Research@UIC > Conflict of Commitment and Interest >Preparing Conflict of Interest (COI) Statement of Explanation and Management (SEAM)

Guidelines for preparing the Statement of Explanation And Management (SEAM) Form

Form - Statement of Explanation and Management (SEAM) UPDATED!

This page contains guidance for preparing the Statement of Explanation and Management (SEAM) form. The SEAM explains the situation giving rise to conflict and presents the management techniques in place to manage the conflict. It covers the areas outlined below. We recommend you contact the COI office for guidance before submitting a funding proposal or human subjects research protocol disclosing a potential COI. Doing so facilitates the submission and review process.

Disclosure & Management
1. Elimination of the conflict
2. Reduction or Management of conflict
  1. RNUA-Management Plan (RNUA-MP)
  2. Statement of Explanation and Management (SEAM)
SEAM Content
SEAM Review Process

I. Disclosure & Management

A conflict of interest is a function of the situation, and does not imply improper behavior. Potential and actual conflicts of interest must always be disclosed. Once disclosed, potential or actual conflicts of interest should be managed, reduced, or eliminated.

A. Elimination of the conflict

For situations in which the elimination of the potential conflict of interest is desired (e.g. where reduction or management is insufficient to protect the objectivity of the research), several options are possible. For example:

the conflicted individual may elect to cease consulting for the study sponsor or to divest his/her ownership interests in the company sponsoring the study.

the conflicted individual may choose not to participate in the study, and have the study conducted by an independent investigator.

B. Reduction or management of the conflict

For situations in which the reduction or management of the potential conflicts of interest is desired, then you are required to disclose and manage activities using (i) the Report of Non-University Activities (RNUA) and (ii) the Statement of Explanation and Management (SEAM) form.

i. Report of Non-University Activities (RNUA) and RNUA-Management Plan (RNUA-MP)

The annual Report of Non-University Activities (RNUA) process is described here. We recommend that you check that your RNUA form lists the activities with the external entity related to the study and that your RNUA form is approved by your Unit Executive Officer. If activities are not listed, you should submit a revised RNUA form to your Unit Executive Officer before engaging in any non-University income-producing activities.

When an academic staff member’s company will license University intellectual property, then an RNUA-Management Plan (RNUA-MP) is required prior to the execution of the license agreement. RNUA-MPs are annual reports that present general information about the company which includes “Terms and Conditions” that the academic staff member must follow (Section II, B).

Unless otherwise agreed to by the University, all sponsored research agreements with the Company will be negotiated by appropriate University personnel. The conflicted academic staff member(s) or other conflicted persons may not be involved in these negotiations.

The academic staff member will disclose all conflicts of interest on all protocol/proposal applications (e.g., Institutional Review Board (IRB) applications, Proposal Approval Forms/ PAF, etc.) as required, and complete a protocol-specific Statement of Explanation and Management (SEAM) for all transactional disclosures.

ii. Statement of Explanation and Management (SEAM)

The Statement of Explanation and Management (SEAM) form is required when significant financial conflicts of interest are disclosed on proposals or human subjects research applications. Guidelines on drafting the SEAM follow below. We recommended that you contact the COI office prior to submitting a proposal or human subjects research application in which a COI is disclosed. The COI office will work with you to provide feedback on your SEAM drafts.

II. SEAM Content

The Statement of Explanation And Management (SEAM) form includes the following sections:

A. Threshold for significance

“Significant” financial interest means having a financial interests in business enterprises or entities that (when aggregated for the individual, one’s spouse or domestic partner, parents, siblings, and children) meets or exceeds $5,000 or 5% or more ownership (equity) regardless of dollar value. The $5,000 threshold also applies to salary, royalties, and other payments aggregated for the individual, one’s spouse or domestic partner, parents, siblings, and children expected over the next 12 months.

Does the relationship with the external entity meet the threshold of significance?

YES: You should continue to complete the remaining sections of the SEAM and submit a draft to the COI Office for feedback.

NO: You may consult the COI Office, but typically, when the relationship does not reach the threshold for significance, then disclosure by the investigator is optional and disclosure may be sufficient to manage the conflict. The COI Office does not advise on further management techniques when the disclosure is not significant.

B. Relationship with the external entity

Indicate the conflicted investigator’s name and the name of company or external entity with which the investigator has a relationship.

Indicate all that apply and explain. Provide sufficient detail to describe the relationship with the external entity.

Ownership interest/investment

Consulting/Salary/Equity

Other (e.g. University ownership of intellectual property, fiduciary role with the external entity, etc.)

C. Conflicted investigator’s role and function in the study

Describe the conflicted person’s role and function in the study. You should indicate all that apply:

Design

Conduct

Reporting (including authorship)

You may provide additional explanation about the role of the conflicted investigator in the study.

SBIRs/STTRs

As funding mechanisms, SBIRs and STTRs are made to small business concerns, and involve subcontracts to research institutions. The mechanism does not necessarily create a conflict of interest for university personnel involved in the project, but such conflicts are frequently introduced. Should any actual or potential conflicts of interest exist, they must be properly managed. Management mechanisms must be applied as appropriate given the specific situation. Some general issues to be aware of include the following:

These funding mechanisms involve a primary grant to the small business concern and a subcontract to the university. Thus there are two PIs; one is PI for the company; one is PI for the university. Barring extraordinary circumstances, the same individual should not serve as PI on both.

The tasks conducted at the company and at the university should be clearly distinguishable from each other.

Any University employees being compensated through the subcontract should not receive compensation for the same task from the company.

D. Justification (Rebuttable Presumption)

Provide justification for the conflicted investigator’s involvement in the study. The investigator may have special skills, knowledge, techniques, resources, etc., or the nature of the work may be such that the conflict cannot have an effect on the outcome.)

For studies involving human subjects research, the principle of rebuttable presumption applies. According to the Investigator Conflict of Interest Disclosure Policy for Human Subjects Research, rebuttable presumption is defined as:
Rebuttable presumption: An assumption that an investigator with a significant financial interest may not be involved in research that uses human subjects.

The rule is not intended to be absolute; an investigator with a significant financial interest may rebut the presumption by demonstrating facts that constitute compelling circumstances, in the opinion of the reviewing bodies (Unit Executive Officer, Conflict of Interest Officer, Conflict Review Committee, COI-Human Subjects Research subcommittee, and Institutional Review Board).

If compelling circumstances are found, the individual is allowed to design, conduct, report, or manage the research under conditions specified in an approved management plan (SEAM) and in accordance with regulatory and ethical requirements.

An investigator with a significant financial stake in the outcome of the research will need to provide both a sufficient reason detailing his/her unique contribution to the research and a reasonable plan that will protect human subjects, the research data, and the integrity of the Human Subjects Protection Program.

E. Conflict management techniques

i. Standard management mechanisms
These management mechanisms are required unless there is a special circumstance that warrants an exception to exclude these management mechanisms:

The relationship with the external entity giving rise to the COI must be disclosed on the RNUA (Report of Non-University Activities) and must be approved by the Unit Executive Officer.

The external entity may not have access to non-publicly available information unless agreed to by the University.

No University resources may be utilized for the benefit of the external entity without prior written agreement from the University.

ii. Additional management mechanisms
Most studies already include practices or mechanisms which help reduce or manage conflicts of interest, and if so, they should be indicated on the SEAM. The COI Office may further recommend including some of the management mechanisms listed below.

A conflict management plan has been approved by the Vice Chancellor for Research. You should indicate the name of the investigator with the RNUA-Management Plan and the company or external entity’s name.

The researchers will employ an impartial review mechanism.

Impartial Review

When a significant financial interest has been disclosed the COI Office typically recommends oversight of the sponsored research project to help ensure that the results are not biased. Guidelines for nominating an impartial reviewer and conducting the impartial review are available here.

General principles on selecting an impartial reviewer:

The impartial reviewer can be, but need not be, someone from within the UIC community.

The impartial reviewer should not have a conflict of interest related to the research.

The impartial reviewer should not have a university reporting line to the conflicted person.

The impartial reviewer should not be one of his/her research collaborators.

The conflict will be disclosed in publications, presentations, etc. according to the norms of each publication venue.

The conflict will be disclosed to other research personnel (e.g., co-investigators, fellows, students).

The COI will be disclosed to the PIs of all study sites. The UIC PI will disclose the potential COI to the PIs of the other study sites (if UIC is primary site) or to the PI at the primary institution, who will follow their institutional policies pertaining to notifying their IRB (human subjects) or IACUC (animal subjects) as applicable of potential conflicts of interest and follow the recommendations of their IRB/IACUC.

The conflicted person will not be involved in data collection or data entry.

The conflicted person will not be involved in data analysis or the dataset will be given to an independent statistician for analysis.

The protocol is an analysis of existing data. If the study involves human subjects research, then indicate whether the data is de-identified; a limited data set; or other and describe.

Non-conflicted individuals will be involved in study development (design, conduct, reporting).

This is a multi-center trial, at which UIC is just one site. If so, then indicate what percent of the total study population will be enrolled at UIC?

The study uses a blinded design (e.g., double- or triple-blind).

The study includes oversight by an independent advisory board that will monitor the data (e.g. Data Safety Monitoring Board, Contract Research Organization, Scientific Advisory Board).

A monitoring board has a priori rules (e.g., safety and efficacy) for stopping the study.

iii. Management mechanisms for human subjects research

If the study involves human subjects research, the Institutional Review Board (IRB) has final authority regarding whether the conflict management techniques are appropriate or if additional safeguards are needed to protect the rights and welfare of the subjects. The conflict must be disclosed to the IRB. See also the “Investigator Conflict of Interest Disclosure Policy for Human Subjects Research.”

Most human subjects research studies already include practices or mechanisms which help reduce or manage conflicts of interest, and if so, they should be indicated on the SEAM. The COI Office may further recommend including some of the management mechanisms listed below.

The conflict has been/will be disclosed to the IRB and the investigators agree to follow all IRB recommendations regarding conflict management.

The COI will be disclosed to the sponsor of the research (for clinical trials).

The conflict will be disclosed to potential research participants during the informed consent process.

Disclosure in informed consent

As a general principle, informed consent documents include the disclosure of potential conflicts of interest. If you are required to disclose the Conflict of Interest in the consent form, the COI office has model language available.

The conflicted person will not solicit informed consent.

The study design includes a non-conflicted medical monitor.

A non-conflicted individual serves as research subjects’ advocate or ombudsperson.

The protocol presents no more than minimal risk to research subjects.

The protocol will undergo increased frequency of continuing review and/or monitoring by the IRB.

III. SEAM Review Process

A. Unit Executive Officer review and approval of the SEAM

The SEAM requires the review and approval of the Unit Executive Officer (UEO), which is typically the department head or department chair. By signing the SEAM, the UEO agrees to monitor the management mechanisms described in the SEAM. The UEO’s signature also indicates that the UEO deems that the SEAM includes management mechanisms which are sufficient means to manage, reduce or eliminate financial conflicts of interest disclosed on the study.

B. Expedited review of financial COI disclosures (PAF)

The Conflict of Interest Office conducts an expedited review of the SEAMs following the VCR approved guidelines on “Expedited Review of Financial Conflicts of Interest Disclosures (PAF).” Review procedures are described in the guidelines.

C. Expedited review of COI disclosures on IRB applications

At the request of the Institutional Review Board (IRB), the Conflict of Interest Office conducts an expedited review of the SEAMs following the VCR approved guidelines on “Expedited Review of Conflicts of Interest Disclosures on IRB Applications.” Review procedures are described in the guidelines.

The IRB has final authority for approving research protocols, which includes evaluating whether the conflict management techniques are sufficient to protect the rights and welfare of the subjects.