Financial Conflicts of Interest for Awardees -- NIAID Staff Response

This SOP has internal roles only.

Purpose

To delineate staff roles in making sure financial interests at awardee institutions do not affect the design, conduct, or reporting of research funded under NIAID grants or cooperative agreements (SBIR phase I awards are exempt).

Procedure

By law, institutions must manage, reduce, or eliminate financial conflicts of interest (FCOI) for any person -- including subawardees and collaborators -- responsible for designing, conducting, or reporting NIAID-funded research.

They also have to report financial conflicts of interest to NIAID before spending funds on a new grant, or within 60 days of learning about a conflict on a funded grant.

For more information on institutional responsibilities, see the Financial Conflicts of Interest for Awardees SOP.

Staff review incoming reports and prioritize incidents that have the highest risk of tainting NIAID-funded research.

NIAID's financial conflict of interest liaison follows up on the matter and leads any response. When appropriate, the liaison brokers NIAID's response with the NIH Office of Extramural Research.

All Staff

Discuss an incident only with PIs, institutional business officials, and staff identified in this SOP.

In all cases where you become aware of a possible financial conflict of interest, email the information to the financial conflict of interest liaison and copy the chief grants management officer.

In the following situations, also take the additional steps below:

• Notifications directly from PIs.
  • Tell them to contact their institutions. Get the PI's grant number and the name of the institution.
    • For multiproject grants, discuss the conflict with program director only. Refer other PIs to the program director, and instruct them to contact their institutions.
    • For multiple PI grants, discuss the conflict with the contact PI only. Refer other PIs to the contact PI.
  • When you send the email described above, copy the grants management specialist, program officer, division coordinator, and division FCOI contact for the award.
• Notifications from third parties -- e.g., peer reviewers or other investigators.
  • Tell them to contact the institution in question and refer them to OER's Conflict of Interest Web site for more information.
  • When you send the email described above, copy the grants management specialist and program officer for the award.
  • Don't discuss the matter with anybody else.
• Inquiries from the press. Follow the instructions in the Responding to Media Inquiries SOP.
• Inquiries from Congress, central NIH, and other official sources.
  • Tell the liaison only. These types of inquiries should go through official NIH channels.
  • You don't have to alert anybody else.

Program Officers

• Hewing to internal divisional procedures, review notifications from grants management specialists and assess whether the conflict involves any of the following programmatic high-risk situations:
  • Clinical research involving any of the following:
    • High risk populations.
    • Multisite components.
    • Clinical trials.
    • FDA-regulated drugs or devices.
    • One or more sites outside a clinical trials network.
  • An investigator associated with an industry connected to the research.
  • An individual who plays a critical role in the research.
• If the conflict doesn't fall into a high risk category, send the specialist a memo that says "Research does not fall into an NIAID administrative or programmatic high-risk category with regard to FCOI," and copy your division FCOI contact and division coordinator.
• If the conflict falls into a high-risk category, notify the specialist.
  • Cosign a request for synopsis. The specialist has a template for this request.
  • After the institution responds, review the synopsis and gather additional background materials, for example, google search results.
  • Provide the following input to the liaison:
    • Whether the synopsis has enough information to consider the matter resolved.
    • Whether a meeting among NIAID staff is necessary at this time.
    • Whether additional information is needed from the grantee institution.
• Be available for follow-up meetings if called upon.
• When NIAID has completed its response and the conflict is resolved, send the specialist a memo stating this for the official grant file. Copy the division coordinator and division FCOI contact.

Scientific Review Officers

• Contact the grants management specialist if you notice a possible conflict of interest.

Grants Management Specialists

When an institution notifies NIAID of a financial conflict of interest on a funded grant, eRA Commons generates a email to the Chief Grants Coordinator, who forwards the email to appropriate staff.

Follow the instructions in GMP's Financial Conflict of Interest SOP, which explains the following actions in greater detail:

• Verify that the notification letter includes at least the following information:
  • Grant number and institution.
  • PI of the NIH-supported project.
  • Name of individual with the conflict of interest.
  • Indication of whether the conflict has been managed, reduced, or eliminated.
• If missing any information, follow up with the grantee.
• Enter the information in the FCOI database.
  • Do not include financial details.
  • If the database does not automatically generate an e-mail to the grantee acknowledging receipt, send one.
• Review the notification with the grants coordinator and assess whether the conflict has any of the following high-risk features:
  • One or more foreign sites.
  • Multiple ICs or cofunding with another agency.
  • NIAID clinical terms of award.
• Send the assessment and original report to the program officer for the award in question. Copy the division coordinator and division FCOI contact.
• Update eGrants, FCOI database, and grant file as needed and work with the program officer to assess whether the conflict falls into a programmatic high-risk category.
• Be available for follow-up meetings if called upon.

If you hear about financial conflict of interests directly from PIs, instruct them to tell their institutions. You can direct them to the Financial Conflicts of Interest for Awardees SOP, but also do the following:

• Contact the institution in question to remind it of the NIH policy on reporting conflicts.
• Notify the financial conflict of interest liaison and chief grants management officer.

More information:

• Grantee FCOI Notifications Database
• Policy Topic: Objectivity in Research/Conflict of Interest

NIAID Financial Conflict of Interest Liaison

• Serve as NIAID's liaison to NIH on institutional conflicts of interest and policy.
  • Involve NIH's Office of Extramural Research when additional information is needed from a grantee, and oversee all subsequent actions.
  • Inform other organizations of conflict of interest activities as necessary.
• Advise program staff on resolving problematic cases of institutional conflicts of interest.
  • Organize staff meetings.
  • Determine NIAID response to allegations by third parties and inquiries from public officials.
• Coordinate conflict of interest activities for NIAID.

Contacts

Grantees with questions should contact the appropriate grants management specialist or project officer, listed on their Notice of Award. For more information, see Contact Staff for Help.

Financial Conflict of Interest Liaison -- Contact for NIAID Staff

Chief Grants Coordinator -- Contact for NIAID Staff

Program Division Coordinators:

Contact for NIAID Staff -- DAIDS

Contact for NIAID Staff -- DAIT

Program Division FCOI Contacts:

Contact for NIAID Staff -- DAIT

Contact for NIAID Staff -- DAIDS

Contact for NIAID Staff -- DMID

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with this link and your message. Thanks for helping us clarify and expand our knowledge base.

Links

Bioethics Resources on the Web

Conflict of Interest in Peer Review SOP

ORI Conflicts of Interest tutorial

OER Conflict of Interest tutorial

Promoting Objectivity in Research – Key Points

Responsible Conduct of Research Resources -- Conflicts of Interest and Commitment