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Care New England Research

Compliance

Research and other sponsored programs are governed by strict rules and regulations from sponsors, federal or state government, and CNE policies. The Compliance Department is here to help navigate the complexities of FCOI, foreign influence, sanction screening, and much more. Below you’ll find information on a wide variety of compliance issues commonly encountered during the lifecycle of an award.

FCOI

Financial conflict of interest (FCOI) may occur when outside financial factors compromise or appear to compromise a researcher’s judgment in the design, conduct, or reporting of research. All investigators, including PD/PIs, co-investigators (including those at other institutions), and other key personnel, must disclose financial conflicts of interest.

 

FCOI Policy for Investigators
When to Disclose
  • At the application or award stage
  • Within 30 days of acquisition of new conflict
  • At least annually

Email and Record Retention Policies

Performing your CNE (or affiliate) role requires exclusive use of your CNE email address. Email retention periods vary considerably for different data types. Both the email retention and record retention and destruction policies are available on Convergepoint (Policy #s CNE-IS-017 & CNE-CC-010) for your review and understanding.

In order for CNE to follow federal and state regulations, all business communications related to your work here, whether reporting findings or anything else related to performing your role as an employee, means that CNE will be the platform for that correspondence. There is a strict prohibition against using your school, faculty, or other email addresses to conduct CNE business.

Additionally, the secure login process to access the CNE platform (including your CNE Outlook account) minimizes risk to sensitive data whether it is Protected Health Information, intellectual property, sensitive information or other communications related to your role.

Please review the policies below sited above and use your CNE email address when emailing CNE related correspondence.

Sanction Screening

The purpose of the CNE Sanction & Exclusion Screening for Excluded Individuals and Entities Policy (Policy Number CNE-CC-001) “is to ensure compliance with State statutes and the federal Social Security Act, 42 U.S.C. §1128 which require healthcare providers to perform sanction screenings prior to the hire of employees and independent contractors or the engagement of individuals or entities supplying goods or services.” 

Sanction screening must be done on all research vendors, collaborators (not employed at CNE), consultants, contractors, CROs, sponsors, or institutions prior to engaging in contract discussion.  

**Research participants are considered patients for the purposes of sanction screening and do NOT need to be screened.

What this means for you:

  • Prior to engaging in contract negotiations or initiating contract talks, ensure sanction screening (on the individual, company, or country) has been completed
  • If you are liaising with a CNE department (SPRA, IS, etc) understand who will initiate sanction screening and when
  • When in doubt, initiate sanction screening yourself
  • Do not begin receiving good, services, or contract work prior to sanction screening. If the screening comes back positive, the individual or company cannot be paid by CNE or federal grant funds.

How to initiate sanction screening?

  • After identifying the individual or company you’d like to engage, you will submit a sanction screening request to Compliance Services.
  • Sanction screening forms should be sent to Barbara Hicks and Compliance Services will conduct sanction screening and alert you to any flags that arise. If none, you are free to proceed with contract negotiation and execution. If a flag arises, they will be in contact with next steps.
  • If contract execution is a prolonged process (greater than 1 month), it is prudent to request an updated sanction screening prior to the final execution of the contract.

Sanction screening will be updated automatically by Compliance Services monthly once an individual or company has been registered with CNE.

Questions about sanction screening can be directed to Barbara Hicks, Compliance & Privacy Coordinator.

Responsible Conduct of Research

Coming Soon

Research Integrity & Research Misconduct

Coming Soon

Export Control

Coming Soon

International Travel

Coming Soon

Foreign Influence

Coming Soon