ara tahmassian, ph.d. chief research compliance officer

Ara Tahmassian, Ph.D.

Chief Research Compliance Officer

Harvard University

Presented at: Hokkaido University - Japan

September 17th, 2014

Appreciation

My gratitude to

• Ministry of Education, Culture, Sports, Science and Technology

• University of Tokyo Policy Alternatives Research Institute

• Professor Toshiya Watanabe

• Nahoko Ono, JD

For the invitation

Table of Content

• Introduction

• Definitions

• Types of conflicts of interest

• Management of conflicts

• Policy development

• Discussion

Introduction

• Over the past 10-15 years, multi-disciplinary research has resulted in changes in the research environment

• There is more “transitional research”

• Universities are being asked to transfer discoveries for public benefit

• Universities are good in “research” while industry is better in “development”

• Result is: More interaction with industry

Increased technology transfer from universities

Introduction (continued)

The interaction between industry and academia (both researchers and institutions) while beneficial presents potential conflicts of interest that must be managed in a manner that maintains:

• Objectivity in research: means the results of research project are not influenced by the relationship with industry

• Transparency: means any relationship is disclosed in full, publicly, and open to scrutiny

• The public trust: as the “external examiners” of our work and supporters of research funding; it is extremely important that the public trust and confidence is maintained

We need to manage both “real potentials” and “perceptions” to protect the credibility of the institution and the individual researchers.

Which Conflicts to Manage?

We should review and manage, any potential conflict when

there is a possibility that an outside financial interest could

directly and significantly affect the professional actions or

decisions relating to the University’s activities.

The activities could include:

Research

Teaching

Patient Care

Technology Transfer

Institutional Oversight Committees (e.g. Ethics Committee)

Types of Financial Conflicts of Interest

Two basic types of conflicts of interest may exist:

1. Individual Conflicts of Interest: These are situation in which a

financial or other personal considerations may compromise, or have

the appearance of compromising, the professional judgment of an

investigator in the conduct, evaluation, or reporting of the research.

Examples: professional relationship, consulting agreement; stock in the

company, etc.

2. Institutional Conflict of Interest: These are situations where the

institution and/or a Senior Official may have a financial interests

which may may compromise, or have the appearance of

compromising the conduct, evaluation, or reporting of the research.

Examples: stock equity in the company sponsoring research, Sr. Official

serving on the Board of Directors of the Company

Definition of Interest - Individual

Financial Interest: Exists when the Investigator, the

Investigator’s spouse, and/or dependent children, are

financially invested in, and/or receive compensation from

any of the following:

Publicly traded entities

Non-publicly traded entities

Positions outside of University employment

Intellectual Property rights or interest

Significant Financial Interest (SFI): When the

compensation or pay from the financial interest EXCEEDS a

threshold (e.g. $5,000).

Definition of Interest - Institutional

In 2009, the Institute of Medicine *(IOM) report on Conflict of

Interest in Medical Research, Education, and Practice; stated:

“Institutional conflicts of interest arise when an institution’s own

financial interests or the interests of its senior officials pose risks

to the integrity of the institution’s primary interests and missions.

Institutional conflicts typically appear when research conducted

within an institution could affect the value of equity that the

institution holds in a company or the value of a patent that the

institution licenses to a company”

*Report issued by: Committee on Conflict of Interest in Medical Research,

Education, and Practice; Institute of Medicine (2009)

Definition of Investigator

• Investigator:

• Any person who is responsible for the design, conduct or

reporting of Research under the auspices of the

University.

This includes, but is not limited to, the Principal

Investigator (PI), Co-Investigator, Project Director (PD),

Co- PD, Senior/Key Personnel and any other persons

involved in the Conduct of Research, regardless of title

or position.

An individual’s position, title on the project, employment

status, or percent of effort devoted to the project do not

impact the definition of Investigator.

What are Possible Institutional Conflicts?

Potential sources of institutional conflict of interest may arise from:

• Payment to University Officials (e.g. serving on a Board of Directors)

• Procurement of goods and services (e.g. purchasing equipment or supplies for research)

• Major gifts from commercial sponsors

• University Investments

• Technology Transfer

Licensing

Start-up Equity

Sponsored Research agreements with companies

What Does Managing a Conflict Mean?

It really means developing a POLICY and PROCEDURES that describes the full process that includes:

• Disclosure: Disclose all potential conflicts of interest

• Review: Review conflicts in an objective manner (Policy)

• Impact: Determine potential impacts on objectivity or reputational risks

• Management: Develop a method to eliminate or reduce the risks to an acceptable level

The process can be managed by a Financial Conflict of Interest Review Committee made-up of faculty, administrators and public

Management Of Individual Conflict of Interest

• Investigators involved with the project disclose all relevant information

• the Committee reviews the information

• Determines if there is a conflict (e.g. is the company for which the investigator is a consultant going to benefit from the research?)

• If yes: determines if it is “significant”

• If yes: develop a management plan that follows the institution’s Individual Conflict of Interest Policy

• Inform the investigator of the management plan

• Monitor the plan

Management of Institutional Conflict of Interest

Develop an Institutional Conflict of Interest

Policy to address all potential situations where a

conflict may arise; these include:

• Payments to University’s Senior Officials and

Administrators

• Procurement of goods and services

• Major gifts from commercial sponsors

• University Investments

• Technology Transfer

Consideration for Policy

When developing your policy, consider the following issues:

• What is the effective date of the new policy?

• How will you manage the existing conflicts after the new policy

becomes effective?

Will you grandfather them?

Will you change after a period of time?

• What impact does the new policy have on other existing policies?

Will other policies have to be changes?

Will all the offices involved be able to implement the policy?

• How will sensitive information be managed (e.g. confidentiality)?

• Will there be a single Committee for both Individual and Institutional

Conflicts of Interest review?

• Diversity of cultural factors within the institution (e.g. biomedical

research, involvement of human subject, engineering, etc.)

Payment to Senior Officials and Administrators

Who should be covered?

Those who are in a position to make decisions or influence business or research at the university:

• Presidents, Vice Presidents, Chancellors, Vice Chancellor, Provosts, Vice Provosts, deans, department chairs, institute/center directors, IRB/Ethics Committee chairs, COI Committees, Research Review Committees, etc.)

• Income from royalties, equity, consulting, honoraria, gifts, other payments

Policy should clearly define:

• Who is covered, what are the limits of acceptable gifts, payments, etc., before approval is needed;

• Who approves it

• How often do they disclose (e.g. annually)

• Reporting of potential conflicts when the become aware

• Recusal from decisions and documentation

• Appeal Process

Procurement of goods and services

Who is covered?

Anyone who is authorized to decide on purchase

equipment, supplies and services on behalf of the

from companies that sponsor research at the

institution

Procurement Policy should clearly define:

• Who is covered,

• What are the thresholds for price

• Who approves it

Major Gifts From Commercial Sponsors

What is Covered?

Major gifts from companies that sponsor research at the university

Gifts Policy should clearly define: What is

• What is the purpose of the gift (e.g. no- restriction, scholarship,

professorship, building, research, etc.)?

• Is it a gift (i.e. do they want anything delivered, licensing or IP access)?

• Does it impose any limitations on the ethical conduct and reporting of

research, or violate any ethical standards?

• Does it follow the institution’s gift policy?

• Who reviews the proposed gift?

University Investments

What is covered?

University investment of funds (e.g. endowments) in companies that

sponsor research at the University

Investment Policy should clearly define:

• The firewall between investment management and research

• Investment mangers should be forbidden from communicating with

university officials or faculty conducting research regarding the conduct

or interpretation of results

Technology Transfer

What is covered?

Potential areas of conflict of interest include

Licensing

Start-up Equity

Sponsored Research Agreements

Policy should clearly define:

• What is covered?

• What is acceptable?

• How are decisions made?

• Who reviews them?

Technology Transfer- Licensing

Licensing Policy should define:

• Can the licensee sponsor research at the university?

• Can the research group have a interest in the Intellectual

Property (IP) subject to licensing?

• What if there is no income/payment from IP?

• How is it disclosed?

• Who manages the licensing?

• How is it determined that the license terms are the best?

Technology Transfer- Start-Up Equity

What is covered?

Anytime the University takes equity in a start-up with ties to the university (e.g. equity in lieu of licensing fees or royalties).

Institutional Policy should:

• Acknowledge that increase in value of company directly impacts the university equity

• How University decisions about research are made so they are not influenced by the equity holding

• Describe the management process by controlling who holds position in the start-up company

Important one is fiduciary responsibility such as board of directors, CEO, CFO, Chief science advisor, etc.

Sponsored Research Agreements

What is covered?

Situation where a company, in which there is an institutional

conflict of interest, wants to sponsor research at the

University

• This is one of the more sensitive areas that is most likely to

create the perception of influencing the “objectivity of

research”.

• There should be careful scrutiny for each instance and

regular reviews and monitoring

Sponsored Research Agreements – Policy Considerations

• Can the company in which the university has equity or licensing agreement sponsor research at the university?

• How do you manage the perception that the university is being used a “laboratory for the company”?

• Can it be in the researcher’s lab that also has the IP or equity in the company?

Is there limitation on what can be done?

What percentage of total research can be from the company?

• How do you manage the participation of students?

• How about staff in the lab?

• Is there a difference in what can be done based on risk?

Basic Research?

Development or prototype?

Pre-clinical?

Human subjects?

• What is the review and approval process?

One Policy?

Should there should be one policy to cover all the elements discussed?

• Depends on institutional preference

• One policy is more complex to develop and manage

• Most institutions prefer to have have specific language about “conflicts of interest” in individual policies such as their: Gift Policy

Investment Policy

Senior officials Conflict of Interest Policy

Technology Transfer Policy

Etc.

One Committee?

• The link between Individual and Institutional often exists

• They are not totally separate

• A Sr. Official could also be a Investigator on a grant with

equity or IP interest

• Preference to have a single office coordinating all so there

is “full picture”

• One Committee to manage all potential conflicts of interest

related to research

Practical Considerations

• Having a conflict is not necessarily bad – researchers are contacted to serve of committees, advisory boards, review panels, etc., because of their expertize in the field.

• Interactions with Industry is essential – as stated previously University based discoveries need to be transferred for the betterment of the society and industry is a key partner in this effort.

• Maintaining objectivity - focus of conflict of interest policy is the preservation of objectivity and integrity of research

• Flexibility – any policy needs to be flexible and adaptable to the circumstances of each case. Rigid policies designed for “one size fits all” are often detrimental to the mission of the university and difficult to implement

• Risk based – the policy and procedures should be risk based

• Consistency – once a policy and procedure is in place, they must be implemented consistently for a similar case to maintain credibility of the process.


• Transparency – determine, in advance, what information can be

disclosed publicly if asked

• Research integrity – regardless of the importance of interaction with

the industry the most important factor for a University is ensuring that

research integrity is not compromised

• Training – a successful program should have a training program for all

stakeholders including:

Investigators

Senior Administrators

Procurement Officials

Technology Transfer Officers

Sponsored Research Administrators

Conflict of Interest Committee members


• Management plans – management plans are the final documents

describing the outcome of the review, if there is a conflict, is it

significant, and finally how will the conflict be managed. For an

effective management plan:

Briefly describe the process (could be a standard template)

List conflicts identified and if they are significant

Clearly describe what must be done to manage the conflict and by whom

Decide whether a draft will be shared with the investigator for their input

Define the effective date of the management plan

Clearly list and follow-up actions, or reports, that the investigator must

provide and the timeline for the actions or reports


• Authority – the policy and procedures should define who has the

authority for approving what; if necessary there may be multiple

approvals from different offices, but one final authority

• Exceptions – policy should have a clear statement if exceptions are

allowed, what are some types, how are they reviewed and who

approves them, and how are the logic and decision making for the

exemption documented?

• Appeal process – describe the process for appealing a decision by

Conflict of Interest Committee or final authority in approval process

How to appeal?

How to appeal to?

Who is the final authority in appeal process?


• Monitoring – develop a monitoring program as part of the policy and

procedures to check implementation of any management plan that has

been developed

• Updates – define the process of obtaining updates on the information

provided, which information elements should be updated, and the

frequency (e.g. annually)

• Non-Compliance – clearly define what are the consequences of non-

compliance and enforce in a consistent manner

ara tahmassian, ph.d. chief research compliance officer

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