FCOI Policy

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PURPOSE

Hemanext is committed to conducting honest, truthful, and reverent research activities, which are consistent with its Mission Statement. Hemanext assures objectivity of its research by maintaining that its Public Health Service (“PHS”), including the National Institutes of Health (“NIH) funded research is free from bias that may result from financial conflict of interest (“FCOI”). Persons conducting research and creative endeavors for, or on behalf of, Hemanext shall do so under the highest standards of ethical practices, and with utmost integrity. These persons shall keep timely, complete, thorough, and verifiable records, and shall preserve these records as required by applicable law, acknowledging that all records conducted on Hemanext’s behalf remain the property of the Hemanext Inc.

HEMANEXT’S MISSION STATEMENT

Hemanext is committing its resources to the continuing effort of the transfusion medicine community to save lives and improve patient outcomes. Our distinctive focus is on innovations in systems enabling blood collection, processing, storage and transfusion that will promote radical improvement in the quality, safety, efficacy and cost of transfusion therapies.

In pursuing our objectives, we will:

  • Honor the invaluable altruism of blood donors by enhancing the therapeutic value of the blood they donate
  • Deploy a team of outstanding science, bio-technology and business professionals dedicated to the well-being of the transfusion recipient and to achieving substantial, continuous improvement in patient outcomes and healthcare economics
  • Engage all constituents in the transfusion medicine community in sustained, productive, respectful dialogue and partnership
  • Demonstrate in all we do a commitment to excellence, impact and probity

We believe accomplishing our mission will generate extraordinary benefits for patients, their caregivers, medical professionals, our team and our investors, and will contribute to the achievement of new standards of excellence in the transfusion medicine industry worldwide.

SCOPE

This document applies to each employee or contractor who is planning to or participating in research activity that is supported by PHS/NIH funds. As of the effective date of this policy, each investigator, subrecipients, subgrantees and collaborators affiliated with Hemanext, Inc. (“Hemanext”), formerly known as New Health Sciences, Inc. (“NHSi”), by NIH or any other applicable grant or contract, shall follow applicable provisions of 41 C.F.R. Part 50 for grants and cooperative agreements and 45 C.F.R. Part 94 for contracts for research involving:

A person who, at the time of the alleged financial conflict of interest, was employed by, was an agent of, or was affiliated by contract or agreement with Hemanext or NHSi; and

  • PHS supported biomedical or behavioral research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information,
  • applications or proposals for PHS support for biomedical or behavioral research, research training or activities related to that research or research training, or,
  • includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in a grant, contract, cooperative agreement, or other form of PHS support.

TERMS & DEFINITIONS

eRA Commons FCOI module — The Electronic Research Administration (eRA) Commons is a Web-based system for applicants and institutions to participate in the electronic grant administration process. Commons provides a modular framework and infrastructure that allows National Institutes of Health (NIH) extramural grantee organizations, Operating Divisions (OPDIVs), grantees, and the public to conduct grant-related business with NIH.

HHS – The United States Department of Health and Human Services (HHS), also known as the Health Department, is a cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human service.
Institution – as used in this policy and procedure means Hemanext/NHSi as the grant awardee.

Key personnel include the PD/PI and any other personnel considered to be essential to work performance in accordance with HHS Acquisition Regulations subpart 352.242-70 and identified as key personnel in the contract proposal and contract.
Investigator — Investigator means 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 the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Management Plan – means a written document that the Institution will create to manage or take 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.

NIH – National Institutes of Health, which is an agency of HHS and is the Federal focal point for health research.

ORI – The Office of Research Integrity (ORI) oversees and directs PHS research integrity activities on behalf of the Secretary of HHS with the exception of the regulatory research integrity activities of the Food and Drug Administration.

PHS – Public Health Service (PHS) comprises all Agency Divisions of Health and Human Services (“HHS”) and the Commissioned Corps.

Research Integrity Officer (RIO) – individual having overall responsibility for enforcing & administering this policy & procedure. Refer to Responsibilities Section for specific role & responsibilities details.

Significant Financial Interest (SFI) – is defined by applicable regulations as:
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:
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;

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

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 (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. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) 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.

The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Hemanext/NHSi to the investigator if the investigator is currently employed or otherwise appointed by Hemanext/NHSi, 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.

RESPONSIBILITIES

It is the responsibility of all Hemanext employees, including contract employees, involved with research activities, to comply with the requirements of this procedure.

All employees should report any observed, suspected, or apparent FCOI to the RIO, or a member of Hemanext’s Executive Team. If an individual is unsure whether a suspected incident falls within the definition of FCOI, he or she may meet with, or contact, the RIO, or Human Resources, to discuss the suspected FCOI, which may include discussing it anonymously and/or hypothetically.

At any time, any employee may have confidential discussions with their supervisor, or Human Resources about concerns of FCOI.

Research Integrity Officer (RIO) – Hemanext’s legal representative will serve as the RIO and will have primary responsibility for implementation of the institution’s policies and procedures on FCOI and research misconduct.

The RIO is responsible for:

  • Consulting confidentially with persons who are uncertain about whether to submit an allegation of FCOI;
  • Receiving allegations of FCOI;
  • Assessing each allegation of FCOI to determine whether it falls within the definition of FCOI and significant financial interest;
  • Taking interim action and notifying NIH CI as warranted.
  • Notifying and making reports to NIH CI as may be required by 45 CFR Part 94;
  • Maintaining records of the FCOI as may be required by 45 C.F.R. Part 94.

When the Institution determines that an FCOI exists, the Institution must report to the NIH awarding IC, which is the NIH organizational component responsible for a particular grant program or set of activities, through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module. The initial FCOI report will include the following information:

Grant number and PD/PI or Contact PD/PI if the grant is awarded under the multiple PI model;
Name of Investigator (if different from the PD/PI) with the FCOI;
Name of the entity with which the Investigator has an FCOI;
Nature of the FCOI (e.g., consulting fees, honoraria, paid authorship, equity interest, intellectual property rights and interests, and reimbursed or sponsored travel);
Value of the financial interest $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 a value cannot be readily determined;
A description how the financial interest relates to the NIH-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research; and
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.
The annual FCOI report must be submitted to the NIH through the eRA Commons FCOI Module each year within a competitive segment or until the Institution reports that the FCOI no longer exists. The annual FCOI report will include the following information:
Status of the FCOI

Changes to the management plan, if applicable
The Institution will incorporate, as part of a written agreement with a subrecipient, terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements. Subrecipient Institutions who rely on their FCOI policy must report identified Financial Conflicts of Interest to Hemanext/NHSi as the awardee Institution in sufficient time to allow it to report the FCOI to the NIH to meet its reporting obligations.
Hemanext will make certain information available concerning identified FCOI held by Key personnel as defined in the regulation via a publicly accessible Web site or by a written response to any requestor within five business days of a request and update such information as specified in the regulation.

PROCEDURE

RIO will review all disclosure forms and evaluate for findings of FCOI. If no FCOI is found, the disclosure form will be maintained in the company files within Medical Affairs and maintained by the Medical Information Specialist.
Based on the FCOI Management Plan, the Institution will include an FCOI on an FCOI report which will be submitted to the eRA Commons FCOI module before additional expenditure of funds under the Notice of Award.
Any interests identified as conflicting subsequent to the initial FCOI report will be reported to NIH CI within 60 days of such identification through the eRA Commons FCOI module.
Each investigator subject to this policy and procedure shall submit an updated disclosure of an SFI at least annually.
Should a PHS/NIH funded project be conducted by an investigator with a conflict not previously disclosed or managed by a Management Plan, Institution will disclose the conflict in each public presentation related to the results of the research.

TRAINING ON FCOI

PHS/NIH funded Investigators subject to this policy and procedure shall undergo required training on this policy and procedure and PHS/NIH FCOI regulations, including:
When a new employee joins Institution and will work on a NIH grant award, training will be mandatory before such work is begun and at least once every four years.
Whenever Institution changes the FCOI policy; and,
Whenever Institution may identify an Investigator who is subject to this policy and procedure who is not adhering to the FCOI policy and procedure or a Management Plan created under the policy and procedure.

NON-PERFORMANCE

Noncompliance by an investigator subject to this policy and procedure within 120 days shall result in retrospective review of investigator’s activities for the presence of bias.
Upon a finding of bias, Institution shall prepare a Management Plan, including a requirement that investigator will disclose the conflict in each public presentation related to the results of the research and submit a report to NIH CI.