October 9, 2014 Vanderbilt University Circa: 1901 Photo Courtesy Library of Congress Photo Archives.

25
VANDERBILT UNIVERSITY CONFLICT OF INTEREST AND COMMITMENT POLICY AND PROCESS October 9, 2014 Vanderbilt University Circa: 1901 Photo Courtesy Library of Congress Photo Archives

Transcript of October 9, 2014 Vanderbilt University Circa: 1901 Photo Courtesy Library of Congress Photo Archives.

VANDERBILT UNIVERSITYCONFLICT OF INTEREST AND COMMITMENT POLICY AND

PROCESS

October 9, 2014

Vanderbilt University Circa: 1901Photo Courtesy Library of Congress Photo Archives

What is a COI?

Individual conflicts of interest refer to situations in which an individual’s or family member’s financial, professional, or other personal considerations may directly or

indirectly affect, or have the appearance of affecting, an individual’s professional judgment

in exercising any university duty or responsibility, including the conduct or

reporting or research.

Why is this policy important?

The public may lose trust and confidence in Vanderbilt as a hospital, academic center or research institution.

Individual and institutional reputations could be harmed.

Many research sponsors require it in their contracts or grant terms and conditions.

The policy serves to protect BOTH the University’s interests and the interests of the faculty and staff who are disclosing.

Nashville Tennessee Newspaper Delivery boys in downtown Nashville;Circa: 1900-1910Photo Courtesy Library of Congress Archives Nashville Tennessee Collection

Conflict Disclosure

Who? Everyone – all VU Faculty and Staff

When? Every year and ALSO when

your circumstances change

Where? Online Web-based system

How? Login with your VUNetID and e-

password

Highlights of COI/COM Policy

Personal Interests in Vanderbilt Activities Business Relationships with Vanderbilt Gifts and Contributions University Assets Student Activities Family Members Conflict of Commitment Research Activities

1. Personal Interests in VU Activities

Avoid decisions in which you have a personal interest or an APPEARANCE of a personal interest:

Hiring Purchasing

Contracting/ConsultingNashville City HospitalCirca: 1890-1910Photo Courtesy Metropolitan Government Archives of Nashville and Davidson County

2. Business Relationships with VU

Avoid Situations in which you or a family member has a Business Relationship with VU

Includes spouse’s, children’s, parents’ businesses

Nashville Tennessee Maxwell House Hotel on 4th Ave.Circa: 1890-1910Photo Courtesy Metropolitan Government Archives of Nashville and Davidson County

3. Gifts and Contributions

No gifts or accommodations may be accepted by the University or individual members of the University if this puts them in a prejudicial or compromising position.

USS Nashville Gunboat "I Christen Thee"Circa: 1895Photo Courtesy Library of Congress Photo Archives

Gifts and Contributions

Gifts in support of the institutional mission must be directed through the Development Offices

Individuals may accept gifts, meals, entertainment, etc. no greater than $300/year/vendor from NON-HEALTHCARE INDUSTRY sources

$0 may be accepted from Healthcare by individuals

4. Use of University Assets

Misappropriation or unauthorized use of University assets in connection with external activities not allowed.

Assets include: buildings, personnel, equipment, patents, technology, and the University’s reputation.

Vanderbilt University Kissam HallCirca: 1900Photo Courtesy Library of Congress Photo Archives

5. Student Activities

Students, postdocs, or other trainees should not be assigned University projects sponsored by a business if the individual or family member has a SFI in the business.

Vanderbilt Class of 1912

6. Activities with Family Members

Members of the University may not participate in the hiring process or employment-related decisions regarding their family members.

Members should not be in a position to supervise a family member or review a family member’s work.

Downtown View #4 From the State CapitolCirca: 1864Originally Taken by: George N. BernardPhoto Courtesy Library of Congress Photo Archives

Activities with Family Members- Test Your Knowledge

You are hired to be the Director of a lab on campus. Your spouse is very good at organizing and keeping

track of your work for you. You can hire a administrative assistant to work in the lab, and you feel that she is the best person for the job. Is this allowed?

1. Yes2. No3. Maybe4. I don’t know

Activities with Family MembersTest Your Knowledge - Answer

No. You cannot hire, supervise or do job evaluations for a member of your family. If the family member is the only person qualified to do the specific job, another reporting hierarchy must be established.

7. Conflict of Commitment Distribution of effort between

University employment or faculty appointment and commitment to external activities.

Staff do not have allotted consulting days and are required to take vacation days for approved consulting time.

Time off for Faculty appointed on a nine-month basis should not exceed 40 days (including holidays) during the academic year.

Time off for Faculty appointed on a twelve-month basis should not exceed 50 days per year (including holidays).

Fort Negley showing Union troops and munitionsCirca: Civil WarPhoto Courtesy Library of Congress Archives

8. Research Activities

Conflicts of Interest in Research are situations in which Financial, Professional, or Personal considerations may compromise judgment in design, conduct, or reporting of research.

Southern Turf SaloonCirca: 1880-1910Photo Courtesy Library of Congress Archives Nashville Tennessee Collection

Research Activities

You should not be involved in the review, approval or control of the research if you or a family member has a SIGNIFICANT FINANCIAL INTEREST.

This is especially important if you are doing Human Subject Research as no research will receive final approval until the conflict of interest is addressed.

NSF, PHS, and FDA have specific guidelines regarding conflicts of interest.

PHS-Funded Research The SFI threshold is $5,000. Equity interest in any non-publicly traded company is

automatically an SFI. Travel may also be an SFI, so all travel related to your

institutional responsibilities must be reported (for PHS-funded faculty/staff only*).

There are specific exclusions from SFIs under the PHS regulations. (See the PHS website for more details).

Public Accessibility Requirement-Vanderbilt has chosen to provide a written response to

any requestor regarding SFIs for faculty/staff with PHS funding.• Investigator Training

-FCOI training is required for Investigators before engaging in PHS- funded research, every four years thereafter, and immediately under designated circumstances.

• Many other funding sources now follow the PHS regulations!

Research Activities – Test Your Knowledge

You have developed a survey tool that most school administrators would like to use. An education company has asked to license the

tool and pay for the license. Is this a reportable conflict?

1. Yes2. No3. Maybe4. I don’t

know

Research ActivitiesTest Your Knowledge - Answer

Probably. Since you could receive royalties for the licensing (as will Vanderbilt) and if your research will be funded by the same company (or involves the same technology), a management plan is necessary to address this potential conflict of interest. If Human Subjects are involved, the IRB would also have to approve, applying further scrutiny. When in doubt, go ahead and disclose the potential conflict!

Review of Disclosures

Initial Review by the Approver - Senior Associate Dean Cindy Kam has primary oversight of conflict of interest matters

in A&S- Sharon Buchanan performs initial reviews and and typically is the first point of contact in the Dean’s Office

Second Review performed by the Office of Conflict of Interest and Commitment Management

Third Review may be necessary by UCC

Considerations for Review

Does this disclosure constitute a conflict of interest?

If it is a conflict, can it be managed? If it can be managed, what requirements should

the management plan contain? Conflicts that cannot be managed are presented

to the UCC for resolution (ie cease and desist or other actions).

Management Plans

Plans are put into place to limit the risks to the University and the faculty/staff member with the conflict.

Having a “conflict” does not necessarily mean an activity is prohibited. In many cases, all that is needed is a management plan.

Initial oversight of all management plans remains a duty of the approver.

Questions about implementation of a management plan may be brought to the COI Office at any time.

YOU CAN ACCESS THE COI DISCLOSURE WEBSITE AT:

https://webapp.mis.vanderbilt.edu/coi/

QUESTIONS?

Contact [email protected] [email protected]

The ArcadePhoto courtesy Mike Slate