Engineers Applying for Ethics ApprovalDaniel Shapiro

Computer Architecture Research Group (carg.site.uottawa.ca)http://site.uottawa.ca/~dshap092

Source Material: http://www.research.uottawa.ca/ethics/

Overview

• Why Ethics?• REB• ORM• TTBE• Ethics Application Procedures• Example

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Why Ethics?

• Are you planning on testing on humans?• Testing with dangerous materials or tools?• Get ethics approval. It is not optional.• e.g. http://rfip.ca

REB - Research Ethics Board

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REB: Research Involving Humans (1)

• POLICY– To set the policies of the University of Ottawa in matters relating to the

ethics approval of research involving human participants in accordance with the Tri-Council Policy Statement.

• CONSULTATION– To be available for consultation by researchers and individuals or interested

groups within the university community.• ETHICS EDUCATION

– To undertake an educational function on ethical matters related to the conduct of research with human participants within the university community.

• PROJECT APPROVAL/REJECTION– To examine research projects for adjudication and to issue ethics approval

to projects meeting ethical standards.

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REB: Research Involving Humans (2)

• ANNUAL STATUS REPORTS BY PIs– To examine annual status reports for ongoing projects and

grant or refuse extension of ethics approval for such projects.• REVIEW POLICIES

– To review policies and procedures at timely intervals to ensure that research projects evaluation respect the principles established by the Tri-Council Policy Statement.

• APPEALS BOARD– The Appeal Board reviews cases in which the decision of a

REB is being contested and confirms or modifies the REB's decision after consultation with this REB.

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REB Appointment of Members• Each member of the ethics committee is appointed by the Vice-

President for Research Mona Nemer.• REB is made up of professors + student representatives• Professors:

– The mandate is a two-year period, renewable once, with the terms staggered to maintain continuity.

– During the transition period, some members will be appointed for a three-year term to maintain continuity.

• Students: – Observation and training before the beginning of the mandate. Mandate is

one-year, renewable twice.• The Vice-President (Research) may appoint substitute members so

that REB activities are not paralyzed by any unforeseen eventualities.

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REB for Engineers• Engineers are governed by the Health Sciences and Science Research Ethics Board• 11 voting members:

– At least 6 professors familiar with the research methods & disciplines relevant to the REB. Of these, there are at least 2 from each faculty: Engineering, Science, and Health Sciences

– 1 is a graduate student– 1 is a physician or someone with a strong background in physiology– 1 other member is recruited from the community, or within the University of Ottawa or its affiliated

organizations– 2 must be from the community served by the University of Ottawa while having no affiliation with it– At least 1 must be a lawyer or have a legal background, and – At least 1 must be an ethics expert

• Each REB is presided by a faculty member from a discipline not represented on the REB, or by a member of the community.

• The Chair is a non-voting member of the REB.• The Protocol Officer for Ethics in Research acts as the Secretary of each REB. • The Secretary is a non-voting member of the REB.

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Health Sciences and Science Research Ethics Board Members

Non-voting members: 1. Chair: Daniel Lagarec, Department of Geography 2. Secretary: Germain Zongo, Protocol Officer for Ethics in Research (also see Leslie-Anne

Barber) Voting members: 3. Xudong Cao, Department of Chemical Engineering, Faculty of Engineering4. Riadh Habash, School of Information Technology and Engineering, Faculty of Engineering 5. Douglas Johnson, Department of Biology, Faculty of Science6. Empty chair, Faculty of Science 7. Gordon Roberston, School of Human Kinetics, Faculty of Health Sciences

Hélène Laperrière, School of Nursing, Faculty of Health Sciences8. Stephanie MacKay, School of Nursing, Student Representative9. Mark Audcent, Community member 10. Patrick Bedford, Community member11. Muriel Paradelle, Legal Expert

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REB Procedures (1)• POLICY

– The REBs and the Appeal Board operate under the policies and guidelines established by the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans adopted in August 1998.

• OUTSIDE ADVICE– By the council: The REBs and the Appeal Board may seek the advice of the University of Ottawa Legal

Counsel. It may also consult any member of the University whose knowledge and expertise could assist in its deliberations.

– By the applicant: The REBs and the Appeal Board may seek the opinion of persons not employed by the University. Such consultations may be requested by a Board or by an applicant for ethics approval.

• APPLICANT ATTENDANCE / MEET THE REB– The REBs or the Appeal Board may request an applicant's attendance at its meeting prior to making a

decision about a research project. Similarly, an applicant may request to meet with the REB or the Appeal Board at the meeting where the applicant's project is discussed. Such requests should be addressed to the Chair of the appropriate Board prior to the meeting.

• APPLICANT CLARIFICATION– If an applicant attends a REB or Appeal Board meeting, the board members will discuss the project and

issues first, and then invite the applicant to clarify issues identified by the Board members or to make a presentation about the project.

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REB Procedures (2)• MONITORING

– Monitoring of all ongoing research projects involving human participants will be the responsibility of the REB which initially assessed the project. Continuation of approval will be based on the annual status report submitted by the principal investigator or student supervisor or on a method deemed appropriate by the REB when it initially evaluated a specific project.

• RECORDS– The Protocol officer for ethics in research keeps the minutes of the meetings of the REB and

the Appeal Board and of all files for which a final decision has been taken– The Chair of each REB and of the Appeal Board must provide an annual report to the Vice-

President (Research) and to the members of their Board.

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REB Resources

• http://www.research.uottawa.ca/ethics/links.html

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ORM - Office of Risk Management

• ORM can do research for you on what is safe and what is not.

• ORM can contact other universities, and consultants, to get more information on a safety issue.

• ORM has databases for you to search, training courses, and consultants.

• Contact: http://www.uottawa.ca/services/ehss/contacts.htm

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TTBE - Technology Transfer and Business Enterprise

• Your funding and relationship with TTBE can have a direct impact on the way you write an ethics application.

• NSERC, OCE, I2I, private funding, all can be held back by TTBE until your study passes through the ethics committee.

• Therefore maybe your first study should be designed to pass through the ethics committee, even if it does not make all of the observations that you wanted.

• The “missing” observations can be done in follow-up studies filed with REB as extensions of the approved ethics project.

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Ethics Application Procedures

Ethics Forms (click me!):– http://www.research.uottawa.ca/ethics/forms.html

Consent Forms (rules and template):– http://www.research.uottawa.ca/ethics/consent.html– Review Process (deadlines, # copies to submit, time for evaluation):– http://www.research.uottawa.ca/ethics/review.html

Guidelines(lots of stuff, no regulations for clinical trial using devices, random 5%-10% audits):– http://www.research.uottawa.ca/ethics/guidelines.html

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Example: NEAR Ethics Application• Review types: Expedited, delegated, full board

– Ethics_screening_tool_list_E.pdf• Review decisions

(http://www.research.uottawa.ca/ethics/approvals.html):– Approval– Approval for initial stage only – Delayed approval– Decision deferred – Not approved

• Application Checklist: App_checklist_2010.pdf

• 1st application: 1st_application_form.pdf • 2nd application: 2nd_application_form.pdf

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Questions?