Responsible conduct of research

• Would it be possible to keep an updated list of fake journals and organizers of fake symposiums (monitoring or watch process)?
• And could a list of these journals be posted on the CHUM Web site?

Answer: Web sites featuring fake scientific journals and symposiums are highly sophisticated and look incredibly like legitimate sites. Vigilance is necessary to avoid getting caught in a trap. There are sites that provide information on this phenomenon. The CHUM library site, in turn, offers advice on how to confirm sources (in french only).

The site (in French only) notes the following:

There are tools.

And while Jeffrey Beall’s “Scholarly Open Access” site, which monitored predatory journals and publishers, has been taken down, the January 3, 2017 version of Scholarly Open Access has been saved and is available on the Internet Archive Wayback Machine.

The Journal Blacklist, available from Cabells Scholarly Analytics on a membership basis, is a list of predatory journals selected on the basis of 65 criteria.

PLOS is a non-profit publisher of peer-reviewed articles which promotes reutilization and redistribution through an open-access model. PLOS is an innovative advocacy organization.

The Directory of Open Access Journals (DOAJ) is a directory of open-access publications that meet a series of quality control criteria.

We also offer training on literature and Internet-based searches.

Dr. Vincent Poitout, who heads the CHUM Research Centre (the CRCHUM), notably recommends checking the U.S. National Institutes of Health (NIH) article entitled “Think Check Submit” and to only publish in journals from publishers that are members of the Committee On Publication Ethics (COPE).

• What is a contractual commitment?

Answer: Given that it is responsible for all research activities at its institution, the CHUM must comply with the requirements of the Ministère de la Santé et des Services sociaux and the FRQ as well as all applicable laws and regulations designed to ensure that the research environment and climate promote the efficient use of the institution’s resources, the ethical and scientific quality of research projects, and the dignity and safety of the persons involved.

 

Moreover, numerous research activities are governed by contracts with private industry, academic and hospital partners and funding agencies. Researchers and all other concerned parties must be aware of and comply with these contractual agreements.

• Younger researchers, often subject to significant pressure to publish their findings, may speed up their hunt for data by keeping their verifications to a minimum. Wouldn’t it be wiser to judge researchers on more factors than just what they have published?

Answer: Regardless of the factors on which researchers are evaluated, they must still process data as carefully and precisely as possible (including during the selection, collection, recording, analysis, interpretation, publication, retention and other phases),  carry out their research with a true quest for knowledge, and adhere to an approach based on honesty and trust.

 

• Representatives of funding companies will often tell clinical researchers that physician researchers are responsible for research projects, regardless of the phase during which a failure or negligence is observed. A physician gave the example of how a single missing pressure measurement during a verification could constitute a failure, despite the fact that researchers cannot be next to all of the patients during this phase. Another example is double-blind studies, where researchers are not entitled to know who is given what, yet can be blamed if the drug management process of the pharmacy - whose data they cannot access - is less than stellar. This physician asked whether, in light of these examples, the hospital/research centre should not also be responsible for the research process and whether this shared responsibility should not be clearly indicated in the legal documents signed by the parties.

Answer: According to the CHUM’s policies, the researcher is responsible for the performance of his research projects. In the case of a double-blind study, the physician researcher is required to train the personnel involved so that all research tasks are well done. It is also important to note that everyone involved is nonetheless responsible for the work carried out. The pharmacists and nurses are bound by obligations with regard to professional liability.

It also bears recalling that involuntary errors (outside of all possible human control, particularly with regard to double-blind studies), are not considered as a failure under the FRQ’s policies. The CHUM also carries civil and professional liability insurance that covers all of its employees, among them pharmacists and nurses, meaning that they are protected in the event of a mistake.

 

• How long must a researcher keep (save) his raw data and findings?

Answer: This information is available in the classification program and retention schedule (Plan de classification et calendrier de conservation).        

Go to the Intranet, portal: Accueil → Les Directions → DQEPE → Gestion de l’information et documentaire → Gestion documentaire → Outils de gestion documentaire → Plan et calendrier de conservation  → (Home / Instructions / DQEPE / Information and documentation management / Documentation management / Documentation management tools / Classification program and retention schedule) 50 000 - Recherche (Research).  

Consult the following documents (In French only):

50 550: Gestion des dossiers de recherche (management of research records)

50 560: Recherche clinique (clinical research)

50 561: Essai clinique avec médicaments (clinical drug trials)

50 562: Registre des sujets d’essais cliniques (log of clinical trial subjects)

50 563: Projet de recherche clinique (clinical research project)

50 570: Recherche fondamentale (basic research)

Funding agencies, academic partners, companies and clients can adopt requirements that differ from those of our institution. The strictest regulations are always the ones that prevail. The regulations, moreover, are always included in the contracts signed by the CHUM/researcher and all other parties.

The federal government is presently holding consultations on data management and should eventually issue new directives in this regard. The institutions affected will need to modify their processes as required. 

• Has the CRCHUM adopted an official position in terms of the definition of “significant contribution to research” that will need to be taken into account when deciding whether or not to name certain people in connection with a publication?  
• Does the CHUM have a policy governing the rules for listing authors (e.g., at which point does an author’s name need to or need not be listed)?  

Answer: It is important to not wait to discuss this issue at the last minute, in other words, just prior to publication. Speak with the contributors ahead of time to agree on which authors will be named. A number of items will need to be checked. It will also be critical to do a bit of research, as contributors are not addressed in the same way in all disciplines. One such example is the use of databases, where the authors to be listed will need to be determined. The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations, which includes recommendations for cross-border, interdisciplinary and intersectoral research, is a good place to start.

Another reputable source of information consists of the rules governing certain journals (such as the International Committee of Medical Journals Editors [ICMJE]).

The Web sites of the Committee on publication ethics (COPE) and the Université de Liège also provide useful information on rules for determining which authors to include with regard to scientific articles (in french only).

This authorship guidelines recommends rules for inclusion as an author or in the acknowledgements section naming various persons in scientific domains.

• If an associate researcher affiliated with another institution can provide proof of having completed this training, must he nonetheless attend the CRCHUM’s training? 

Answer: Everyone involved in the research process is encouraged to complete the training offered by the CRCHUM.

 

• Do outside resources/collaborators working on a CRCHUM project need to complete the training?

Answer: Yes, they do.

• If a researcher lends a portion of his research funds to help out a colleague until such time as the latter receives funding, is this considered a failure.

Answer: It depends on the rules established by the funding agency or the clauses of the contract signed with, for example, an organization, an academic institution or the agency that funded or sponsored the project. In some cases, research funding amounts may be used to lend or advance funds to collaborators. In other cases, this is prohibited. The researcher receiving such an advance could be a collaborator of the research project having already received funding (in which case his name would be listed in the funding agreement). Any other loan of funds is a failure. The researcher wishing to use a portion of his funding in such a manner must obtain prior approval from his institution, the company and the funding agency. The unauthorized sharing of funding can have serious repercussions. 

• When a team has only one employee, how can this person’s identity be protected if the employee files a complaint against the researcher?

Answer: This is a very touchy matter. There are a few possible ways in which such an employee can be protected. The person in question could be removed from the team, although this could result in stigmatization, with other parties thinking that the person had been somehow punished.   It is also possible to file an anonymous complaint. An employee in such a situation could also ask a middleman to file the complaint; the employee’s name would then not be revealed. Persons who report a failure with regard to the responsible conduct of research are in fact providing an important service to the CHUM. Such a warning could have the effect of protecting the institution from serious repercussions in the future. If an allegation is found to be legitimate following an investigation and a researcher is prohibited from carrying out further research, every effort will be made to have the employees/students who worked with this researcher join other teams. That being said, the filing of a complaint is not a guarantee that the person blowing the whistle will automatically be provided work elsewhere.

 

• Once a complaint has been filed against a researcher or other member of a research team, does HR have a program or mechanism for ensuring that the whistleblower can work in another team? People may well avoid reporting certain situations or inappropriate conduct for fear of losing their employment if a researcher loses his status or his project is brought to a halt.

Answer: If no one dares blow the whistle, an allegation should be filed or a report submitted anonymously (so that it will be kept confidential). An anonymous complaint must include enough details to enable an investigation. It must provide facts, as rumours or hearsay will not be sufficient.  

If an allegation is found to be legitimate following an investigation and a researcher is prohibited from carrying out further research, every effort will be made to have the employees/students join other teams.  That being said, the filing of a complaint is not a guarantee that the person blowing the whistle will automatically be provided work elsewhere.

 

• Are complaints handled in a confidential manner? 

Answer: Yes, all complaints are handled in a confidential manner. The only people who will have any knowledge of the matter will be the members of the review committee mandated to handle the complaint. No one’s identity (i.e., no named) will be revealed to the FRQ until such time as a violation has been confirmed. The complainant is also bound by confidentiality rules, and may not disclose that a complaint has been filed, as this could result in a leak of information that could in turn lead to rumours or negatively impact someone’s reputation. 

• Who forms the complaint review committee and how are they chosen?

Answer: The process for handling allegations regarding a failure to comply with the policies concerning responsible conduct of research is illustrated in the following diagram:

Processus de gestion des allégations de manquement à la politique sur la conduite responsable en recherche

It is also described in section 8.2 Processus de gestion des allégations (process for managing allegations) of CRCHUM Policy No10 130: Politique sur la conduite responsable en recherche (policy concerning responsible conduct of research).

 

• Can a report be submitted regarding past inappropriate conduct (i.e., retroactively)?
• And if yes, how far in the past can the events in question have occurred?

Answer:  Yes, a complaint can be filed regarding past events. There is no set time period, especially as regards fraudulent or predatory publications that hinder scientific research.

 

• What steps should be taken when a complaint concerns a person who is not a CRCHUM employee or researcher? (For example, an outside client that makes use of a CRCHUM device or a person on sabbatical.) Is the same complaint and investigation process applicable?

Answer: The process will be different in the case of an outside client that makes use of our instruments or facilities. Seeing as the person who fails to comply with research integrity criteria is neither an employee nor a researcher of the institution and given that the activities in question were performed for the outside client and not the CHUM, the provisions of the contract signed with the outside client will prevail. Breach of contract may ensue, given the failure, and legal consequences could follow.

In the case of a person on sabbatical, seeing as the person is conducting research activities at the CHUM, this person is subject to the institution’s policies and regulations, including the Politique sur la conduite responsable en recherche, direction de la recherche du chum (CRCHUM) (policy concerning responsible conduct of research). Should there be a failure in terms of responsible conduct, the CHUM may transmit all relevant information to the institution with which the person is affiliated. The person in question will be notified of the exchanges between the two institutions.

This is an example describing a real situation. Its source is the file summaries that provide a brief description of every confirmed breach of the Tri-Agency Framework: Responsible Conduct of Research (RCR Framework) that involved applications to, or funding by, the Agencies or any tri-Agency programs. These summaries cover the period from the launch of the Framework on December 5, 2011 to March 31, 2016.

Summaries of all RCR files involving a confirmed breach (closed before april 1^st, 2016)

FILE 35

Allegation: Mismanagement of grant funds

Findings: R, a faculty member, was the recipient of an Agency award in which he/she would work on a research project partly at the premises of a sponsoring partner. R engaged a number of students to assist him/her. By carrying out an investigation and an audit, the Institution concluded that R and the partner breached the conditions of the grant in a number of respects, including the following:

• the partner did not supervise the students as required by the program, and the students did not spend the required amount of time working at the partner’s site;
• R likely received money from at least two of the students, which he/she likely used to improperly pay back the partner for its expenses;
• R was reimbursed in full for the same grant expenses from the Agency as well as from two other organizations involved in the research project;
• R was aware that reports submitted by students concerning their work included false information; and
• R counselled students to mislead the investigators.

Breaches: Mismanagement of Agency grant or award funds (3.1.3); breach of Agency policies or requirements for certain types of research (3.1.4)

Institutional Disposition:

• terminated R’s employment; and
• informed the police of R’s financial impropriety. Agency Recourse:
• declared R permanently ineligible to apply for Agency funding or to participate in Agency peer review processes;
• issued a letter of concern to the partner outlining the manner in which it failed to meet the Agency’s expectations and the impact that this had; 17
• required the Institution to reimburse all misspent Agency funds; and
• required the Institution to develop a plan to prevent similar breaches.