ניגוד עניינים כספי

Regulations for Preventing Conflict of Interest in Research

(Approved by the Senate on ___________________)

Introduction

The University of Haifa is committed to the quality of the research conducted under its authority. In order to support research activity, the University of Haifa insists that all those engaged in research strictly implement the rules of conduct applicable to research, including the rules for preventing conflict of interest in research as detailed in these regulations.

1. Objective

a) These regulations are intended to insure that those engaged in research, as defined hereinafter, carry out their research and the accompanying activities while conducting themselves in a manner appropriate to research, that is, in a manner that is professional, independent, impartial and without any secondary interests, all this in order to avoid reaching a situation of research conflict of interest.

b) Included in these regulations are a number of basic rules constituting the framework for proper research conduct and based upon professional and ethical standards.

c) Every provision among the provisions set out in these regulations and/or among its related documents and provisions is to be interpreted in light of its aforementioned objective and is binding upon all those engaged in research under the authority of the University.

2. Definitions (list is not all-inclusive)

a) University: University of Haifa

b) Carmel: Carmel Ltd., The Technology Transfer Organization (TTO) of the University of Haifa, Private Company No. 513257022.

c) Individuals engaged in research: University of Haifa employees, pensioners, guests and students pursuing master's and doctoral degrees, who are involved in planning research, submitting research proposals for funding, administering or reporting on research, or making decisions regarding the commercialization of said research, as well as any individual who makes use of the resources of the University and/or is involved in research with any of the people designated above.

d) Secondary interests: Including personal, professional, financial, commercial and any other considerations liable to contravene the purpose of the research and/or the regulations. Such a secondary interest can be in the interest of those who are themselves engaged in the research, of their close family members, their close friends, of funding organizations or of any other individual or organization.

3. Status of these regulations

a) Inter alia, these regulations for all intents and purposes constitute a policy document for handling financial conflicts of interest (Financial Conflicts of Interest Policy).

b) These regulations are intended to add to any other provision and/or document regarding proper research conduct, to the laws of the State of Israel and to the basic documents of the University, and are not meant to detract from these and/or the University's procedures and its academic and other regulations.

4. Research funding

a) Requests for research funding shall be submitted in accordance to the regulations of the University and the regulations of the external funding foundations, as relevant.

b) The individual submitting the request is responsible for making sure that the proposal contains accurate and complete information, that it is scientifically valid and that it is budgeted in accordance with the work plan.

c) After receiving funding, the individual engaged in research is responsible for seeing to it that the monies are used for the purpose to which they are designated, without any secondary interests taken into account, and for maintaining the rules of reporting to which said individual is obligated.

5. Conflict of interest in research

a) A conflict of interest in research exists when a suspicion arises that a secondary interest will divert the independent and professional judgment required by the research. The test for determining whether a conflict of interest exists is an objective test. That is, it is sufficient that from the perspective of the objective data and on the basis of considerations based on life experience and common sense a situation is liable to arise in which conflict of interest is suspected. If any doubt arises based upon the personal feeling of the individual engaged in research regarding the degree of influence exerted by secondary interests, then said individual engaged in research must take stringent action to eliminate this doubt and must report this to the Vice President and Dean of Research and to all relevant bodies in accordance with these regulations.

b) The Vice President and Dean of Research will act in this matter in accordance with his professional judgment while consulting with relevant bodies.

c) Those engaged in research will be considered tarnished by substantive, anticipated or potential conflict of interest when, inter alia, there exists a substantive, anticipated or potential possibility that secondary interests will divert their independent and professional judgment required for academic research, as outlined in the following:

1) Substantive conflict of interest:

A situation in which a possibility exists that the independent and professional judgment required for academic research will be diverted by secondary interests.

2) Anticipated conflict of interest:

A situation in which it appears to a reasonable individual that there is a reasonable chance that the independent and professional judgment of the researcher will be diverted.

3) Potential conflict of interest:

A situation liable to develop into substantive or anticipated conflict of interest.

d) Typical though not exhaustive situations in which conflicts of interest in research arise:

1) When those engaged in research (or their close relatives, close friends, students or any individual or organization with which they are associated) are connected to the organization funding the research in a way that enables them to derive from the research direct or indirect financial profits beyond the addition to their salary customary at the University, a substantive conflict of interest exists, which requires disclosure and administration under the supervisory arrangement defined hereinafter. Even when no possibility exists of deriving financial profits, an anticipated conflict of interest still exists, which requires disclosure and administration under the supervisory arrangement defined hereinafter. When one of the individuals mentioned above considers making contact with the funding organization, a potential conflict of interest exists, which requires disclosure and administration under the supervisory arrangement defined hereinafter.

2) When the body funding the research has a financial interest or some other non-academic interest in the results of the research, e.g., commercialization, a substantive conflict of interest does not always exist. Nevertheless, such a situation is liable to constitute an anticipated conflict of interest, which requires disclosure and administration under the supervisory arrangement defined hereinafter, and said situation is even liable to constitute a potential conflict of interest, which requires disclosure and administration under the supervisory arrangement defined hereinafter.

3) When the funding organization or those engaged in the research (or their close relatives, close friends or students) or any organization to which those engaged in the research have an association or interest are interested in or liable to derive benefit from the postponement of publication, from partial or misleading publication, or from the lack of publication of the research results, a substantive conflict of interest exists, which requires disclosure and administration under the supervisory arrangement defined hereinafter.

4) Inasmuch as an individual involved in research who has a personal interest is liable to be affected by the course or the results of the research, said individual has a substantive conflict of interest which requires disclosure and administration under the supervisory arrangement defined hereinafter. Included in "personal interest" are the personal interests of said individual's relatives or the interests of an organization in which the individual engaged in research or said individual's relatives manage or belong to or are responsible employees of, or the interest of an organization in which any of these aforesaid individuals holds shares, the right to receive profits, the right to appoint a director or voting rights. For the avoidance of doubt it is hereby clarified that minimal holdings in corporations whose shares are traded on the public stock exchange, directly or indirectly, under the framework of securities portfolios and/or mutual funds, pension funds, etc., as is customary among a large portion of individuals in the population, will not be considered a matter of personal interest.

5) When personal gain or significant personal or professional benefits (deviating from ordinary professional advancement) are dependent upon the results of the research, this constitutes a substantive conflict of interest which requires disclosure and administration under the supervisory arrangement defined hereinafter.

6. Committee for the Prevention of Conflict of Interest in Research

The University will establish a committee for the prevention of conflict of interest in research in order to prevent, control and solve conflicts of interest as they emerge, and in order to provide consultation in situations liable to develop into situations of conflict of interest in research ("Committee for the Prevention of Conflict of Interest in Research" or "Committee").

a) Committee Composition

1) The Committee will be composed of seven members: The Vice President and Dean of Research, four members who are full professors and who represent the various research areas at the University, a representative of Carmel, and the Director of the Research Authority. The Vice President and Dean of Research will serve as Committee Chair.

2) The members of the Committee will be appointed by the University Standing Committee upon the recommendation of the Rector. Members will be appointed for three years, and the appointment period can be extended by an additional three years.

3) As a rule, no more than 30% of the members of the Committee will be replaced at one time in order to ensure continuity in the work of the Committee.

b) Committee Activities and Authorities

In any case that is brought to the attention of the Committee for the Prevention of Conflict of Interest in Research, whether by the Research Authority, by disclosure on the part of an individual engaged in research or by consultation with an individual engaged in research, the Committee will decide how to act. If required, the Chair of the Committee will appoint two members from among the members of the Committee with voting rights, of whom at least one comes from a field close to that of the individual engaged in research whose interests are under consideration. The Chair and these two members will decide how to closely supervise the conflict of interest and to prevent it from being abused ("Supervisory Panel"). The Committee member representing Carmel can be added to the Supervisory Panel.

The Committee is authorized to decide as follows:

1) that the situation does not require any treatment;

2) that the individual engaged in research must disclose the conflict of interest to stipulated individuals or organizations;

3) that the research plan must be changed, to the extent possible, in a way that will prevent conflict of interest or will improve its administration by the Supervisory Panel;

4) that an individual must be appointed to independently supervise the research plan, administration or reporting, in coordination with the individual engaged in research;

5) that the individual engaged in research must exempt himself from financial interests in the organization funding the research or in an organization that has a non-academic interest in the research results;

6) that the individual engaged in research must sever his relations with the individual or organization due to which the conflict of interest was created;

7) that the individual engaged in research must be totally or partially disqualified from participating in the research;

8) that any other step deemed appropriate must be taken in order to prevent the conflict of interest or to administer it by the Supervisory Panel.

c) In making a decision to declare the existence of a substantive, anticipated or potential conflict of interest that requires administration and supervision and in determining the appropriate means for administering the conflict of interest under the Supervisory Panel, the Committee is not bound by any formal rules whatsoever. Nevertheless, before making such a declaration, the Committee must hear the position of the involved individuals engaged in research with respect to the situation under consideration and with respect to the appropriate means of administering it, if they so desire. In special cases the individuals engaged in research will be permitted to submit the positions of others to the Committee, in writing or orally.

d) In making a decision to declare the existence of a substantive, anticipated or potential conflict of interest, when the regulations of the University do not set out explicit and relevant arrangements, the Committee will be aided by accepted standards at academic institutions in Israel and abroad.

e) All of the Committee's deliberations, including those in which the individual engaged in research participates, and excluding preliminary clarifications and exchanges of opinions, will be held in person and not in writing or via e-mail. Nevertheless, the individual engaged in research is entitled to submit his position in writing if he so desires. Documentation of the content of all deliberations will be saved.

f) All decisions of the Committee will be submitted in writing. The decisions and the documentation of the deliberations and of the process of making the decision will be made available to the Committee members upon their request. The decisions of the Committee will be made available to the members of the University faculty in a way that will not reveal to unauthorized individuals the identity of those engaged in research whose research is under deliberation or any other details that are not essential to understanding the conflict of interest under deliberation.

g) In making a decision to declare the existence of a substantive, anticipated or potential conflict of interest that requires administration and in determining the appropriate steps to administer the conflict under the Supervisory Panel, the Committee is authorized to make temporary decisions as it deems appropriate, for example, suspension of the individual engaged in research from involvement in the research, disclosure of the situation to the source of funding, freezing the research funds, etc., until the final decision is reached. This authorization will not be activated without giving the individual engaged in research an opportunity to be heard, and no action will be taken that will harm the progress of the research beyond what is necessary or the relations between the individual engaged in research and the funding organization.

h) Appeals/repeat deliberations of the Committee's decisions will be heard before the Committee plenum. The minimum number of members required for a quorum of the plenum for this purpose is 4 members, and this quorum must include the Vice President and Dean of Research and/or the Director of the Research Authority.

i) Decisions of the Committee for the Prevention of Conflict of Interest in Research and of the Supervisory Panel are binding upon those engaged in research.

Violation of this clause and any actions taken against a decision of the Committee for the Prevention of Conflict of Interest in Research constitute a breach of conduct. The contents of this clause are in addition to breaches of conduct as described in the various conduct regulations applying to researchers at the University.

7. Obligations of individuals engaged in research

a) Those engaged in research will carry out their research without diversions or deviations. All those engaged in research must apply their professional judgment independently and without secondary considerations affecting any aspect of their research.

b) Those engaged in research will report to the Committee for the Prevention of Conflict of Interest in Research any suspicions regarding conflict of interest, and any matter that involves, or is likely to appear to involve, anything that can divert the research or have an inappropriate impact on decisions regarding the administration of the research, as soon as such suspicions come into being or are disclosed – whether at the time of submitting the request to register the research proposal or whether during the course of the research. Such disclosure will make it possible to take steps to ensure that the research will be conducted without diversions and in an independent and professional manner.

c) Close to the signing of the research agreement the relevant researcher will submit to the University written approval certifying his knowledge that the regulations regarding proper conduct in research and the regulations for preventing conflict of interest in research apply to the research. Such instructions will be brought to the attention of all researchers hired by the University and will be included in the employment documents signed by all new researchers.

d) Every research agreement will include a conflict of interest declaration referring to all those researchers involved in the research, the wording of which will be validated from time to time, after approval by the Vice President and Dean of Research and the University's legal adviser. Every substantive, anticipated or potential conflict of interest that emerges during the course of the research will immediately be reported to the Committee for the Prevention of Conflict of Interest in Research. Such instructions will be brought to the attention of all researchers hired by the University and will be included in the employment documents signed by all new researchers.

e) Those engaged in research will on their own initiative disclose to the Committee for the Prevention of Conflict of Interest in Research any substantive, anticipated or potential conflict of interest that emerges during the course of their research that was not disclosed in the request for research funding or that changed since its disclosure. The conflict of interest will be reported immediately upon its appearance.

8. Consultation

Those engaged in research are authorized to consult with the Committee for the Prevention of Conflict of Interest in Research in order to clarify whether a situation in which they find themselves constitutes a case of substantive, anticipated or potential conflict of interest and to determine how to avoid said situation or to administer it under the Supervisory Panel, and they are obligated to consult with the Committee in the case of any doubt or suspicion of such.

9. Documentation and Filing

The declarations and petitions for consultation with the Committee and documentation pertaining the work of the Committee for the Prevention of Conflict of Interest in Research will be filed with the Research Authority, and any authority authorized to handle matters of conflict of interest and violations of the University's rules and regulations will be authorized to read said documents.

10. General

a) The existence of University rules that handle other issues deriving from the commercialization of research, such as rules dealing with the relationship between academic employees and business organizations and those dealing with the exploitation of inventions and patents, does not exempt individuals engaged in research from their obligations under these regulations.

b) Individuals engaged in research will implement the requirements of organizations funding their research with respect to conflicts of interest and their disclosure.

c) Individuals engaged in research will maintain the basic ethical rules with respect to the dignity, freedom of action, safety and welfare of all those liable to be affected by the research.

d) Research that involves human beings and/or animals will be conducted in accordance with customary international and internal institutional standards.

e) Individuals engaged in research will strictly provide clear, accurate and complete documentation that will enable reconstructing the course of the research and its results by academic and professional referees. The documentation will be kept for a period of ten years unless otherwise determined by law or by the funding organization.

f) Individuals engaged in research will bear total responsibility for the research published under their names, and this applies to all details of the publication.

g) Those engaged in research will conduct themselves in accordance with the rules of the University with respect to anything concerning the commercialization of knowledge and the preservation of intellectual property.

h) In accordance with the requirements of the funding organizations, these regulations will be accessible on the University Internet site.

i) In accordance with the requirements of the funding organizations, and as necessary, those engaged in research will be trained in how to prevent financial conflicts of interest in accordance with the instructions of these regulations, all this in compliance with the decisions of the relevant parties at the University.

j) Masculine language used throughout these regulations is applicable to both genders, and singular language is also applicable to plural, and vice versa.

k) The lack of proper enforcement of any of these regulations, or any delay in enforcement, will not constitute any relinquishment or avoidance on the part of the University in enforcing said regulation, and will not constitute any agreement whatsoever to its violation, and no similar decree can be derived from it regarding other regulations herein and/or in other instructions or documents related to it.

l) Any change in these regulations will not be valid unless submitted in writing and approved by the Senate.