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Responsible Conduct in Research Policy of 10

Policy on Responsible Conduct in ResearchDouglas Hospital Research Center

Recipients

Researchers, students, postdoctoral fellows, members of research teams, managers of research funds.

Preamble

Research and research training are at the heart of the activities of the Douglas Hospital Research Center (DGRC). the goal of these activities is to advance knowledge that will improve the diagnosis, management and treatment of mental illness.

Whereas it is vital to respect the academic freedom of researchers, it is equally important to ensure that all research and training activities be conducted in accordance with the following values: honesty, integrity, trust, accountability and collegiality, respecting the highest scientific and ethical standards.

This policy aims to reinforce an ethical culture within the scientific community, a culture recognizing a shared responsibility between the various players in research.

The policy outlines the values of and expectations for responsible conduct in research and describes the elements of the process by which allegations of misconduct are managed by the DHRC.

1 - Responsible Conduct in Research

Responsible conduct in research relates to the behavior expected of the various actors targeted by the policy when they conduct research activities.

This procedure applies to all research activities performed by a researcher.

These behaviors are based on values such as honesty, reliability, thoroughness, objectivity, impartiality and independence, justice (recognizing the contribution of others), trust, responsibility and benevolence, openness and transparency.


2 - The Douglas Hospital Research Center

The DHRC is responsible for promoting an environment that an environment that upholds responsible research conduct that conforms to best practices and promotes it among all research teams in the institution.

Furthermore, the DHRC must ensure that it disseminates all information concerning changes to the regulations of the granting agencies. It must also safeguard responsible and ethical management of public funds.

The institution must manage allegations of breach of research misconduct by members of its team in collaboration with the university.

3 - Responsibilities of the Researcher

Each researcher must :a) maintain the highest standards of honesty, integrity and ethical conduct in all research

activities.b) responsibly use and account for research fundsc) be familiar with all regulations, procedures and guidelines of the research

agencies that fund the research.d) be transparent and honest whjen applying for and managing public funds.e) Obtain the required approvals before starting all research activities requiring approval.f) treat data rigorously, both when recording this data and, subsequently, when

analyzing and writing reports or publications.g) avoid situations of conflct of interest and, when unavoidable,addresses them ethically.h) disseminate research results in a responsible and timely manner.

the researcher must never falsely represent him/herself with respect to academic or professional status, or expertise.

I the case of collaborative research with other investigators, the principle investigator hold the responsibility of ensuring that the members of the research team are informed of and respect the applicable directives and regulations.

The resposiibilities of the researcher with respect to supervision of student training area) to educate students with respect to their obligations related to responsible research

conductb) inform students as to the regulations of the granting agencies.

c) ensure that students have signed confidentiality and other commitment documents.


d) share with them information about publications, constraints and regulations to followregarding intellectual propertt

A researcher covers the costs of CSST (generally less than 1%) for the scholarship recipients of his/her team.

A researcher who conducts research in a field other than his academic designation is still required to act with integrity and ethics.

A researcher who does research outside his field of expertise at the request of persons external to the university to which he is affiliated, must act in accordance with the regulations and the policy in force on conflicts of interest in the external establishment where he conducts his research activities. He must therefore:

a) notify the external person who hired him in writing that the research activities heundertakes under this agreement are carried out on an individual basis and not on behalf ofthe establishment.b) obtain the written approval of his department head, the dean or vice-dean for researchand his director of center to be able to participate in a personal capacity in this research.c) take adequate financial measures to reimburse the center or university.

The researcher must ensure that publications are in accordance with the data collected, that the figures/images are well explained, and undertakes to respect the data collected without adding or deleting relevant information

the researcher is required to respect the best practice within the discipline with respect t publications.

In clinical research, the researcher is required to respect the subjects who participate in the research.

The researcher cannot enter into an agreement with a third party to write or publish without recognizing another researcher's contribution to the publication.

The researcher must acknowledge university affiliation in all publications resulting from research work that takes place during his/her academic career.

If a researcher is no longer a member with a university, he/she must stop mentioning the university in his publications, unless there is an agreement with the university administration to do so.


4 - Research data

Researchers can collect data during their research work with human or animal subjects, albeit always respecting the regulations in force in the DHRC.

Researchers must respect the regulations in force

Researchers are required to comply with the rules in force in connection with the law on access to information and respect for privacy during the data collection and dissemination stage.

A student may use research data as long as the publication of the results of these data is permitted and the time for publication of the results does not exceed one year, unless an arrangement is made between the supervising researcher and the DHRC.

Researchers are obliged to not publish ant data which they consider or suspect to be fraudulent or unreliable.

Researchers are required to maintain their data in a manner that allows for verification by a third party.

4.1 Retention of Research Data

The researcher is required to maintain research data in conformity with best practices within the discipline, in conformity with the regulations of the granting agency. L

In the absence of regulations, the researcher mus retain the data for 7 years after the first publication.

A researchers who ceases research activity must supply the collected data to the centre or insitution where the research was conducted.

In the case where the obtained data are stored in a facility with limited access, the researcher must inform the director of the director of the centre where the data have bene deposited.

4.2 Access to research data

The principal investigator is required to make available to the granting agency the data which he has collected within the framework of a project funded by that agency and for which the results have been published.

In the event of a conflict with the granting agency, the problem can be directed to the head of department, the dean and, if necessary, to the vice-principal research.


4.3 Research data from collaborations

For research projects conducted in collaboration with other partners, the researcher is required to have a written agreement between the researchers, preferably signed, before the start of the work.

In the absence of a written agreement, the rights of collaborators and use of data will be determined via the policy on intellectual property in force at that time.

In the case of conflict between collaborators regarding the right to use the data, the university will be consulted and will assist the researcher to mediate an acceptable resolution.

5 -Using the work of others

the researcher is prohibited form engaging in plagiarism

In the case of an accusation of plagiarism, the researcher is responsible for defending and proving innocence.

the researcher is required to obtain the agreement of a third party if the researcher intends to use the data of the third party.

No researcher may enter into an agreement with a third party or a granting agency concerning data obtained within the framework of a research project with collaborators, unless he has written approval from his collaborators.

Documents linked to a research project must be archived according to the archiving policy of the institute.

The researcher is required to acknowledge, in all publications, the contributions of collaborators, including students.

6 - Authorship

For all publications, the researcher must ensure that the names of all individuals making significant contributions and who share responsibility and accountability for the published results are included as authors.


In the absence of a formal agreement between collaborators:a) authorship is attributed to researchers who have made a significant contribution to

the project and who assume responsibility and accountability for the publishedresults.

b) authorship is recognized according to the quantity and quality of their contributions:i. according to the scope of responsibility and accountability for the resultsii. according to best practice guidelines in the discipline

c) the order of names is not based on the amounts allocated to collaborators in thecontext of the grant.

Administrative support to a researcher in the case of a collaborative research project will not be acknowledged with authorship.

It is the responsibility of the senior/corresponding author to ensure that the names of all who have contributed are included in the author list.

The senior/corresponding author must demonstrate that consent has been obtained with the co-authors to determine the order of authorship.

It is also the responsibility of the senior/corresponding author to ensure that those not included in the author list be acknowledged for their contributions according to the standards of the discipline.

The senior/corresponding author must allow all coauthors to evaluate the manuscript, in order to obtain their comments and suggestions prior to submission.

The senior/corresponding author must provide a copy of the manuscript to all coauthors prior to submission.

7 - Intellectual Property

Researchers must ensure that they have an agreement based on the current policy on the management of intellectual property.

In the case where no agreement exists the policy on management of intellectual property shall apply.

In the case of collaborative research with other investigators, universities of countries, the researcher must consult with the university, and with the help of the Office of Technology Transfer (OTT), establish a contract in relation to the management of intellectual property, the rights and obligations of all parties and the sharing of the revenues and royalties which will be possibly generated following publication.

In case of dispute, the university will be solicited to mediate a resolution of the conflict. However, the university is not obligated to ensure that the conflict is resolved.


The parties to the conflict are required to find a solution to their conflict.

University authorities will be informed of the situation and university policy will be followed.

8 - Use of Research funds

The principal investigator is responsible for ensuring that all research funds that he/she administers are used in an honest, accountable manner.

The principal investigator is obliged to use the research funds in accordance with the rules for the use of funds as defined by the granting agency.

the principal investigator is obliged to include the funding source of the project, be that private or public.

When selling used equipment purchased with funds from granting agencies, the revenue from these sales must necessarily be reinvested in research.

9 - Research with humans subjects

Research conducted with human subjects must be conducted in accordance with the highest ethical standards, in compliance with the legal and moral rights of the persons who are subjects of research and in accordance with the current regulations which govern the research discipline. The research must respect the ethical policy as described by the three Councils.

The researcher must obtain approval of the Research Ethics Board (REB) before initiating the research project.

The researcher cannot derive any benefit (bonus or other) for having recruited a determined number of research subjects, or for having successfully completed a study within the planned schedule or for having evaluated potential recruits within the framework of the study.

10 - Research with Animals

Research conducted on laboratory animals must be conducted in conformity with the normative ethical standards in compliance with the rules and regulations of the Canadian Council on animal Care (CCAC).


A research project cannot be initiated prior to approval of the research protocol from the Facility Animal Care Committee (FACC).

11 - Covert Research

A researcher cannot conduct covert research while receiving benefits from the university and its affiliated institution.

12 - Research with Dangerous Materials

A researcher leading research activities that pose risk for accidents or injury must:

a) respect the regulations for use of dangerous materials.b) obtain any necessary approvals prior to receiving the material(s).c) divulge, before the initiation of the work, all potential risks tha tcould result from use

of the material(s)

As part of the research activities, the researcher should be aware of the potential risk and take the necessary measures in the event of accidents in accordance with the laboratory safety rules established by the institution.

The researcher must report any incident to the director of the research center along with the measure taken to correct it.

13 - Commercialisation

A researcher is not obligated to pusue commercialize of an invention. The university and the establishment undertake to respect the researcher's decision not to commercialize the invention, the software developed or other discoveries.

A researcher who chooses not to commercialize an invention or discovery may, in accordance with the regulations in force on the sharing of intellectual property, allow collaborators to develop it commercially.

A researcher who chooses to develop an invention or a discovery and who wants to get involved in its commercialization, is bound to respect the regulations on the management of the intellectual property of the university.

All negotiated research agreements must be approved and executed repecting the regulations in force.


14 - Conflict of Interest

All researchers must comply with the policy in force on the management of situations of conflict of interest.

The researcher has the obligation to disclose to the persons in charge of the establishment (including other establishments, granting agencies and others), any situation of conflict of interest which may influence the decision of these persons and organizations if the researcher is called upon to :

a) review grant applications or publications.b) test inventions or software or other discoveries.c) present research results.d) develop research projects funded by an external organization.

15 - Misconduct

Any action taken by the researcher that does not respect honesty, integrity and the regulatory framework may constitute misconduct requiring disciplinary measures. These actions can trigger the process for handling complaints and disciplinary action accordingly.

Misconduct includes: data fabrication, falsification, destruction of research records, plagiarism, re-publication, false authorship, inadequate reporting, mismanagement of conflicts of interest.

This policy does not apply to honest errors, differences in the interpretation of data, or results generated under special circumstances..

The DHRC will appoint a person responsible for responsible conduct in research, the main role of which is to promote a culture of responsible conduct in research by training people in its community. The Research Integrity Officer is responsible for overseeing the procedure to investigate allegations of misconduct for the DHRC and will be the contact person between the center and the funding agency.

The DHRC is resposible for protecting sensitive information concerning all individuals involved in the investigation of an allegation of misconduct.

Those involved in handling allegations should:

a) undertake to exercise the strictest transparency in any conflict of interest situation, real or apparent, and to manage these situations adequately.

b) b) be impartial, exercise discretion and respect the confidentiality of sensitive information.


c) manage the entire investigation respecting the principles of procedural fairness and natural justice.

d) to this end, ensure that necessary legal advice is obtained.

A procedure to manage allegations of misconduct will be implemented and respected by all members of the DHRC:

a) receipt of the allegations by the Research Integrity Officer.b) preliminary assessment of the admissibility of the complaint. The person in charge

should have at least one manager from the center to assess the admissibility of the complaint.

c) decision-making regarding the admissibility of the complaint.d) informing the Fonds de Recherche du Quebec (FRQ) (director of ethical and legal

affairs) of the decision taken.e) Immediate contact with the FRQ should an urgent intervention be required (protection

of research subjects, security of laboratory animals or research personnel). If an urgent intervention is to be made on the part of the FRQ, it will be necessary to communicate the identity of the person(s) implicated in the complaint and to inform them of the of the procedure that has been initiated.

An examination committee to investigate the complaint will be formed, including at least one member from outside the center, one member from the field of research or professional competence in which the person concerned by the complaint works.

the examination of the complaint, if judged admissible, will follow directives from McGill University and will inform the FRQ when the process is finalized.

The investigation of a complaint should be completed in a maximum of 2 months for the assessment of the admissibility of the allegation and, following a judgment of admissability, a maximum of 5 months for the examination of the complaint. Should sanctions or interventions be deemed necessary, the FRQ will be informed of the conclusions reached by the examining committee.

History - Responsible Conduct in Research Policy

ApprovedDHRC Board of Director September 21 2015

This policy will be revised every four years and submitted to the DHRC Board of Directors.

Subsequently, it will be distributed to all researchers and research teamsUpdates to the policy will be distributed via the DHRC intranet.