Health Canada Research Ethics Board Researcher Survey of REB Members 2009

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Prepared by Praxis Research

Table of Contents

• 1. Background
  • 1.1 Purpose
  • 1.2 Approach
    • 1.2.1 Survey Design
    • 1.2.2 Sample and Response Rate
    • 1.2.3 Survey Implementation
• 2.0 Survey Results
  • 2.1 Meetings
    • 2.1.1 Meeting - planned in accordance with the needs of the workload
    • 2.1.2 Meetings -sufficient time at a REB meetings
    • 2.1.3 Meeting - locations in regions and Ottawa
    • 2.1.4 Meetings - facilities/meeting rooms
    • 2.1.5 Meetings - travel arrangements
    • 2.1.6 Meetings - translators provide clear and precise translation
  • 2.2 Support
    • 2.2.1 Support - overall satisfaction
    • 2.2.2 Support - resources
    • 2.2.3 Support - initiatives and issues arising in Health Canada, regarding research ethics?
    • 2.2.4 Support - presentation effective and efficient use of time?
    • 2.2.5 Support - should Secretariat work more closely with researchers to prepare them to present?
  • 2.3 Priorities for the REB
  • 2.4 Impact
    • 2.4.1 Key impacts
    • 2.4.2 Necessary to improve the efficiency and effectiveness of the REB
    • 2.4.3 Appreciation of REB members
  • 2.5 Training    
• Summary
• Appendix A REB Member Survey
• Appendix B Introductory Email

1. Background

1.1 Purpose

In 2002, Health Canada established an independent research ethics board - the Research Ethics Board (REB) Secretariat. The REB Secretariat is responsible for reviewing all Health Canada research involving human subjects.

Since 2003, the REB Secretariat contracted out research to conduct an independent assessment of the efficiency and effectiveness of the Research Ethics Board and the ethics approval process. Initially both researchers and Board members were surveyed to provide feedback for this assessment. In 2004/05 Praxis Research replicated the survey to assess researchers' perspectives about the REB process during its second year of operation.  This survey was also conducted in 2006 and 2008.

In December of 2008, the Research Ethics Board (REB) Secretariat retained the services of Praxis Research to carry out a survey of current and alternate Ethics Review Board Members. The purpose of the survey is to ascertain if the service that the Secretariat provides to the board members on a daily basis is satisfactory or if improvements are required in certain areas. The information obtained from the survey is intended to assist the Secretariat and the Chief Scientist to maintain or improve performance as needed and make plans for the future. This report presents the findings of this survey.

1.2 Approach

1.2.1 Survey Design

The survey was designed which asked board members to report about their experiences in the following areas:

1. Meetings
2. Support
3. Priorities of the Research Ethics Board
4. Training

The survey included a combination of closed- and open-ended questions. French and English versions of the survey were prepared (See Appendix A for English version).

1.2.2 Sample and Response Rate

In January 2009, Health Canada REB Secretariat provided Praxis Research with an email contact list of REB members who currently serve as REB members.  This list consisted of 13 Board members. Twelve Board members were able to complete the survey. 

1.2.3 Survey Implementation

The survey was administered online. Initially, an introductory email was sent to all Board members by Praxis (Appendix B). This email explained the purpose of the communication, the purpose of the study and provided a link to the survey and an individual password.  The purpose of the password was to ensure the confidentiality of responses and to secure access to the responses.  Participants who were not able to complete the survey in one session were able to re-enter the survey using their password and complete it at a later date. The survey was administered online from January 16 until Feb. 20, 2009.  Board members received the introductory email, a reminder email and one or two phone call reminders (5 members completed the survey without any reminders, 4 required one email reminder and the remaining members required 1-3 phone calls). 

2.0 Survey Results

2.1 Meetings

2.1.1 Meeting - planned in accordance with the needs of the workload

The majority of members agreed (7 strongly agreed and 4 agreed) with the statement "Meetings are planned in accordance with the needs of the workload". One member disagreed.

All members stated that monthly meetings are warranted. One respondent suggested that summer meetings could be considered and one asserted that summer meetings should not be instituted. The respondent who disagreed with the statement indicated that the workload is quite heavy when traveling time and preparation time are considered and suggested that anything less than monthly meetings would be inadequate.

Example of a typical written response:

I believe it is very important to have monthly meetings for at least four reasons. First, the workload is steady and the buildup of applications for a two month period would be overwhelming in terms of review time in advance of the meeting, as well as length of meeting. Second, researchers who are the applicants would likely also find the time between meetings problematic in terms of initial review and their full application. Third, it is important to ensure that Committee members continue to interact on a regular basis and build on each others' strengths. Fourth, there is a need for continuing updates for members as new guidelines are developed or revised, eg. the TCPS 2nd edition now under review. While we all need to take time to read this material independently, the learning and applications that occur come as a result of discussions among members. . .

Regarding the time that the REB Secretariat provides members to review research protocols prior to scheduled meetings, eleven members responded.  Seven respondents were satisfied with the lead time and two commented that those members who work full-time may benefit from receiving materials at least 2 weeks time prior to meetings. Several respondents made a point to acknowledge their understanding that the Secretariat does its best to get materials out to Board members but is limited by the efficiency of '3rd party' persons.

Example of a typical written response:

The time for review can often be tight but with planning ahead, it is workable. I do appreciate the short timeline the REB Secretariat has to turn these applications around and have them vetted and ready for us. Thus, I believe the Secretariat does a fine job of ensuring the applications are complete and ready for our review.

2.1.2 Meetings -sufficient time at a REB meetings

All respondents agreed that the REB Secretariat provides sufficient time at REB meetings for the members to discuss research protocols of the presenting researchers

Example of a typical written response:

Yes, I believe we do have sufficient time for our discussions. Mapping out the agenda and time-lines cannot always be done with precision since members may find unexpected issues during review or during discussion with the researchers present or teleconferencing in to the meetings. Only on rare occasions have we been short of time for one or more applications, but normally there is time at some point in the agenda to return to an earlier discussion on a protocol and complete it.

2.1.3 Meeting - locations in regions and Ottawa

The majority response to the statement "Meetings should continue to be held in the Regions as well as in Ottawa" was agreement (7 strongly agreed). The one respondent who disagreed did not indicate in any written comments why they thought meetings should not continue to be held in the Regions as well as Ottawa.

2.1.4 Meetings - facilities/meeting rooms

All respondents to this question agreed with the statement "Meetings are held at suitable facilities/meeting rooms".

Of the eleven comments submitted: nine respondents conveyed satisfaction with meeting locations and facilities, and two respondents cited problems in terms of room size and temperature control, specifically at the Marriott (no jurisdiction given).

Example of a typical response:

Arrangements are usually excellent and the facilities are normally very good but occasionally, the rooms have been not as good as usual.

2.1.5 Meetings - travel arrangements

Eleven members responded to questions regarding travel arrangements to meetings. The majority strongly agreed (8) and two agreed with the statements "Travel arrangements are made promptly" and "Travel arrangements are convenient". The other respondent selected 'neutral' for an answer possibly indicating that the question was not applicable.

2.1.6 Meetings - translators provide clear and precise translation

Respondents who answered this question agreed (6) or strongly agreed (3) that the translators used provided clear and precise translation. The other respondent selected 'neutral' for an answer possibly indicating that the question was not applicable.

2.2 Support

2.2.1 Support - overall satisfaction

Overall satisfaction with the support provided by the Secretariat was high with one exception. No comments were submitted by this one member to explain the reasons for their dissatisfaction and had no suggestions for improvement.

Two members suggested improvements to the length of time that Health Canada takes to reimburse REB members for expenses (one person mentioned that a 3 month time period for reimbursements).

The typical response by respondents in terms of suggestions for improvements to the support provided by the Secretariat is illustrated by this response:

Example of a typical response:

Cannot think of a single thing that the Secretariat hasn't thought of first!

2.2.2 Support - resources

All respondents answered 'no' to the question - "are there other resources required to assist members participating at REB meetings?" The only comment left was:

 I find the Secretariat very thoughtful and generous in seeing to our needs.

2.2.3 Support - initiatives and issues arising in Health Canada, regarding research ethics?

Most agreed that it would be helpful to have the Secretariat inform the REB members of initiatives and issues arising in Health Canada, regarding research ethics. The one person who disagreed stated that "It can be presented at the REB meetings - briefly. Then if requested, we can have additional information sent via email".

2.2.4 Support - presentation effective and efficient use of time?

All respondents indicated that they agreed that the researchers' presentations meet the need for effective and efficient use of time.

Examples of comments within this section:

Depends entirely on the researchers. The presence of the researchers is important for the effective use of time. Sometimes their initial presentations seem to assume that no one has even looked at their submissions.

Most of the time yes, but some proposals require more time for evaluation because of their complexity and the quality of proposals is not consistent across the board.

Usually they are well prepared.  At times they could have benefitted from advice perhaps from within HC or PHAC or from REB in order to better prepare for the presentation especially if they are expecting a decision out of the meeting.

2.2.5 Support - should Secretariat work more closely with researchers to prepare them to present?

The answers for this question were split. Most of the comments left in this section did not indicate that the Secretariat should improve their performance. Instead, the comments left indicated that the onus was left with the researchers to avail themselves of the support provided by the Secretariat.

Example of written responses:

 "I think the Secretariat does a very good job of instructing researchers about their presentations. That does not mean that all researchers pay attention to these instructions, but they are always warmly greeted and warmly dismissed in appropriate ways that build relationships between the REB and the researchers."

"I think this is the responsibility of the presenters but Sect could offer assistance as well."

"The answer to this question is not black and white. Some researchers have more experience than others. As a committee member my opinion is that the Secretariat fulfills its responsibilities in a fully satisfactory manner."

2.3 Priorities for the REB

Respondents were asked to comment on whether there is a need for the REB to devote more time to policy development. Nine respondents answered this question. Four said 'no' and four agreed there is such a need. One member suggested the need is for communication /promotion of ethics policies throughout REB, HC and PHAC.

The members that disagreed submitted the following comments:

Example of written responses:

"The PRE group, NCEHR and Health Canada itself do enough policy development. There may be some value in developing some practical instruments to help researchers interpret policy, i.e. How distinguish research from QI or from mandated surveys?"

"I think we should (and do) stay connected to other activities in this area, through CIHR, for example. If there is a policy needed, we would be hard-pressed to find the time to address this need with the current volunteers on this Board, who are very busy people. The REB does have a role to identify a policy gap and then, perhaps, to work through partnerships or solicit outside resources for this work."

"Adequate time is spent on policy development."

When asked what respondents felt should be the priority for policy development, the responses include:

1. Especially in terms of policies regarding regulations on food and drugs
2. Aboriginal Health Research Ethics Guidelines (mentioned by 3 members)
3. New TCPS guidelines (mentioned by 3 members)
4. Issues associated with ethical review of public health research (eg. criteria for surveillance and research). (mentioned by 4 members )
5. Greater attention to PAR guidelines for REB review and other qualitative policy guidelines
6. REB's role is vis a vis internationally funded projects
7. Determining how the REB should respond to government funded research that is discriminatory, but not necessarily unethical.
8. Developing clearer definitions of what should come before the RE: research vs evaluation, surveys, surveillance, community consultations etc. that can be defined as non-research
9. Mention that there is need to be coordination/collaboration on policy between various 'bodies' - PHAC, REB, TCPS, PRE, HC.

2.4 Impact

2.4.1 Key impacts

Eleven respondents provided answers to the question - "What do you think are the key impacts for the Research Ethics Board in Health Canada?" The answers include the following:

Protection for the human subjects participating in Government funded research

Improved research design and implementation  education of HC and PHAC researchers and managers as to ethical principles

"Researchers in Health Canada or involved with Health Canada are slowly but surely beginning to appreciate the importance of research ethics review

Key impact is the education of researchers about their ethical responsibilities

Helps to bring some consistency to research review for Northern communities and for a lot of community based or public health research in general. And provides some rigor and education about research in those areas.

"Improves the quality of research and makes the researchers more aware of their responsibilities"

Contributes to a culture of excellence

Making researchers give the priority it deserves to consideration of the ethics of their research

Raising awareness of the importance of ethical review of research involving human subjects

Gives people a sense of confidence that research conducted in Canada is ethical

Role of the REB . . .  in ensuring that the scientific integrity is within the applications also. . . That is about ensuring the research is ethical [when the integrity of the research is maintained]

2.4.2  Necessary to improve the efficiency and effectiveness of the REB

When asked what things members thought are necessary to improve the efficiency and effectiveness of the REB, nine responses were submitted. These included the following suggestions:

1. Better training re ethical issues for researchers, managers and partners
2. Collaboration with PHAC and CIHR, of which CIHR has guidelines available for ethics review.
3. Continuing development of tools for review  -  the application forms always need ongoing revisions (true for all REBs), as well as considering what can be expedited and what cannot.
4. More bilingual people are needed
5. More time to prepare before a meeting is necessary.
6. Devote some time to discover listen to each other speak about their research ethics knowledge and experience so that we could better appreciate and utilize their unique knowledge and skill and their connections to various agencies that are important for our work together.
7. Minimize beaucracy.
8. Have minor amendments reviewed by e-mail by the chair and 1 or 2 members.
9. Have a committee with a sufficient number of alternate people

2.4.3 Appreciation of REB members

When asked whether the respondents felt that the Department appreciated their efforts serving on the REB, nine members agreed. Seven members provided written answers - two felt they were appreciated by the way they are supported, three said they had no way of knowing and two said "I hope so!"

2.5 Training

The Board members were asked for their level of agreement on the statement:  "I was provided with the necessary training to perform my responsibilities as a REB member."

One member disagreed with this statement and also indicated that they are dissatisfied with the opportunities currently provided for ongoing training to REB members (see Graph 4 and 5).

The lone member who disagreed and was dissatisfied gave the following reason: "There should be a protocol in place for training when new ethical developments occur such as the release of the Aboriginal Health Research Guidelines by CIHR and the updated Tri-Council Policy."

Level of satisfaction with the opportunities currently provided for ongoing training toREB members. (n=12)
Percentage

45 40 35 30 25 20 15 10 5 0

very dissatisfied
dissatisfied
neutral
satisfied
very satisfied

When members were asked to identify any further training initiatives they would like to see undertaken for REB members, some Board members responded with the following:

As a group the REB needs additional education about the ethical issues in various forms of public health research.

Ffor members that come without any REB experience, there may be training opportunities, but I am not sure what they might be, perhaps an orientation day of some sort.  But I suggest that primarily or only for members without prior REB experience.

Presentation and discussion on the new TCPS guidelines.

We are given open invitations to attend many external research ethics education events, and it is up to us to take them. I cannot think of much more the Secretariat could be offering us -- they are very generous.

3.0 Summary

The results of this survey demonstrate an overwhelmingly positive view of the REB members towards the work of the Secretariat. There were a very small number of negative responses to the questions posed. In addition, there were mainly minor suggestions for improvements to the process and conduct of the support of the Board members as they conduct the Ethics review of human subjects research for Health Canada.

Improvements that were suggested by the Board members include the following:

1. Participate in the collaboration of Ethics review with other agencies such as PHAC, CIHR etc.
2. Continue development of tools used in the ethics review process, i.e. forms.
3. Possibly provide additional support to members who feel overburdened.
4. Provide a means for Board members to understand each other's background, experience, and connections to other agencies to facilitate the best use of each individual on the REB.
5. Although the Board member all felt the presentations to the Board by researchers were satisfactory, they were split on whether the Secretariat should be doing more to help researchers prepare.
6. Training initiatives including but not limited to - additional education in ethical review of public health research, ensuring that newer members without REB experience receive adequate training and discussion of the new TCPS guidelines.
7. Members indicated room for policy development and suggested some areas for
8. consideration
9. Facilitate action to decrease time that it takes for Health Canada to reimburse expenses to the Board members. 

Health Canada Research Ethics Board Survey of REB Members

Appendix A REB Member Survey

Health Canada Research Ethics Board (REB):

2009 Survey of the REB members

Please complete the following questions about your experience as a member and/or as an alternate member of the Health Canada Research Ethics Board.

I. Meetings

1. Please rate your level of agreement with the following statements about the Research Ethics Board meetings at Health Canada.

	Strongly disagree	Disagree	Neutral	Agree	Strongly agree	N/A
a. Meetings are planned in accordance with the needs of the workload.	1	2	3	4	5
b. Travel arrangements are made promptly.	1	2	3	4	5
c. Travel arrangements are convenient.	1	2	3	4	5
d. Meetings are held at suitable facilities/meeting rooms	1	2	3	4	5
e. Meetings should continue to be held in the Regions as well as in Ottawa.	1	2	3	4	5
f. The translators provide clear and precise translation about various issues discussed at meetings (when these are    required)	1	2	3	4	5

1. Please provide your comments on how you feel about the current workload and whether it warrants a monthly meeting.
2. Please provide any comments about the REB meeting arrangements or facilities.
3. Please provide your comments on whether the REB Secretariat is providing sufficient time for the members to review research protocols prior to a scheduled REB meeting.
4. Please provide your comments on whether the REB Secretariat is providing sufficient time at a REB meeting for the members to discuss these research protocols.

II. Support

• 1. Rate your overall satisfaction with the support provided to you by the Secretariat.

  1 - Very dissatisfied
  2- Dissatisfied 
  3 - Neutral
  4 - Satisfied
  5 - Very satisfied
  

• 2. Please identify any improvements to service offered by the Secretariat that will improve the efficiency and effectiveness of the REB's role?
• 3. The Secretariat provides resources to members to meet their needs for minor expenses such as printing, paper, etc. Are there other resources required to assist you in participating at REB meetings?
  
  [ ] Yes  [ ] No

Please identify additional required resources.

• 4. Would it be helpful to have the Secretariat inform the REB members of initiatives and issues arising in Health Canada, regarding research ethics?
  
  [ ] Yes [ ] No Please comment
• 5. Do you feel the researchers' presentations meet the need for effective and efficient use of time?
  
  [ ] Yes   [ ] NoPlease comment.
• 6. Should the Secretariat work more closely with researchers to ensure presentations meet with the Board's requirements?
  
  [ ] Yes   [ ] NoPlease comment.

III. Priorities for the REB

• 1. Please comment on whether you believe there is a need for the REB to devote more time to policy development.
• 2. What do you think should be the priorities for the REB in the area of policy development?

IV. Impact

• 1. What do you think are the key impacts for the Research Ethics Board in Health Canada?
• 2. What do you see as being necessary to improve the efficiency and effectiveness of the Research Ethics Board?
• 3. Do you feel that the Department appreciates your efforts as a volunteer on the Health Canada Research Ethics Board?

   [ ] Yes [ ] No Please comment.

V. Training

• 1. Rate your level of agreement with the following statement: "I was provided with the  necessary training to perform my responsibilities as a REB member."

  1 - Very dissatisfied
  2- Dissatisfied 
  3 - Neutral
  4 - Satisfied
  5 - Very satisfied

• 2. Rate your level of satisfaction with the opportunities currently provided for ongoing training to REB members.

  1 - Very dissatisfied
  2- Dissatisfied 
  3 - Neutral
  4 - Satisfied
  5 - Very satisfied

• 3. Please identify any further training initiatives you would like to see undertaken for REB members.

Thank you very much for your participation!

Appendix B Introductory Email

Dear <<Board member>>:
The Research Ethics Board (REB) Secretariat has retained the services of Praxis Research to carry out a survey of current and alternate Ethics Review Board Members. The purpose of the survey is to ascertain if the service that the Secretariat provides to the board members on a daily basis is satisfactory or if improvements are required in certain areas. The information obtained from the survey will be used to assist the Secretariat and the Chief Scientist to maintain or improve performance as needed and make plans for the future. Your participation is invaluable to help maintain REB Secretariat's high standards of ethical review administration.

Important Information:

1. To access the online survey, please click on the following Internet link: http://surveys.praxis.ca/hcreb_2009en/
2. We have assigned a password for each board member.
3. The password for <<Board member>> is XXXXXXXX
4. If you do not complete the survey at one sitting you can use your password to re-enter the survey and finish your partially completed survey or revise your responses.

6. Please submit your completed survey by January 30, 2009. 

Your responses are confidential. Only Praxis Research has access to the data. Comments will be aggregated by Praxis Research to maintain individual confidentiality. If you have any questions or concerns about the online survey please contact Joanne Miller at Praxis Research, phone number at 403 685-8383 or by email at miller@praxis.ca .

Your participation in this survey is greatly appreciated.

Sincerely,
Praxis Research

1. (403) 685-8383 (phone) 1-866-249-8822
2. (403) 249-8983 (fax)

www.praxis.ca