 Some links will work for NIAID staff only.
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This SOP has internal roles only.
Standard Operating Procedure Table of Contents
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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 grantor within 60 days of learning about a conflict on a funded grant. For more information on institution 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 brings in 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.
- When you send the email described above, copy the grants management specialist, program officer, division coordinator, and division FCOI contact for the award.
- 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.
- 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 has any of the following programmatic high-risk features:
- 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 important part of the research that is dependent on the person with a conflict.
- 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 and cosign a request for synopsis.
- 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.
Grants Management Specialists
When an institution notifies you of a financial conflict of interest, take the following actions:
- Verify that the notification letter includes at least the following information:
- Grant number.
- PI of NIH-supported project.
- Name of investigator with the conflict of interest.
- Indication of whether the conflict has been managed, reduced, or eliminated.
- If any of the data noted above are missing, follow up with the grantee to obtain the information.
- Enter the information in the FCOI database. Do not include financial details.
- 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.
- Wait for the program officer to assess whether the conflict falls into a programmatic high-risk category.
- If a conflict doesn't fall into any high risk category, the program officer sends a memo saying so. Place a copy of it in the official grant file.
- If a conflict falls into any high-risk category, cosign a request for synopsis with the program officer and send it to the institution.
- Ask the institution for the following information:
- Confirmation that the institution has an institutional conflict of interest policy that meets NIH requirements.
- Verification that the institution followed its policy.
- Description of the nature of the reported conflict.
- Which method -- management, reduction, or elimination -- was used to protect the research from bias.
- How the response was employed.
- Whether additional NIAID awards are impacted, and if so, how.
- Send it to the grantee institution with a deadline of 10 business days.
- Notify the financial conflict of interest liaison.
- If the synopsis says the conflict has been eliminated, the program officer sends a memo saying so. Place a copy of it in the official grant file.
- If the synopsis says the conflict has been reduced or managed, gather QVR and conflict of interest data and send this information to the staff involved.
- Be available for follow-up meetings if called upon.
- Once the conflict is resolved, update the database and grant file.
If you hear about a financial conflict of interest 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:
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 Grant 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
Contact for NIAID Staff --
DMID
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 |
