frequently Asked Questions

A: Several federal regulations require that institutions maintain a process for identifying and managing conflicts of interest. Those regulations include:

• Anti-Kickback Statute, (42 USC § 1320a-7b(b))

• Stark Law, (42 USC § 1395nn)

• CMS – Centers for Medicaid & Medicare Services

•  CMS - 42 CFR part 402 and 403 (Sunshine Act)

•  IRS – Form 990

• Public Health Service (PHS): 42 CFR part 50 Subpart F

• National Science Foundation (NSF) Grantee Standards, Chapter IVA

A: The employee is responsible for disclosing their relationships annually and within 30 days of a significant change in their relationship, which could include (1) a relationship with a new outside entity, (2) a new role with the outside entity, or (3) a significant change in the value of an existing relationship.

A: The electronic Outside Interest Disclosure (OID) form in REDCap is the only mechanism for disclosing outside financial relationships.  https://redcap.link/2024ioi.disclosure  The completion of this survey satisfies your annual disclosure requirement.

A: We need to document that you have no outside relationships, and we do that through the annual Outside Interest Disclosure form.  Even if you do not currently engage in any outside activities, you must still submit a disclosure.  The REDCap survey will show you only the questions that you are required to answer, and this training and disclosure process should take less than 20 minutes.

A:  The federal regulations require that each investigator disclose all relationships (i) that would reasonably appear to be affected by the research; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.  Therefore, SLU’s policy asks that “Covered individuals must disclose their own outside interests . . . that reasonably appear to be related to the covered individual's institutional responsibilities.”

A: We ask you to consider two time periods: Last Year and the Current Year.

• Calendar Year 2023: January 1, 2023 – December 31, 2023

•  If completed before 12/31/24:

  • • Year to Date 2024: January 1, 2024 – Date of your Disclosure

A: The University used the InfoEd platform to gather disclosures in previous years.  Our contract with InfoEd expired at the end of April, 2023 and University leadership determined that its costs outweighed the benefits.  We aim to establish a stronger, more integrated disclosure system in the future, and will use REDCap during this interim 2023-2024 disclosure year.  

A: REDCap (Research Electronic Data Capture) is a secure, free, turn-key cloud-based research survey and data management application that readily supports creating and managing online surveys and databases.  Since REDCap can be used to collect virtually any type of data, we’ve opted to use it during the 2023 - 2024 Outside Interest Disclosure cycle as our leadership searches for a suitable Conflict of Interest platform for the future. 

Your impression is correct, though: REDCap is typically geared to support data capture for research studies.  It is supported by SLU’s AHEAD Institute because it provides secure data capture for research studies with the ability to invite survey participants external to SLU. 

If you would like to use REDCap in your research, please contact redcap@health.slu.edu or ahead@health.slu.edu

https://sites.google.com/view/redcapatslu/support-and-resources    

A: In theory, Yes, you may use your mobile device to complete your OID.  However, we did not test the system on mobile devices due to the University's resource limitations. We recommend that you access the OID through your desktop or laptop, and we cannot provide support if you are having troubles on your mobile device.

A: Every internet browser should work well with no special browser configurations.  However, we tested the system in Google Chrome and Firefox.

A: No, all disclosures should be submitted electronically through the REDCap survey link.  Paper copies of the form are not available. 

A: If there's any question about whether or not you need to disclose something, we always recommend to err on the side of disclosure. Over-disclosure is never a problem, but under-disclosure can be problematic. If you want to talk to someone about a particular situation, please contact coi@slu.edu or one of the office staff (see Contact Us).

A: Yes, in order for the Compliance Office and Conflict of Interest Office at SLU to have complete records we ask that you complete the disclosure regardless of whether it will be applicable to you in the near future. 

A: Situation in which a significant financial interest of an investigator could directly and significantly affect the design, conduct or reporting of the investigator’s research or research-related educational activities.

A: Anyone who is responsible for the design, conduct, or reporting of externally-sponsored SLU research must fill out an Outside Interest Disclosure (OID). This includes SLU personnel named as a research team member within the WorkDay Committed Effort Table, all members of IRB or IACUC research teams, all individuals listed as senior/key in a grant application, and any individual determined by the Principal Investigator.

consultant?  

A: Probably not.  Consultants typically provide advice or services to a research initiative that typically addresses minor, insignificant gaps in the project, such as supplying software, providing technical support or training, or setting up equipment.  If, however, they contribute “substantively and measurably” to the scientific development or execution of the research (as determined by the PI), then Yes, they must submit a disclosure.

mentor?  

A:  No, mentors who act as a trusted counselor or provide indirect coaching and moral support will typically not be considered a SLU Researcher and are not required to submit a disclosure.

co-author? 

A:  Yes, co-authorship is considered reporting of research, and they must submit a disclosure. 

non-SLU collaborator covered by a sub-award? 

A:  It depends.  Look to the Letter of Intent to Establish a Sub-Award with SLU as the Prime Applicant, Section F, which names the organization responsible for the oversight of COI.  (For federally-sponsored research, you may also look to the Subaward Agreement, usually in an Attachment on Federal Award Terms & Conditions, which also names the organization responsible for the oversight of COI.) If SLU is responsible, then Yes, they must submit a disclosure.  However, if SLU is not responsible but the non-SLU collaborator will directly interact with SLU research subjects or animals, have access to identifiable SLU data, use SLU resources (facilities, laboratories, equipment, digital or technological systems) in the performance of their duties, or contribute unpaid expertise for credit (potential future publication rights), they must also submit a disclosure.

non-SLU collaborator not covered by a sub-award?

A:  Yes, if they directly interact with SLU research subjects or animals, have access to identifiable SLU data, use SLU resources (facilities, laboratories, equipment, digital or technological systems) in the performance of their duties, or contribute unpaid expertise for credit (potential future publication rights), they must submit a disclosure.

SLU faculty member conducting no SLU research or patient care, and am not considered an Institutional Official, yet I have an outside relationship?  

A: No, you are not required to submit an annual disclosure.  The University presently does not have an official Conflict of Commitment Policy and no formal disclosure method.  The matter remains within each college, and the “Extramural Activities” expectations are set forth by our Faculty Manual.  We encourage you to discuss your outside relationship with your department or college leadership.

SBIR/STTR Phase I investigator?  

A: Yes, you are asked to disclose your outside relationships through the annual disclosure process.

SSM-SLUCare physician conducting funded SLU research? 

A: Yes, you are a SLU research investigator, and the regulations require that we collect your annual disclosure.  You will also be asked to disclose your outside relationships to SSM every autumn. Both institutions’ compliance teams regret your inconvenience due to that duplication of effort.  The institutions have separate policies and review thresholds and are not prepared to adopt a single approach.

SSM-SLUCare physician conducting no SLU research?

 A: No, you are not required to submit the annual Outside Interest Disclosure to SLU.  You will be asked to disclose your outside relationships to SSM every autumn according to SSM institutional policies. 

student conducting unfunded research?

A:  No, student-initiated research is not externally-sponsored - or- it is internally sponsored and therefore they are not required to submit a disclosure.

undergraduate student?  A:  Probably Not.  It’s unusual for an undergrad to significantly influence the design conduct or reporting of research.  However, if their PI wants them included on the WorkDay Committed Effort Table or named in an IRB or IACUC Protocol, then they must submit a disclosure. 

A: No. All members of the research team must complete the disclosure prior to the submission of the grant application. This timeline is based on the Public Health Service (PHS) COI regulations, 42 CFR part 50 Subpart F. 

A: Yes, but travel is no longer disclosed separately. Since moving the disclosure platform away from InfoEd into REDCap, we’ve incorporated the travel questions into the single annual disclosure.

A: The Research Integrity and Safety Group reviews the disclosure along with other pertinent information, such as your research roles and responsibilities.  If you have an outside relationship that potentially overlaps with your research, your case will be reviewed by the Committee on Individual Outside Interests, who meet monthly. The Committee determines whether the relationship creates a Conflict of Interest, and if so, decides an appropriate management plan that will be practical and effective in reducing the likelihood of decision-making bias.  Management Plans aim to reduce, manage or eliminate the conflict.

Domestic: when a non-monetary Outside Interest is received, it will be considered on the nature and value of the outside relationship.  If a monetary Outside Interest is received, it will be reviewed by the electronic system and/or administrative staff to determine if it is a “Significant interest” using the following thresholds:

• If the investigator is involved in research sponsored by an agency of the U.S. Public Health Service (PHS) or a sponsor that follows PHS regulations, then the Significant Interest threshold is $5,000 income, $5,000 equity, or any amount of non-public equity or external intellectual property revenue.

• If the individual is not involved in PHS-sponsored research, then the Significant Interest threshold is $10,000 income, public equity stock ownership with a fair value more than $40,000, or any amount of private equity stock ownership or external intellectual property revenue.

Foreign: All foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or foreign governments (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000) are considered to be a “Significant interest”.  All foreign relationships are reviewed by the University’s Export Control Officer.

A: Yes, you must complete the Conflict of Interest training module linked in the REDCap survey if you are involved in sponsored research.  This training module is approximately 12 minutes in length and different from the CITI training for human subject research.     

A: Supporting information varies by outside relationship, so the following list is not exhaustive, but may help you compile relevant information:

• Personal scheduling calendar, appointment journal, and travel records

• Formal written agreements and personal contracts with outside entities

• W-2 federal forms from institutions other than Saint Louis University and SSM Health

• 1099 federal forms are frequently issued by outside entities

• Quarterly statements showing your equity ownership in outside entities

• CMS Open Payments Search Tool can be used to search payments made by drug and medical device companies to physicians, physician assistants, and advanced practice nurses: https://openpaymentsdata.cms.gov/ 

A: Within 30 days of a significant change in your outside relationship (which could include (1) a relationship with a new outside entity, (2) a new role with the outside entity, or (3) a significant change in the value of an existing relationship), email coi@slu.edu and we will assist you in updating your REDCap disclosure.

A: Yes, you must complete the Conflict of Interest training module linked in the REDCap survey if you are involved in sponsored research.  This training module is approximately 12 minutes in length and different from the CITI training for human subject research.     

A: Yes, the Phase I grants from the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs encourage research with the potential for commercialization and are exempt from the determination of a Conflict of Interest by the University.  SLU supports participation in SBIR/STTR programs by its faculty, as this may allow faculty and their start-ups to make rapid progress towards commercialization of important inventions.  However, we remain mindful of the following types of issues that also occur with this class of research:

• Concern that the individual may be using their SLU lab, students, staff, funds or other SLU resources to support their start up, jeopardizing academic research and the progress of their students or staff;

• Blurring of the non-profit/for-profit boundary (i.e., use of SLU’s tax-exempt facilities in a way that competitively advantages a for-profit start up); and

• If the start up has licensed the IP from SLU, there exists a possibility of an institutional conflict of interest, whereby the University might benefit financially from the success of the start up that has licensed its technology.

A: An Institutional Official is someone who can affect the strategic direction of the University through their organizational role. IO’s include the President of Saint Louis University, Provost, Vice Presidents, Associate and Assistant Vice Presidents, Deans, Associate and Assistant Deans, and other individuals as determined by the University’s executive leadership.

A: Yes

A: No

A: Yes

A: No

A: Yes

A: The policy applies to health professions faculty and clinical, educational, and research support staff (including full time, part time, adjunct, volunteer); as well as health professions trainees at the undergraduate, graduate, and post-graduate level, (including fellows and residents); and Medical Center Administration.

A: The purpose of SLU’s Individual Outside Interest Policy describes the necessity for reporting, tracking, and monitoring relationships between healthcare providers and outside entitites in order to protect the learning environment and the patient-centeredness focus of all practitioners.

A: No. You do not need to disclose retirement and mutual funds if you (or your immediate family) do not personally make the investment decisions.

A: LCME Accreditation Standards expect a medical school to have effective policies and procedures for board members, faculty members, and any other individuals who participate in decision-making affecting the medical education program to avoid the impact of conflicts of interest in the operation of the medical education program, its associated clinical facilities, and any related enterprises.

A: The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal health care program business.

A: No, the Stark Law prohibits a physician from this practice.