Initial Implementation Working Group Final Report with Recommendations (2007)

For the Canadian Institutes of Health Research
Best Practices for Protecting Privacy in Health Research
(September 2005) document


September 13, 2007

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Table of Contents



List of Acronyms and Abbreviations


CAREB Canadian Association of Research Ethics Boards
CIHR Canadian Institutes of Health Research
IIWG Initial Implementation Working Group
NCEHR National Council on Ethics in Human Research
NSERC Natural Sciences and Engineering Research Council of Canada
PBPs document
CIHR Privacy Best Practices document. Full title: CIHR Best Practices for Protecting Privacy in Health Research (September, 2005)
PRE Interagency Advisory Panel on Research Ethics
REB Research ethics board
SRE Secretariat on Research Ethics
SSHRC Social Sciences and Humanities Research Council of Canada
SSHSWC Social Sciences and Humanities Research Ethics Special Working Committee
TCPS Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 1998 (with 2000, 2002, 2005 amendments). For the most recent version, consult the online version at Interagency Advisory Panel on Research Ethics.
Tri-Agency
Tri-Council
Pertaining to these three federal research agencies: Canadian Institutes of Health Research, Social Sciences and Humanities Research Council of Canada, and the Natural Sciences and Engineering Research Council of Canada

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Summary of Recommendations

1. Promotion of Educational Value

The Initial Implementation Working Group (IIWG) recommends that the educational value of the CIHR Privacy Best Practices (PBPs) document be promoted widely and complemented by various teaching tools. These should be tailored to a wide range of potential users, including researchers, undergraduate and graduate students, research ethics boards, other funders of research such as health charities, and regulatory colleges.

2. Communications

Communication efforts should be intensified and broadened, and should be ongoing to ensure that the research community is notified of any changes to the document. These outreach efforts should have a broad range of targets, including Vice Presidents - Research, research ethics offices, university research offices, and researchers. The communication mechanisms can be straightforward, such as existing organization email lists (e.g., the member email list of the Canadian Association of Research Ethics Boards), the CIHR News for Researchers, and the web sites and forums of the National Council on Ethics in Human Research (NCEHR) and the Canadian Association of Research Administrators. A new email list could be set up by inviting interested users to register to receive notification of changes to the document.

3. (a) No major revision to content or format.
    (b) Improvement to the electronic format.

(a) The IIWG recommends no major revision to the document at this point, but there needs to be the capacity to update its contents over time (e.g., update the legal concordance tables and/or add sections). The document should be nimble enough to respond to significant issues and changes that impact on content. Criteria for determining when content changes are appropriate should be developed.

The colourful and tabbed printed format of the document could be a model for this kind of educational document. It is recommended that a base supply of printed copies be maintained. Printed copies are useful for distributing at venues such as conferences and meetings, and can lead satisfied users to refer others to the electronic version.

Recognizing the high costs of printing the document and the need for timely revision, the electronic format of the document should become the official version. The URL of the document should remain the same for successive updates, and previous versions should be archived.

(b) The electronic format of the document should be improved by adding:

  • A hyper-linked subject index
  • The capability to print only selected sections of the document
  • "Thumbnail" tabs in the document.

The electronic and new print versions of the document should have the "How to Navigate the Document" more prominently displayed (e.g., on the cover or first page).

4. Outreach to Social Science Researchers

The IIWG recommends setting an objective of reaching out to social scientists in the development of research guidelines and best practices so that social and health researchers will have "collective ownership" of the outcome. The IIWG recommends that CIHR maintain liaison with the Interagency Advisory Panel on Research Ethics and its Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC), in the context of ensuring changes to the Tri-Council Policy Statement: Ethical Conduct in Research Involving Humans are more reflective of the social sciences. To that end, CIHR should maintain its representation on SSHWC.

CIHR is encouraged to remind the health sciences community in its communications that CIHR funds social scientists, and social scientists are on CIHR-funded interdisciplinary teams.

There are useful good practices in the PBPs document that are transferable beyond personal health information. Social scientists are encouraged to think of the PBPs document as a valuable resource.

5. Promotion as Voluntary Companion Document to the TCPS

The IIWG recommends that the PBPs document be a companion document to the Tri-Council Policy Statement: Ethical Conduct in Research Involving Humans (TCPS), but not become incorporated into the TCPS. The PBPs document should be a voluntary resource for practical assistance in implementing the TCPS, and not mandatory Tri-Council policy. It is also recommended that as initiatives come forward that relate to research integrity relevant to privacy and confidentiality (e.g. data integrity), the PBPs document be used (or revised as needed) to help inform efforts to resolve these issues.

Voluntary use of the PBPs document can be promoted through such means as:

  • voluntary "Certificates of Completion" when an online tutorial (to be developed) is completed;
  • contribution to points for continuing medical, dental, nursing education credits; and
  • where applicable, recognition by accrediting bodies for professional training and teacher training for graduate students.

6. International Recognition

The IIWG recommends that a long-term implementation strategy involve assessing the comparability of the PBPs document with international guidance documents (e.g., those of the United States National Institutes of Health) and fostering international acceptance. For example, CIHR should aim to have the PBPs document included in the The International Compilation of Human Subject Research Protections, a listing of the laws, regulations, and guidelines that govern research involving human participants in many countries around the world, compiled by the United States Department of Health and Human Services Office for Human Research Protections.

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Background

In response to the need for Privacy Best Practices voiced by the broad research community, the CIHR Ethics Office established a multi-sectoral Privacy Advisory Committee (PAC) in 2003 to assist in developing a draft set of Best Practices. PAC consulted on this draft document widely in 2004. A revised document - CIHR Best Practices for Protecting Privacy in Health Research - was published in September 2005.

The CIHR Privacy Best Practices document was intended to:

  • provide guidance for health researchers in the design and conduct of health research involving personal information;
  • be a resource for research ethics boards (REBs) and institutions to consult when reviewing and evaluating health research involving personal information; and
  • through the uptake and application of these Best Practices in the development of privacy laws or policies across Canada, contribute toward a more coherent and harmonized framework for addressing privacy and confidentiality issues in health research.

The PAC recommended that the impact of the PBPs document be evaluated after an initial two-year implementation period and revised as needed. PAC expected that, after this two-year evaluation period, the document would be endorsed as CIHR funding policy and referred to the Interagency Advisory Panel on Research Ethics (PRE) with a view to encouraging the document's eventual application, in revised form, as Tri-Agency funding policy.1

Responding to comments during the consultations and PAC recommendations, the CIHR Ethics Office established and chaired an Initial Implementation Working Group (IIWG) to shepherd the document through the first two years of the document's implementation. IIWG members are drawn from key stakeholder groups. IIWG Terms of Reference and members list are in Appendix A. During the period 2005-2007, the IIWG had one to two meetings per year in Ottawa and teleconferences on an as needed basis.

During this initial implementation phase, the IIWG undertook:

  • to engage key target users of the document to provide feedback with respect to the use, usefulness and impact of the Privacy Best Practices, on the understanding that the document would be evaluated, not the users, and adherence to the PBPs document would be on a voluntary basis; and
  • at the end of evaluation period, to make recommendations regarding:
    • any improvements to the CIHR Privacy Best Practices document, and
    • a longer term implementation strategy.

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Evaluation Process

The IIWG worked with evaluation experts to fulfill its mandate. From 2005-2006, an evaluation consultant assisted the IIWG in developing a conceptual framework for the implementation of the CIHR PBPs document (see Appendix B). During this planning phase, evaluation tools targeted at specific user groups were developed and pilot-tested (see overview in Table 1).

Conceptual Framework: Key Desired Outcomes

Within the conceptual framework, the IIWG identified the following key desired outcomes over the short and medium term:

  • better understanding of key privacy issues among research ethics boards and of the impacts of the PBPs document on decision-making;
  • increased awareness of privacy issues among researchers;
  • development of a common language and more harmonious dialogue around privacy issues among researchers and REBs; and
  • articulation of the optimal relationship between the PBPs document and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).

Priority Evaluation Questions

Based on these desired outcomes, priority evaluation questions were articulated. These questions were:

  • Use: How is the PBPs document being used? By whom, and in what context (REB policy, teaching, general information, etc.)? Should or could the utilization level be accelerated or intensified, and if so, how?
  • Dissemination: What is the extent and growth of dissemination of the PCBs document? Should or could the dissemination be accelerated or intensified, and if so, how?
  • Improvements: General: How satisfied are the users with the PBPs document? What areas for improvement are identified? Social Sciences: What are areas for improvement from a social science perspective?
  • Future Promotion and Development: What is the level of support for linking of the PBPs document to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans? What type of integration is supported: mandatory, educational or other?
  • Impact: To what extent has use of the PBPs document facilitated better understanding of key privacy issues among REBs? To what extent has use of the PBPs document resulted in increased awareness of privacy issues among researchers? How, if at all, are the PBPs affecting decision-making of REBs and researchers? To what extent has use of the PBPs facilitated development of a shared understanding of privacy issues among researchers and REBs?
  • Privacy Costs: To what extent does or will application of the PBPs document affect researcher costs? In what ways? Are there implications for institutions employing researchers? For data custodians?

Evaluation Tools and Time Lines

An external evaluation team was hired to conduct data collection and report on the results. The consultants' final report is in Appendix F.

The evaluation team obtained feedback on the use, usefulness and impact of the PBPs document from various user groups by means of a web survey, customized telephone surveys, and focus groups. These tools, target groups and timelines are summarized in Table 1. The CIHR Ethics Office also compiled information for the IIWG on online accessing of the PBPs document and web pages, and on its related communication and dissemination activities (see Appendix C).

Prior to the formal data collection phase, a preliminary mini-survey was posted on CIHR's website for a number of months in 2005/06, asking those who had sought out the CIHR PBPs web pages how they had found out about the document and why they were accessing it. The IIWG used this mini-survey to get preliminary data on effective vehicles to reach target user groups (e.g., via NCEHR and CAREB web sites and university research ethics offices).

Table 1: Overview of Evaluation Tools for the Initial Implementation Phase of the CIHR Privacy Best Practices (PBPs) document

Evaluation Tools & Target Groups Time line
Web survey: outreach to the general public, researchers, research ethics board members, etc. September 2006 to Spring 2007
Telephone surveys of key user groups (ethics community stakeholders; government privacy offices and legislative staff; REBs; CIHR peer review committee chairs) and of volunteers from those who received printed copies of the PBPs on request or at conferences Fall 2006 and Winter 2007
Focus groups with REB members (recruited mainly from attendees of the National Council on Ethics in Human Research annual conference and from members of the Canadian Association of Research Ethics Boards) Coordinated with the NCEHR Annual Conference, March, 2007
Compilation of outreach information from the CIHR Ethics Office's records and web site (distribution of PBPs, dissemination at workshops and conferences, web statistics, initial mini-survey) October 2005 to Spring 2007

Limitations

It was recognized at the outset that this evaluation process might be biased toward "early adopters" of the PBPs document. However, the evaluation was not intended to be a repeat of the broad consultations conducted in 2004, but rather, a closer look at the effectiveness of dissemination efforts, and at the current and potential usefulness and impact of the PBPs document.

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Findings and Recommendations

These recommendations are provided to the CIHR Ethics Office, with the intention of their being brought forward to the CIHR Standing Committee of Ethics for consideration and for eventual endorsement by CIHR. The IIWG expects that CIHR will refer the CIHR Privacy Best Practices document to the Interagency Advisory Panel on Research Ethics (PRE)2, with a view to PRE recommending that the three federal research agencies (the CIHR, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada) endorse the Privacy Best Practices document as a voluntary companion document to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), with relevance to all Tri-Agency funded research.

Proposed leads and time lines for each recommendation are outlined in Appendix E.

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Priority Evaluation Questions: Use

How is the PBPs document being used? By whom, and in what context (REB policy, teaching, general information, etc.)? Should or could the utilization level be accelerated or intensified, and if so, how?

Findings

Overall, the evaluation of the PBPs document indicated that it is a potentially valuable reference and education document. Respondents did not question the content, which was typically described as accurate.

More than half of the respondents have used the PBPs document for study and for reference purposes. There has also been some use made in teaching and training (of research ethics board members, students, and researchers). Some government officials reported using the PBPs document as a reference in developing guidelines and legislation.

One reason given by many researchers, including CIHR Peer Review Chairs, for not being familiar with privacy issues (or the PBPs document) is that they do not see a need. They view the issue as being well handled elsewhere (e.g., by REBs, provincial privacy legislation, and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans). However, many of the REB members surveyed who used the document reported that the PBPs document enhanced their capacity to interpret and comply with other privacy guidelines, policies or laws, and increased their general awareness of privacy issues.

Recommendation #1: Promotion of Educational Value

The IIWG recommends that the educational value of the PBPs document be promoted widely and complemented by various teaching tools. These should be tailored to a wide range of potential users, including researchers, undergraduate and graduate students, REBs, other funders of research such as health charities, and regulatory colleges (see Appendix D for suggested teaching tools and target groups).

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Priority Evaluation Question: Dissemination

What is the extent and growth of dissemination of the PCBs document? Should or could the dissemination be accelerated or intensified, and if so, how?

Findings

The CIHR web site registered high levels of activity in accessing the online PBPs document. For the period April 2006 to March 2007, there were about 1500 downloads a month for the English PDF version of the document, and 100 downloads per month for the French version. During the same period, the html version of the document received 3,397 hits from 1,833 "unique" users in a variety of contexts, including universities, hospitals, health regions and government.

CIHR's targeted dissemination efforts, outlined in the Appendices, were most effective at reaching research ethics stakeholder organizations and government privacy policy and legislative officers, most of whom surveyed were quite familiar with the PBPs document. Although some REBs were very familiar with the PBPs document, about half of those surveyed were either unaware of the document or not sufficiently familiar with it to respond to a detailed survey. Given the small sample of researchers that responded to the online survey and feedback from the CIHR Peer Review Committee Chairs indicating that they had only recently become aware of the document, it is clear that dissemination efforts have not yet effectively reached researchers.

Satisfied users were from various groups, including researchers, research coordinators, research ethics board members, and policy-makers. Therefore, the document does not need to be targeted to a narrow "niche" of users. Outreach efforts should be intensified and aimed at a wide range of potential users.

Recommendation #2: Communications

Communication efforts should be intensified and broadened, and should be ongoing to ensure that the research community is notified of any changes to the document. These outreach efforts should have a broad range of targets, including academic Vice Presidents-Research, research ethics offices, university research offices, and researchers. The communication mechanisms can be straightforward, such as existing organization email lists (e.g., member email list of the Canadian Association of Research Ethics Boards), the CIHR News for Researcher, and the web sites and forums of the National Council on Ethics in Human Research (NCEHR) and the Canadian Association of Research Administrators. A new email list could be set up by inviting interested users to register for notification of changes to the document.

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Priority Evaluation Question: Improvements - General

How satisfied are the users with the PBPs document? What areas for improvement are identified? What areas for improvement in the social science perspective?

Findings

Overall, those familiar with the PBPs document reported that it was highly readable, well-formatted, comprehensive and very useful. Many respondents did not see the need for major changes to the document.

The document is generally viewed as useful in the area of health sciences research, although it was recognized that privacy issues related to the banking, storage and use of biological materials are beyond the scope of the document. Several respondents reported that they would like guidance on privacy issues of research involving human biological materials.

Many respondents preferred the colourful and tabbed printed copies of the document. Some who use the document less, or not at all, commented that it was too long. There was little criticism of the style and format, except for searching difficulties in the PDF version.

Among the suggestions for CIHR to improve the development of privacy best practices were a tool box of cases and interpretations modelled on the case law approach; an online set of Frequently Asked Questions (FAQs); an ongoing discussion forum on-line; additional training sessions; and more CIHR presentations.

Recommendation #3: (a) No major revision to content or format (b) Improvement of the electronic format.

(a) The IIWG recommends no major revision to the document at this point, but there needs to be the capacity to update its contents over time (e.g., update the legal concordance tables and/or add sections). The document should be nimble enough to respond to significant issues and changes that impact on content. Criteria for determining when content changes are appropriate should be developed.

The colourful and tabbed printed format of the document could be a model for this kind of educational document. It is recommended that a base supply of printed copies be maintained. Printed copies are useful for distributing at venues such as conferences and meetings, and can lead satisfied users to refer others to the electronic version.

Recognizing the high costs of printing the document and the need for timely revision, the electronic format of the document should become the official version. The URL of the document should remain the same for successive updates, and previous versions should be archived.

(b) The electronic format of the document should be improved by adding:

  • A hyper-linked subject index
  • The capability to print only selected sections of the document
  • "Thumbnail" tabs in the document.

The electronic and new print versions of the document should have the "How to Navigate the Document" more prominently displayed (e.g., on the cover or first page).

Comment on Suggestions for a Bank of Interpretations and Online Discussion Groups

Some respondents suggested developing a bank of "interpretations" but the IIWG did not think interpretations were appropriate for a Best Practices document, which is intended to guide but not dictate appropriate practice. There was also the suggestion of the usefulness of online discussion groups, such as the NCEHR Web Forum. However, the IIWG did not have a consensus on the usefulness of such discussion groups.

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Priority Evaluation Question: Improvements - Social Sciences

What areas are identified for improvement from a social science perspective?

Findings

Some respondents from a social sciences perspective indicated that the PBPs document did not deal adequately with issues such as confidentiality and data retention periods which can differ in the social as compared to the health sciences.

Comments from other perspectives included the need for more emphasis on Aboriginal research (although there was recognition of the current CIHR work on the Guidelines for Health Research Involving Aboriginal Peoples). There were also comments that there needed to be more focus on cross-cultural and natural sciences research.

Recommendation #4: Outreach to Social Scientists

The IIWG recommends setting an objective of reaching out to social scientists in the development of research guidelines and best practices so that social and health researchers will have "collective ownership" of the outcome. The IIWG recommends that CIHR maintain liaison with the Interagency Advisory Panel on Research Ethics and its Social Sciences and Humanities Special Working Committee (SSHWC), in the context of ensuring changes to the Tri-Council Policy Statement: Ethical Conduct in Research Involving Humans are more reflective of the social sciences. To that end, CIHR should maintain its representation on SSHWC.

CIHR is encouraged to remind the health sciences community in its communications that CIHR funds social scientists, and social scientists are on CIHR-funded interdisciplinary teams.3

There are useful good practices in the PBPs document that are transferable beyond personal health information. Social scientists are encouraged to think of the PBPs document as a valuable resource.

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Priority Evaluation Question: Future Promotion and Development

What is the level of support for linking of the PBPs document to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)? What type of integration is supported: mandatory, educational or other?

Findings

The PBPs document is generally recognized as one of many influences, policies and laws relating to privacy in the jurisdictions in which the respondents work. Among REBs and research ethics community stakeholders surveyed, most would like to see the PBPs document linked to the TCPS as a voluntary, not mandatory, resource. Most respondents liked the idea of linkage between the PBPs document and the TCPS because the PBPs document provides more detailed clear examples, useful in trying to implement the TCPS.

Recommendation #5: Promotion as Voluntary Companion Document to the TCPS

The IIWG recommends that the PBPs document be a companion document to the Tri-Council Policy Statement: Ethical Conduct in Research Involving Humans (TCPS), but not become incorporated into the TCPS. The PBPs document should be a voluntary resource for practical assistance in implementing the TCPS, and not mandatory Tri-Council policy. It is also recommended that as initiatives come forward that relate to research integrity relevant to privacy and confidentiality (e.g. data integrity), the PBPs document be used (or revised as needed) to help inform efforts to resolve these issues.

Voluntary use of the PBPs document can be promoted through such means as:

  • voluntary "completion certificates" when an online tutorial (to be developed) is completed;
  • contribution to points for continuing medical, dental, nursing education credits; and
  • where applicable, recognition by accrediting bodies for professional training and teacher training for graduate students.

Recommendation #6: International Recognition

The IIWG recommends that a long-term implementation strategy involve assessing the comparability of the PBPs document with international guidance documents (e.g., those of the United States National Institutes of Health) and fostering international acceptance. For example, CIHR should aim to have the PBPs document included in the The International Compilation of Human Subject Research Protections, a listing of the laws, regulations, and guidelines that govern research involving human participants in many countries around the world, compiled by the United States Department of Health and Human Services Office for Human Research Protections.4

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Priority Evaluation Question: Impact

To what extent has use of the PBPs document facilitated better understanding of key privacy issues among REBs? To what extent has use of the PBPs document resulted in increased awareness of privacy issues among researchers? How, if at all, are the PBPs affecting decision-making of REBs and researchers? To what extent has use of the PBPs facilitated development of a shared understanding of privacy issues among researchers and REBs?

Findings

Among REBs familiar with the PBPs document:

  • it was more frequently reported that the PBPs document was helping their own understanding of privacy issues than that it was contributing to more harmonious dialogue between REBs and researchers;
  • most said that the PBPs document had improved their understanding of privacy issues, and some said that the document had not changed their approach to privacy but was useful in confirming the validity of their existing practices;
  • many reported that the PBPs document was having an impact on research ethics board decisions related to a number of privacy issues, particularly those of secondary uses of data and conditions for consent (e.g., determining when consent is required, and the conditions for opting out of consent);
  • some commented that the PBPs document could lead to shorter time periods for research ethics board approvals because of fewer requests for changes to researcher's submissions, whereas others stated that the document could lead to longer times for approvals due to additional privacy-related requirements for submissions; and
  • there was no consensus that there had been any impact on research submissions but the PBPs document was generally viewed as a good reference source for researchers and lay (community) research ethics board members, and helped with a common approach among REBs.

Researchers surveyed were generally less familiar with the PBPs document than REBs. Among those researchers who had views on the impact of the PBPs document on REB submission and approval processes, negative impacts (e.g., longer time to prepare research ethics applications) were cited as often as positive impacts (e.g., shorter REB approval times).

Comment on Impact

The results of the evaluation indicated that the PBPs document is a sound resource document for both researchers and REBs. However, recognizing that privacy and confidentiality issues require interpretative judgements by REBs, and local autonomy of REBs inevitably lead to some degree of local variation, the tensions between REBs and researchers over how these issues are handled will not be solved with one document alone. Nevertheless, the PBPs document does have the potential to improve consistency across REBs by providing a common reference point, which could help to resolve some of that tension. Also, increased education efforts aimed at researchers have the potential to assist in improving the researcher-REB dialogue concerning privacy issues, and inter-REB dialogue could also be enhanced.

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Priority Evaluation Question: Privacy Costs

To what extent does or will application of the PBPs document affect researcher costs? In what ways? Are there implications for institutions employing researchers? For data custodians?

Findings

The small sample of researchers who participated in the evaluation process did not indicate that the PBPs document was being used to anticipate the costs of privacy protections in research, or that it was viewed as having had an impact on the privacy - related costs.

Comment on Privacy Costs

Recognizing that compliance with privacy legislation can have financial implications, this evaluation process did not elicit specific information on financial costs associated specifically with the PBPs document. The findings did elicit views that the PBPs document could lead to more time and care being taken in preparing submissions and time is money. However, in the REB review process, improved understanding by researchers could result in less back and forth between REBs and researchers, so that overall time is saved. At this point, the findings showed no consensus among REBs and researcher respondents on costs financial or other associated with the PBPs document. It is also important to recognize that particular privacy-related issues (such as the content of informed consent forms) can have an impact on REB review processes.

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Appendix A: IIWG Terms of Reference

(June 2007 update)

Working Group Mandate


  • To bring the perspectives of key target users of the PBPs document.
  • To provide advice or strategies for the Ethics Office on user engagement and uptake during this initial implementation phase.
  • To provide a sounding board for the research community for its comments on the PBPs document.
  • To advise and assist the Ethics office on developing mechanisms or tools for an in depth examination of the use, usefulness and impact of the PBPs document.
  • To provide recommendations to the Ethics Office on:
    • improvements to the PBPs document (but not to include involvement in revising the document); and
    • a longer-term implementation strategy.

Membership

Chair: Sheila Chapman (CIHR Ethics Office)

Deputy Chair: Margo Farren (CAREB Board member)

Members:

  • Susan Hoddinott (CAREB member; University of Western Ontario)
  • Susan Sykes (CAREB member; University of Waterloo)
  • Richard Carpentier (NCEHR Executive Director)
  • Mike Enzle5 (NCEHR Education Committee Chair; University of Alberta)
  • Thérèse De Groote (SRE; liaison with PRE, NSERC and SSHRC)
  • Karen Szala-Meneok, (CIHR-funded Researcher; qualitative methods; McMaster University, Ontario)

Meetings

As needed. Primarily teleconference and email. One to two face-to-face meeting per year if budget allows.

Period of Mandate

September 2005-2007, ending at release of Initial Implementation Working Group recommendations.

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Appendix B: Conceptual Framework for the Implementation

Conceptual framework for the Implementation of the CIHR Privacy Best Practices document

Conceptual framework for the Implementation of the CIHR Privacy Best Practices document

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Appendix C: Summary of Dissemination Activities and Uptake, 2005-2007


  • Notification to the research ethics community: The web sites of the National Council on Ethics in Human Research, the Canadian Association of Research Ethics Boards, and the Canadian Bioethics Society featured news about the release of the 2005 PBPs document.
  • Distribution of printed copies: About 1100 English and 154 French copies were distributed at conferences (Canadian Bioethics Society Conference, Circumpolar Conference, Symposium on Electronic Health Information and Privacy, National Council on Ethics in Human Research Annual Conference, the Canadian Association of Research Ethics Boards Annual General meeting, and the Canadian Association of University Research Administrators Conference). CIHR received requests from about 60 individuals for one or more copies for research centres, universities, REBs, government departments and health region offices.
  • Presentations at Conferences, Meetings, and Training Sessions: Between 2005 and 2007, presentations on the PBPs document were given at a variety of venues, including meetings of researchers and data custodians, privacy-related conferences, and four NCEHR training sessions for REBs and researchers in Ontario (Ottawa and Sudbury), Alberta and Prince Edward Island.
  • Information aimed at researchers: On the CIHR website, the PBPs document was added to the list of resources on the TIPS for Writing Successful Grants or Request for Renewal webpage. News about the PBPs document was included in a couple of issues of the CIHR E-News for Researchers bulletin. In fall 2001, about 1500 bilingual one-page information sheets about the PBPs document were included in the information packages to successful applicants of CIHR awards or grants and to Peer Review Committee Chairs.

Uptake:

  • Web statistics: Between April 2001 and March 2007, there were 1,833 unique users of the html version of the PBPs document, which received 3,397 "hits" on the CIHR web site. The PDF version of the document was a popular CIHR document, with roughly 1,500 downloads a month for the English version, and 100 downloads a month for the French version. Users of the online document came from a variety of contexts, including government departments, universities, hospitals, and health region offices.
  • Universities: Out of the 34 universities for which CIHR has regular communications through University Delegates, only four universities had links to the PBPs document on their websites, on their research ethics web pages.
  • Research Ethics Boards: Of those REBs randomly surveyed who were familiar with the PBPs document (about half), some reported that their application forms address the ten elements in the PBPs document, and a smaller number said that the PBPs document had been cited in decision letters to researchers, or had been featured in memos or bulletins to researchers.
  • Legislative/Policy makers. Many legislation and policy makers in the privacy area reported using the PBPs document as a reference document, and for some the document influenced policy and legislation.

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Appendix D: Suggestions for Education and Communication

Teaching Tools:

  • Online PowerPoint presentations:
    • long version with scenarios
    • short version
    • for REBs
    • for researchers
    • for undergraduates and Masters students
  • TIPS sheet-3-hole punched, 8 ½ X 11
    An abridged two-sided TIPS sheet of the PBPs contents should be created, for broad distribution in information packages to researchers, research ethics board members, conference booths, etc. This TIPS sheet could be laminated and three-hole punched, for easy inclusion in binders.
  • Online tutorial, with case studies

Target Groups and Communication Mechanisms:

Researchers:

  • Continue reference to PBPs in TIPS for Writing Applications, CIHR website
  • Include TIPS sheet in CIHR decision letters, and PRC Chairs information packages
  • TIPS sheets in CIHR booth at conferences

Research Ethics Stakeholder Organizations:

  • Links to websites
  • Communications
  • Include Rx&D

Universities:

  • Senior Grant Officers, Office of Research Services: include TIPS sheet in application writing workshops; mentoring (accessed through CAURA)
  • Administrators: CAURA booth (TIPS sheet)

REBs:

  • PowerPoint presentations (REBs can customize these presentations for their own training sessions)
  • NCEHR training sessions, as part of the basic NCEHR REB 101 session, and as a special theme in REB 201 (in development) sessions
  • CAREB training sessions
  • Include TIPS sheet in orientation package for new members

Research Participants:

  • Access through new NCEHR web page

Privacy Commissioners Offices:

  • Web links

Clinical Research Coordinators/Practitioners courses: training, communications

Professionals in the health sciences, epidemiology, nursing, communicable disorders

Health Charities

Government websites

Regulatory Colleges (e.g., the Royal College of Physicians and Surgeons is developing a research ethics tutorial)

Community Colleges

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Appendix E: IIWG Recommendations, Proposed Leads, Time Lines


IIWG Recommendations Proposed Lead Proposed Time Line
1. Promotion of Educational Value

The educational value of the PBPs document should be promoted widely and complemented by various teaching tools. These should be tailored to a wide range of potential users, including researchers, undergraduate and graduate students, REBs, other funders of research such as health charities, and regulatory colleges. (See Appendix D for a list of proposed education mechanisms and target groups).
CIHR, with the assistance of relevant stakeholder organizations for tools aimed at particular user groups and with NCEHR with respect to its education mandate. A PBPs education committee could be created. 2007/08 - 2008/09
2. Communications

Communication efforts should be intensified and broadened, and should be ongoing to ensure that the research community is notified of any changes to the document. These outreach efforts should have a broad range of targets, including Vice Presidents--Research, research ethics offices, university research offices, and researchers. The communication mechanisms can be straightforward, such as existing organization email lists (e.g., the member email list of the Canadian Association of Research Ethics Boards), the CIHR News for Researchers, and the web sites and forums of the National Council on Ethics in Human Research and the Canadian Association of Research Administrators. A new email list could be set up by inviting interested users to register to receive notification of changes to the document.
CIHR 2007/08 - ongoing
3. (a) No Major Revision to Content or Format
    (b) Improve the electronic format


(a) No major revision to the document need to be done at this point, but there needs to be the capacity to update its contents over time (e.g., update the legal concordance tables and/or add sections). The document should be nimble enough to respond to significant issues and changes that impact on content. Criteria for determining when content changes are appropriate should be developed.

The colourful and tabbed printed format of the document could be a model for this kind of educational document. It is recommended that a base supply of printed copies be maintained. Printed copies are useful for distributing at venues such as conferences and meetings, and can lead satisfied users to refer others to the electronic version.

Recognizing the high costs of printing the document and the need for timely revision, the electronic format of the document should become the official version. The URL of the document should remain the same for successive updates, and previous versions should be archived.

(b) The electronic format of the document should be improved by adding:
  • A hyper-linked subject index
  • The capability to print only selected sections of the document
  • "Thumbnail" tabs in the document.
The electronic and new print versions of the document should have the "How to Navigate the Document" more prominently displayed (e.g., on the cover or first page).
CIHR 2007/08
4. Outreach to Social Science Researchers

The IIWG recommends setting an objective of reaching out to social scientists in the development of research guidelines and best practices so that social and health researchers will have "collective ownership" of the outcome. The IIWG recommends that CIHR maintain liaison with the Interagency Advisory Panel on Research Ethics (PRE) and its Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC), in the context of ensuring changes to the Tri-Council Policy Statement: Ethical Conduct in Research Involving Humans are more reflective of the social sciences. To that end, CIHR should maintain its representation on SSHWC. CIHR is encouraged to remind the health sciences community in its communications that CIHR funds social scientists, and social scientists are on CIHR-funded interdisciplinary teams. There are useful good practices in the PBPs document that are transferable beyond personal health information. Social scientists are encouraged to think of the PBPs document as a valuable companion document.
CIHR, in collaboration with SSHRC and PRE's SSHWC Ongoing
5. Promotion as Voluntary Companion Document to the TCPS

The IIWG recommends that the PBPs document be a companion document to the Tri-Council Policy Statement: Ethical Conduct in Research Involving Humans (TCPS), but not become incorporated into the TCPS. The PBPs document should be a voluntary resource for practical assistance in implementing the TCPS, and not mandatory Tri-Council policy. It is also recommended that as initiatives come forward that relate to research integrity relevant to privacy and confidentiality (e.g. data integrity), the PBPs document should be used (or revised as needed) to help inform efforts to resolve these issues.

Voluntary use of the PBPs document can be promoted through such means as:
  • voluntary "completion certificates" when an online tutorial (to be developed) is completed;
  • contribution to points for continuing medical, dental, nursing education credits; and
  • where applicable, recognition by accrediting bodies for professional training and teacher training for graduate students.
PRE Pending PRE's recommendation, and Tri-Agency endorsement, of the Privacy Best Practices document as a voluntary companion document to the TCPS.
6. International Recognition

The IIWG recommends that a long-term implementation strategy involve assessing the comparability of the PBPs document with international guidance documents (e.g., those of the United States National Institutes of Health) and fostering international acceptance. For example, CIHR should aim to have the PBPs document included in the International Compilation of Human Subject Research Protections, a listing of the laws, regulations, and guidelines that govern research involving human participants in many countries around the world, compiled by the United States Department of Health and Human Services--Office for Human Research Protections (OHRP).
PRE (assuming the PBPs document is explicitly included as a companion document to the TCPS) and NCEHR, which provides liaison with the OHRP. Pending endorsement of the Privacy Best Practices document as a companion document to the TCPS


  1. CIHR Privacy Advisory Committee Recommendations and membership are included in the PBPs document (September 2005), and can be accessed online at CIHR Best Practices for Protecting Privacy in Health Research (September 2005) .
  2. PRE is tasked with providing multi-disciplinary independent advice to the Tri-Agencies on the evolution, use, interpretation and associated educational activities of the TCPS.
  3. This recommendation is in line with an early CIHR-SSHRC publication, Social Sciences and Humanities in Health Research. A Canadian Snapshot of Fields of Study and Innovative Approaches to Understanding and Addressing Health Issues, CIHR information page at Social Sciences and Humanities in Health Research.
  4. The international listing is online at Office for Human Research Protections (OHRP).
  5. Mike Enzle was an invaluable contributor to the first phase of the IIWG’s work.