Office of Research Ethics Simon Fraser University Office of Research Ethics Director Hal Weinberg. 778 782 6593 Ethics Officer Barb Ralph 778 782 3447 Ethics Assistant Janet Yule 778 782 5719 Ethics Office Assistant 778 782 5236 Balancing Research With Ethical Considerations http://www.sfu.ca/vpresearch/ethics/
R.E.B firstname.lastname@example.org Office of Research Ethics Simon Fraser University Review Procedures Electronic Copy Application Minimal Risk Non Minimal Risk Medical Review Modifications DORE Miminal Risk Approvals No Approval Monthly Report on DORE approvals of Minimal Risk Approval U. Victoria Appeal on Procedure No Approval
Office of Research Ethics Simon Fraser University Research Ethics Appeal Board Researchers have the right to request, and the REB has an obligation to provide, a reconsideration of a negative decision. Researchers may appeal decisions of the Research REB to the Research Ethics Appeal Board within 15 working days. The Research Ethics Appeal Board will be the University of Victoria's Human Research Ethics Committee (HREC). The decisions of the HREC shall be final and binding in all respects for any appeal lodged against a decision of the REB.
Office of Research Ethics Simon Fraser University New On-Line Application Forms
Office of Research Ethics Simon Fraser University New On-Line Application Forms
Office of Research Ethics Simon Fraser University New On-Line Application Forms New Study and Protocol Development
Office of Research Ethics Simon Fraser University New On-Line Application Forms Main Information Page
Office of Research Ethics Simon Fraser University New On-Line Application Forms Two Primary Documents to Upload in pdf Format
Office of Research Ethics Simon Fraser University New On-Line Application Forms The Check List
Office of Research Ethics Simon Fraser University New On-Line Application Forms Help Files
Office of Research Ethics Simon Fraser University New On-Line Application Forms Polices and Templates of the REB and TCP
Office of Research Ethics Simon Fraser University New On-Line Application Forms Two Critical Documents That Must Be Uploaded as PDF Study Details and Consent Document(s)
Office of Research Ethics Simon Fraser University New On-Line Application Forms Help For What Must Be Included in Consent Document
Office of Research Ethics Simon Fraser University Research Ethics Board 8 faculty members elected by faculty, with one from each of the Faculties of Applied Sciences, Business Administration, Education, Science, Health Sciences, Faculty of Communication, Art and Technology, and two from the Faculty of Arts and Social Sciences; At least 2 members to be elected by Senate, from the university community at large (these may include faculty and staff); 1 student member and one alternate to be elected by Senate; 2 members elected by Senate, from the community outside of the university; Every two years, Senate will approve a list of individuals with medical degrees and/or law degrees qualified to serve on the REB
Office of Research Ethics Simon Fraser University Research Ethics Board The REB will normally meet at least once per month with no more than six weeks between meetings, unless there is no business to transact. Policy or procedural matters will be discussed at the open session of the meeting; ethics applications will be discussed in the closed session A quorum of the REB for meetings at which applications involving non-minimal risk will be considered, is the Chair or Deputy Chair plus six of the voting members (i.e., seven in total). The REB has the authority to establish its own procedures and internal policies that do not conflict with those established by Senate and to make recommendations to Senate for revisions to the Policy.
Office of Research Ethics Simon Fraser University Members of Research Ethics Board Director Office of Research Ethics (ex-officio, non-voting) Faculty Members: Dr. Simon Verdun-Jones (Chair), Arts and Social Sciences Dr. Ted Kirkpatrick, Applied Sciences Dr. Haumei Han, EducationDr. Jerry Sheppard, Business Administration Dr. Denise Zabkiewicz, Health Sciences Dr. Mary-Ellen Kelm - Arts & Social Sciences Dr. Robert Young, Science (Vacant) Communication, Arts @ Technology University Community at Large: Dr. Kim Bartholomew, Psychology Ms. Bergen Butterfield, Student Ms. Trisha Patidar, Student University Student Member: Mr. Sean Robertson, Student Representative Ms. Risha Patidar, Student Alternate Representative Community Members from Outside the University:Ms. Margit Nance, Deputy ChairDr. Laurence Turner, M.D.
Office of Research Ethics Simon Fraser University Policy R20.01 This Policy provides a mechanism for ethics review of research involving human subjects to protect those subjects, researchers, support staff, students, and third parties, and to educate those involved in this type of research. Its procedures are consistent with the educational and research mandates of Simon Fraser University and respect the academic freedom and responsibilities of faculty members and the principle of informed consent with respect to potential participants. No more than three years after the implementation of this Policy, and no more than every five years thereafter, Senate will undertake a review of the Policy and Procedures for Ethics Review of Research Involving Human Subjects, and make amendments should they be deemed necessary.
Office of Research Ethics Simon Fraser University Requirements for Ethics Review Research involving living human participants occurs when data are derived from: Information that is collected through intervention or interaction with a living individual (e.g., interviews, questionnaires, observations taken that are noticeable by the individual); Secondary sources/non-public sources (e.g., interviews about a living individual, company personnel records, student records collected by an educational institution); Identifiable private information about a living individual. All research involving human participants that proposes the systematic, controlled, empirical and objective inquiry into natural phenomena using currently accepted investigation procedures, the immediate product of which is evidence, with the objective of discovering how that aspect of the physical world works, requires ethics approval. Research that utilizes human tissue may require review and approval by the Research Ethics Board before research is started. Research involving identifiable human remains, identifiable cadavers, primary tissue cultures, biological fluids, embryos, or foetuses must be reviewed by the Research Ethics Board.
Office of Research Ethics Simon Fraser University Requirements for Ethics Review Primary Tissue Cultures which are the mixture of cells that grow out of or from tissue samples taken from participants placed into culture; Secondary Tissue Cultures which are derived from cells in Primary Tissue Culture by serial passages and dilution, often leading to clonally derived lines of cells having relatively uniform properties that have adapted to growth in tissue culture. REB approval is not required for the use of human secondary tissue cultures(providing appropriate ethical approval was obtained for creation of the primary culture) nor for the use of established cell lines; . Biological Fluids which are fluids of human origin including blood, mucus, perspiration, saliva, semen, vaginal fluid, and urine. DNA collection and analysis
Office of Research Ethics Simon Fraser University Requirements for Ethics Review Exclusions Research by Adjunct Faculty that are not carried out under the auspices of SFU Research in the public domain about a living individual, based exclusively on publicly available information, documents, records, works, performances, actuarial materials, or third party interviews, is not required to undergo research ethics review. However, such research requires ethics review if the individual is approached directly for interviews or for access to private papers. The ‘public domain’ includes all information that is available under FOI (Freedom of Information) legislation in British Columbia and Canada, whether or not the information has been exposed to the public. All course-based research assignments involving living human subjects, including Directed Studies require ethics review and approval.
Office of Research Ethics Simon Fraser University Exclusions Research conducted by a member of the academic staff as an Outside Professional Activity as long as the research data are not collected by asserting connection or affiliation with Simon Fraser University, and the results are not disseminated in the public domain indicating association with Simon Fraser University. Research on public policy issues, public institutions, and other matters that in a free and democratic society can properly be considered as part of the public domain is not required to undergo ethics review, even when interviews with individuals occupying positions connected to such matters are involved. Public policy is defined as follows: Research protocols that require contact with human participants as part of the study and whose regular occupational duties involve communicating with the public on behalf of their organizations do not require ethics review, Research protocols in which inquiries are referred to other members of an organization by a public-relations officer, official spokesperson, etc., of the organization, do not require ethics review. Research on ancient unidentifiable human remains
Office of Research Ethics Simon Fraser University Informed Consent A mandatory condition of approval from the Research Ethics Board is that participants, or authorized third parties, have given informed consent about participation in the research. Normally, all communication with research participants will be in writing, unless circumstances of the research prevent this. The Research Ethics Board must approve methods of communication which are not in written form for all non-minimal risk projects. The Director of the Office of Research Ethics is authorised to approve methods of consent for Minimal Risk studies. The Board reviews and may amend decisions made independently by the Director, Chair or Deputy Chair, at their regular monthly meetings.
Office of Research Ethics Simon Fraser University Informed Consent Documents Should Include a) information that the participant is being invited to participate in a research project. b) an understandable description of the research, the identity and institutional affiliation of the researcher, contact information, the duration, the nature of participation, and a description of research procedures, c) an understandable description of reasonably foreseeable harms and benefits that may result from participation as a research participant. In research which involves treatment procedures, this description must include an assessment of potential harms and benefits of not undertaking the treatment.
Office of Research Ethics Simon Fraser University Informed Consent Documents Should Include d) an assurance that subjects are free to avoid participation or to withdraw from participation at any time. e) an understandable description of the type(s) of data to be collected, the method(s) of data collection (e.g. interview, video recording), the purpose(s) for which the data will be used, and limits on the use, disclosure and retention of data. f) anticipated secondary uses of identifiable data collected during the research, and anticipated linkages of data with other data about research subjects. g) methods for data archiving, and provisions for ensuring security and confidentiality of data.
Office of Research Ethics Simon Fraser University Informed Consent Participants who are not Legally Competent a) free and informed consent will be obtained from authorised representatives. b) research is in the "minimal risk" category, or has the potential to provide distinct benefits to the research participant. c) the researcher can show how the participans best interest will be protected. d) provision must be made for participants who are legally incompetent to express their opinions about participation in the research; dissent on the part of a research participant must preclude further participation in the research, regardless of his/her legal competency.
Office of Research Ethics Simon Fraser University Researchers' Procedural Responsibilities In supervised research, the term "researcher" is defined as including both the supervisor and the individual(s) being supervised. When a graduate or undergraduate student is shown as the principal investigator on an application, the supervisor of the student is always the co-investigator. It is the responsibility of researchers to obtain ethical approval as described in this policy for any project, funded or not, involving human subjects before commencing the research. It is the responsibility of researchers to ensure that there is adequate lead time available for ethical review in relation to other deadlines. Project funds will not be released by the University to the project principals until ethics approval for the project has been obtained and a copy of the approval is on file in the Office of Research Services.
Office of Research Ethics Simon Fraser University Risk Analysis (a) minimal risk, which occurs when potential participants can reasonably be expected to regard the probability and magnitude of possible harms incurred by participating in the research to be no greater than those encountered by the participant in those aspects of his or her everyday life; (b) non-minimal risk, which includes applications not covered by a) above. .
Office of Research Ethics Simon Fraser University Database Data If a database is used by an investigator as secondary data, and the use of that data is not consistent with the use to which the participant consented, explicitly or implicitly, or if the information to the participant at the time of consent did not inform the participant that the data may be used for other purposes in the future than the use for which they consented, then the data must be anonymous and published in an aggregate form and no attempt must be made to contact the original providers of the data. Database Data of Communities If the data relate to identifiable communities the REB must, on a case-by-case basis, determine if the risk to communities justifies the use of the data without approval of those communities. Participants must be informed of the methods for data archiving, and provisions for ensuring security and confidentiality of data.
Office of Research Ethics Simon Fraser University Research Ethics Appeal Board Appeals may only be heard on the basis of a procedural error that materially and adversely influenced the decision of the REB, including real or reasonably apprehended bias, including epistemological bias, or undeclared conflict-of-interest on the part of one or more members of the Research Ethics Board. The Research Ethics Appeal Board will first determine whether a procedural error, bias or a conflict of interest (as described above) occurred, and if so, the REB would then determine whether to amend the procedures used based on the recommendations of the appeal body and make a final determination on the research proposal.
Office of Research Ethics Simon Fraser University Director of the Office of Research Ethics The duties and responsibilities of the Director of the Office of Research Ethics include, but are not limited to: a) being responsible for research ethics education programs at Simon Fraser University in conjunction with the Research Ethics Board. b) assisting researchers in the preparation of applications for submission to the Research Ethics Board c) reviewing all applications submitted to the Research Ethics Board for the completeness of these applications and their compliance with this Policy. d) advising the Research Ethics Board with respect to the category of risk (i.e., minimal, in-course student, or non-minimal) of an application. e) approving minimal risk applications, and providing summaries of such approvals to the Research Ethics Board. f) acting in an ex officio non-voting capacity as Secretary to the Research Ethics Board. g) managing the Office of Research Ethics. h) undertaking other duties assigned by the Research Ethics Board, such as monitoring, data collection, and communication with other universities and granting councils.
Office of Research Ethics Simon Fraser University Research Ethics Board The Research Ethics Board is responsible for responding to inquiries from external agencies with responsibility to monitor ethics review procedures at universities. The Research Ethics Board is responsible for ensuring that the research community at Simon Fraser University is aware of the principles and practices of ethical conduct of research and for publicizing issues that will lead to changes in its current review process. The Research Ethics Board provides an annual report of its activities in the previous year to Senate.
Office of Research Ethics Simon Fraser University Internal Policies A department wishing to offer an undergraduate or graduate course that requires or allows students to participate in research projects involving human subjects will submit an application for course approval with the exception of a thesis, honours thesis, dissertation and directed studies. These will be dealt with under the normal avenues of the REB. The REB considers the student researcher of every thesis conducted at Simon Fraser University to be the Principal Investigator of the thesis project. All projects in Directed Studies courses, involving human subjects, must be submitted for individual review each time the course is offered. The interpretation of ‘public domain’ includes all information that is subject to FOI (Freedom of Information) provincial, federal and SFU policy, whether or not the information has been exposed to the public. If students are approached or tested on school grounds, permission of the school district is required.
Office of Research Ethics Simon Fraser University Internal Policies Signed consent forms do not have to be used in all circumstances. If the researcher proposes to not use a signed consent form the application should include an explanation of why. When written or other forms of documented consent is acquired as part of the research protocol, it is the responsibility of the researcher to maintain those records for a period of 1 year after the research has been completed, and it is the responsibility of the supervisor to ensure this for graduate student or undergraduate student research. The DORE is authorized to approve non-written consent procedures in minimal risk applications
Office of Research Ethics Simon Fraser University Internal Policies For minimal risk protocols only, persons greater than or equal to 16 years of age and less than 19 years of age may in some circumstances consent to participate as a research subject in the absence of parental consent, subject to specific approval by the REB in that instance. Persons under the age of 16 may not participate as research subjects in either minimal or non-minimal risk protocols, without parental consent. Persons greater than or equal to 19 years of age are considered adults and may consent to participate as research subjects in both non-minimal and minimal risk protocols. All persons registered at SFU as students are considered adults. The DORE will evaluate all research that proposes to use the internet in accordance with the five requirements below, with respect to the level of risk: a) The method of giving informed consent; b) The method of communicating data between respondent and researcher; c) The method of storing data; d) Who will be able to legitimately access the data and why? e) How were the names and email addresses of the potential respondents collected.
Office of Research Ethics Simon Fraser University Internal Policies ‘Public Policy’ is defined as follows: a) Research protocols that require contact with human participants in the study, whose regular occupational duties involve communicating with the public on behalf of their organizations (such as public relations officers, official spokespeople, diplomatic officials, freedom of information officers, archivists, etc. or the Chief Executive of an organization) do not require ethics review, to the degree that answering questions posed by the public are within the ordinary occupational duties of the subject. b) Researchers whose inquiries are referred to other members of an organization by a public relations officer, official spokesperson, etc. for the organization does not require ethics review, to the degree that their inquiries are in keeping with the initial protocol and the substance of the interviews are attributable. c) As per the Tri-Council Panel on Research Ethics recommendation, interviews with elected officials are exempt from ethics review to the degree that such interviews are part of their ordinary obligations to communicate with the public. The same exemptions apply to declared candidates for public office.
Office of Research Ethics Simon Fraser University Internal Policies Applications that are considered by the Director of the Office of Research Ethics to utilize or involve medical procedures, or which may have medical implications, will be sent to the Director, Office of Research Ethics (DORE) with a request that the DORE ask one of the persons shown below, or others at the applicant’s discretion, who is a licensed MD to: Designate the protocol as Minimal Risk, or Designate the protocol as Non-Minimal Risk, or Designate the protocol as one that needs external or internal review, and suggest who might be approached to do the review. The researcher must confirms that the equipment used in the protocol of the.application for Ethics Approval for human research has been certified by CSA or other acceptable national or international agencies, and meets Medical Devices Regulations. If the equipment has not been certified as safe or the PI does not know if the equipment has certification the researcher must contact the Environmental Health and Safety (EHS) Office and DORE for guidance on the certification and approval process Application.
Office of Research Ethics Simon Fraser University Internal Policies Approval of Assistants to Amend Projects. Background: Several Faculty who are the PI for many approved projects have assigned assistants to administer the project, and to insure compliance with provisions of the approval. These faculty are frequently in transit to international conferences or have obligations that make it difficult for them to respond to requests by the ORE for approval of minor changes to the protocol of minimal-risk studies. In several cases it is critical that the amendments be approved expeditiously. Therefore: The PI be authorized to approve the authority of 'Assistants' to the PI who may request minimal-risk amendments to a minimal-risk study. Minimal-risk amendments to minimal-risk studies, requested by the Assistants, and approved by the DORE, be sent to the PI by email as notification. Implementation of the amendments can begin without prior approval of the PI. Letters by the PI authorizing (2) will be included in the file of the project and reported to the REB as information at their monthly meetings
Office of Research Ethics Simon Fraser University British Columbia Legislation The Personal Information Protection Act (PIPA) sets out how B.C. organizations, including corporations, sole-proprietorships, partnerships and non-profit organizations, may collect, use and disclose personal information about individuals (including administration in teaching organizations, and spin-off companies). The Freedom of Information and Protection of Privacy Act (FOIPPA) creates specific information and privacy rights regarding information that is collected or controlled by public bodies in B.C.
Office of Research Ethics Simon Fraser University FOIPPA Accountability: An organization is responsible for personal information under its control and shall designate an individual or individuals who are accountable for the organization's compliance with the following principles. Identifying Purposes: The purposes for which personalinformation is collected shall be identified by the organization at or before the time the information is collected. Consent: The knowledge and consent of the individual are required for the collection, use or disclosure of personal information, except when inappropriate. Personal Information Protection and Electronic Documents Act (PIPEDA). Applies to the collection, use and disclosure of personal information related to the operations of a federal work, undertaking or business (e.g., banks, airlines, telecommunications companies). Since 2002, universities performing human subject research must comply with the Personal Information Protection and Electronic Documents Act (PIPEDA).
Office of Research Ethics Simon Fraser University FOIPPA Limiting Collection: The collection of personal information shall be limited to that which is necessary for the purposes identified by the organization. Information shall be collected by fair and lawful means. Limiting Use, Disclosure, and Retention: Personal information shall not be used or disclosed for purposes other than those for which it was collected, except with the consent of the individual or as required by the law. Personal information shall be retained only as long as necessary for fulfilment of those purposes. Accuracy: Personal information shall be as accurate, complete, and up-to-date as is necessary for the purposes for which it is to be used. Safeguards: Personal information shall be protected by security safeguards appropriate to the sensitivity of the information. Openness: An organization shall make readily available to individuals specific information about its policies and practices relating to the management of personal information. Individual Access: Upon request, an individual shall be informed of the existence, use and disclosure of his or her personal information and shall be given access to that information. An individual shall be able to challenge the accuracy and completeness of the information and have it amended as appropriate.
Office of Research Ethics Simon Fraser University FOIPPA Challenging Compliance: An individual shall be able to address a challenge concerning compliance with the above principles to the designated individual or individuals for the organization's compliance. Exemptions: Personal information collected, used or disclosed solely for journalistic, artistic or literary purposes or permission could infringe on the information’s accuracy where such data can contribute to a legal investigation or aid in an emergency where peoples lives and safety could be at stake and if disclosure aids, in times of emergency, matters of legal investigation, or facilitates the conservation of historically important records.
Office of Research Ethics Simon Fraser University What is the US Patriot Act? Summary of Critical Provisions • Gives government the power to access any data base, personal, business, political and social without a court order including: • Includes medical records, tax records and • books purchased, financial records, • membership in clubs or societies, use of Internet • Includes the power to break into a home and conduct secret searches without telling the resident for weeks, months, or indefinitely. • Prohibits anyone from disclosing to anyone that the information has been accessed.