FAQs
General Questions
TU EForm Questions
- Which personnel does the term "investigator" include?
- What has changed between the old NIH regulations and the new NIH regulations.
- What should I do if I'm having difficulty accessing eRA or the External Interest module in eRA?
- How can I complete conflict of interest training?
- What is Significant Financial Interest (SFI)?
- If I do not have any significant financial interests including travel, do I still need to log into eRA and file a disclosure?
- If my spouse is a Temple employee, do I still have to disclose his or her significant financial interest?
- What happens if there is a conflict of interest in my disclosure?
- When must investigators receiving PHS funding disclose financial interests?
- What are the Agencies within the Public Health Service?
- When should I file a conflict of interest disclosure?
- One of the personnel on my project is a collaborator/ consultant that is not a subrecipient and not a Temple employee, but they are an investigator on my project. How will they file a disclosure?
- When will Temple University implement the revised FCOI regulations?
Basic Questions
SFI Questions
PHS Questions
FCOI Questions
- Who is considered an immediate family member?
- What are my institutional responsibilities?
- What is considered equity?
- Which indirect investments should be considered?
- Who must disclose entities and entity details?
- What is research?
- Who must disclose travel details?
- Who is considered to be in a fiduciary position?
General Screening Questions
Entity Page and Detail Page
Travel Page
Fiduciary Page
General Questions
Basic Questions
Which personnel does the term "investigator" include?
Any University employee, regardless of title or position, who has the ability to make independent decisions related to the design, conduct or reporting of University research, but not including individuals who perform only incidental or isolated tasks related to a University research project. Since title and position are not indications of who is an "Investigator", it is possible for students and post docs to meet this definition.
What has changed between the old NIH regulations and the new NIH regulations.
-
Previous Regulation
- PI determined if they had a financial interest greater than $10,000
- That was a financial Conflict of Interest
- Disclosed to school and NIH
-
New Regulation
- PI discloses all financial interests greater than $5,000 related to their institutional responsibilities
- For themselves and immediate family
- Institution must decide if it is an conflict
What should I do if I'm having difficulty accessing eRA or the External Interest module in eRA?
Please email your issue to eRA@temple.edu. If necessary, you may have to give your TU ID so that you can be given access.
Go To TopHow can I complete conflict of interest training?
To complete conflict of interest training log into Blackboard (https://blackboard.temple.edu/) using your Temple log on and password. "Conflict of Interest Training" should be listed under My Courses. If you do not see it listed, click on "Browse Course Catalog". Search by typing "Conflict of Interest". When located, click on the dropdown arrow next to the course name and then click enroll.
Go To TopSFI Questions
What is Significant Financial Interest (SFI)?
- A Financial Interest consisting of one or more of the following interests of the Investigator and the Investigator's Immediate Family that reasonably appears to be related to the Investigator's Institutional Responsibilities, including but not limited to:
- With regard to any publicly traded entity, if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of the disclosure, when aggregated, exceeds $5,000. This includes:
- Remuneration for salary and services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); and
- Equity interest including any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- With regard to any non-publicly traded entity, if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or if the Investigator or his/her Immediate Family holds any equity interest (e.g. stock, stock option or other ownership interest) in the entity; or
- Intellectual property rights and interests (e.g. patents and copyrights), upon receipt of income related to such rights and interests.
- Any reimbursed sponsor travel (i.e. that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator's Institutional Responsibilities, other than travel that is reimbursed or sponsored by:
- A federal, state or local government agency ("Public Agency");
- An institution of higher education as defined at 20 U.S.C. 1001(a); or
- An academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.
- Significant Financial Interest does not include:
- Salary or other remuneration paid by Institution, if the Investigator is employed by Institution, including intellectual property rights assigned to the Institution and agreements to share royalties related to those rights;
- Income from investment vehicles such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures or teaching engagements sponsored by a Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education; or
- Income from service on advisory committees or review panels for a Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education.
If I do not have any significant financial interests including travel, do I still need to log into eRA and file a disclosure?
Yes, you must log into the eRA External Interest module and answer the questions indicating that you do not have any significant financial interests.
Go To TopIf my spouse is a Temple employee, do I still have to disclose his or her significant financial interest?
Yes, and this includes travel. The conflict of interest offices on the main campus and health science campus do not have a database of related employees. However, you can notify your respective office and inform them of your spouse, and the conflict of interest office can add that Temple employee's name to your conflict of interest disclosure case.
Go To TopWhat happens if there is a conflict of interest in my disclosure?
The conflict of interest office on your campus will determine whether your disclosed significant financial interests are financial conflicts of interests related to your project. Each campus has it's own conflict of interest committee. If the committee determines that there is financial conflict of interest, a management plan will be put in place. The committee may ask for your input and you will have the right to appeal the committee's decision.
Go To TopPHS Questions
When must investigators receiving PHS funding disclose financial interests?
Investigators receiving PHS funding must disclose all financial interests related to their institutional responsibilities if those interests are greater than $5000.What are the Agencies within the Public Health Service?
The following is a list of the 8 PHS-funded agencies and the 3 PHS-funded offices that are PHS-funded and covered under the COI regulation. Each link will take you to the agency or office's website, where you can find a list of all centers, institutes and sub-offices that are also covered.
Agencies:
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare and Medicaid Services (CMS)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
Offices:
When should I file a conflict of interest disclosure?
You must have conflict of interest disclosure on file by the time of submitting an application for a grant from an agency that follows the PHS regulation. The disclosure must be reviewed by your conflict of interest office before it is submitted.
You must also update your disclosure within thirty (30) days of acquiring a new significant financial interest. The conflict of interest office will review your disclosure at notice of award and noncompeting renewals to see if there are any financial conflicts of interest with the funded project.
Go To TopOne of the personnel on my project is a collaborator/ consultant that is not a subrecipient and not a Temple employee, but they are an investigator on my project. How will they file a disclosure?
Please contact your respective conflict of interest officer: (For SOM: coihsc@temple.edu for all other schools coimain@temple.edu) for the assurance of compliance for that external investigator.
Go To TopFCOI Questions
When will Temple University implement the revised FCOI regulations?
Implementation by Temple University of the 2011 revised FCOI regulations, which applies to all grantees of PHS funding, must be in effect at this institution on August 24, 2012.TU EForm Questions Questions
General Screening Questions
Who is considered an immediate family member?
The disclosing individual's spouse or spousal equivalent and dependent children.What are my institutional responsibilities?
A disclosing individual's professional responsibilities on behalf of the Institution, including, but not limited to, activities such as research, research consultation, teaching professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.What is considered equity?
Includes but is not limited to stock, stock options or other ownership interest.Which indirect investments should be considered?
Applies so long as the disclosing individual does not directly control the investment decisions made in the investments.Entity Page and Detail Page
Who must disclose entities and entity details?
Only School of Medicine faculty are required to disclose all payments received or equity held related to their institutional responsibilities.
Faculty and non-faculty of all other schools, and non-faculty of SOM, are only required to disclose if the aggregate amount of payment or equity exceeds $5,000 in any one entity.
What is research?
A systematic investigation, study or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. This term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).Travel Page
Who must disclose travel details?
Only School of Medicine(SOM) faculty are required to disclose all travel away from Temple University related to their institutional responsibilities regardless of the funding source. PHS Regulations will be used to determine SFI for PHS/ NIH reporting purposes.
All others, faculty and non-faculty of all other schools and non-faculty of SOM, are not required to disclose travel reimbursed or sponsored by the following excluded entities: Federal, state or local government agency, an Institution of higher education as defined at 20 U.S. 1001 (a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
