Institutional Guidelines for Good Research Conduct

Researchers in the Faculty of Medicine at Dalhousie University working both within the research laboratories of the University and the Affiliated Teaching Hospitals are involved in a wide variety of research, from basic, wet-laboratory research at one extreme, to patient oriented clinical trials and chart reviews at the other. In spite of the diversity of the research being conducted, we like to think that the principles guiding clinical and basic science researchers is a conviction to a set of truths which are related to the fundamental process of scientific inquiry. The basic and most important element in this whole process of data accumulation, interpretation and reporting is the objective and scrupulous attention to the detailed procedures which each and every scientist must apply to the scientific process, to ensure that the ultimate conclusions and interpretation of the work is scientifically valid. In spite of hopes that the scientific process is above reproach, a number of very serious allegations of blatant research fraud have been made and substantiated in The United States over the past ten years. More alarming are the increasing numbers of concerns and allegations that research is being conducted in a manner which is questionable, with the suggestion of misconduct. Although we would like to think that these are the problems of large research laboratories in big American institutions, the fact of the matter is that a number of Canadian universities, including, the Faculty of Medicine at Dalhousie University, have had to investigate and deal with accusations of research misconduct. In dealing with such allegations it is important for the administration at all levels to remain open and sensitive to the need to protect the innocent, while at the same time ensuring that justice is not only done but is seen to be done. The process must be such that it can withstand legal challenges and at all times must protect the rights of the accused. In all of this, there must be a balance between ensuring that the process is fair and that the reputations of honest individuals and the Institution are upheld. Although the number of cases of research misconduct have been relatively few in Canada, when they have occurred it has been clear that in most instances the Institution has no formal procedure in place to deal with this issue, regardless of the severity. There is then a very pressing need for Dalhousie University to put in place a credible system for dealing with this important issue.

Researchers in the Faculty of Medicine at Dalhousie University working both within the research laboratories of the University and the Affiliated Teaching Hospitals are involved in a wide variety of research, from basic, wet-laboratory research at one extreme, to patient oriented clinical trials and chart reviews at the other. In spite of the diversity of the research being conducted, we like to think that the principles guiding clinical and basic science researchers is a conviction to a set of truths which are related to the fundamental process of scientific inquiry. The basic and most important element in this whole process of data accumulation, interpretation and reporting is the objective and scrupulous attention to the detailed procedures which each and every scientist must apply to the scientific process, to ensure that the ultimate conclusions and interpretation of the work is scientifically valid. In spite of hopes that the scientific process is above reproach, a number of very serious allegations of blatant research fraud have been made and substantiated in The United States over the past ten years. More alarming are the increasing numbers of concerns and allegations that research is being conducted in a manner which is questionable, with the suggestion of misconduct. Although we would like to think that these are the problems of large research laboratories in big American institutions, the fact of the matter is that a number of Canadian universities, including, the Faculty of Medicine at Dalhousie University, have had to investigate and deal with accusations of research misconduct. In dealing with such allegations it is important for the administration at all levels to remain open and sensitive to the need to protect the innocent, while at the same time ensuring that justice is not only done but is seen to be done. The process must be such that it can withstand legal challenges and at all times must protect the rights of the accused. In all of this, there must be a balance between ensuring that the process is fair and that the reputations of honest individuals and the Institution are upheld. Although the number of cases of research misconduct have been relatively few in Canada, when they have occurred it has been clear that in most instances the Institution has no formal procedure in place to deal with this issue, regardless of the severity. There is then a very pressing need for Dalhousie University to put in place a credible system for dealing with this important issue.

In spite of the level of experience that any individual researcher may have, there are some very simple and fundamentally important steps which can be taken at all levels to help reduce the chance that research will be conducted in a way which may ultimately be viewed as suspect or fraudulent. 

A. Supervision of Trainees and Technicians: 

1.       Each trainee and research technician must have a clearly designated supervisor. It is the responsibility of the Department Head (in larger departments through the Divisional Head) to ensure that this is the case. 

2.       The ratio of trainees to supervisors should be small enough that close interaction is possible to ensure both meaningful scientific exchange and to facilitate reasonable overview of work in progress at all stages. 

3.       Each supervisor shall be encouraged to meet with research trainees and technicians at regular intervals to review data, progress and future plans. The Supervisor or Department Head is responsible for ensuring the designation of replacement supervision in the event of the supervisor's absence for extended periods of time (in excess of one month).

4.       Researchers (supervisors and trainees) shall be encouraged to present findings at laboratory, as well as at Departmental review sessions and seminars, to promote open and realistic assessment of progress.

5.       The supervisor should provide each new staff member and trainee, whatever the level, with applicable governmental and institutional requirements for the conduct of studies involving health volunteers or patients, animals, radioactive or other hazardous substances, including recombinant DNA. Copies of these documents should also be provided by the Faculty of Medicine Research Office.

B. Data Gathering, Storage and Retention:

1.       The procedure for recording, storage and retention of primary research data should be formally outlined by the supervisor at the beginning of the project. 

2.       All primary data should be recorded in clear, adequate, original and permanent form, and where possible, data and all notes should be recorded in bound notebooks. It is the responsibility of the principal investigator to ensure that all original and primary laboratory data is retained by the laboratory or research unit in which they are generated; however, an investigator trainee may make copies of the primary data for his/her own use. The department head, division head or chief, immediate supervisor and all collaborators must have free access at all times to review all data and products of an investigator's research. Data for a given study must be retrievable for at least five years after the work is completed (if the data form permits).

3.       Upon the departure of a trainee from Dalhousie University, Faculty of Medicine, all permanent primary data will normally remain in the laboratory or unit where they were generated. Departing investigators may take copies of data with them, or may make alternate arrangements with their supervisor (Principal Investigator) with the knowledge of the Department Head, to have copies kept by Dalhousie University, instead of the original records. Where primary data is allowed to leave Dalhousie University, written acceptance of responsibility for maintaining this data will be required from the new institutional home.

4.       Upon the departure of a faculty member from Dalhousie University, Faculty of Medicine, custody of permanent primary data will normally be transferred to the new institution. Such an arrangement must be made with the Department Head's written consent, with copies of this correspondence to the investigators file in the Dean's Office. Where primary data is allowed to leave Dalhousie University, written acceptance of responsibility for maintaining this data will be required from the new institutional home.

5.       Before disposing of any material products of research activity such as cell lines, bacterial clones, other specific organisms and substances, or software developed and prepared during the course of research, for non-commercial scientific purposes within or without the laboratory, the approval of the principal investigator or supervisor must be obtained, and through the principal investigator, the department head should be informed. 

6.       Disposition of material products by non-faculty for the purpose of commercializing such products, requires the approval of the Office of Technology Transfer (Dalhousie University) and the Office of Research Services. 

7.       When a department head wishes to remove his/her own primary data from Dalhousie University, the written consent of the Dean of Medicine is required.

C: Authorship: 

As the need for collaborative research increases with the advancement of scientific technology and the diverse approach to the investigation of complex biological problems, the responsibility for multi-authored or collaborative studies has become increasingly important but also more difficult to define. There are, however, some crucial safeguards which should be considered in the publication of scientific results:

1.       One author, usually the senior author, must be identified as being responsible for the validity of the entire manuscript. 

2.       Ideally, all listed authors should have been involved in the research from its inception. However, at the very least, it is expected that all authors have made a significant intellectual or practical contribution to the project and have participated in the writing of the paper and understand the significance of the conclusions and can share in the responsibility for the scientific content and reliability of the reported data. The concept of "honourary authorship" is unacceptable. 

3.       There should be clearly stated guidelines within each department or laboratory concerning where research trainees' names will appear on papers and what their responsibilities are. This policy should be discussed with all trainees at the beginning of their rotation in the laboratory. 

4.       Since Department Heads are responsible to the Dean of Medicine for all activities of department members within their academic unit, Department Heads are expected to be kept informed of the ongoing activities of each laboratory by the Principal Investigator. Therefore, at least one copy of all publications and conference abstracts, as well as all grant applications and contracts must be submitted either before or at the time of external submission to the Department Head. These will be kept in the departmental files. 

5.       All co-authors should be encouraged to sign manuscripts to acknowledge responsibility for the contents before their submission.

D. Collaborative Research 

In cases of collaborative work at a number of sites, the principal investigator should ensure that all co-workers are familiar with the whole project (at very least with the broad details) and that protocols and ethical requirements for all sites have been approved.