (“the Company”), including their employees, contractors, and consultants.

This Policy mandates that all Investigators, subrecipients, subgrantees, and collaborators affiliated with the Company on projects funded by any Funding Agency comply with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). The Company is committed to complying with these regulations for all other Federal Agency grants and contracts, with appropriate adjustments.

SCOPE

2.1. This Policy applies to Investigators involved in applying for and conducting research funded to KRIBS. Investigators are required to disclose significant financial interests related to their institutional responsibilities. Investigators include all individuals, regardless of title or position, responsible for the design, conduct, or reporting of research proposed for funding, as well as collaborators or consultants. This Policy provides a framework for identifying, evaluating, and managing real, apparent, and potential conflicts of interest.

RESPONSIBILITIES

3.1. Investigator: Responsible for reporting Significant Financial Interests (SFI) Disclosures as outlined in Section 6.2.1 and for completing training on this Policy as specified in Section 6.

3.2. Policy Coordinator: Responsible for reviewing each SFI Disclosure and determining if any disclosed SFI constitutes an FCOI, as detailed in Section 6.2.2.

3.3. The Company: Responsible for reporting FCOIs in accordance with Section 6.2.2.

REFERENCES

4.1. Regulatory

– 4.1.1. Code of Federal Regulations, Title 42, Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought (42 CFR Part 50, Subpart F)

– 4.1.2. Code of Federal Regulations, Title 45, Part 94, Responsible Prospective Contractors (45 CFR Part 94)

DEFINITIONS AND ABBREVIATIONS

5.1. Definitions

5.1.1. Financial Conflict of Interest (FCOI): Exists when KRIBS reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of Funded Research.

5.1.2. Funded Research: Any research funded by a Funding Agency.

5.1.3. Investigator: Any person (including subrecipients, subgrantees, and collaborators) responsible for the design, conduct, or reporting of Funded Research.

5.1.4. Management (of an FCOI): Actions taken to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of Funded Research are free from bias.

5.1.5. Policy Coordinator: The FCOI Policy Coordinator for KRIBS.

5.1.6. Significant Financial Interest (SFI):A financial interest of the Investigator, including those of the Investigator’s spouse and dependent children, that reasonably appears to be related to the Investigator’s institutional responsibilities.

5.1.7. SFI Disclosure: A report that each Investigator must submit to the Policy Coordinator (a) at the time of application for Funded Research and prior to the expenditure of any Funding Agency funds; (b) annually thereafter; (c) in the event of certain sponsored travel; and (d) within thirty (30) days of discovering or acquiring any SFI.

5.2. Abbreviations

5.2.1. CFR: Code of Federal Regulations

5.2.2. FCOI: Financial Conflict of Interest

5.2.4. SFI: Significant Financial Interest

5.2.5. USC: United States Code

PROCEDURE

6.1. Determination of a Significant Financial Interest (SFI)

6.1.1. What is an SFI?

6.1.1.1. For any publicly traded entity, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity, subject to the Exemptions defined below, as of the date of disclosure, when aggregated, exceeds NRs. 500,000.00.

6.1.1.2. For any privately held company, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure, when aggregated, exceeds NRs. 500,000.00, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options, or other ownership interest).

6.1.1.3. For purposes of defining an SFI, remuneration includes, subject to the Exemptions defined below, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); and equity interest includes stock, stock options, or other ownership interest, as valued through reference to the public trading price or other reasonable measures of fair market value.

6.1.1.4. An SFI exists, subject to the Exemptions defined below, with respect to intellectual property rights and interests (e.g., patents, trademarks, copyrights) upon receipt of (or right to receive) any income or other value related to such intellectual property rights and interests.

6.1.1.5. Investigators must disclose (and such disclosure shall constitute an SFI Disclosure) any reimbursed or sponsored travel (i.e., travel 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. However, 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, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure, the Policy Coordinator will determine if further information is needed, including a determination or disclosure of monetary value, to determine whether the travel constitutes a FCOI.

6.1.2. Exemptions: What is not an SFI?

6.1.2.1. An SFI does not include the following types of financial interests:

6.1.2.1.1. Salaries, royalties, or other remuneration paid by KRIBS to the Investigator if the Investigator is currently employed or otherwise appointed by KRIBS, including with respect to intellectual property rights assigned to KRIBS and agreements to share in royalties related to such rights;

6.1.2.1.2. Any ownership interest in KRIBS held by the Investigator;

6.1.2.1.3. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made by these vehicles;

6.1.2.1.4. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education; or

6.1.2.1.5. Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

6.2. SFI Disclosures and Reporting Process

6.2.1. Each Investigator shall submit SFI Disclosures to the Policy Coordinator as follows:

6.2.1.1. At the time of hire or engagement with KRIBS regarding any Funded Research on which they will be working;

6.2.1.2. At the time of application for Funded Research on which they will be working and prior to the expenditure of any Funding Agency funds;

6.2.1.3. Annually, on or before the anniversary date of the Investigator’s initial SFI Disclosure;

6.2.1.4. Promptly, in the event of certain sponsored travel, as outlined above; and

6.2.1.5. Within thirty (30) days of the discovery or acquisition of any SFI by the Investigator.

6.2.2. The Policy Coordinator will review each SFI Disclosure and evaluate whether it has resulted in an FCOI. If no FCOI is found, the SFI Disclosure will be filed with the Policy Coordinator’s records. If an FCOI is identified, it will be included in KRIBS’s FCOI report submitted (or, where KRIBS is a sub-grantee or sub-awardee, then KRIBS will report the FCOI as required under the applicable subgrant or subaward agreement) prior to the expenditure of any Funding Agency funds. KRIBS will report any newly identified FCOIs to the applicable Funding Agency within 60 days of KRIBS’s determination and implement, at least on an interim basis, a management plan specifying the actions taken to manage the FCOI. If an Investigator with an FCOI conducts any Funded Research, KRIBS shall disclose the FCOI in each public presentation related to the results of the Funded Research. KRIBS will also provide an annual progress report on the status of an FCOI and any changes to the management plan.

6.3. Training

6.3.1. All Investigators are required to complete training related to this Policy and applicable laws as follows:

6.3.1.1. Upon joining KRIBS;

6.3.1.2. Prior to engaging in Funded Research;

6.3.1.3. At least once every four years;

6.3.1.4. In the event of any modifications to this Policy that affect an Investigator’s obligations under it; and

6.3.1.5. In the event KRIBS determines that an Investigator is not in compliance with this Policy or any FCOI management plan. NIH web-based training can be accessed through the NIH website at [NIH FCOI Tutorial](https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html), and participants are required to provide KRIBS with proof of completion.

6.4. Public Disclosure and Records Management

6.4.1. This policy will be publicly available on KRIBS’s website at [KRIBS Website]( https://kribs.org.np/aims-and-objectives/ ), and certain information regarding FCOIs will be available within five days of a qualified written request. KRIBS will maintain records of all SFI disclosures, and records of.

6.5. Compliance and Penalties for Non-Performance

6.5.1. Within 120 days of any determination by the Company that an Investigator has failed to comply with this Policy, the Company shall complete a retrospective review of such Investigator’s activities to determine the possibility of any bias in such Investigator’s research activities. If the Company determines that there has been any such bias, the Company shall submit a mitigation report to the applicable Funding Agency, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the Funded Research and the actions the Company has taken to mitigate the bias and manage the FCOI. The Company will work with the Investigator to establish an FCOI management plan, and the Investigator shall disclose the FCOI in each public presentation related to the results of the applicable Funded Research if not previously disclosed.