We provide Clinical Decision Support for

Accurate decision support empowers the public to better understand medical conditions they are concerned about and make informed medical decisions about seeking care.

Providing accurate information to patients is an evidence-based approach that increases patient engagement in their care and improves patient satisfaction.

Giving care providers accurate tools to understand a patient’s condition improves care and decreases healthcare costs.


Partners

We are proud to work with a wide variety of public, private, and academic partners to improve the lives of the populations we serve.

Partners

We are proud to work with a wide variety of public, private, and academic partners to improve the lives of the populations we serve.

Applications

We have several mobile CDS applications under development, with more coming soon! Reach out to partner with us on one.


Contact

We would love to talk with users of our products and potential partners about how to help people make more informed healthcare choices.

Get to know our work

Why we are here

FTHR Group was founded in 2024 as a logical extension of the work we had been doing to lead CDC’s COVID-19 Self Checker forward triage tool and the agency’s telehealth unit during the pandemic. The Self Checker had more than 21 million conversations with users during its two years of operation. Its companion program, CDC’s vSafe post-vaccine checker, has had more than 200 million interactions, all with around four staff. These programs remain some of the most highly visited websites in the CDC’s history and some of the most widely used forward triage/symptom monitoring applications in the U.S. during the pandemic. These applications and similar work signaled a new era of patient- and public-facing clinical decision support (CDS) applications that can now build upon a substantial evidence base of using clinician-focused CDS in healthcare systems.

Where we work

Enhanced public awareness of CDS applications and success in deploying them will continue to catalyze the use of public- and patient-facing CDS applications. These will help users identify (and potentially address) medical issues before or while they seek further care, direct them to the most appropriate care, and reduce unnecessary costs in the fractured and high-friction U.S. healthcare system. In addition, advances in technology will allow first-entry healthcare providers (e.g., emergency service personnel and nursing staff) to use CDS to better assess patients and implement evidence-based approaches earlier in the healthcare process. These interventions will further improve health outcomes, quality of patient care, and overall patient satisfaction. The low use of physician and mid-level provider CDS, as well as variable accuracy of symptom checkers that attempt to diagnose a broad range of conditions, provides opportunities for FTHR Group to develop accurate, condition-specific applications with evidence-based interventions or guidance for the public, patients, healthcare systems, and healthcare payers.

Measuring success

FTHR Group will build on its experience to develop, implement, evaluate, and manage public-, patient-, and first-entry healthcare provider-driven CDS. Our success will be measured by users of institutionally-associated or individual CDS applications that provide accurate information to empower them to make informed healthcare decisions. These tools will increase user satisfaction and reduce costs associated with unnecessary care, improving the health of these populations and saving the precious time of both patients and providers.

FAQs

Common Questions

Navigating the gap between "Home Care" and "Health Care"

Should I go to the ER for chest congestion?
Not always. While chest congestion can be alarming, it is often viral or manageable at home. FTHR Group's tools evaluate the context of your symptoms—like oxygen levels and duration—to distinguish between uncomfortable congestion and dangerous respiratory distress, saving you unnecessary trips to the hospital.
Is my fever high enough for emergency care?
The number on the thermometer is only part of the story. A high fever in a toddler is different than one in a senior. Our "Forward Triage" algorithms consider age, vaccination status, and other vital signs to tell you exactly when a fever requires a doctor and when it can be managed with rest and hydration.
How is this different from Googling my symptoms?
Search engines provide possibilities (often showing you the worst-case scenario). FTHR Group provides probabilities based on clinical evidence. We use the same triage protocols used by healthcare systems to give you a definitive "Next Step," rather than a list of scary diseases.
Can I use FTHR for pediatric questions?
Yes. Pediatric triage requires specific protocols. Our systems are designed to ask age-appropriate questions for children, helping parents differentiate between a common playground virus and a condition that needs urgent pediatric care.
What is "Forward Triage"?
Forward Triage is the process of assessing a patient's condition before they leave their house. Instead of driving to an ER to find out you're okay, our technology acts as a "digital front door," checking your symptoms first and routing you to the right care—whether that's a telehealth call, a pharmacy, or the emergency room.
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Didn't find the answer you were looking for?

We are happy to walk you through our protocols and technology personally.

Get to know our staff

Tony Neri

MD, MPH, FACPM, Lean / Six Sigma Blackbelt, Captain USPHS (Ret.)
Founder and Chief Executive Officer

Tony Neri

MD, MPH, FACPM, Lean / Six Sigma Blackbelt, Captain USPHS (Ret.)
Founder and Chief Executive Officer

Tony has more than 30 years of experience in medicine and population health. A bachelors degree in microbiology with work in recombinant gene therapeutics led to medical school in Chicago. He then led several high-impact domestic and international public health programs during a 20-year career at the U.S. Centers for Disease Control and Prevention (CDC). His career highlights at CDC included being the Director of CDC’s Preventive Medicine Residency and Fellowship, helping to lead CDC’s telehealth and COVID-19 Self Checker programs, and serving as the Chief Data Scientist and Acting Division Director at CDC’s Division of Environmental Health Science and Practice. He maintains board certifications in Public Health and General Preventive Medicine as well as Clinical Informatics.Tony contributes to national efforts as a board member of the ACGME Preventive Medicine Review Committee and as a member of many AMIA workgroups. Since the early 1990’s he has maintained his medical skills by working in both professional and volunteer emergency service organizations. He has been the physician for the Georgia Department of Natural Resources’ prescribed fire program since 2012. He continues his service as an Eagle Scout by helping to lead the local Cub Scout troop.

Vlad Schorstein

MD, MPH
Director of User Engagement

Vlad Schorstein

MD, MPH
Director of User Engagement

Vlad’s journey to the field of public health began with a bachelor’s degree in biology from Oglethorpe University. That interest in bioscience led to earning an M.D. from Spartan Health Sciences University School of Medicine and ultimately a Master of Public Health from Mercer University.He then became involved in addressing Georgia’s opioid crisis, first as a graduate intern with the Georgia Department of Public Health’s Opioid and Prescription Drug Misuse and Overdose Project, and then as the Prescription Drug Monitoring Program Integration Coordinator for the state. This role allowed him to develop and strengthen partnerships with healthcare payers, providers, and patient groups across the state to facilitate clinical workflows and improve patient outcomes.He eventually transitioned to the Centers for Disease Control and Prevention (CDC) and managed a portfolio of states participating in the Overdose Data to Action in States program.His career goals center around finding innovative solutions to address a nationwide physician shortage, disparities in healthcare delivery, and gaps between clinical medicine and population health.


Ready to reach out?

Join us to explore how our products and partnerships can lead to more informed healthcare choices for individuals.

Let's get in touch!

We would love to talk with users of our products and potential partners about how to help people make more informed healthcare choices.

Privacy policy

At Forward Triage Healthcare Resources Group (FTHR Group), we take your privacy seriously. This Privacy Policy explains how we collect, use, and disclose your personal data when you access or use our Services.By using our Services in any manner, you acknowledge and accept the practices described below. Your use of our Services is also subject to our Terms of Use, which incorporates this Privacy Policy.We may update this Policy from time to time and will notify you of material changes via our website, email, or other means. Continued use of the Services after any changes constitutes your agreement to the updated Policy.

What We Collect

Profile & Contact Data
Name, email, phone number, unique identifiers.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Business Partners, Authorized Parties.
---Identifiers
Year of birth, zip code, race/ethnicity, gender, medical conditions.
Used for: Providing and improving the Services.
Shared with: Service Providers.
---Payment Data
Name, financial account info, card type, last 4 digits, billing address.
Used for: Processing transactions.
Shared with: Payment processing Service Providers only.
---Commercial Data
Purchase history on FTHR Group platforms.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers.
---Device & IP Data
IP address, device ID, browser type, operating system.
Used for: Providing and improving the Services.
Shared with: Service Providers, Analytics Partners.
---API Usage Data
API calls and user interface interactions.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Business Partners, Authorized Parties.
---Web Analytics
Page interactions, referral sources, session statistics.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Business Partners, Authorized Parties.
---Social Network Data
Email, username, IP address, device ID from linked social accounts.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Analytics Partners, Business Partners, Authorized Parties.
---Professional & Employment Data
Job title, research objectives, employer affiliation.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Business Partners, Authorized Parties.
---Geolocation Data
IP-address-based location information.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Business Partners, Authorized Parties.
---Special Categories of Data
Government-issued ID numbers (SSN, driver's license, passport, state ID).
Used for: Services, correspondence, and marketing.
Shared with: Service Providers, Business Partners, Authorized Parties.
---Other Identifying Information
Emails, letters, texts, or communications you send us.
Used for: Services, marketing, and correspondence.
Shared with: Service Providers, Advertising Partners, Business Partners, Authorized Parties.

Why We Collect Your Data

Providing, Customizing & Improving Services
- Creating and managing your account
- Processing orders, transactions, and billing
- Providing requested products, services, or information
- Improving the Services through testing, research, and analytics
- Personalizing your experience
- Verifying your identity (KYC)
- Fraud protection, security, and debugging
Marketing
- Marketing and selling our Services
Correspondence
- Responding to your inquiries and requests
- Sending communications based on your preferences
Legal & Compliance
- Meeting legal obligations and court orders
- Preventing and investigating illegal activity
- Protecting the rights, property, or safety of users or FTHR Group
- Enforcing our agreements and resolving disputes
We will not use your data for materially different purposes without providing notice or obtaining your consent.

How We Share Your Data

Service Providers
Technology, hosting, analytics, security, customer support, fulfillment, and payment processors. Our payment partner collects card data directly — please review their privacy policy for details.
Advertising Partners
Ad networks, data brokers, and marketing providers who help us reach you with relevant offers.
Analytics Partners
Companies that track how users find and interact with our Services.
Business Partners
Businesses we collaborate with to offer joint services or promotions.
Parties You Authorize
Third-party services, social media platforms, or other users you connect with through our Services.
Legal Authorities
Government agencies or law enforcement when required by law or legal process.
Business Transfers
In the event of a merger, acquisition, or bankruptcy, your data may be transferred to a successor entity.
Anonymized Data
We may create de-identified or aggregated data for lawful business and research purposes. This data will not identify you personally.

Cookies & Tracking

We use cookies and similar technologies (pixel tags, web beacons, JavaScript) to recognize your browser, understand usage patterns, and improve our Services.Types of Cookies We UseEssential Cookies — Required to provide features you've requested, such as secure login. Disabling these may limit access to certain Services.Performance & Analytical Cookies — Help us understand how visitors use our Services, including page views and session length. Google Analytics is one tool we use. You may opt out at google.com/privacy_ads.html or via the Google Analytics Opt-out Add-on.Session Replay Technology
We may use session replay tools to identify issues and improve the user experience. By continuing to use our Services, you consent to this use. You may adjust settings through your browser's cookie management tools.
Managing Your Cookies
You can control or delete cookies through your browser settings. Note that disabling cookies may impact Service functionality. Learn more at allaboutcookies.org or ico.org.uk.
Our Services do not currently support "Do Not Track" browser requests.

Data Security & Retention

Security
We use physical, technical, organizational, and administrative safeguards to protect your data. You can help protect your account by using a strong password, limiting device access, and signing out when finished. No data transmission or storage method is completely secure.
Retention
We retain your data as long as necessary to provide Services or meet legal obligations:
- Profile & credentials — For as long as you have an account
- Payment data — For as long as needed to process your transaction
- Device/IP data — For as long as needed to maintain system performance
- API usage data — Per our responsible development framework
Data may also be retained in anonymized or aggregated form after your relationship with us ends.Children's Privacy
We do not knowingly collect data from individuals under 18. If you believe a minor has provided us with data, contact us immediately at [email protected] and we will delete it promptly.

Your Privacy Rights

California Residents
Under California Civil Code §§ 1798.83–1798.84, you may request that we not share your data with third parties for their direct marketing purposes. Contact us at [email protected] to submit a request.
Nevada Residents
We do not sell personal data as defined under Nevada Revised Statutes Chapter 603A.
EU, UK & EEA Residents (GDPR)
If you reside in the EU, UK, Liechtenstein, Norway, or Iceland, you have the following rights:
- Access — Request a copy of the data we hold about you
- Rectification — Request corrections to inaccurate or incomplete data
- Erasure — Request deletion of some or all of your data
- Withdrawal of Consent — Withdraw consent where processing is consent-based
- Portability — Receive your data in a machine-readable format
- Objection — Object to use of your data for direct marketing or other purposes
- Restriction — Ask us to limit how we process your data
- File a Complaint — Lodge a complaint with your national supervisory authority (edpb.europa.eu)
To exercise any of these rights, contact us at [email protected]. We may need to verify your identity before processing your request.Data Transfers
Our Services are hosted in the United States. By using our Services, you authorize the transfer and processing of your data in the U.S., which may have different data protection laws than your country of residence.

Contact

Questions About This Policy?Email: [email protected]
Website: www.fthrgroup.com
FTHR Group, LLC

Financial Conflict of Interest (FCOI) Policy

Effective: June 1, 2026

1) Introduction

The purpose of this policy is to ensure that research funded by the National Institutes of Health (NIH) is designed, conducted, and reported objectively and without bias resulting from Investigator financial conflicts of interest (FCOI). The 2011 revised regulations are 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible Prospective Contractors”, which set requirements for promoting objectivity in Public Health Service (PHS)–funded research for grants, cooperative agreement, and research contracts, respectively. The regulations do not apply to SBIR or STTR Phase I applications or awards. This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements.Forward Triage Healthcare Resources Group, LLC (“FTHR Group”, “The Institution”) adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research. It establishes processes to identify, disclose, and manage Investigator financial conflicts of interest to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH-supported research.

2) Applicability

This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the NIH. This policy applies to individuals who meet the regulatory definition of “Investigator” (as defined below) who are planning to participate in or who participate in PHS/NIH-funded research.

3) Definitions

For the purpose of these policies and procedures, the following definitions apply:Financial Conflict Of Interest (FCOI)
A significant financial interest that is related to the PHS/NIH- funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
Financial Interest
Anything of monetary value, whether or not its value is readily ascertainable.
Institutional Responsibilities
The professional responsibilities of an Investigator on behalf of FTHR Group, which may include activities such as research, research consultation and collaboration, product development, product testing and validation, development of datasets, models, or systems, publication and communication of research results, and other professional services performed on behalf of FTHR Group.
Designated Official (DO)
The individual appointed by FTHR Group to solicit and review disclosures of significant financial interests, determine FCOIs in accordance with 42 CFR 50.604(f) and this policy, and develop management plans for identified FCOI.
Institution
Any public or private organization, domestic or foreign (excluding a federal agency) that is applying for or receives PHS/NIH research funding.
Investigator
The Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH or proposed for such funding, which may include, for example, collaborators or consultants. The Institution determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research. The Institution will consider the individual’s role, rather than the title (e.g., senior/key personnel, faculty, MD, PHD, etc.), of those individuals involved in the research and the degree of independence in carrying out the work when determining who is responsible for the design, conduct, or reporting of the PHS/NIH-funded research. Institutional responsibilities mean an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include activities such as: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
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.
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 the regulation, 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.
PHS-Funded Research
Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract; whether funded 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 within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge.
Senior/Key Personnel
The PD/PI and any other individual identified as senior/key personnel by the Institution in a grant application, progress report, or other submission to PHS/NIH. For this policy, the term applies specifically to the public accessibility requirement, which mandates disclosure only of financial conflicts of interest held by these senior/key personnel, as described in Section 9.
Significant Financial Interest (SFI)

  1. A domestic or foreign financial interest consisting of one or more of the interests of the Investigator, and those of the Investigator’s spouse, domestic partner, and dependent children, that reasonably appears to be related to the Investigator’s institutional responsibilities performed on behalf of FTHR Group, and that consists of one or more of the following:

  1. Investigators must disclose any reimbursed or sponsored travel in excess of $5,000 related to their institutional responsibilities. Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact cost may not be known. The disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip.

The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

  • A federal, state, or local government agency located in the United States,

  • A United States Institution of Higher Education,

  • An academic teaching hospital,

  • A medical center, or

  • A research institute affiliated with a United States Institution of Higher Education

  1. The term “significant financial interest” does not include, and therefore investigators are not required to disclose, the following types of financial interests:

  • Salary, royalties, or other remuneration paid by FTHR Group to the Investigator if the Investigator is currently employed or otherwise appointed by FTHR Group, including intellectual property rights assigned to FTHR Group and any agreements to share royalties related to those rights.

  • Any ownership interest in FTHR Group held by the Investigator, since FTHR Group is a commercial or for-profit organization. This exclusion applies only if the applicant or recipient (including a sub- recipient) is a for-profit or commercial institution.

  • Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions for those vehicles.

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

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

Foreign Financial Interests
Investigators must disclose all financial interests originating outside the United States, including income from seminars, lectures, teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel received from any foreign entity. This includes foreign institutions of higher education and foreign governments (including local or provincial governments). Disclosure is required when the aggregated amount of such income meets the threshold for disclosure (e.g., income in excess of $5,000).

4) Significant Financial Interst (SFI) Disclosure Requirements

Investigators will disclose their SFIs that are related to their “institutional responsibilities” as defined in the policy.The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the 2011 regulation.The Investigator SFI Disclosures will be retained by the Institution as part of the record maintenance requirements.Investigators are required to disclose SFIs at the following times:

  1. At the time of application: The PI and all other individuals who meet the definition of “Investigator” must disclose their SFIs to the DO. Any new Investigator who joins the project after the NIH application has been submitted or during the course of the research must also disclose their SFIs to the DO promptly and before participating in the project, using the SFI Disclosure Form.

  2. Annual disclosure during the award: Each Investigator participating in research under an NIH award must submit an updated SFI disclosure at least annually (on or before January 1 or as otherwise designated by the DO) during the award period. The annual disclosure must include: (1) any new information that was not previously disclosed to the DO under this policy, including SFIs associated with NIH-funded projects transferred from another institution; and (2) updated details for any previously disclosed SFI, such as changes in the value of an equity interest.

  3. Ad-hoc based during the award: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

5) Review of SFI Disclosures

The FTHR Group Chief Executive Officer or their designee serves as the Designated Official (DO) responsible for reviewing all SFI disclosures. In cases where the DO has a disclosed SFI related to the research under review, or where additional independence is warranted, the DO will recuse themselves from the review and determination. In such cases, an alternate qualified designee or external advisor may be appointed to perform the review. The use of such alternative review arrangements will be documented.Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible for the design, conduct, or reporting of research, to determine whether the SFI is related to the funded research and, if so, whether it constitutes a Financial Conflict of Interest (FCOI).The SFI disclosures will be reviewed as described below:

  1. Prior to the issuance of a new award or before any expenditure of any awarded funds (e.g., during a Just-in-Time stage): The DO will review the Investigator’s SFIs before NIH issues a new award. If an FCOI is identified, an FCOI report will be submitted to NIH via the eRA Commons FCOI Module prior to any expenditure of funds.

  2. Annual SFI disclosure: As part of the annual disclosure process, Investigators must provide updated information on any previously disclosed SFIs (e.g., revised value of an equity interest). The DO will review these updates to determine whether changes to an existing management plan are needed. Any modifications will be reflected in the next Annual FCOI report submitted to NIH, if applicable.

  3. Ad hoc basis during award period: If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days:

  1. Review the disclosure;

  2. Determine whether the SFI is related to the PHS/NIH-funded research;

  3. Determine whether an FCOI exists; and, if so,

  4. Implement, on at least an interim basis, a management plan.

An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.

6) Relatedness of SFIs to PHS/NIH-Funded Research and FCOI

The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute a FCOI.Relatedness Test: The DO determines whether an Investigator’s SFI is related to research under an NIH award. An SFI is considered “related” when the DO reasonably determines that:

  1. The SFI could be affected by the PHS/NIH-funded research, or

  2. The SFI is in an entity whose financial interests could be affected by the PHS/NIH funded research.

Investigator involvement: The DO may consult with the Investigator when assessing whether an SFI is related to the research.Designated Official FCOI Determination: An FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH- funded research (“significantly” meaning that the financial interest would have a material effect on the research).

7) Management of SFIs that Pose an FCOI

When an FCOI is identified, the DO will determine and implement management strategies to ensure the research is conducted objectively. Examples of management conditions include, but are not limited to:

  1. Public disclosure of the FCOI (e.g., in publications or presentations, to study personnel, to the Institutional Review Board (IRB), to the Institutional Animal Care and Use Committee (IACUC), or a Data Safety Monitoring Board (DSMB)). While public posting of FCOIs is required only for senior/key personnel, the DO may require disclosure of any Investigator’s FCOI as a condition of a management plan.

  2. For human subjects research, disclosure of the FCOI to participants in the informed consent document

  3. Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research

  4. Modification of the research plan

  5. Change of personnel roles or removal from portions of the research

  6. Reduction or elimination of the financial interest (e.g., divesting equity)

  7. Severance of relationships creating the conflict

The DO will communicate the determination and the management plan in writing to the Investigator and the appropriate supervisor.No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DO will submit an FCOI report to NIH via the eRA Commons FCOI Module.In addition to FCOI, FTHR Group recognizes that certain financial interests at the institutional level, including company equity, intellectual property interests, or financial relationships of senior leadership, may present potential conflicts related to PHS/NIH-funded research. Such interests will be evaluated and managed as appropriate to ensure the objectivity of the research.

8) Monitoring Investigator Compliance

The FTHR Group DO will monitor Investigator compliance with the management plan for the duration of the NIH award.FCOIs are made in publications, presentations, and other communications. Investigators must also disclose the FCOI in writing to study personnel and provide a copy of this disclosure to the DO for recordkeeping.

9) Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

FCOI Policy: A copy of this FCOI policy is available on FTHR Group’s public website as required by Section 4.1.10 Financial Conflict of Interest of the NIH Grants Policy Statement.Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH award FTHR Group will ensure public accessibility by providing a written response within five business days to requests for information about any SFI that meets all three of the following criteria:

  1. The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and any other individual identified by FTHR Group as senior/key personnel in the application, progress report, or other NIH submission).

  2. FTHR Group has determined that the SFI is related to the PHS/NIH-funded research.

  3. FTHR Group has determined that the SFI constitutes an FCOI.

When applicable, FTHR Group will make available at least the following information:

  1. Investigator’s name

  2. Investigator’s title and role with respect to the research project

  3. Name of the entity in which the SFI is held

  4. Nature of the SFI

  5. Approximate dollar value of the SFI in the following ranges: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the value cannot be readily determined by public prices or reasonable fair market value measures

The information posted on FTHR Group’s website will be updated at least annually and within 60 days of:

  1. Receiving or identifying an additional SFI of Senior/Key personnel related to the NIH-funded research that was not previously disclosed, or

  2. A new SFI being disclosed by Senior/Key personnel joining the project and determined by the designated official to be related to the research and an FCOI.

Information on SFIs subject to the public accessibility requirement will remain available for at least three years from the most recent update. The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the institution’s identification of a new FCOI, which should be requested subsequently by the requestor.When the subrecipient Investigator is required to comply with the subrecipient’s FCOI policy, the subrecipient Institution will also make such information publicly accessible.

10) Reporting Identified Financial Conflicts of Interest

Prior to spending any funds under an NIH-funded award, FTHR Group will submit an identified FCOI report to NIH, in accordance with the FCOI regulations, for any Investigator’s SFI determined to be a FCOI. FTHR Group will also ensure that the Investigator has agreed to and begun implementing the associated management plan.FTHR Group will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active, and an FCOI has been identified (i.e., no award means no FCOI report, and no FCOI means no FCOI report).The NIH eRA Commons FCOI Module User Guide, available at the following location, provides instructions for preparing and submitting FCOI reports. https://www.era.nih.gov/files/fcoiuserguide.pdfInitial (Original) FCOI Reports: The report must include all information required under 42 CFR 50.605(b)(3) or as outlined in the NIH FAQH.5.

  1. Prior to the expenditure of funds: If an FCOI is identified at the time a new NIH award is issued, the FCOI SO will submit an “Original” FCOI report (2011 FCOI) through the eRA Commons FCOI Module before any funds are spent.

  2. Within 60 days during the award: If an FCOI is identified during the award period (e.g., a new SFI is disclosed or a new Investigator joins the project), the Institution must submit an Original FCOI report within 60 days of identifying the FCOI.

Annual FCOI Reports: For the duration of an award, including any extensions with or without funds, the Institution must submit an annual FCOI report to NIH. This report will indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable.

  1. The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report, and at the time of any grant extension, following NIH guidance (see NIH’s FAQ H.2). NIH creates the opportunity for the FCOI SO to submit the Annual report 75 days prior to the next budget period start date for continuation awards. NIH will notify the Institution by email when an annual report is due.

  2. Annual FCOI reports are not required at grant closeout.

Revision (or Mitigation) FCOI Reports: After completing a retrospective review, the Institution will submit a Revision report to NIH if new information about the FCOI is discovered, or a Mitigation report if the review finds that bias has occurred.Types of FCOI Reports, content, and timeline requirements:

Required FCOI Reports to be Provided to NIH through
eRA Commons FCOI Module
ReportContentRequired When?
New FCOI Report (Initial submissionGrant Number, PI, Name of Entity with FCOI, Nature of FCOI, Value of financial interest (in increments), Description of how FI relates to research, Key Elements of Management Plan.(1) Prior to expenditure of funds

(2) Within 60 days of any subsequently identified FCOI
Annual FCOI ReportStatus of FCOI (i.e., whether FCOI is still being managed or no longer exists) and Changes to Management Plan, if applicable.Annual report due at the same time as when the Institution is required to submit annual progress report, multi-year progress report, or at time of extension.
Revised FCOI ReportIf applicable, update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward or make changes to originally submitted FCOI report.Following the completion of a retrospective review when there is noncompliance with the regulation, if needed.
Mitigation ReportProject Number, Project Title, Contact PI/PD, Name of Investigator with FCOI, Name of Entity with FCOI, Reason for review, Detail Methodology, Findings and Conclusion.When bias is found as a result of a retrospective review.

NIH FCOI Module guide: era.nih.gov/files/fcoiuserguide.pdf

11) Training Requirements for Investigators

Each Investigator will be informed of FTHR Group’s FCOI Policy and trained on their responsibility to disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training must be completed before an Investigator engages in PHS/NIH-funded research, at least once every four years, and promptly (as described below) when any of the following occur:

  1. FTHR Group revises this policy or related procedures in a way that affects Investigator requirements.

  2. An Investigator is new to FTHR Group research under an NIH award (training must be completed before participating in the research).

  3. FTHR Group determines that an Investigator has not complied with this policy or with a management plan issued under it (training must be completed within 30 days as directed by the DO).

To meet the NIH training requirement, FTHR Group requires Investigators to complete the NIH FCOI Training Module from the following location: https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training. FTHR Group also requires Investigators to review the NIH Virtual Seminar presentation on FCOI compliance from the following location: https://www.youtube.com/watch?v=D292YZ6BX24. Investigators need to send the DO the date of completion of each of these through email to ensure they can be audited.

12) Noncompliance With FCOI Policy and Corrective Actions

If FTHR Group identifies an SFI that was not disclosed, reviewed, or managed in a timely manner, the DO will, within 60 days: review the SFI; determine whether it is related to NIH-funded research; determine whether it constitutes an FCOI; and, if so, implement an interim management plan describing actions that have been and will be taken to manage the FCOI going forward. FTHR Group will also submit an FCOI report to NIH via the eRA Commons FCOI Module.In cases of noncompliance, including:

  1. Failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI

  2. Failure by the institution to review or manage an FCOI

  3. Failure by the Investigator to comply with an established management plan

FTHR Group will, within 120 days of identifying noncompliance:

  1. Conduct a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether the research, or any part of it, was biased in the design, conduct, or reporting.

  2. Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or NIH’s FAQ I.2.

If bias is found, FTHR Group will promptly notify NIH and submit a mitigation report as required by 42 CFR 50.605(a)(3)(iii) or as described in NIH’s FAQ I.3 to NIH via the FCOI Module.The report will include:

  1. The impact of the bias on the research project, and

  2. The plan of action or corrective steps taken to eliminate or mitigate the effect of the bias.

FTHR Group will thereafter submit FCOI reports annually to NIH as required by the regulations and the terms and conditions of the award. Depending on the circumstances, FTHR Group may implement additional interim measures regarding the Investigator’s participation in the research until the retrospective review is complete.If bias is not found following completion of the retrospective review, no further action will be taken unless new information is discovered that needs to be reported to the NIH. If applicable, the Institution will update an existing FCOI report to specify the actions that have been, and will be, taken to manage the FCOI going forward or update a previously submitted report information (e.g., increase in value of the SFI or add any newly identified SFIs) following the completion of the retrospective review.If the failure of an Investigator to comply with an Institution's FCOI or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research, the Institution shall promptly notify the PHS/NIH Awarding Component of the corrective action taken or to be taken. The PHS/NIH Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS/NIH-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS/NIH award or when the transfer of a PHS/NIH grant(s) involves such an Investigator.

13) Clinical Research Requirements

If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, FTHR Group will require the Investigator to disclose the conflict in every public presentation of the research results and to request an addendum to previously published presentations.

14) Subrecipient Requirements

A subrecipient relationship exists when federal funds flow from or through FTHR Group to another individual or entity that will carry out a substantive portion of a PHS/NIH-funded research project and is accountable to FTHR Group for programmatic outcomes and compliance.Subrecipients (e.g. collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees) are subject to FTHR Group’s terms and conditions. FTHR Group will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. FTHR Group will include in each written agreement with a subrecipient terms specifying whether FTHR Group’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators (see NIH Grants Policy Statement Section 15.2.1 on Written Agreements).

1.    If the subrecipient’s FCOI policy applies:The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to FTHR Group in time for FTHR Group to meet NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI). Typically, this means requiring subrecipients to report FCOIs to FTHR Group within 50–55 days of identification. FTHR Group’s DO will then submit the subrecipient FCOI report to NIH through the eRA Commons FCOI Module.2.     If the subrecipient cannot certify compliance:The agreement will specify that FTHR Group’s FCOI Policy applies. In this case, subrecipient Investigators must disclose their SFIs to FTHR Group. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for FTHR Group. The agreement will allow sufficient time for FTHR Group to review, manage, and report any resulting FCOIs. When an FCOI is identified, FTHR Group will implement a management plan, monitor compliance by the subrecipient Investigator, and submit the required FCOI report to NIH via the eRA Commons FCOI Module.

15) Maintenance of Records

FTHR Group will maintain records of all Investigator financial interest disclosures, FTHR Group’s review and response to those disclosures (whether or not they resulted in a determination of an FCOI), and any actions taken under this policy or through retrospective review. These records will be retained for at least three years from the date of submission of the final expenditures report, or for longer periods as specified in 2 CFR 200.334 for specific situations. FTHR Group will retain these records for each competitive segment as required by regulation. Copies of management plans will be retained as part of the record maintenance requirements.

16) Enforcement Actions for Investigator Noncompliance

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Failure to comply with this policy, including failure to disclose Significant Financial Interests, failure to comply with a Conflict Management Plan, or failure to complete required training, may result in appropriate corrective or disciplinary actions.Such actions may include, but are not limited to, formal notification or disciplinary measures, restrictions on participation in research activities or use of research funds, suspension or termination of employment or contractual relationship, and/or disqualification from participation in Government Award–funded research, as appropriate.In addition, FTHR Group will take all actions required under applicable federal regulations and sponsor requirements, including conducting retrospective review, implementing mitigation measures where necessary, and notifying the sponsor when required.

17) Useful FCOI and NIH Resources

NIH e-mail address for FCOI-related inquiries: fcoicompliance[at]mail.nih.govFCOI Regulation 42 CFR Part 50 Subpart F - Promoting Objectivity in Research: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-FFinancial Conflict of Interest: https://grants.nih.gov/policy-and-compliance/policy-topics/fcoiFCOI Training: https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-trainingNIH “Welcome Wagon” Letter: Information for New Recipient Organizations: https://grants.nih.gov/policy-and-compliance/welcome-wagon

18) Point of Contact

If you have a question related to the FCOI Policy of FTHR Group, or would like to disclose a financial interest, contact us using the information below:

Contact:
Antonio Neri, MD, MPH, FACPM, Capt. USPHS (Ret.)
Chief Executive Officer
FTHR Group, LLC.
Email Antonio