ࡱ>  <>9:;~Myuq` ܓbjbjqPqP C`::m4 5rrrr8`0L|"l, _______$wche `1#bV|1#1#`r:,l-`2)))1#^V$l_)1#_))U<^6Zl$ @6e'&BX&\d_`<`hXBfy(fLZfZ )X l ``[)v`1#1#1#1#yFrrr  Task Force for the Development of an Accreditation System for Human Research Protection Programs DRAFT FINAL REPORT January 27, 2006 Table of Contents ACKNOWLEGEMENTS 3 I. INTRODUCTION 6 II. THE TASK FORCE PROCESS 8 III. WHY ACCREDITATION IS NEEDED FOR ALL RESEARCH ON HUMANS 9 IV. WHAT IS ACCREDITATION? 12 ADVANTAGES OF ACCREDITATION 16 VI. RESPONSES TO THE OPTIONS PAPER 18 Table 1 18 Figure 1 20 VII. THE INVITATIONAL WORKSHOP 22 VIII. EDUCATION, ACCREDITATION AND NCEHR 23 IX. STAKEHOLDERS IN PEERH 25 X. THE ACCREDITATION CYCLE 27 Figure 2 28 XI. THE ACCREDITING ENTITY 30 Figure 3 32 Table 2 33 Figure 4 35 Table 3 36 XII. CRITICAL FACTORS FOR SUCCESS 38 XIII. REFERENCES 40 XIV. APPENDICES 41 ACKNOWLEGEMENTS Members of the Task Force for the Development of an Accreditation System for Human Research Protection Programs Dr. Kenneth Davey Co-chair York University Dr. Michael Owen Co-chair Brock University Dr. Barbara McGillivray University of British Columbia Prof. dith Deleury Universit Laval Dr. Henry B. Dinsdale Kingston General HospitalDr. Deborah Poff University of Northern British Columbia Ms. Marianne Vanderwel Pfizer Canada Inc. Dr. Richard Carpentier NCEHR Executive Director Ms. Felicetta Celenza NCEHR Coordinator of Educational Visits Members of the Sub-Committee on Standards Development Dr. Michael Owen Chair Brock University Mr. Jack Corman IRB Services Dr. Kenneth Davey York University Prof. dith Deleury Universit Laval Ms. Patricia Lindley Canadian Association of Research Ethics Boards Dr. Barbara McGillivray University of British Columbia Dr. Susan Sykes University of Waterloo Dr. Richard Carpentier NCEHR Executive Director Ms. Felicetta Celenza NCEHR Coordinator of Educational Visits Production of this document and sample standards for accreditation has been made possible through a financial contribution from Health Canada and the Canadian Institutes of Health Research. The views expressed herein do not necessarily represent the views of Health Canada and the Canadian Institutes of Health Research. January 27, 2006 Dear Madam / Sir: This Draft of the Final Report of the Task Force for the Development of an Accreditation System for Human Research Protection Programs established by the National Council on Ethics in Human Research (NCEHR) is being widely distributed for comment by interested organizations and individuals. The Draft Report describes briefly the evolving environment in which research with humans is situated, and confirms the characteristics of a system of accreditation for Canadian organizations. In response to comments received in earlier consultations, it offers a description of the process generally associated with accreditation. It describes two possible models, one at each end of a spectrum of associations with NCEHR, by which an accrediting entity might be organized. It also contains a sample of possible standards based on some of the existing policies and regulations. This Draft Report does not contain any recommendations. The final report with recommendations will be informed by comments in response to the draft, and is currently scheduled to be submitted to NCEHR by 31 March 2006. The disposition of the final report will rest with NCEHR. In the past several months, a Table of Sponsors with senior representatives of stakeholder organizations has been developed that intends to explore the implementation of a system of oversight for research with humans in Canada. NCEHR and the Task Force have agreed that the report will be made available to that group. If we are to meet the agreed time table, it is essential that responses be submitted no later than March 10, 2006. Replies can be sent electronically to options@ncehr-cnerh.org or by hard copy to NCEHR at: Consultation on Options Paper National Council on Ethics in Human Research 240 Catherine St., Suite 208 Ottawa, Ontario Canada K2P 2G8 Fax: (613) 233-0658 If you have any question about this consultation, please contact Dr. Richard Carpentier, Executive Director of NCEHR at 613-233-5445 or write to: rcarpentier@ncehr-cnerh.org. Yours truly, Dr. Kenneth Davey, Co-Chair Dr. Michael Owen, Co-Chair York University Brock University I. INTRODUCTION The National Council on Ethics in Human Research (NCEHR) is an independent, non-governmental organization composed of a volunteer council and a small staff with a mandate extending to all research involving humans. Its mission is the advancement of the protection and well-being of human participants in research and fostering high ethical standards for the conduct of research involving humans. At its meeting in November of 2003, the NCEHR Board passed a resolution establishing the Task Force for the Development of an Accreditation System for Human Research Protection Programs Recognizing that the development of a system of accreditation of human research protection programs is an important component of our responsibilities in enhancing the protection of human participants in research, and recognizing that Council has endorsed the recommendations of its Task Force on Models of Accreditation for Human Research Protection Programs in Canada, be it resolved that NCEHR establish a Task Force for the Development of an Accreditation System for Human Research Protection Programs. The terms of reference and membership for the Task Force appear in Appendix I. In establishing the Task Force, NCEHR was responding to increasing expressions of the need for increased oversight of the system of protection of humans who volunteered as subjects of research, as well as its own perception that oversight deserved immediate attention. The Involvement of NCEHR in Oversight of Human Research Protection Programs Early reports In 1995, NCEHR (then known as the National Council on Bioethics in Human Research) issued a report on its findings from site visits to the Faculties of Medicine in Canadian universities, pointing out that while the efforts of dedicated volunteers were contributing to the protection of human volunteers, not all of the then existing guidelines were being followed. This led to the Fortin-Leroux report (1996) detailing options for improving the oversight of the process, and pointing out the strengths and weaknesses of various models for oversight. These included informal visits, visits within a formal framework, either accreditation or certification, and investigation. While the first two conferred education and information exchange, there would be no universality. Accreditation would have a clear status, while investigation was thought to be a complex and overly rigorous approach. In the autumn of 1999, NCEHR, as the result of a strategic planning retreat, issued a vision statement that included the development of a system of accreditation. This statement was endorsed by the Medical Research Council (MRC), the Natural Sciences and Engineering Research Council (NSERC), the Social Sciences and Humanities Research Council (SSHRC), Health Canada and The Royal College of Physicians and Surgeons of Canada (at that time, the funders of NCEHR, and known as the Coordinating Committee for NCEHR) , and later by the Standing Committee on Ethics of the Canadian Institutes of Health Research (CIHR). The First Task Force In 1999, NCEHR established a Task Force to Study Models of Accreditation for Human Research Protection Programs in Canada. That Task Force issued its report in March 2002. The Task Force surveyed the national and international landscape relating to accreditation and other models of oversight, and recommended to the NCEHR Council: That it affirm the need for a nation-wide oversight process for the ethics review of research in humans in Canada; That such an oversight take the form of an accreditation program to be conducted by an arms-length non-governmental organization; That NCEHR facilitate discussions with organizations that would be stakeholders or observers in a new Program of Accreditation for Human Research Participants Protection Programs. NCEHR approved the report and distributed it widely. Recent Site Visits NCEHR has continued its program of invited educational site visits, extending the visits to universities without medical schools, community hospitals, other community based organizations, and organizations with private REBs. These site visits have covered all areas and modes of research. Most visits revealed some inadequacies in terms of conforming to the requirements of TCPS or other relevant policies and regulations. They are summarized in a report available on the NCEHR website. Recognition of NCEHR by the Wider Community In January of 2000, the Canada Gazette, in introducing new regulations governing clinical trials, drew attention to the need for accreditation of human research protection programs in Canada. In the autumn of 2000, the Coordinating Committee also recognised the need for accreditation and suggested that Health Canada and NCEHR work together. In April 2004, the Parliamentary Committee on Health noted the role of NCEHR in assisting research ethics boards in interpreting and implementing guidelines for the ethics of research involving human subjects. They also saw the need for a national system of accreditation and recommended that Health Canada develop standards that establish an accreditation process for research ethics boards assessing clinical trials.. The Canadian Biotechnology Advisory Committee, in its December 2004 report Biotechnology and the Health of Canadians  recommended that the Ministries of Industry and Health, in consultation with NCEHR and other stakeholder groups, establish a body or mechanism to both set standards and accredit organizations responsible for REBs (as well as for population health databases and banks of biological specimens used for research purposes). II. THE TASK FORCE PROCESS The current Task Force held meetings with representatives of three different accreditation programs (Association for Accreditation of Human Research Protection Programs, Inc. from the United States, Post-Secondary Education Quality Assessment Board of the Province of Ontario, and the Royal College of Physicians and Surgeons of Canada). These consultations led it to endorse the findings of the previous Task Force (2002), particularly the key elements of an accreditation process. Its principal tasks have therefore been to identify how an accrediting entity might be organised and to determine how the standards upon which an accreditation system rests should be developed. Sub-Committee on Standards The Task Force recognised that the initial development of the standards for accreditation required intimate knowledge of the regulations, policies and guidelines that govern the ethics of human research in Canada as well as any international standards or regulations that might be applicable to selected research in Canada. It therefore struck a Sub-committee on Standards to begin the work of developing the structure of the standards and to elaborate on a sample set of standards for this report, including the corresponding instructions to organisations seeking accreditation as well as relevant sections of a sample Site Visitors Manual. The activities of the Sub-committee have continued throughout 2005 with the intention of pilot testing the sample set of standards during planned NCEHR Educational Site Visits in 2006. A sample of proposed standards appears in Appendix II. Consulting the community The Task Force, throughout its work, has endeavoured to keep the broader community informed by presentations at NCEHR conferences, at conferences hosted by professional organizations such as the Canadian Association of University Research Administrators, the Canadian Association of Research Ethics Boards, and The Canadian Chapter of the Society for Quality Assurance, by posting proceedings on the NCEHR web site, and by issuing bulletins through the NCEHR list serve and NCEHR web site. The Options Paper In order to initiate the process of more formal consultation with the community, the Task Force developed an Options Paper describing different possibilities for the organisation of the accrediting entity, the development and stewardship of standards, and the financing of the enterprise. That paper, attached as Appendix III, was widely distributed and written responses were invited. These responses are summarised later in this report. The Issues Paper and Invitational Workshop Informed by those responses, the Task Force developed an Issues Paper that served as background for an Issues Workshop (Reviewing Options for the Implementation of a System of Accreditation for Human Research Protection Programs) where individuals from a wide spectrum of interested parties, including REB members, researchers, administrators, research participants, ethicists, as well as sponsors and regulators of research met for a day and a half in June 2005. The intent of this second consultation was to engage selected members of the community in a structured discussion of the issues that emerged from the written responses. Appendix IV contains the Issues Paper, a list of organizations and individuals informed, and a list of those attending. Status of this Report This Draft Report has been informed by the written responses to the Options Paper and by the discussion at the Workshop and elaborates on the continued discussions of the Task Force on how accreditation may be implemented in Canada. It is important to recognise that this Draft Report will be circulated for comment and will constitute a third formal consultation with the community on this topic. It is intended to inform the community about the current thinking of the Task Force, particularly with respect to organisational matters, and to raise issues about the process of accreditation. As such, it does not yet include final recommendations. It is intended that responses from the communities of interested parties and stakeholders can inform the preparation of the Final Report to NCEHR, scheduled to take place before the end of March, 2006. It is hoped that the Final Report will include observations arising from pilot trials of a sample set of the standards at NCEHR Educational Site Visits. III. Why Accreditation is needed for all research on humans The Report of the first Task Force documented the issues that led NCEHR to endorse the desirability of a national system of accreditation. The primary objective of an accreditation system is to ensure that the systems designed to enhance the protection of the human subjects on whom the research depends are operating according to agreed standards. The Importance of Research Involving Humans In Canada and elsewhere, research on humans fulfils many functions the creation of new knowledge, the formation of new social and economic policy, and the development of innovative new products and processes for human health, education and social development. The research enterprise is viewed by many in the public and private sectors as a driver of economic and social development, innovation, and national prosperity. A sub-sector of this research enterprise, research with humans, depends on the willingness of individuals, organizations, collectivities and communities to become engaged in research in the social, behavioural, natural, and medical and health sciences. It is essential that the public trust on which the participation of volunteer subjects depends be maintained and increased. The Numbers of Humans Participating in Research is Large There has been a recent increase in research and innovation activities in Canada. This increase has been particularly significant in the general field of health including research in the behavioural and social sciences related to health. Yet, there is no reliable estimate of the number of humans involved as participants or subjects nor of the number of research ethics boards operating in or with oversight of research with humans in Canada. NCEHR, as a result of information gathered on site visits to research intensive universities, has conservatively estimated that annually about 3,000,000 individual Canadians are research participants in projects conducted at Canadian universities. The number of human subjects involved in clinical, medical, or social research studies that are not based in universities but conducted in private clinicians office or by non-governmental organizations is unknown. A significant number of these studies involve the behavioural and social sciences. In addition, the number of clinical trials of drugs, devices and medical procedures in Canada has increased greatly in recent years. This has been accompanied by a major shift of drug trials away from academic centres. As a result, the majority are conducted in community hospitals and physicians offices, where the rigour of oversight is unknown. Only Alberta has a system in place for overseeing the research ethics of these studies. Non-compliance is known to Occur Canada has experienced a number of highly visible cases in which ethical breaches have occurred during research studies involving humans. Yet, these transgressions have not led to sanctions similar to those imposed on researchers and institutions in the United States, where federal research funding was discontinued to research institutions until corrective action was taken. In Quebec, one case was a factor in the establishment of oversight by the Quebec Ministry of Health and Social Services. Site visits conducted to Canadian organisations by NCEHR have revealed problematic practices in the oversight of research with human participants. While the results of individual site visits are confidential, reports that deal with general findings indicate that these problematic practices, while in the main not serious, are common in all areas of research including the behavioural and social sciences as well as biomedical research. Canadas Health Products and Food Branch Inspectorate has reported on its inspection activities and has published a summary of its observations concerning gaps, omissions and irregularities in the oversight of research involving humans. Inconsistency in Application There is increasing concern amongst researchers, participants, sponsors, and the public with respect the lack of consistency in the application of ethical principles and processes in human research and the absence of a commonly accepted oversight mechanism for the systems for the protection of human participants. On the one hand, the Federal Tri-Council (CIHR, NSERC and SSHRC) have instituted a greater degree of oversight of the institutions that receive their funding. Health Canada regulates Phase I-IV clinical trials. Quebec requires an annually renewed ministerial permission for designated Research Ethics Boards to operate. On the other hand, no comparable system exists for the largely invisible, but significant, and growing research enterprise involving humans that exists outside the academic institutions. The broad scope of research involving humans is not limited to clinical trials conducted in community hospitals or physicians offices, for there is substantial medical and non-medical research undertaken by the private sector, community and non-governmental organizations, and departments and agencies of government. Education It is generally agreed that the level and extent of education in research ethics is inadequate. While the Interagency Panel on Research Ethics (PRE) and the Quebec Ministry of Health and Social Services (MHSS) have launched web-based training, based on their particular policies, there is no general system of education for REB members, researchers, students and administrators that includes other policies and other research jurisdictions, nor are there standards for such education. NCEHR and the Canadian Association of Research Ethics Boards provide REB 101 training courses for research ethics board administrators and members. NCEHR also provides Educational Outreach Programs, Regional and National Conferences and individual institutional consultations. NCEHRs program of voluntary site visits is strongly educational. Much more needs to be done. Accreditation programs have strong educational elements that include a virtual learning loop: site visitors, in addition to providing constructive advice to the organisation being assessed, invariably learn from practices at those same institutions. A member of an organisation who has experience in accreditation visits is an important resource person for that organisation. An accreditation system will not substitute for the broad spectrum of education programs that is needed, but it will ensure that organisations are aware of their obligations to provide appropriate education for all parties involved in human research, and will provide a base of standards for that education. Education, rather than credentialing is the goal of accreditation. Conflict of Interest In the United States and Canada, there is increasing concern about the potential for conflict of interest for investigators who engage in, and for their organisations that support, research involving human participants. For example, questions have been raised about the propriety of the financial involvement of investigators with the sponsors of research and about a close relationship of the ethics approval process with the direct administration of research agreements. Experience from NCEHRs quality improvement site visit program has demonstrated that these potential conflicts may not be recognised by the researchers or their institutions. An accreditation process with appropriate standards will draw attention to the potential perceived conflicts for organisations, their REBs and their researchers and encourage the establishment of robust methods by which such actual or potential conflicts of interest can be managed. However, it is important to note that accreditation, in itself, will not address all governance issues raised in this document and elsewhere and that continued discussions of governance of research involving humans must continue to promote the highest standards in the conduct of human research. IV. WHAT IS ACCREDITATION? It is important to understand what is implied by the term accreditation. For the purposes of this document, the Task Force is agreed on the following definition that is based on the Final Report of the first NCEHR Task Force to Study Models of Accreditation for Human Research Protection Programs in Canada. Accreditation is based on continuously evolving standards derived from guidelines, regulations, policies and best practices. It is a self-assessment and peer-assessment process used by organizations to accurately assess their level of performance in relation to established standards and to implement ways to continuously improve the system. Blind trust and unintelligent accountability based on acceptance or deference should now play little part in institutions, professional life or anywhere that relationships are no longer personal. Unintelligent accountability is based on managerial conceptions centered on establishing systems for controlling performance. Intelligent accountability based on conscientious peer involvement includes an intelligent account of what ought to be done. Other Forms of Oversight While certification shares some of the characteristics of accreditation, it is most frequently focused on the competence of individuals and involves standards set by government or professional organisations. Accreditation is also different from licensure, which is normally issued by a government authority to recognise that an individual has met a set of minimum standards or competence. Unlike licensure, accreditation focuses on continuous improvement strategies and achievement of optimal quality standards, rather than adherence to minimal standards. Neither certification nor licensure is based on peer review. The Public Assurance System proposed by the SSHRC Standing Committee on Ethics and Integrity shares many of the characteristics of an accreditation system, but is focused on Research Ethics Boards (REBs) and the Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans (TCPS). A system of accreditation would have standards based on all applicable policies for the type of research involved, and would consider the broader Programs Ensuring Ethical Research with Humans (PEERH) that would encompass researchers, staff, subjects, and educators as well as the interface with external groups such as sponsors and regulators of research. Key Elements of Accreditation The 2002 Task Force Report identified some key elements of a system of accreditation for systems of protection of human research participants. The present Task Force has endorsed these. Thus, this report is based on the following assumptions. The system would be educational, with the objective of continuous quality improvement in the process of ethical review, rather than simply meeting a minimum standard. With the evolution of the standards, the quality of the review process will increase. The strong educational component is an element usually not appreciated by those unfamiliar with the process. The system of accreditation would be voluntary. In the future, regulatory bodies may require proof of accreditation provided by a non-governmental organisation (NGO). The system of accreditation must be proportionate, flexible and adaptable from several perspectives. It must recognize the differences among organisations, including: universities, not all of which will engage in the full range of research on humans; hospitals, both those connected to universities, and community hospitals; private practice clinics, government departments and agencies, many of which conduct research on humans; organisations in the private sector; and REBs not connected to an institution, such as community REBs and independent for profit REBs. It must recognize the differences in methodological approaches to research in the various disciplines. It should recognise existing programs of oversight, such as the program of designation in Quebec (see below) and the Inspectorate of Health Canada dealing with clinical trials. Any accreditation proposal needs to strive to harmonise standards and reporting requirements to avoid the imposition of unproductive duplication. The flexibility of accreditation with its ability to respond promptly to changing circumstances is one of its major advantages over the regulatory process. The system must be transparent, so that the public has free access to the standards and the process. The results of the process, at least in terms of the institutions that have achieved accreditation, should also be available to the public. This transparency will help to render the system accountable to stakeholders, especially research participants and subjects, and to the public. An accreditation system is based on peer review. The review would involve a site visit following a period of guided self-study. The system involves members of the public and research subjects or participants. The accreditation standards would be based on Canadian and applicable international legislation, regulations, policies, and guidelines and best of class practices drawn from universities, government, non-governmental organizations, community and health care organizations, and industry. These standards are to be established with the advice of experts in human research ethics, administration, regulation and research from all disciplines; stakeholders from government, non-governmental organizations, academic and research institutions, and sponsors of research; and research participants. In Canada, the underlying policy framework is the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (TCPS), federal and provincial legislation and regulations, and institutional policies. In addition, standards will draw on policies and regulations from appropriate jurisdictions depending on the nature of the research, sponsoring agencies and governing law; and best practices established by research institutions and accrediting organizations in Canada and elsewhere. Standards for accreditation generally set higher goals than regulations. Thus standards evolve and change over time through regular review and consultation together with feed back from accreditation site visits. With the global nature of the research enterprise and the emergence of international standards, the accreditation process should recognize and respond to these influences. The Task Force recognizes that an accreditation process must consider the entire PEERH within an organisation. Accreditation focuses on an organizations program not simply individual REBs within an organization. Thus an organization may request accreditation for its overall program of PEERH or may select from among its range of PEERHs for accreditation (e.g., bio-medical/clinical; behavioural and social science), leaving other PEERHs to be assessed later or not at all. The flexibility of the accreditation system will allow it to address different PEERH structures within organizations, including those with multiple PEERHs or those that rely on regionally-based, independent, non-institutional REBs, or multi-site REBs for elements of their PEERH. The accreditation system should be arms-length-from-government, thereby encouraging a non-regulatory approach and institutional commitments, and facilitating interaction across national borders and continents.  While recognising the legitimate interests and responsibilities of the provincial authorities in oversight of human research within their jurisdictions, the system of accreditation should be national and involve national standards. That is, the system would be national in scope in the sense that its services would be available across the country but would also be flexible and sensitive to and reflective of unique provincial and territorial requirements such as that currently operating in Quebec. Accreditation should be awarded for a specified term (3 or 5 years). During the term, an interim follow-up is required to ensure that the standards continue to be met until the next review cycle. A typical cycle is illustrated in Figure 2. Harmonising an Accreditation Program with Provincial and Territorial Existing Policies The objective of a system of accreditation is to help ensure that the PEERH of an organization meets established standards, as expressed in laws, regulations, and policies guidelines and best practices. Laws or regulations may be issued by provincial, territorial or federal governments or agencies or by international agencies or foreign governments. Consultations with stakeholders and interested groups showed a deep concern that a program of accreditation should not duplicate effort but instead build or draw on other procedures or systems that require the submission of similar data and information. For example, the Province of Quebec has developed a very extensive system of oversight for REBs approving research involving minors or incompetent adults (Designation). Based on a article 21 of the Civil Code and Ministerial Action Plan, the system requires that any research proposal involving minors or incompetent adults be approved by a Research Ethics Board designated by the Minister of Health and Social Services. It also directs institutions to implement a normative framework that is aimed at ensuring that institutional responsibilities to protect research participants are discharged effectively. Reporting requirements are extensive. The system extends beyond hospitals and health care institutions to reach universities, colleges and other research organizations and has the potential to cover independent REBs. Any provincial institution which does not have a designated committee may have such research reviewed by a designated REB or by a provincial central committee. In addition, when researchers are members of a recognized profession (such as physicians, psychologists or social workers), their professional organization has a responsibility to ensure professional oversight, most notably with a Code of Ethics. In Quebec, these codes have legal force and any violations thereto can lead to disciplinary sanctions. The Department of Health and Social Services of Quebec has sponsored the development of an on-line bilingual education system ( HYPERLINK "http://ethique.msss.gouv.qc.ca/didacticiel/index.php?lang=en" http://ethique.msss.gouv.qc.ca/didacticiel/index.php?lang=en) which is offered free of charge to all those interested. The interactions between such a provincially-mandated oversight system that focuses on the operations of Research Ethics Boards or their equivalents and a new program of accreditation focusing on an organizations PEERH need to be managed in order to avoid duplication and any unproductive outcome. To that end, the Task Force considers that the establishment of a system of accreditation should be based on the following principles: Recognize that the system in place in Quebec and planned for other provinces such as Newfoundland may constitute the normative basis for accreditation or is a significant step toward accreditation of an organizations PEERH; Recognize all documentation submitted to MSSS of Quebec, or other provincial authority, including the annual report, so that there is no duplication of requirements for provision of information; Recognize the designation process in Quebec, or similar processes in other jurisdictions, and consider whether it is effectively equivalent to the pre-accreditation visit process; In the case of REBs within the Health Department system in Quebec which have not sought designation, still make maximum use of the Ministry of Health and Social Services regulatory framework. The recognition of these principles will be particularly important as the Standards Setting process develops. While the standards will remain country-wide in scope, the way in which they are implemented in Quebec will recognise these principles It is not unreasonable to expect similar adaptations of a national system of accreditation to best of class practices and standards in other provinces and territories. V. ADVANTAGES OF ACCREDITATION Increase in Public Confidence The research enterprise involving humans in Canada depends on a supply of willing volunteers. Interviews with research participants during NCEHR educational activities and quality improvement site visits reveal that while some of the volunteer activity occurs in the expectation of benefit for the participant, an often more powerful motivator is altruism. If the confidence of the public in the systems that protect the volunteer research participant is eroded, all of those involved in the research enterprise, researchers, their organisations and the sponsors of research may be adversely affected. It is in the best interests of all that the public retain confidence in the system. An effective and visible accreditation program represents an important contribution to increasing the credibility of all aspects of human research protection. Facilitating Collaborative Research Research is increasingly collaborative and international in scope. Research on and with humans often involves more than a single investigator, organisation or sponsor, and is sometimes conducted concurrently in more than one country. When trans-institutional or trans-national, it is customary for each organizations REB to conduct review of a protocol. While adhering to common principles, different REBs may have differing and conflicting requirements. These result in duplication of effort and delays for the researchers and sponsors. A system of accreditation, based on agreed and readily accessible standards, ought to reduce the burden on REBs to feel compelled to conduct full reviews of the same protocol. The key to any system of mutual recognition is that each party must have confidence that the other party will adhere to equivalent standards of review and assessment. Accreditation provides a basis for improved communication enhanced opportunities for synergy amongst the stakeholders and maintains Canadas attractiveness as a location to pursue international research. Easing International Acceptance The past decade has seen a continuing and complementary rise in awareness of the need for some form of standardization and accreditation of research ethics boards and/or research organizations within and across nation states. In 2001 in the United States, for example, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) was incorporated to be the body to accredit institutional research boards (IRBs) in the U.S. This system is based on a voluntary, peer-reviewed educational process. Across Europe, the RESPECT project aims to establish a pan-European voluntary code with a number of established standards for all socio-economic human subject research. Similarly, in the United Kingdom the Central Office for Research Ethics Committees (COREC) has adopted mandatory accreditation for the UK for biomedical research and is exploring a standards process for social science human subject research. Other jurisdictions, such as New Zealand have legislated REBs and their operation. The development of an effective accreditation program for Canadian research with humans should increase the recognition of our PEERHs internationally. Encouraging Education for all Involved Accreditation has a strong emphasis on education at multiple time points in the accreditation cycle: first, in terms of the self-study and self-examination preceding the accreditation visit; then during the screening of applications; followed by a site visit; and finally during the development of the final report of the site visit. This educational emphasis promotes an awareness of, and commitment to, the protection of research participants by an organisation, its researchers and administrators. Education promotes a culture of ethical research on humans within the entire organisation. In summary, a system of accreditation will benefit all of those engaged in and concerned with research involving humans. Research participants and the public will have greater confidence in a system that is performing to a set of readily-accessible standards. Researchers will benefit from the increased confidence of the public and the participants, and from the respect and increased confidence that the system will engender in other organisations and jurisdictions. They will not lose access to willing publics to volunteer as participants. Organisations will have a set of standards to embrace and administrators within those organisations will have increased confidence that their systems are operating effectively and independently. An independent assessment of institutional systems for the protection of human participants will increase the confidence of sponsors that organisations are adhering to high ethical standards in their research involving humans. Regulators (government, industry and professional) will see demonstrated benefits as accreditation will assists them in discharging their duty of care for health and safety of the public by improving regulatory compliance for clinical trials with drugs and devices and for guidelines of professional organisations such as the Canadian Psychological Association. The economic activity that increased research involving human subjects has brought to Canada will be supported and protected. VI. RESPONSES TO THE OPTIONS PAPER As part of its process of public consultation, an Options Paper (see Appendix III) describing the background and reasons for accreditation was posted on the NCEHR web site and sent out for comment to a wide variety of organizations and individuals in April of 2005. Respondents were asked to indicate whether they or their organizations favoured a system of accreditation and to consider options for three areas: the organization of the accrediting entity, the development of standards, and the funding of the system. In summary the choices were: Table 1 Organization Options1. NCEHR transformed into accrediting entity2. enhanced NCEHR3. a new accrediting entity separate from NCEHR4. use an existing entity other than NCEHRStandards Development Options1. professional standards organization2. expert committeeFunding Options1. fee for service2. funding from government3. consortium of stakeholders4. blend of options Ninety-five responses were received, with participation from governments (federal and provincial), sponsors, academic institutions (universities, colleges, and academic hospitals), NGOs, industry, independent or non-institutional and community REBs, and individual responses. Most provinces and one territory provided comment. A summary of responses follows: The Need for Accreditation Do you or your organization support the development of a system of accreditation as outlined in this document? Over 85% of respondents were in favour of accreditation. Some acknowledged the Options Paper, but made no specific recommendations in any area. Two were opposed without providing alternate options. The Options Of the options described in the various sections, are there particular options that you or your organization favour? Among these options are there particular issues that you or your organization feel need further or special attention? Are there any that you or your organization find unacceptable? Organisational Options There were a number of ways in which this section was answered. Of 68 where an Option was preferred, just over half made a single choice, another quarter made two choices, and a small number chose an option to begin the process of accreditation, then another to continue. Some had no choice. Whether a single or two choices were described, Option 2 (enhanced NCEHR) was preferred by 54% when all choices were considered, and was clearly the most popular choice of those listed. Figure 1 provides an overview of the summary of all choices An enhanced NCEHR, adding accreditation to NCEHRs present role, was seen as having some advantages. The organization has a trust relationship with the research community, having been involved with a broad sector of organizations, research ethics boards, and researchers for over ten years. Respondents appreciated and valued the present activities of analysis of emerging issues, the education programs (including the National Conference), and the voluntary program of site visits. Particular mention was made of this option allowing continuation of the site visits for those organizations not ready or desiring accreditation itself. Figure 1  EMBED PowerPoint.Slide.8  Respondents were also asked to list which organizational entities would not be an option. These listings, as well as comments regarding choices made, highlighted several statements regarding the community of those involved in research ethics in Canada. While Option 1 was chosen by 11%, concerns were raised by others that NCEHR would cease to exist as it is currently structured or that its educative role would be disrupted. It was not clear how NCEHR would or could convert itself into an accrediting entity. A valuable networking organization would be lost, and there was risk of confusion in the research community with NCEHR having a new role but with the same name. Those opposed to Options 1 and 2 (NCEHR having an involvement) suggested that having a new or outside entity would remove the lingering concern that a biomedical model was driving the process. Option 3 (a new entity) received 17% of support; those opposed indicated a lack of credibility of an unknown entity in the community, a failure to build on work already done by NCEHR, and a concern of an increased cost to set up an entirely new system. It was felt that a new structure would not have the dialogue between the legislative and judicial components of the system possible with an enhanced NCEHR. Taking into account the concern of additional costs, one respondent felt such a new entity would have to rely heavily on volunteers. Citing confusion on the part of REBs and researchers regarding the existing players in research ethics (NCEHR, CAREB, PRE), one respondent felt a new entity would only crowd the federal field. Overall, it was unclear to respondents who the new group might be. Some of those in support, though, felt Option 3 could allow the development of an entity similar to the Canadian Council on Animal Care (CCAC), a successful program in the area of animal research. Option 4 was the least favoured as a single choice, but was listed as a possible means to initiate the process, or as a possible pairing with NCEHR. Most respondents apparently assumed this option suggested involvement of an existing U.S. accrediting group. There was strong feeling that the differences in the health care and educational systems mandated a made in Canada solution. Other points mentioned against this option included further delay resulting from a non-Canadian organization having to engage in a steep learning curve. Partnering with an existing organization, or using some members from such a group was put forward. Generally, the uniqueness of the Canadian system of guidelines, and the local expertise were cited as requiring a Canadian solution. It is important to review the criticisms of Option 2 as well as the positive feedback indicated above. Two types of perceived conflict were seen by some respondents; firstly that NCEHR was spearheading the Task Force on Accreditation and therefore biased as to the outcomes, and secondly, the perceived conflict between the differing roles NCEHR would have as educator and accreditor. As accreditation would be a major activity, there were fears that NCEHRs activities in other spheres might suffer. Respondents asked for additional clarity on how the accreditation activity would be managed within the current NCEHR organization and governance. The Task Force has attempted to address these concerns during its discussions of possible models for the Accrediting Entity, as discussed later in this Draft Report. How should the accrediting standards be set and maintained? Over 80% clearly preferred that standards be set up by an expert committee, with help from a professional in standards development. A standards setting organization would lack expertise in the area of research ethics, and would therefore take additional time to gain this knowledge, or in preparing revisions after community input. As well, such an organization was more likely to be concerned with process issues, possibly limiting a full evaluation of a program for ensuring ethical research with humans. Respondents felt that the expert committee might suffer from a lack of credibility with the community and need more time for acceptance. Care needed to be taken to include in the process representatives of constituencies as well as individuals to hear the larger voices. It was also recognized that standards based accreditation would be challenging in terms of definition and interpretation of various documents and norms. How should the system be financed? Of the three options (fee for service, government funding, and a consortium, or some blend of options) a blend of options was preferred by two thirds of the respondents. Universities in particular expressed concern that service based only on a fee for service could not be borne in addition to other costs, such as those involved in preparation for accreditation and would detract from the voluntary nature of review. Those respondents opposed to accreditation or deferring comment expressed concern about the expense of such a system. Any system of accreditation must recognise that concern. Those respondents did not address the potential cost, both in finances and credibility, of not acting to increase oversight. VII. THE INVITATIONAL WORKSHOP The responses to the Options Paper permitted the Task Force to identify a number of issues that emerged. It prepared an Issues Paper (see Appendix IV) that served as a basis for discussion. Approximately 50 organizations and individuals were invited to a Workshop held on June 21-22, 2005 (a list of attendees appears in Appendix IV). The paper identified some issues that arose from the clear preference for NCEHR to undertake accreditation in addition to its existing responsibilities. The Organisation of the Workshop The participants included representation from governments, funding agencies, industry, universities, research national associations, the health sector, research participants, and researchers. The invitees covered the broad spectrum of disciplines and research methodologies. Four groups of questions were prepared (Appendix V) relative to the interests of stakeholders, adding accreditation to NCEHRs current responsibilities, maintaining flexibility in the accreditation process, and setting up the standards and evaluations of research protection systems. The questions were designed to be as broad as possible and enable free discussion. One group considered the questions specifically in light of the regulatory system already in place in Quebec. Arrangements were such that all attendees were able to address all of the issues identified in small groups, with reporting to and discussion by, the full assembly. The discussion was wide-ranging, but a small number of issues, largely organizational in nature, was of particular concern and have influenced the preparation of this draft report. The relationship of an Accrediting Process to NCEHR While the delegates in the main continued to favour the accreditation process being included in a revised mandate for NCEHR, there were some concerns about the consequences of such an initiative. The delegates emphasized the importance of NCEHRs existing roles, including the identification of emerging issues, education as manifested by its National Conferences, its national and regional workshops and its program of voluntary, confidential, quality improvement site visits. It is the last activity that evoked the greatest concern. Most delegates would prefer those visits to continue to be available, and, while they saw the potential for conflict of interest to arise, they felt that the conflict could be managed. This issue has always concerned the Task Force and has been a frequent topic of discussion. Given that both the accreditation process and many of the other activities of NCEHR are educational, there is the potential for confusion of the roles. For example, a quality improvement site visit of the existing type provided by NCEHR might review a particular organization in a reasonably favourable way, yet a subsequent accreditation visit might identify shortcomings. Furthermore, if the accreditation process puts itself in the position of recommending attendance at educational workshops (from which NCEHR derives income), the conflict of interest is clear and unacceptable. It will be essential for NCEHR to organize itself so that the potential for confusion and perceived or real conflicts are minimized. A small number of delegates indicated that the Task Force, as a creation of NCEHR, was itself in a conflict of interest in suggesting NCEHR as the accrediting entity. The Task Force is aware of this, but has seen no way to remove the conflict short of not establishing the Task Force in the first place. It included Options 3 and 4 as clear alternatives for assessment and comment by the community. Throughout the meeting, the Task Force heard a firm commitment overall to an enhanced NCEHR as the most workable model. Standards and the Involvement of Stakeholders The development of standards was an important issue for discussion at the workshop. While most delegates recognized that the matter required expertise from those who are very familiar with all of the guidelines policies and regulations governing research with humans, they regarded it as important that the process involve regular consultation with stakeholders. The involvement of stakeholders was seen to be important not only in the development of standards, but in the governance of the process and as site visitors in the accreditation process. Process A major concern was the avoidance of bureaucracy. In particular, in Quebec, there is a well-organized system for reporting and evaluating REBs. An accreditation system should respect this existing system, and others beginning to emerge in other Provinces and not create an additional bureaucratic work-load that duplicates information already provided. The workshop emphasized the importance of recognising the broad variety of research methodologies in the social science and humanities community, where minimal risk protocols are the norm. Participants from universities In particular emphasized the importance of ensuring that the needs of the majority of universities in the country not be subjugated by the requirements of the minority with medical schools. Smaller organizations may lack the resources to respond to accreditation in the same way as larger organizations. In general, this feedback fortifies issues that the Task Force had already identified and highlighted. It is perhaps worth noting that the resolution of many of the issues will lie in the development and application of appropriate standards, a process that may take some time. In addition, the workshop participants emphasized that evaluation of the accreditation process will be essential, although there were few suggestions and there was no consensus in terms of how this should be done or what questions should be addressed in the evaluation. VIII. Education, Accreditation and NCEHR With some exceptions research ethics education in Canada is minimal given the breadth and depth of issues. Not all faculty researchers and certainly not all students or others, such as community practitioners, are fully informed about the ethical requirements of research in humans or relevant guidelines and regulations. All those engaged in research with humans or in positions of responsibility for the conduct of such research should participate in and promote participation in educational programs in the ethics of research in humans. The need for such ethics education, particularly the development of an agreed curriculum, is touted repeatedly at national conferences and elsewhere. What is not clarified is where responsibility lies for developing and delivering that education. An accreditation process would play a major role in improving the situation. Accreditation would not only help ensure the protection of the research subject or participant; it is also the type of initiative necessary if the higher education community wishes to maintain its independence. Examples of ethics teaching initiatives in Canada can be found in universities, hospitals, some research funding agencies and provincial governments. For example, on-line tutorials exist for the TCPS and for the provincial program in Quebec. However, there is considerable variability in the quality, availability, depth and requirement to participate in such programs. Documents such as the Tri-Council Policy Statement and ICH GCP refer to investigator qualifications in very general terms; they make no reference to educational responsibilities or resources. The two fundamental purposes of accreditation are to assure the quality of the institution or program and to assist in the improvement of the institution or program. Accreditation not only ensures that PEERHs are operating to agreed standards, but it also offers opportunities for education that are usually underestimated by those who have not participated in the process. Educational elements of accreditation include the following: Accreditation standards have a major influence on educational content. Self-assessment preparatory to an accreditation visit is instructive by its identification of institutional strengths and weaknesses. That process of self-evaluation enhances the local visibility and emphasizes the importance of ethical issues in research with humans. Site visitors workshops and review of material preparatory to a site visit are educational for the peers who constitute the site visit teams. Involving peers from diverse disciplines as site reviewers is an effective method of crossing interdisciplinary boundaries. It facilitates broader understanding of the nature of ethics review in different disciplines and the adaptability of ethics policies and guidelines. The site visit provides an opportunity for an exchange of views and information between the team and members of the institution that is informative for all concerned. Site visitors not only provide advice to the institution during the visit and exit interview, they often return to their home institution with important new insights and ideas. That educational feedback loop is an important component of accreditation. Accreditation visits create an opportunity to identify issues directly at the research site; that experience provides feedback that informs the standards setting process and the evolution of resources such as the TCPS. Accreditation reports provide important advice and recommendations about the institutions process of ethics review and an assessment of the infrastructure support required for that process, including local educational activities. NCEHR has done much to provide educational opportunities in Canada including Educational Outreach Programs, REB 101, individual institutional consultations and well attended Regional and National Conferences. Evaluation visits to institutions have had important educational components. All these activities have been well received and NCEHR has been strongly urged to continue to make education its major mandate. The establishment of a program of accreditation would require NCEHR to work closely with the accrediting organization to ensure that the educational activities of the two organizations were complementary and that conflicts of interest were minimised. Sources of Conflict of Interest for NCEHR NCEHR engages in a number of educational activities, including national and regional workshops on specific subjects, such as REB 101, minimal risk and aboriginal research, and the National Conference. NCEHR also operates educational site visits that are invited and confidential. If these activities are to continue while NCEHR is engaged in accreditation, there are some potential hazards. There is the difficulty, common in a number of similar situations that do not involve accreditation, that NCEHR would teach to the exam, focusing its educational efforts primarily aimed at assisting organisations to become accredited. There is also the problem that the accreditation process in a particular organisation might reveal the need for additional training. The fact that another branch of NCEHR operates such training for a fee raises questions about conflict. The community generally regards it as important that NCEHR continue to offer its educational, quality improvement site visits. The conflict here arises if the community, including NCEHR and the accrediting entity come to regard the site visits as practice for accreditation, such that a visit from NCEHR that failed to identify shortcomings would guarantee accreditation. The accrediting entity and NCEHR will have to ensure that these potential conflicts are minimised. Participants in the Issues Workshop identified the importance of independent funding for the accreditation operation, but there are other actions that could be taken, such as ensuring that NCEHR site visitors and accreditation site visitors are separate, and that there is separation of the staff involved. IX. STAKEHOLDERS IN PEERH The term Stakeholder has been used many times in this document. Stakeholder may be defined as somebody or something with direct interest, involvement, or investment in something, for examples the employers, shareholders, and customers of a business concern.8 The word stakeholder has entered corporate and bureaucratic jargon, means different things to different people, and often serves to obfuscate the roles and responsibilities of individuals or organizations in initiatives and activities. There are obvious differences between direct interest, involvement, and investment. For clarity in communicating and understanding of roles and responsibilities, organizations or individuals should be differentiated within the broad category of stakeholder. The element of responsibility must also be considered when dealing with professionals that may, in the case of certain professions such as medicine, psychology and social work, include a duty of care. Stakeholders in the protection of human participants in research may be categorized in a number of ways. The following may serve as a basis for discussion: 1. Responsible stakeholders: Organizations employing individuals who do research in humans such as universities, hospitals, non-governmental organizations, government laboratories, and industry. Professional organizations licensing individuals who do such research Federal and provincial governments responsible for the regulation and oversight of research. Investigators engaged in research in humans Sponsors of research with humans, including departments and agencies of federal and provincial governments, industrial, voluntary organizations that fund research. 2. Stakeholders with a direct interest: Participants Professional standards setting and certifying organizations (e.g., Royal College of Physicians and Surgeons, Canadian Psychological Association) Public (those who might be impacted) Both groups of stakeholders have a legitimate claim to involvement in the governance of accreditation. The way in which responsible stakeholders have participated and may participate in oversight mechanisms varies depending on the process. For example, a list of the stakeholders interested in the financing and governance of the operation of an accreditation operation may not be identical to the list interested in standards development. In Canada, while it is clear that many organisations and individuals can be identified as stakeholders with a direct interest, no coherent group of responsible stakeholders has yet emerged with the exception of the three national granting agencies, Health Canada and the AUCC, as a representative of the university and college sector. Without the identification of such a core and coherent group of responsible stakeholders, the movement toward accreditation is unlikely to be successful. During the later phases of the operation of the Task Force, a Sponsors Table representing responsible stakeholder organisations has begun to meet with the objective of encouraging greater oversight. This is a useful development. X. THE ACCREDITATION CYCLE The Task Force does not wish to be prescriptive in its description of a process of accreditation. However, in view of widespread unfamiliarity and misunderstanding of accreditation, it was considered useful to describe in some detail how the process might work. A Typical Process The actual process of accreditation is a cycle with organisations working toward and achieving accreditation, then preparing for re-accreditation after a specified period of time (for example, after 5 years). An overview of the accreditation cycle is shown in Figure 2 and described below; the details of implementing the process will be the responsibility of the Accrediting Entity, once it is formed. The process that is described here is based on the strong belief of the Task Force that the Accrediting Entity must be committed to helping organisations successfully achieve accreditation. This process must be user friendly to small organisations as well as larger ones, and appropriate to the various approaches to research across the broad research community. Pre-visit Support for Organisations The Accrediting Entity will make available a number of tools to guide an organisation that chooses to seek accreditation. These tools will be based on the standards for accreditation and will include a self-assessment guide, site visitors workbook, and application form. Ideally, these instruments will be freely accessible at a web-site. Prior to seeking accreditation, an organisation will perform the self-assessment in order to address any gaps in the organisation. The length of time required to prepare for accreditation will vary. Some organisations may already have important structural and procedural aspects in place due to provincial or institutional requirements and may only need to assemble existing supporting documents with the completed application form. Other organisations may need to reflect on their organisational structure and policies to determine how to meet the standards and implement the necessary changes prior to submission of the application form. The Accrediting Entity will be committed to reviewing an application with supporting documentation in a defined time period. It is crucial that all applications are appropriately evaluated to ensure completeness and adequacy of supporting documentation. It may be necessary to seek clarification from an organisation during this screening period in order to maximise the effectiveness of the site visit. The Site Visit Once an application completes this screening process, the Accrediting Entity will schedule a site visit. The site visit team will be composed of trained volunteer peer reviewers supported by knowledgeable staff of the Accrediting Entity. Figure 2  The site visit will be conducted in a manner that takes into account the size of the organisation, the nature of research that it conducts, and the volume of research. The site visit will conclude with a meeting of relevant personnel from the organisation to debrief and discuss the preliminary findings that will be included in the Draft Report submitted by the site visitors to the Accrediting Entity. The Draft Report will be available to the organisation to provide an opportunity to respond to any issues that were identified during the site visit. There may be extensive communication between the accrediting entity and the organisation during this period to ensure that the organisation understands and meets the standards. The length of time that this activity takes will depend on the nature and extent of any corrective action needed as well as the commitment of the organisation to achieving accreditation. The Report and Decision The Final Report will contain the findings of the site reviewers, comments on the strengths and weaknesses of the program and identification of any necessary corrective actions. The Final Report will be reviewed by the Accrediting Entity to determine the accreditation status of the organisation. The Accrediting Entity, in consultation with responsible stakeholders, will want to establish levels or categories of accreditation such as full accreditation, provisional accreditation or limited accreditation. Provisional accreditation might be used for an organisation that requires additional time to make specified minor or administrative adjustments to their PEERH. Limited accreditation would permit discrete segments of an organisation to be accredited prior to other segments. The final step in the process involves the issuance of the certificate of accreditation. Accredited organisations customarily report on an annual basis on changes in the PEERH. Appeals In those cases that involve recommendations (i.e., less than full accreditation) that are disputed by the organisation seeking accreditation, the question of an appeal mechanism arises. These could be of two sorts: there could be an appeal mechanism established within the Accrediting Entity, as is the arrangement, for example at AAHRP, or an entirely independent body, external to the Accrediting Entity, could undertake the task. In either case, members of an appeals body must be knowledgeable, but without involvement in the report under dispute. The membership of an appeals body (or a panel from which the specific appeals body is selected) should be specified in advance, as should the basis on which appeals are allowed. Decisions of the appeals body should be recognised as final. Instances of dispute between the organisation and the Accrediting Entity after all processes internal to the accrediting entity have been resolved are likely to be rare. If an appeal mechanism, either external or internal or both, is to be available, it will be essential that both the Accrediting Entity and the organisation, understand and agree to the rules in advance of applying for accreditation. Functions to be undertaken In order to undertake a system of accreditation, the following functions need to be performed: Standards: Establishment and maintenance of the standards for accreditation. Operations: Management of the accreditation process and eventually the re-accreditation process. This will include screening and acceptance of applications for accreditation, scheduling of site visits, management of site visit reports, collaboration with organisations to ensure appropriate actions are undertaken, follow through to the decision on accreditation status, and the development of an appeal process. Independent Review: A body to evaluate site visit reports and corresponding corrective action plans and to make a recommendation or decision on the accreditation status. This body should be comprised of a panel of experts representing the stakeholders but may also include experienced site visitors. Issuance of the accreditation certificate based on the recommendation of the review body. Quality assurance activities including internal quality review of accreditation activities, to ensure: that the Accrediting Entity strives for the highest standards of quality in its operation, and that systems are in place to ensure the establishment and maintenance of standard operating procedures, training of staff, etc., these assurance activities may include the Accrediting Entity seeking accreditation from an appropriate body. Administration of the accreditation process, including policy setting and strategic planning. Communication about accreditation with: Organisations seeking accreditation to provide information about the standards and guidance and training in preparing for accreditation. The research ethics community to provide information about the standards and the accreditation process and to offer workshops or other training in the preparation for accreditation. The research community to provide information about the standards and the process and to receive reactions. The broader public, particularly research subjects and participants about the accreditation process. XI. The Accrediting Entity From the responses to the Options paper and the discussion at the Issues Workshop, it was clear that the general preference was for an Accrediting Entity as a separately identifiable enterprise, but associated with NCEHR so as to benefit from its experience and credibility. It was also important that the structure should preserve, so far as possible, the current functions of NCEHR. In order to minimise perceived conflicts of interest, the funding and budget of the Accrediting Entity should be separate from that of NCEHR for its other activities. As pointed out in the Options Paper, there is a spectrum of possibilities for the interaction between the two bodies. We have set out in the models below the two extremes of the spectrum. At one end of the spectrum, there might be a separate legal entity (Model 1), with a Board or Council composed of key stakeholders, and related to NCEHR by mutual representatives on the respective Boards. In this model the only responsibility for the operational aspects of accreditation that rests with NCEHR is the development and maintenance of the standards. The Accrediting Entity would make decisions about accreditation status without reference to NCEHR. In this model in particular, it will be essential to ensure that there is regular communication between the site visiting operation of the Accrediting Entity and the Standards Committee of NCEHR so that the latter is aware of any difficulties created by the current standards or of emerging best practices. There are several mechanisms that could accomplish this essential task, such as having a section of the site visit reports that deals with the subject. . At the other end of the spectrum, The Accrediting Entity would become part of the NCEHR organisation. In order to maintain some degree of independence the entity would exist within NCEHR as an Office of Accreditation, with an independent budget. NCEHR would establish as one of its committees a new Accreditation Committee, members of which were key stakeholders, and experienced site visitors and the chair of which was a member of NCEHR Council. This committee would receive reports from site visitors and make recommendations to the Council of NCEHR concerning accreditation status. The responsibility for standards would reside with NCEHR as in the first model. Thus, in model 1, NCEHRs experience and credibility is expressed only through its responsibility for standards, while accountability for the accreditation operation lies solely with the Accreditation Entity. In model 2, by contrast, NCEHR accepts accountability for the accreditation process while the quasi-separate Office of Accreditation functions with a large degree of independence. This independence might be fortified, if desired, by the formation of an external Advisory Board. Structural Model 1: The Accrediting Entity is a Separate Legal Entity Description of the Model In this model, the Accrediting Entity is a separately incorporated legal entity, with a separate Board and staff and a separate budget. The Board would be composed, at least in part, of stakeholders or their nominees. It would function independently of NCEHR and the new entity would be responsible for all aspects of the delivery of the accreditation process except the development and maintenance of standards, which would reside in NCEHR as a Committee of Council with appropriate staff. It is possible, in the interests of efficiency that NCEHR and the Accrediting Entity might share common financial and administrative services. The involvement of NCEHR would find expression in the development and maintenance of standards. The standards operation would be the responsibility of a Standards Committee of NCEHR. Like all of the Committees of Council, it would be chaired by a member of Council. As in the other Committees, membership on the Standards Committee would include non-members of Council. It would have appropriate staff support. Like all of the Council committees, this would be a working committee, and it might have advice from an advisory group of stakeholders. The NCEHR Standards Committee and the new Accrediting Entity would have close connections, primarily in the articulation between standards setting responsibilities of the NCEHR Standard Committee and the site visit and Entitys Accreditation Committee. It is important that the Standards Development and Revision Committee learn from the Entitys site visit experiences about what works, what does not work, what requires minor modification, and what requires significant modification or new standards. This example is located at one extreme of a range of possible associations between NCEHR and the Accrediting Entity. In the model presented here, there is total independence of Entity, but within this model variations are possible. For example, the new entity might be incorporated as a subsidiary of NCEHR, with some interchange of Board members between the two organisations. In this way, NCEHR could be aware of the activities of the entity and the entity could benefit from advice and experience of NCEHR, while preserving independence of action. Possible Organisational Structure The structure of NCEHR and the Accrediting Entity will look something like that shown in Figure 3. Figure 3  EMBED Visio.Drawing.11  Distribution of Functions The functions that are needed for accreditation will be performed as described in Table 2. Table 2 FunctionResponsible part of the organisationStandards for accreditationDevelopment, implementation, and revisions of standards will be performed by an Accreditation Standards Committee as a Standing Committee of NCEHR. The committee would be a working committee, with an external advisory body of stakeholders. The standards and revisions to them will be approved by NCEHR Council.Operations: Management of accreditation processThis will be performed by the staff of the Accrediting Entity and will include oversight and training of site visitors as well as interactions with organisations seeking accreditation.Review BodyThe Accreditation Committee of the Accrediting Entity will receive the reports of site visitors with the corresponding action plans of the organisations seeking accreditation. The Accreditation Committee will make a recommendation regarding the accreditation status. Issuance of accreditation certificateThe Board of the Accrediting Entity will issue the certificate, or it may delegate to the Accreditation Committee the authority to do so. The Board will bear the ultimate responsibility. Quality AssuranceQuality assurance should be a dedicated staff function in the Accrediting EntityGovernance including policy setting and strategic planning This is the responsibility of the Board of the Accrediting Entity. Discussion There are a number of challenges that should be pointed out about this model for the Accrediting Entity. Legal Aspects: It is envisaged that the Accrediting Entity will be established as an incorporated body. This will require a definition of shareholders and the development of by-laws including mechanisms for electing the Board. It might be possible to define a number of members of the corporation from among stakeholders who would exercise the rights of shareholders in an incorporated body. Governance: In this model, the Accrediting Entity is both accountable for accreditation (setting policy and strategies) as well as responsible for operational aspects (acting as the review body). Potential for Separation: Should NCEHR decide in the future to separate itself from the Accrediting Entity, this could easily be done as there already is a clear separation of responsibilities. Conflict of Interest: Any potential for conflict between the existing educational site visit program and the planned accreditation site visits will be addressed by having these performed by separate legal entities. Similarly, any potential conflict regarding standard setting and site evaluation will be resolved by having these performed by NCEHR, separate from the Accrediting Entity. Human Resources: This model assumes that there are sufficient knowledgeable and available persons in Canada to adequately resource the Council, relevant Committees, and the Accreditation Board. This may not be a concern, since the expertise required in each organisation may be different. Funding: Given the limited and inadequate sources of funding for research ethics in Canada, it may be a challenge for both NCEHR and the Accrediting Entity to be funded adequately. There is a potential for inconsistencies in funding levels across the two organisations to occur. Independence: It may be difficult to maximise the independence of both NCEHR and the Entity from the sponsors as monies may be linked to specific activities. Long-term survival of current NCEHR activities: Given the aspects discussed above, a shortage of funding and resources may affect NCEHRs ability to continue its current activities. Involvement of NCEHR in accreditation: The minimal involvement of NCEHR in the visible process of accreditation may affect the initial credibility and acceptance. The assignment to NCEHR of the crucial responsibility for standards should, however, contribute to the communitys confidence in the system. Structural Model 2: The Accrediting Entity is a separately identified structure within NCEHR Description of the Model In this model, all of the functions related to accreditation are carried out by NCEHR, but the Accrediting Entity exists as a separately funded Office of Accreditation with a dedicated staff. The Office, headed by a Director, would contain an Accreditation Committee that would receive the reports of site visitors supported by staff. That Committee, composed of stake holders and experienced site visitors, would forward recommendations on accreditation status to NCEHR Council. Thus the NCEHR Council in this model is responsible and accountable for all of the operations associated with accreditation. The Accreditation Committee, in the extreme end of the spectrum represented by this model, would exist as a Standing Committee of Council, chaired by a member of Council, although relations between the Committee and Council might have to be specified in standard operating procedures. The development and stewardship of standards would operate as in the first model, through a standing committee of NCEHR Council. While some support services such as accounting, information technology or personnel services, will be shared, it is essential that the Office of Accreditation have dedicated staff, and that its budget is separate from that of NCEHR, although it might be identified as a line item in the total budget of NCEHR. The continuance of the Educational Site Visits by NCEHR to those organizations not yet ready to embark on accreditation will require evaluation to ensure appropriate separation of activities and minimisation of potential or perceived conflict of interest moving this activity to the Educational Committee may be one way to ensure adequate separation from the accreditation activities. NCEHR is already considering such an arrangement within an Office of Education with a dedicated Director. Possible Organisational Structure The structure of NCEHR and the Accrediting Entity might look something like that shown in Figure 4. Figure 4  EMBED Visio.Drawing.11  Distribution of Functions The functions that are needed for accreditation would be performed as described in Table 3. Table 3 FunctionResponsible part of the organisationStandards for accreditationEstablishment and maintenance of standards will be performed by an Accreditation Standards Committee of NCEHR. Standards and revisions to them would be approved by Council.Operations: Management of accreditation processThis will be the responsibility of the Office of Accreditation, operating under a Director. This will include oversight and training of site visitors as well as interactions with organisations seeking accreditation.Review BodyThe Accreditation Committee will review the reports of site visitors with the corresponding corrective action plans of the organisations seeking accreditation to make a recommendation regarding the accreditation status. Issuance of accreditation certificateThe recommendations of the Accreditation Committee will be forwarded to Council for issuance of the accreditation certificate. Council might delegate to the Accreditation Committee responsibility for issuing certificates. Quality assuranceQuality assurance should be a dedicated staff function in the Accrediting Entity.Governance including policy setting and strategic planningThis would be the responsibility of the Council, acting on advice from the Office of Accreditation. Discussion There are a number of challenges that should be pointed out about this model for the Accrediting Entity. Membership of Council: The expansion of responsibilities and the interests of stakeholders may require some revision of the current arrangements for appointment to the NCEHR Council. Currently, the Council is an incorporated body, in which all of the members of the corporation are members of the Board of Directors. While this model envisages that Council will continue to consist of individuals appointed for their interest, expertise and willingness to perform significant work between meetings, there will be significant interest from various organisations in accreditation. This might imply a return to a previous arrangement whereby a small minority of members of Council were appointed from lists of nominees submitted by selected stakeholders. Alternatively, the incorporated Council might develop a larger body of members at large who would attend an annual meeting and exercise the rights of shareholders assigned by incorporation. Governance: In this model, the accountability for accreditation lies with the Council (setting policy and strategies) while the operational aspect is clearly separated and lies with the Office of Accreditation. Potential for Separation: Should NCEHR decide in the future to separate itself from the Accrediting Entity, this may not be so easily accomplished as in the first model. On the other hand, the existence of a separately budgeted Office of Accreditation identifies the principal entity to be separated. Conflict of Interest: There is a potential for conflict between the existing educational site visit program and the planned accreditation site visits. Any potential perceived conflict regarding standard setting and site evaluation also needs to be resolved. Human Resources: This model, like the previous model, assumes the existence of a base of willing volunteers in Canada. Because it does not involve the development of a separate Accreditation Board, any concern is reduced. Funding: Sponsors will be approached once, although there will be separation of funds for accreditation versus other NCEHR activities. Independence: It may be difficult to maximise the independence of NCEHR from the sponsors as monies may be linked to specific activities. Long-term survival of current NCEHR activities: Because the activities are located within a single governance structure, NCEHR, the various accreditation activities and the sponsors should find it easier to agree on the continuation of the current programs of NCEHR. Assessing the Operation of the Accreditation Process It will be important for the performance of the accreditation process to be assessed at regular intervals to determine whether its objectives are being met. While the structures outlined above include an internal quality control assessment, an external assessment at regular intervals is also essential. In undertaking such an assessment, there are at least three categories of questions that might be asked: Are the finances being deployed in the agreed manner? 2. Has the accreditation process resulted in changes in the system of accreditation in those organisations seeking accreditation? 3. Does accreditation result in increased protection for research subjects and participants? Of these questions, the first can be fairly easily answered. The second, while more difficult, is highly relevant and must be addressed in such an assessment. The third is not at all easy to approach. Moreover, while it is assumed that increased compliance with policies, guidelines and regulations will lead to increased protection (since the policies, guidelines and regulations are designed to accomplish that task), the focus of the accreditation process is the organisation, not only in terms of its compliance, but also in terms of institutional awareness and commitment. The question is perhaps more properly addressed elsewhere and by other means. Research funding for projects that address questions around the outcome of existing policies and procedures in terms of enhanced protection for research subjects is an obvious need. The assessment process ought therefore to focus on the first two questions and on the second in particular. The assessment should be under the supervision of a representative consortium of stakeholders, including the governmental organizations responsible for core funding for the accreditation system. This consortium would appoint a small committee including a member of the public and/or a research participant to undertake the process. The committee would explore the first question, but would concentrate on the second, developing methods for exploring changes that occurred as the result of the accreditation process. International experts should be a component of such an assessment. Additional accountability could be sought by applying for accreditation of the accreditation process from the appropriate Canadian or international bodies. XII. CRITICAL FACTORS FOR SUCCESS This section of the report is intended to identify some crucial factors that need to be addressed if a program of accreditation for PEERHs in Canada is to be a success. The Task Force has not attempted to produce a business plan. The production of such a plan will be an early task in the development of any accreditation program that eventually emerges. It is not this sort of important detailed planning that is addressed here. The Task Force, however, wishes to draw attention to a limited number of important factors that need to be addressed before NCEHR or any other organisation proceeds with the development of a program of accreditation. Responsible Stakeholders The Task Force regards it as essential that a group of responsible stakeholders identify accreditation as important and use their influence to promote the concept. These need not necessarily be funders. It is interesting to compare the development of accreditation in the United States with the path that has been taken in Canada. The development of the AAHRPP organisation was led by a group of stakeholder organisations following sanctions imposed for non-compliance with established regulations leading to some celebrated incidents. In Canada, although there have been some well publicised failures to follow established policies and regulations, these failures have not led to sanctions, and the movement to accreditation has been slow. This has led NCEHR to take the lead without the active support of responsible stakeholders The report notes that a Table of Sponsors has been meeting to consider the implementation of accreditation or other form of oversight. If this welcome initiative continues to develop, it will be crucial support for the success of an accrediting organisation. Adequate Financing This is perhaps so obvious as not to be worth stating. Obviously much will depend on whatever business model an accrediting organisation chooses to adopt. It is clear, however, that some form of government support will be required at least for the start up phases, and very probably on a sustaining basis. Without appropriate guarantees, NCEHR, or any other organisation, would be foolish to embark on accreditation. Volunteer Peers The accreditation system that we have described relies on a sufficient pool of well-trained, willing volunteers to carry out the crucial site visits and serve on the accreditation and standards committees. Moreover, it is important that this group of volunteers not be confined to researchers, and that the researchers not come exclusively from the academy. Identifying and training an appropriate pool will be an early requirement. If the accreditation program is a success, the pool is likely to become large. Iterative Process for Standards Development, Implementation and Review The development, implementation and review and assessment of standards require a level of trust between the accrediting agency, standards development experts, organizations, researchers, and research participants as well as governmental organizations and sponsors of research involving humans. Standards must be developed, implemented and assessed with the involvement of the research communities research organizations, researchers and human participants. The cycle of development, implementation, review and assessment is an on-going process, one that may be similar to the process of review of the TCPS. The cycle ought to be clearly specified, ensuring that it is predictable, has an established system for feedback from research organizations, is flexible and adaptable to changes in federal, provincial and international standards for conducting research with humans, Moreover, the cycle for development, implementation, review and assessment needs to be incorporated into the budget for the accrediting agency and/or standard setting agency from the outset.        PAGE  -PAGE 3-   XIII. REFERENCES  National Council on Bioethics in Human Research, Protecting and Promoting the Human Research Subject: A Review of the Function of Research Ethics Boards in Canadian Faculties of Medicine, Communiqu, Volume 6 (1), 1995, p. 3-28.  HYPERLINK "http://www.ncehr-cnerh.org/pdf/publications/site_visits/NCEHR_Sitevisits1993_EN.pdf" http://www.ncehr-cnerh.org/pdf/publications/site_visits/NCEHR_Sitevisits1993_EN.pdf  Fortin, Louis-Nicholas, Leroux, Thrse, Reflections on Monitoring Ethics Review of Research with Human Subjects in Canada, Report Sponsored by the National Council on Ethics in Human Research, Ottawa, 1996.  HYPERLINK "http://www.ncehr-cnerh.org/english/communique/monit_e.html" http://www.ncehr-cnerh.org/english/communique/monit_e.html  Coordinating Committee for the National Council on Ethics in Human Research, Minutes of a Meeting held on November 28, 2000.  National Council on Ethics in Human Research, Report of the NCEHR Task Force to Study Models of Accreditation for Human Research Protection Programs in Canada, 29 March, 2002. This Report is available at:  HYPERLINK "http://www.ncehr-cnerh.org/english/NCEHR_Task_Force_Rpt.PDF" http://www.ncehr-cnerh.org/english/NCEHR_Task_Force_Rpt.PDF  National Council on Ethics in Human Research, Report on NCEHR Site Visits 1998 to 2004, Ottawa, May, 2005  HYPERLINK "http://www.ncehr-cnerh.org/pdf/publications/site_visits/ReportSiteVisitsFinal3_June_2005.pdf" http://www.ncehr-cnerh.org/pdf/publications/site_visits/ReportSiteVisitsFinal3_June_2005.pdf  Canada Gazette Part I, Regulations Amending the Food and Drug Regulations (1024 Clinical Trials)  HYPERLINK "http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/1024_e.pdf" http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/1024_e.pdf  House of Commons of Canada, Standing Committee on Health, Opening the Medicine Cabinet: First Report on Health Aspects of Prescription Drugs, Ottawa, April 2004.  HYPERLINK "http://www.parl.gc.ca/infocomdoc/Documents/37/3/parlbus/commbus/house/reports/healrp01/healrp01-e.pdf" http://www.parl.gc.ca/infocomdoc/Documents/37/3/parlbus/commbus/house/reports/healrp01/healrp01-e.pdf , p.4.  Canadian Biotechnology Advisory Committee, Biotechnology and the Health of Canadians. Ottawa, December 2004.  HYPERLINK "http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/BHI-Final_Dec-13-04-E.pdf/$FILE/BHI-Final_Dec-13-04-E.pdf" http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/BHI-Final_Dec-13-04-E.pdf/$FILE/BHI-Final_Dec-13-04-E.pdf  Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (with any additions)  HYPERLINK "http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm" http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm 10 Grayson, P.J., How Ethics Committees Are Killing Survey Research on Canadian Students, University Affairs, January 2004.  HYPERLINK "http://www.universityaffairs.ca/issues/2004/jan/opinion.html" http://www.universityaffairs.ca/issues/2004/jan/opinion.html 11 J. Paul Grayson and Richard Myles, How Research Ethics Boards Are Undermining Survey Research on Canadian University Students, Journal of Academic Ethics, v. 2, n.4 (2004), 293-314. 12 Gouvernement du Qubec, Ministre de la Sant et des Services sociaux, Direction gnrale adjointe de l'valuation, de la recherche et des affaires extrieures, Unit de lthique, Lvaluation et le suivi thiques des projets de recherche multicentriques Mieux conjuguer protection des sujets, quit et efficacit. Orientations ministrielles. Qubec, Dcembre 2004.  HYPERLINK "http://ethique.msss.gouv.qc.ca/site/download.php?id=292597,14,1" http://ethique.msss.gouv.qc.ca/site/download.php?id=292597,14,1 XIV. APPENDICES I Terms of Reference and membership II Sample Standards III Options Paper IV Issues Paper V Participants in the June 2005 Invitational Workshop The Coordinating Committee recognized the need for some form of accreditation for research involving humans by an independent body, while at the same time declaring it premature to suggest the form or identity of such a body. Health Canada agreed to take a lead in developing a national approach to accreditation and bring together the parallel tracks initiated by NCEHR and Health Canada in this area From a letter from Dr Marc Renaud, Chair of the Coordinating Committee, to NCEHR, April 2, 2001. HRP and Research Ethics training are crucial for graduate students. Education opportunities in both Research Ethics and HRP are inconsistent in terms of necessity, variety, content and duration. From a presentation to NCEHR Council by Jeremy Shragge, President, Graduate Students Association of Canada. The educational component of accreditation is crucial. An accreditation process does far more than simply compare the practices of an institution with a check list of standards. An important objective of the process is inducing a culture within the institution so that all levels are aware of and respectful of their responsibilities toward those who are participants or subjects of research. The educational process is continuous and involves more than simple familiarity with the guidelines policies and regulations governing research with humans.) Names are important. The Task Force has recognised that while some researchers prefer to use the term participant to describe the persons who are the subject of research, others find that term unacceptable for their methodology, and use subject. We have used the terms interchangeably throughout this report, but, partly to recognise the different approaches we have changed the name of the programs seeking accreditation to Programs Ensuring Ethical Research with Humans (PEERH) Accreditation: Educational; Voluntary; Transparent; Accountable; Based on peer review; Involves the public and those researched; Based on standards; Considers PEERH of entire organisation; Arms-length-from-government; National; Conferred for a specified term. The requirement for multiple reviews is one of the most common complaints from researchers. While the necessity for two reviews is common, on occasion many more organisations are involved. Professor Paul Grayson has documented his difficulties in obtaining ethics approval from different REBs for a survey research project involving university students. These difficulties have been documented in a letter in University Affairs and an article in the Journal of Academic Ethics. (see end-notes 10 and 11). The Quebec DHSS has addressed this question (end note 12) In one site visit, NCEHR heard from a researcher conducting research at accident sites whose protocols required review by REBs from 13 different hospitals. Benefits of Accreditation Increased confidence in system for participants and subjects Researchers will find greater consistency in REBs, and will continue to enjoy confidence of subjects and the public. Organisations have standards to embrace and will reduce risk. Sponsors will have increased confidence that research adheres to high ethical standards. Economic activity flowing from research with humans supported and protected.  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