Report from REB chairs

Note: To request a copy of the full report, please contact the Ethics office at lfrigaul@uottawa.ca

1. INTRODUCTION

In August of 1998, the three Canadian research councils, the Social Sciences and Humanities Research Council (SSHRC), the Medical Research Council (now the Canadian Institutes of Health, CIHR) and the Natural Sciences and Engineering Research Council (NSERC), adopted the Tri-Council Policy Statement: Ethics Conduct for Research Involving Humans (Tri-Council Policy Statement).

Since then, the University of Ottawa has modified the structure of its research ethics boards regarding human subjects in order to conform to the Tri-Council Policy Statement. The mandate of these boards is to evaluate the research projects conducted by professors and students at the University of Ottawa to make sure that these projects respect the principles used to protect human subjects.

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2. CREATION OF RESEARCH ETHICS BOARDS (REBs) AT THE UNIVERSITY OF OTTAWA (SEPTEMBER-OCTOBER 1999)

i) New Structure of the Research Ethics Boards (REBs)

Following the adoption of the Tri-Council Policy Statement, the University of Ottawa modified the structure of its ethics assessment process for research projects involving human subjects. It implemented new REBs, including:

  1. An REB responsible for medical protocols coordinated by the Ottawa Hospital;
  2. Two REBs responsible for non-medical protocols:
    1. An REB for the social sciences and humanities; and
    2. An REB for sciences and health sciences
  3. An Appeal Board that has the authority to hear appeals regarding decisions made by one of the REBs responsible for non-medical protocols.

Moreover, the University of Ottawa has created the new position of Protocol officer for ethics in research to support the two REBs responsible for non-medical protocols, assist researchers and coordinate issues relating to ethics in non-medical fields.

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ii) Transition Period

The existing Research Ethics Boards (REBs) were directed to continue operating in the usual manner until all the new structures were put in place and that the members of the new committees were ready to take charge of all the cases. The new REBs were to be functional as of November 1, 1999.

The first duties of the Protocol officer for ethics in research were to meet the heads of the former REBs to ensure the transfer of procedures and files, to implement a new review process for research with human subjects, to write the procedure rules for the new REBs and to create information documents to inform the university community how the REBs operate.

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iii) Research Ethics Boards and Appeal Board membership

Social Sciences and Humanities REB

Tim Aubry, School of Psychology, Chair (November 1999 to July 2001)
Lise Frigault, Protocol officer for ethics in research, Secretary (Since November 1999)
Jeffrey Sidney, Administration (Since November 1999)
Swee Goh, Administration (November 1999 to July 2001)
Patricia Raymond, Second Language Institute, Arts (November 1999 to July 2000)
Patrick Brunet, Communications, Arts (Since January 2001)
Daniel Lagarec, Geography, Arts (Since November 1999)
Edward Drodge, Education (November 1999 to May 2001)
Marielle Simon, Education (November 1999 to February 2000)
Barbara Graves, Education (Since March 2000)
Manon Tremblay, Political Sciences, Social Sciences (November 1999 to December 2000)
Louise Bouchard, Sociology, Social Sciences (Since January 2001)
Michèle Kérisit, Social Work, Social Sciences (November 1999 to December 2000)
Louise Blais, Social Work, Social Sciences (February 2001 to July 2001)
Julie Dompierre, Senior Officer - Canada Research Chairs Program, Community member (Since November 1999)
Céline Allard, Lawyer, Community member (November 1999 to November 2000)
Chantal Beauvais, NCERH, Community member (November 1999 to April 2000)
Geneviève Dubois-Flynn, NCERH, Community member (Since August 2000)

Health Sciences and Science REB

Julian Roberts, Criminology, Chair (Since November 1999)
Valerie Whiffen, Psychology, Chair by interim (January 2000 to July 2000)
Lise Frigault, Protocol officer for ethics in research, Secretary (Since November 1999)
Tim Lethbridge, SITE, Engineering (Since November 1999)
Handan Tezel, Chemical Engineering, Engineering (November 1999 to December 2000)
Caroline Barrière, SITE, Engineering (Since January 2001)
François Tremblay, Physiotherapy, Health Sciences (November 1999 to July 2001)
Christine Dallaire, Human Kinetics, Health Sciences (Since November 1999)
George Fouriezos, Psychology (Since November 1999)
Valerie Whiffen, Psychology (Since November 1999)
John Thor Arnason, Biology, Science (Since November 1999)
Christiane Charest, Biology, Science (November 1999 to August 2000)
Bernard Philogène, Biology, Science (Since September 2000)
Julie Greene, Health Canada, Community member (January 2000 to May 2001)
John Dossetor, Physician and Bioethicist, Community member (Since October 2000)
Errol Mendes, Director, Human Rights Research and Education Centre (November 1999 to December 2000)

Appeal Board

Howard Alper, Vice-rector (Research), Chair
Peter Walker, Dean, Medicine
Christian Detellier, Dean, Science
Caroline Andrew, Dean, Social Sciences
Martine Nantel, Lawyer, Privacy Commission
Gordon McKechnie, Lawyer

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3. TASKS OF REB AND APPEAL BOARD MEMBERS

  1. PROTOCOL OFFICER FOR ETHICS IN RESEARCH
    1. Preparation of monthly cases to be evaluated
    2. Preparation of REB meetings
    3. Participation in REB meetings
    4. Follow-up on REB meetings
    5. Follow-up on cases that have not received REB approval
    6. Support for researchers and research administrators
    7. Research and training
    8. Others
  2. REB CHAIR
    1. Monthly case review
    2. Participation in monthly REB meetings
    3. Others
  3. REB MEMBERS
    1. Monthly case review
    2. Participation in monthly REB meetings
    3. Others
  4. STUDENT HIRED AS AN ASSISTANT TO THE PROTOCOL OFFICER
    1. Follow-up on cases transferred from former REBs
    2. Research work for the REB Internet site
    3. Other research work
    4. Administrative and technical support

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4. REPORT ON REB ACTIVITIES (NOVEMBER 1999 TO APRIL 2001)

  1. CASE REVIEW
    From November 1999 to April 2001 inclusively, the REB members have evaluated the following number of cases:
    1. Cases that have been fully evaluated by the REB:
      REB for social sciences and humanities: 107
      REB for health sciences and sciences: 166
    2. Cases that were evaluated in an expeditious manner (by a few members of the REB, the chair or the Protocol Officer). These cases include ethics approval requests for course plans, requests for extended ethics approval, approval requests for changes to research projects and changes to ethics approval requests made by the REB to researchers:
      REB for social sciences and humanities: 71
      REB for health sciences and sciences: 66

    There are approximately 300 active research projects with human subjects at the present moment at the University of Ottawa. The members of the REB foresee that this number should increase with awareness and training of the university community regarding the protection of human subjects participating in research.

    Note: The Protocol officer for ethics in research has sent more than 500 letters to try and update the old cases of the ethics committees. Many professors have yet to complete their annual status report questionnaires.

 

  1. ADOPTION OF PROCEDURE RULES
    The Protocol officer for ethics in research has developed general procedure rules for the Research Ethics Boards, based on previous rules and on the principles established in the Tri-Council Policy Statement. Over the course of the last year, the REB members have proposed other changes. Moreover, the Protocol officer was required to modify the procedure rules to satisfy various situations that arose during the year.

  2. PARTICIPATING IN CONFERENCES AND WORKSHOPS
    The Protocol officer for ethics in research had the opportunity to participate in a few conferences and workshops during the course of the year. Moreover, two of the REB members attended the annual conference of the National Council on Ethics in Human Research (NCEHR) in April 2001 on the consent of research subjects.

    The Protocol officer for ethics in research also gave three training workshops to students majoring in physical activity and nursing. She also conducted a presentation with one of the members from the REB for health sciences and science to the members of the Faculty of Health Sciences.

  3. PROCESSING OF APPEALS OF REB RULINGS
    A few of the REB rulings were appealed by the researchers in question. One of these cases was heard by the Appeal Board. The two REBs submitted their comments regarding the complaint that dealt with the ban on using, in most cases, students in classrooms as research subjects.

    The Protocol officer for ethics in research, with the Office of the Vice-Rector (Research), implemented an appeal process for REB decisions. The two research ethics boards submitted their comments to the members of the Appeal Board. The Appeal Board met on February 9, 2001 to discuss the issue in dispute and to render a decision.

  4. PROCESSING OF COMPLAINTS REGARDING STUDIES CONDUCTED BY UNIVERSITY OF OTTAWA PROFESSORS
    A few complaints were made and a few questions asked by research subjects and by members of the community regarding studies conducted by researchers at the University of Ottawa. The Protocol officer for ethics in research communicated with the main researchers involved in the studies, with the REB that initially evaluated the projects and with the complainant.

    In some of the cases, it was simply a lack of communication between the researchers and the research subjects or someone inquiring about general information. The Protocol officer for ethics in research made sure to send the necessary information to the various parties. In another case, University of Ottawa researchers were only indirectly involved in a program review project. The Protocol officer informed the participants regarding the project's status. In the last case, the complaint was transferred to the REB that had originally examined the ethics approval request.

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5. GENERAL OBSERVATIONS ON REB OPERATIONS

a) Positive Points

Members of both REBs feel that the efficiency of the case review process was improved with the hiring of a Protocol officer for ethics in research and the consistency of the committee meetings.

Moreover, the new composition of the REBs has created an interesting dynamic within the REBs. In fact, the exchanges between the members of the university community from various areas of expertise, the members of the community served by the University of Ottawa as well as the contributions of a chair from a field of study that is different from that of the other members has increased the expertise of the REBs and generated some interesting debates.

The creation of an Internet site for the REBs has also helped in creating awareness among the university community regarding the ethics approval process. This source of information has also helped in guiding researchers through the request process and informing them of changes that have transpired during the course of the year.

b) Problems Uncovered by the REBs

Lack of knowledge and interest of research community

The REB members feel that the university population is not adequately trained in regards to ethics in research with human subjects. Major changes have taken place over the last few years in the area of procedures and principles to be adhered to at the university, Canadian and international level. There is therefore a need for training among the professors, students and employees of the University of Ottawa.

This lack of training is reflected in the way the ethics approval requests are prepared, in the understanding of ethics issues in research, in the help that researchers must be given in their ethics approval requests and in the reaction of certain members of the community regarding the importance of the ethics approval process. The REB members therefore believe in the necessity of educating the university population in order to change the culture in relation to the ethics approval process.

REB quorum

The composition of the REBs has a posed a few problems over the course of the last year. In fact, the quorum was not reached in approximately one quarter of the meetings during the year. The absences were due to schedule conflicts given the large number of committee members, the summer season and other non-controllable factors.

Recruitment of community members

Moreover, it has been difficult to recruit members from the community since they are not being paid and the meetings are held during the day. REB members will have to deal with the quorum issue and the composition of the committees in order to resolve these problems.

Harmonization of decisions

The REB members are concerned with the harmonization of decisions made by various REBs across the country. Many of the researchers must present their requests to several REBs as part of their multi-centre research. The REB members believe that in the future agreements with other institutions should be negotiated in order to facilitate the work of researchers.

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6. RECOMMENDATIONS FOR 2001

a) ADOPTION OF PROCEDURE RULES BY THE ACADEMIC SENATE OF THE UNIVERSITY OF OTTAWA

The Protocol officer for ethics in research created the REB procedure rules in October 1999 basing herself on the rules of the former REBs. The new rules were modified several times over the course of the year following comments from REB members on REB operations and identified needs.

The REB members propose that the latest version of the procedure rules be adopted by the Academic Senate. In the future, any new modification made to the rules adopted by the REB must be ratified by the Academic Senate within the following year for the modification to take effect.

b) ADOPTION, BY THE OFFICE OF THE VICE RECTOR (RESEARCH) AND THE ACADEMIC SENATE OF THE UNIVERSITY OF OTTAWA, OF A PRIORIZATION RESOLUTION FOR THE ETHICS REVIEW PROCESS ON RESEARCH CONDUCTED AT THE UNIVERSITY OF OTTAWA

The new REBs have observed that there is a lack of awareness among the university community regarding the impact of the adopted Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans on environments in which research takes place.

The REB members noted that at several levels the university culture needs to be modified regarding the principles and procedures for research ethics review. The REB members have noted a lack of support from the University of Ottawa's upper administration regarding the ethics approval process for research on human subjects. For example, several professors are not yet aware of changes in this field. Others are not even familiar with the ethics review process, particularly the new professors. Moreover, the Protocol officer for ethics in research was only allocated a permanent office after more than a year and a half of work at the University of Ottawa. In addition, the REBs receive very little administrative support from the Office of the Vice Rector (Research). The University of Ottawa administration also initially ignored an invitation from the National Council on Ethics in Human Research, the organization responsible for coordination the implementation of the Policy Statement and to provide support to research establishments, to organize a site-visit of the University.

Consequently, the REBs recommend that the Office of the Vice-Rector (Research) and the Academic Senate issue a notice to the university community emphasizing the adoption of the Tri-Council Policy Statement, the creation of the new REBs and the new ethics review procedure for research projects as well as the responsibilities of professors as researchers and student supervisors.

c) STUDENT REPRESENTATION WITHIN THE REBs

The REBs are composed of members of the teaching faculty and members of the community served by the University of Ottawa. The former REBs from the various faculties and the School of Psychology also had a student member on their committees.

The REBs thereby proposed that for each REB a student representative at the masters or doctorate level be chosen from a list of nominated candidates issued by the head of advanced studies from the faculties and departments.

d) CREATION OF A PERMANENT AND FULL-TIME POSITION OF EDUCATION AND RESEARCH ETHICS CASE MONITORING COORDINATOR

As was described previously, the REBs and the Protocol officer need support and resources in their activities. It is also important to ensure continuity in the work done by REB members and the chair. Other research institutions similar in size to the University of Ottawa have adopted such a structure to meet the human resources needs created by their ethics review process.

The REB members have therefore recommended the hiring of a permanent and full-time Education and Research Ethics Case Monitoring Coordinator who would work in collaboration with the Protocol Officer for Ethics in Research. This request was approved by the administration of the University of Ottawa in April 2001.

e) CREATION OF AN OFFICE FOR ETHICS IN RESEARCH ON HUMAN SUBJECTS

The position of Protocol officer for ethics in research was created in July 1999. The Office of the Vice-Rector (Research) hired its first Protocol officer for ethics in research in September 1999. The creation of this position was in response to the adoption of the Tri-Council Policy Statement that requested that all research establishments comply with its principles within the following year. The Officer issued her first report to the National Council on Ethics in Research in October 1999, confirming the changes the University of Ottawa had made.

When the Protocol officer for ethics in research began her duties, no permanent office was granted to her, despite the efforts of the Assistant to the Vice-Rector (Research) and the head administrator of the University of Ottawa. In May 2000, the Protocol Officer for Ethics in Research hired a student full time for the summer and part time for the rest of the 2000-2001 academic year. The REB members also recommended that an Education and Research Ethics Case Monitoring Coordinator be hired and that the position of REB Administrator be created.

The REBs recommend that sufficient space be made available to provide the REBs with better visibility at the University of Ottawa and to adequately accommodate the necessary personnel and material resources for the REBs. An office was allocated to the Protocol officer for ethics in research in April 2001.

f) INCREASE IN THE OPERATING BUDGET FOR THE REBs

The REB members recommended that the REB operating budget be increased from $10,000 to $20,000 for the financial year beginning in May 2001. This request was approved by the University administration in April 2001.

This increased budget will allow for attendance to more conferences, the purchase of training tools for ethics in research, the maintenance of the REB Internet site, the organization of workshops destined for the university community, etc.

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7. RECOMMENDATIONS FOR 2002

a) CREATION OF A PERMANENT AND FULL-TIME POSITION OF REB COORDINATOR

As was described previously, the REBs and the Protocol officer also need administrative help in their activities. It is also important to ensure continuity in the work done by REB members and the chair.

The REB members recommend that a permanent and full-time REB Administrator be hired who would act as an assistant to the Protocol officer for ethics in research.

 

 

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