Conflicts of Interest

An important component of the Research Integrity Program at the University at Albany is the management of financial conflicts of interest in research. The Office of Regulatory & Research Compliance, Division for Research, oversees the management process for such conflicts.

The University at Albany procedures fulfill the requirements of the policies of the State University of New York and the Research Foundation for the State University of New York specifying what financial conflicts of interest are and how they are managed at the University at Albany.

Questions concerning the policies and procedures and their application may be directed to:

Adrienne D. Bonilla, Esq.
Assistant VP for Research
Office of Regulatory & Research Compliance
518-437-3850

PHS-Sponsored Activities

The U.S. Public Health Service (PHS) amended its Financial Conflict of Interest (FCOI) Regulation effective August 24, 2012.

Accordingly, the University at Albany has adopted a new PHS Financial Conflict of Interest (FCOI) Policy effective August 24, 2012 (see policy.)

If you plan to apply for funding from a PHS (directly or flowing thru another agency) you must comply with the new FCOI Regulations. PHS Agencies include (see full list at: ttp://nrc59.nas.edu/pub/fcoi_agencies_phs_regs.html):

• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Office of the Inspector General (IG)
• Substance Abuse and Mental Health Services Administration (SAMHSA)

Before a Principal Investigator (PI) may submit a proposal to any of the PHS agencies, all investigators for the project must have a completed Disclosure Form on file and have completed the online CITI Conflict of Interest training. Relevant links are listed later on this page.

PHS defines "Investigator" as the project director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research. For the purposes of this policy, the term "investigator" includes: SUNY or RF employee who is the project director or principal investigator and any other person, including a student or post-doctoral fellow, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

To comply with the SUNY/RF SUNY PHS Conflict of Interest Policy, University at Albany has established campus procedures for financial interest disclosures and identification of conflicts:
Briefly, the PHS COI Policy requires financial interest disclosure upon submission of a proposal for an externally-funded grant, contract, or cooperative agreement, annually (at a minimum) thereafter during the period of PHS-funded awards awards, and within 30 days of acquiring a new financial interest.

Given the importance of respecting investigator confidentiality, we employ a two-step process comprised of two forms: Investigator Disclosure Form Part I and Investigator Disclosure Form Part II.

Part I is a yes/no survey. If the investigator answers ‘yes’ to any of the questions regarding whether or not he or she has a significant financial interest, Part II is completed which asks for specific details concerning the identified interest(s). Part II is always sent directly to the Office of Regulatory & Research Compliance. The details concerning significant financial interests are available only to the Research Compliance Officer (Asst. VP for Research), the Conflicts of Interest Committee, the Vice President for Research, and select others on a ‘need to know’ basis.

Disclosure forms for conflicts of interests related to PHS agencies may be found here:

University at Albany Disclosure of Financial Interests and Obligations for Public Health Service Sponsors (Word Version)

University at Albany Disclosure of Financial Interests and Obligations for Public Health Service Sponsors (PDF Version)

For more detailed information and guidance, see:

http://www.albany.edu/osp/assets/PHS_FCOI_Guidance_UA_Final_8_21_12.pdf

FCOI required training for PHS submissions
Investigators must also receive training in financial conflicts of interest. Please see the University at Albany FCOI Procedures for PHS Sponsored Programs for complete details on how to meet these requirements. The following also provides instructions for completing the required COI Training through the Collaborative Institutional Training Initiative (CITI):
University at Albany PHS COI CITI Training Instructions

Where do I submit the require disclosure forms?

When you are an investigator on a proposal that submitted for funding, you will upload into COEUS the disclosure form Part I, along with all other required proposal documents for submission to the Office of Sponsored Programs. If you check ‘yes’ to any of the questions in Section B of that form, you will then, within 7 working days, submit a completed disclosure form Part II directly to the Office of Regulatory & Research Compliance (ORRC) via email:

fcoi@albany.edu or

via hard copy marked “CONFIDENTIAL” to

Adrienne D. Bonilla, ORRC, MSC 309

When you have a new significant financial interest to disclose, and you must update your disclosures currently on file, within 30 days of obtaining or acquiring that new interest. Submit revised disclosure, parts I and II as necessary, directly to the ORRC.

 

NON-PHS SPONSORED PROGRAMS

In accordance with Federal regulations, a potential conflict of interest exists when the personal or private interests of an individual, their spouse or child might lead an independent observer to reasonably question whether the individual’s professional actions or decisions are influenced by considerations of significant personal interest, financial, or otherwise, particularly if those interests or commitments are not disclosed.

University at Albany's procedures and disclosure form for conflicts of interests related to non-PHS agencies may be found here:

University at Albany Disclosure of Financial Interests and Obligations for Non-Public Health Service Sponsors (Word Version)

University at Albany Disclosure of Financial Interests and Obligations for Non-Public Health Service Sponsors (PDF Version)

Briefly, all University at Albany investigators seeking external grant, contract, or cooperative agreement funding from non-PHS agencies to conduct scholarly activities are required to complete and file a signed disclosure form before a proposal can be endorsed for submission or prior to establishment of an account in instances where proposal submission is not required prior to award of funds. Certification must always be current, so a new form must be submitted in each reporting year and its accuracy will be certified for each new proposal submission during that year. During the period of an award, all financial disclosures must be updated as new reportable significant financial interests are obtained.

In order to provide assurance that any potential conflict is disclosed all investigators must submit a disclosure form annually, but no later than:

•Submission of an application to an external sponsor, or
•Acceptance of award where there was no prior disclosure submitted for that work

In addition, a revised disclosure must be filed whenever an investigator’s significant financial interests and obligations change materially.

The disclosure is always sent directly to the Office of Regulatory & Research Compliance. The details concerning significant financial interests are available only to the Research Compliance Officer (Asst. VP for Research), the Conflicts of Interest Committee, the Vice President for Research, and select others on a ‘need to know’ basis.

The completed disclosure statement(s) should be placed in a sealed envelope, marked “CONFIDENTIAL” to

Adrienne D. Bonilla, ORRC, MSC 309

Or via email:
FCOI@albany.edu