CRA conflict of interest and Bioethics

conflict of interest

A conflict of interest exists when two or more contradictory interests relate to an activity by an individual or an institution. The conflict lies in the situation, not in any behavior or lack of behavior of the individual. That means that a conflict of interest is not intrinsically a bad thing.  Examples include a conflict between financial gain and meticulous completion and reporting of a research study or between responsibilities as an investigator and as a treating physician for the same trial participant.  Institutional examples include the unbalancing of the institutional mission by agreeing to the space requests of a large donor for an individual program.

Bioethics

A field of study concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments such as organ transplants, genetic engineering, and care of the terminally ill.

Significant Financial Interest (SFI)

A financial interest of the Investigator (and those of the Investigator's spouse and dependent children) that: reasonably appears to be related to the Investigator's institutional responsibilities (the Investigator's professional responsibilities on behalf of the Institution) and consists of one or more of the interests identified as a Significant Financial Interest in the regulations. This includes anything of monetary value, such as (but not limited to): Salary or other payments for services (e.g., consulting fees or honoraria) Equity interests (e.g., stocks, stock options or other ownership interests) Intellectual property rights (e.g., patents, copyrights and royalties from such rights)

Determining if it's a COI

A review is taken to determine whether an Investigator's disclosure of a significant financial interest related to their institutional responsibilities is related to the sponsored research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related to sponsored research when the University, through its designated official(s), reasonably determines that the significant financial interest: Could be affected by the sponsored research; or Is in an entity whose financial interest could be affected by the research.

Basic Bioethics Principles

Influenced by Nuremberg Code and the Declaration of Helsinki: Respect for people's rights, autonomy and dignity. Beneficence: Benefits must be proportionate to risks. Justice: The even distribution of benefits and risks throughout society.

Decision-making organizations

Internal Review Boards (IRB's) Presidential Commission for the Study of Bioethical Issues: Commission Established by Executive Order 10 members selected by Executive Office of the President, leaders in medicine, science, ethics, religion, law and engineering Advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology Holds public meetings, and develops public reports and materials. Accepts suggestions from executive departments/agencies and from the public NIH Office of Clinical Research & Bioethics Policy (OCRBP): Mission is planning, developing, and coordinating NIH-wide policy activities for clinical and health care research, as well as promoting full integration of bioethical considerations as foundational to NIH-supported research. 3 main areas of emphasis: Clinical research and protections for human subjects: Adverse Event Reporting Bioethics and NIH-funded research Clinical Trials Ethical Issues in International Research IRB review NIH Data and Safety Monitoring Privacy and Confidentiality in Research Research Involving Human Subjects Genomics research: Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) and the draft Genomic Data Sharing Policy, governance of Genomic Testing Registry. Translation of research findings into healthcare: collection and research use of health-related data, dissemination of findings into health care, policies on best practice for clinical interventions and research in health care settings.

Reporting of Financial Conflict of Interests

PHS: reporting FCOIs is specific to PHS sponsors where reporting FCOIs is a federal requirement. Investigators are required to disclose to an official designated by the institution a listing of significant financial interests that would reasonably appear to be affected by the research proposed for funding. Institutionally: Tufts policy requires the disclosure of financial interests or associations with other organizations including reimbursed or sponsored travel that could directly and significantly affect the design, conduct, or reporting of the funded research.

if there is a COI

Reduce, Eliminate or Manage A financial conflict of interest exists when it was reasonably determined that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the sponsored research. Management of an identified financial conflict of interest requires development and implementation of a management plan. In cases where the University determines it cannot manage the conflict, it may require the conflict be eliminated or the research not proceed. Factors in this decision might include such considerations as the involvement of human subjects in the research; the level of risk involved, the nature and significance of the conflict, the potential for having a serious adverse impact on the scientific field or on the reputation of the University, and the level of difficulty involved in managing the conflict relative to the benefit of doing the research. Examples of conditions or restrictions that might be imposed but are not limited to: Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research); For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest; Modification of the research plan; Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; Reduction or elimination of the financial interest (e.g., sale of an equity interest); or Severance of relationships that create financial conflicts.

COI Management Plan

Reduce: Impose restrictions such as Appointment of an independent monitor, change of research plan..... Eliminate: In cases where the University determines it cannot manage the conflict, it may require the conflict be eliminated or the research not proceed. Manage: Disclose the support the Investigator received from other entities. Disclose the Investigator's financial relationship with company. Describe the steps taken to inform current or new students and other trainees of the conflict of interest.

Conflict of Interest: Definition

Situations in which financial or other personal considerations may compromise, or have the potential of compromising a researcher's professional judgement in conducting or reporting a federally funded research. The potential for personal gain or the existence of competing interests must not jeopardize or appear to jeopardize the integrity of the research, its design, or the interpretation or reporting of research results.

The Institution's responsibility

The PHS regulation requires that each Institution maintain a written, enforced policy on conflict of interest that conforms with the following requirements: Complies with the regulation; Informs each Investigator of the Institution's policy as well as the regulation; Informs each Investigator of his or her reporting responsibilities; Provides adequate guidelines for enforcement mechanisms and sanctions where appropriate.

SFI doesn't include

The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Tufts to the Investigator if the Investigator is currently employed or otherwise appointed by Tufts, including intellectual property rights assigned to Tufts and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization i.e., STTR and SBIR; 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 Federal, state, or local government agency, an Institution of higher education an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Who is required to disclose financial interests?

Under the PHS regulation through its implementation by the Institution, Investigators are required to disclose to an official(s) designated by the Institution: a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that would reasonably appear to be affected by the research for which NIH funding is sought, and in entities whose financial interests would reasonably appear to be affected by the research.

financial conflict of interest (FCOI)

an Investigator's SFI that the Institution determines could directly and significantly affect the design, conduct, or reporting of federally- funded research.

investigator

project director or principal investigator any other person, regardless of title or position, who is responsible for: the design, conduct, or reporting of research funded by the a sponsor, or proposed for such funding, which may include, for example, collaborators or consultants.

Institutional Responsibilities

means an Investigator's professional responsibilities on behalf of Tufts University. That is, all activities that derive or descend from the investigator's standing or expertise and are tied to those responsibilities and activities the investigator was hired to perform and for which the investigator is paid by the University. Some examples are, research, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Not considered FCOI per PHS if:

salary, royalties, or other remuneration from the Institution; any ownership interests in the Institution, if the Institution is an applicant under the SBIR and STTR programs income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; income from service on advisory committees or review panels for public or nonprofit entities; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization i.e., STTR and SBIR an equity interest that, when aggregated for the Investigator and the Investigator's spouse and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.