The Federal Department of Health and Human Services has developed regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. The regulations were first developed in 1995, and in 2011, the regulations were revised. These regulations describe the actions an individual and an organization must take to promote objectivity in PHS-funded research.

The regulations apply to all Public Health Service (PHS) (e.g., National Institutes of Health [NIH])-funded grants, cooperative agreements, and research contracts. The regulations are not applicable to Phase 1 Small Business Innovation Research or Small Business Technology Transfer applications and/or awards. This policy implements the regulatory requirements for ATTMOS Inc.

For the purpose of these policies and procedures the following definitions apply.

Financial Conflict of Interest (FCOI)

A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest

Anything of monetary value, whether or not the value is readily ascertainable.

Institutional Responsibilities

The professional activities an investigator performs on behalf of ATTMOS Inc. (e.g., administration, research, or consulting).

Investigator

The Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by award or proposed for such funding, which may include, for example, collaborators or consultants. ATTMOS Inc.'s Principal Investigator/Project Director, upon consideration of the individual's role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

Designated Individual

Hasan Metin Aktulga, who has been designated by ATTMOS Inc. to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests and identification of FCOIs per the regulatory criteria provided in 42 CFR 50.604(f) and as stated within this policy.

Research

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). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.

PHS

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).

NIH

The biomedical research agency of the PHS.

Senior/Key Personnel

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/NIH by the Institution. This term is defined only as it relates to the public accessibility requirements described under “Public Accessibility to Information Related to FCOI.”

Significant Financial Interest (SFI)

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 appear to be related to the Investigator's institutional responsibilities performed on behalf of ATTMOS Inc.:

• 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. 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.
• 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 spouse or dependent children) holds any equity interest.
• Intellectual property: A significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests (e.g., patents, copyrights).

The term significant financial interest does not include:

• Salary, royalties, or other remuneration paid by ATTMOS Inc. to the Investigator, including intellectual property rights assigned to ATTMOS Inc. and agreements to share in royalties related to such rights.
• Any ownership interest in ATTMOS Inc. held by the Investigator, since ATTMOS Inc. is a commercial or for-profit organization and such interest is excluded from the SFI definition per the regulation.
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions.
• Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the U.S., a U.S. Institution of higher education, an academic teaching hospital, a medical center, or an affiliated research institute.
• Income from service on advisory committees or review panels for such government agencies or educational institutions.

Reimbursed or Sponsored Travel

Investigators must disclose the occurrence of any foreign or domestic reimbursed or sponsored travel that exceeds $5,000 related to the Investigator's institutional responsibilities. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The disclosure requirement does not apply to travel reimbursed or sponsored by a federal, state, or local government agency located in the U.S., a U.S. Institution of higher education, an academic teaching hospital, a medical center, or an affiliated research institute.

Foreign Financial Interests

Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government, when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

At the time of application, the Principal Investigator and all other individuals who meet the definition of “Investigator” must disclose their SFIs to ATTMOS Inc.'s designated official. Any new Investigator who, after applying to NIH for funding or during the course of the research project, plans to participate in the project must similarly disclose their SFI(s) to the designated official promptly and prior to participation in the project.

Each Investigator who is participating in research under an NIH award must submit an updated disclosure of SFI at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to ATTMOS Inc. pursuant to this Policy or in a subsequent disclosure of SFI, and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

Each Investigator participating in PHS/NIH-funded research must submit an updated disclosure of SFI within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). In addition, Investigators must submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.

The designated official will conduct reviews of SFI disclosures. The designated official will review any SFI that has been identified in a disclosure; these interests will be compared to each PHS/NIH research application and/or award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the PHS/NIH-funded research and, if so, whether the SFI creates a FCOI related to that research award. The designated official is Hasan Metin Aktulga, member of ATTMOS Inc.'s board of directors, who can be contacted at hma@attmosdiscovery.com.

The designated official will determine whether an Investigator's SFI is related to the research under an NIH award and, if so, whether the SFI is a financial conflict of interest.

An Investigator's SFI is related to the research when the designated official reasonably determines the SFI:

• Could be affected by the PHS/NIH-funded research; or
• Is in an entity whose financial interest could be affected by the PHS/NIH-funded research.

The designated official may involve the Investigator in determining whether an SFI is related to the research supported by the award.

A financial conflict of interest exists when the designated official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. (“Significantly” means that the financial interest would have a material effect on the research.)

If a conflict of interest exists, the designated official will determine what management conditions and/or strategies will be put in place to manage the FCOI. Examples of conditions that might be imposed include, but are not limited to:

1. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to research personnel, to the Institutional Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.);
2. For research involving human subjects, disclosure of financial conflicts of interest directly to participants in the informed consent document;
3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the financial interest (e.g., sale of an equity interest);
7. Severance of relationships that create financial conflicts.

If the designated official determines that a conflict exists, it will communicate its determination and the means it has developed for managing the FCOI in writing to the individual, to the relevant Principal Investigator/Project Director, and to the appropriate direct supervisor.

No expenditures on an NIH award will be permitted until the Investigator has complied with the disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the Financial Conflict of Interest. The designated FCOI SO of ATTMOS Inc. will submit the FCOI report to NIH via the eRA Commons FCOI Module.

Prior to the expenditure of any funds under an NIH award, ATTMOS Inc. will ensure public accessibility by written response to any requestor within five business days of a request of information concerning any SFI disclosed that meets the following three criteria:

1. The SFI was disclosed and is still held by the senior/key personnel (PD/PI and any other person identified as senior/key personnel by ATTMOS Inc. in the award application, progress report, or any other report submitted to the NIH);
2. ATTMOS Inc. has determined that the SFI is related to the research funded through an award; and
3. ATTMOS Inc. has determined that the SFI is a financial conflict of interest.

The information made available will include, at a minimum:

• The Investigator's name;
• The Investigator's title and role with respect to the research project;
• The name of the entity in which the Significant Financial Interest is held;
• The nature of the Significant Financial Interest; and
• The approximate dollar value of the Significant Financial Interest (in specified ranges: $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 measures of fair market value.

If ATTMOS Inc. uses a publicly accessible website, the information will be updated at least annually and within sixty days of receipt or identification of information concerning any additional Significant Financial Interest of the senior/key personnel that had not been previously disclosed. Information will remain available for at least three years from the date it was most recently updated.

Prior to the expenditure of any funds under an award funded by NIH, ATTMOS Inc. will provide to NIH a FCOI report compliant with NIH regulations regarding any Investigator's Significant Financial Interest found to be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding management plan.

ATTMOS Inc. will assign an institutional official to serve as the FCOI SO within the eRA Commons FCOI Module. The FCOI SO has the authority to submit FCOI reports to the NIH. The FCOI Module User Guide is available at Financial Conflict of Interest User Guide (nih.gov).

While the award is ongoing (including any extensions with or without funds), ATTMOS Inc. will provide NIH with an annual FCOI report that addresses the status of the FCOI (i.e., an indication whether the FCOI is still being managed or if it no longer exists) and any changes in the management plan, if applicable.

For any Significant Financial Interest identified as conflicting subsequent to an initial FCOI report during an ongoing NIH-funded research project (e.g., a new SFI is identified for an Investigator who is participating in the NIH-funded research, upon the participation of an Investigator who is new to the research project, etc.), ATTMOS Inc. will provide to NIH within 60 days of identifying an FCOI, an FCOI report regarding the financial conflict of interest and ensure that ATTMOS Inc. has implemented a management plan and the Investigator has agreed to the relevant management plan.

The original (initial) FCOI report will include the information required in the regulation at 42 CFR Part 50.605(b)(3) or as outlined in NIH's FAQ H.5 at grants.nih.gov.

Each Investigator will be informed about ATTMOS Inc.'s Financial Conflict of Interest Policy and be trained on the Investigator's responsibility to disclose foreign and domestic SFIs per this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. FCOI training will occur prior to an Investigator engaging in PHS/NIH-funded research, at least every four years, and immediately when any of the following circumstances apply:

1. ATTMOS Inc. revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators;
2. An Investigator is new to ATTMOS Inc. research under an NIH award (training is to be completed prior to participation in the research); or
3. ATTMOS Inc. finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the designated official).

In fulfillment of the FCOI training requirement, ATTMOS Inc. requires its investigators to complete the National Institutes of Health's Financial Conflict of Interest tutorial located at: grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and expectations of this Policy. All investigators must print a certification of completion at the end of training and retain it for audit purposes.

When an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose a significant financial interest that is determined to constitute a FCOI, failure to review or manage such an FCOI, or failure by the Investigator to comply with a management plan, ATTMOS Inc. will within 120 days:

1. Complete a retrospective review of the Investigator's activities and the PHS/NIH-funded research project to determine whether any research conducted during the period of noncompliance was biased in the design, conduct, or reporting of research;
2. Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B).

If bias is found, ATTMOS Inc. shall notify NIH promptly and submit a mitigation report addressing the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. If bias is not found, no further action is required.

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Investigators who fail to comply are subject to discipline, including letters of reprimand, restriction on the use of funds, termination of employment, or disqualification from further participation in any PHS/NIH-funded research.

If HHS determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by ATTMOS Inc., ATTMOS Inc. shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

A subrecipient relationship is established when federal funds flow down from or through ATTMOS Inc. to another individual or entity, and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to ATTMOS Inc. for programmatic outcomes and compliance matters. Subrecipients, who include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to ATTMOS Inc.'s terms and conditions, and as such, ATTMOS Inc. will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the federal FCOI regulation at 42 CFR Part 50 Subpart F.

ATTMOS Inc. will incorporate, as part of a written agreement with the subrecipient, terms that establish whether ATTMOS Inc.'s FCOI Policy or that of the subrecipient's institution will apply to the subrecipient Investigator(s).

If the subrecipient's FCOI policy applies, the subrecipient institution will certify as part of the agreement with ATTMOS Inc. that its policy is in compliance with the federal FCOI regulation. In this situation, the agreement shall specify the time period for the subrecipient to report all identified FCOIs to ATTMOS Inc. in sufficient time to enable ATTMOS Inc. to provide timely FCOI reports, as necessary, to the PHS/NIH as required by the regulation (i.e., prior to the subrecipient's expenditure of funds and within 60 days of the subrecipient's identification of an FCOI during the period of an award). The ATTMOS Inc. assigned FCOI SO will submit the FCOI report (subrecipient report) to the NIH via the eRA Commons FCOI Module.

If the subrecipient cannot provide the certification of compliance with the FCOI regulation, the agreement shall state that the subrecipient Investigator is subject to ATTMOS Inc.'s FCOI Policy for disclosing SFI(s) that are directly related to the subrecipient's work for ATTMOS Inc. ATTMOS Inc. will require the submission of all Investigator disclosures of SFIs. The agreement will include sufficient time period(s) to enable ATTMOS Inc. to comply timely with its review, management, and reporting obligations under the regulation. When an FCOI is identified, ATTMOS Inc. will develop a management plan, monitor subrecipient Investigator compliance with the plan, and submit an FCOI report (subrecipient report) to the NIH through the eRA Commons FCOI Module for any FCOIs identified for a subrecipient Investigator.

ATTMOS Inc. will keep all records of all Investigator disclosures of financial interests and the Institution's review of, or response to, such disclosure (whether or not a disclosure resulted in the determination of a Financial Conflict of Interest), and all actions under the Institution's policy or retrospective review, if applicable. Records of financial disclosures and any resulting action will be maintained for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations. ATTMOS Inc. will retain records for each competitive segment as provided in the regulation.

• FCOI Regulation 42 CFR Part 50 Subpart F — Promoting Objectivity in Research
• FCOI Webpage at grants.nih.gov
• FCOI Training Webpage at grants.nih.gov
• FCOI FAQs at grants.nih.gov
• NIH Guide Notices Related to FCOI at grants.nih.gov
• Subscribe to the NIH Guide to Grants and Contracts
• NIH Grants Policy Statement Section 15.2 — Administrative and Other Requirements