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Financial Conflict of Interest (FCOI) Training Requirements for All Investigators and Study Members


   

 

PART I – Financial Conflict Of Interest Declaration Requirements 

 

Investigators and study team members who are involved in research that is conducted under the oversight of NHG or partner institutions should not have conflicting interests that may adversely affect the protection of participants or the credibility of the human subject protection programme.

The definitions of Conflict of interest are as follows: 

Conflicting Interest – A conflicting interest can be broadly defined to refer to any interest of the investigator and/or study team member or immediate family (includes parents, siblings, spouse and each dependent child) that competes with the investigator’s/study team member’s obligation to protect the rights and welfare of research subjects.

Financial Interest – Financial interest related to the research means financial interest in the sponsor, product or service being tested. Significant Financial Interest means anything of monetary value, including but not limited to, salary or payments for services (e.g., consulting fees or honoraria); equity interests (e.g. stocks, stock options or other ownership interests); intellectual property rights (e.g., patents, copyrights and royalties from such rights), and board or executive relationships.


Since 1st January 2015, all investigators and study team members who are involved in the design, conduct or reporting of a research that is conducted under the oversight of NHG or its partner institutions are required to

  • Read through the requirements and updates (if any) on the Financial Conflict of Interest (FCOI) Declaration Requirements during submission of a new ethics application (for new researchers), annually, whenever there is a revision (updates) to the requirements, or when required by the DSRB for researchers or study team members found to be non-compliant to financial conflict of interest requirements,    
  • Declare that the FCOI Declaration Requirements have been read at the annual submission of their FCOI Declaration Form, and
  • Declare any Financial Interests related to their studies at the annual submission of their FCOI Declaration Form.

 

Click HERE to download a copy of the Guide to the FCOI Declaration Requirements (see Part I).


Submission of Annual FCOI Declarations

Please download a copy of the FCOI Declaration Form and send it to the FCOI Secretariat inbox at DSRB_FCOI@nhg.com.sg.

Note:

  • Please send individual forms and do not merge multiple forms together. If you are submitting on behalf of others, please copy them in the email.
  • Please ensure all investigators and study team members keep a copy of their own annual FCOI Declaration Form on file for their own documentation purpose.



List of Available Guides, Forms and Useful Links (FCOI Declaration)


Related Links


Contact Details

For more information and queries, please contact the Administrator:

FCOI Declaration Secretariat
Email: DSRB_FCOI@nhg.com.sg
DID: 6471 3266
Office of Human Research Protection Programme (OHRPP)
NHG Group Research Office

 

 

PART II – Financial Conflict Of Interest Training Requirements 

 

Since 1st January 2015, all investigators and study team members who are involved in the design, conduct or reporting of the research that is conducted under the oversight of NHG or its partner institutions are required to complete the Financial Conflicts of Interest (FCOI) course. It aims to educate investigators and study team members on how conflicting interests may adversely affect the protection of participants or the credibility of the human research protection programme.
 

  1. What is the NHG CITI FCOI course? Go
  2. I have not obtained my CITI certification, do I need to complete the FCOI course/modules in addition to the basic set of CITI modules? Go
  3. I have obtained my CITI certification, do I need to complete the FCOI course/modules? Go
  4. Are there any alternative ways to complete the FCOI training? Go
  5. How do I update my FCOI Training Status with the DSRB and the Research Online Administration & Management (ROAM) Portal? Go

 

1. What is the NHG CITI FCOI course?

The Financial Conflicts of Interest (FCOI) course is a sub-component of the CITI Program. It comprises of 2 core modules:

1. NHG – Singapore. Overview of Domain Specific Review Board (DSRB) Review Process (ID: 810)
2. Conflicts of Interest in Human Subjects Research (ID:17464)

It is important to affiliate with “National Healthcare Group – Singapore” so that you can access the FCOI Course.

Please refer to the List of Available Guides, Forms and Useful Links available for download at the end of this page.  

 

Back to FAQ


 

2. I have not obtained my CITI certification, do I need to complete the FCOI course/modules in addition to the basic set of CITI modules?

Principal Investigators and Co-Investigators who have not obtained their CITI certification as of 1st January 2015 will need to complete the full set of 10 core modules and 5 elective modules, as described in item 1.1 above. The 2 FCOI modules are encompassed within the 10 core modules in CITI. Therefore, there is no need to complete the FCOI course/modules separately.

It is not mandatory for Study Team Members to complete the full set of 10 core modules and 5 elective modules. They will only need to complete the 2 modules described in item 1.1.

Please refer to the List of Available Guides, Forms and Useful Links available for download at the end of this page.

Back to FAQ
 

 

 

3. I have obtained my CITI certification, do I need to complete the FCOI course/modules?

Principal Investigators, Co-Investigators and Study Team Members who have obtained their CITI certification before 1st January 2015 will be considered to have completed the FCOI course if they had completed the 2 FCOI modules.

If they had not completed the modules, they can choose to complete the missing elective CITI module “Conflicts of Interest in Research Involving Human Subjects” or complete the FCOI course.

Please refer to the List of Available Guides, Forms and Useful Links available for download at the end of this page.

Back to FAQ
 

 

 

4. Are there any alternative ways to complete the FCOI training?

Yes. If you have completed either of the following alternative methods, you will be considered as having completed the FCOI training:

Alternative method 1

(i) You have completed the CITI Conflicts of Interest Course* and
(ii) You have declared that you have read the latest FCOI Declaration Requirements in your FCOI Declaration Form.

*The CITI Conflicts of Interest Course contains the following modules:
 

a. Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules (COI-Basic) (ID: 15070)
b. Institutional Responsibilities as They Affect Investigators (COI-Basic) (ID: 15072)
 


Alternative method 2

(i) You have completed the CITI Biomedical Basic Course which contains the Conflicts of Interest in Human Subjects Research (ID:17464) module and
(ii) You have declared that you have read the latest FCOI Declaration Requirements in your FCOI Declaration Form.

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5.  How do I update my FCOI Training Status?

When you have completed the FCOI Course, you are encouraged to upload a copy of the completion certificate onto your ROAM profile under ‘Personal Info’ -> ‘Upload Minimum Training Status Proof’.

If you have multiple certificates for verification, please upload a zipped folder containing these documents.

Upon receipt and verification, the Administrator will update your FCOI Training status in our internal database and you will receive an acknowledgement of receipt email.

Please note that whenever you re-upload a document onto your ROAM profile, the Minimum Training status will revert to “Not Completed” until the uploaded document is verified.

If you do not have a ROAM account, you may forward your certificate to the Administrator at min_ethics_training@nhg.com.sg and we will update your FCOI Training status in our internal database.

Back to FAQ
 

 

List of Available Guides, Forms and Useful Links

  1. Click here to download a step-by-step Guide to Completing the FCOI Course for Investigators.
     
  2. Click here to download a step-by-step Guide to Completing the FCOI Course for Study Team Members.


Contact Details

For more information and queries, please contact the Administrator:

Minimum Ethics Training Secretariat
Email: min_ethics_training@nhg.com.sg
DID: 6471 3266
Office of Human Research Protection Programme (OHRPP)
NHG Group Research Office