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TCPS 2 Guidance: Interpretations R Us

TCPS 2 Guidance: Interpretations R Us. Laura-Lee Balkwill, PhD, Policy Analyst Secretariat on Responsible Conduct of Research. CAREB Atlantic - Fredericton November, 2013. Agenda. TCPS 2 interpretation service Hot topics Q & A. TCPS 2 Interpretation Service.

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TCPS 2 Guidance: Interpretations R Us

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  1. TCPS 2 Guidance: Interpretations R Us Laura-Lee Balkwill, PhD, Policy Analyst Secretariat on Responsible Conduct of Research CAREB Atlantic - Fredericton November, 2013

  2. Agenda • TCPS 2 interpretation service • Hot topics • Q & A

  3. TCPS 2 Interpretation Service • SRCR responds to individualinterpretation questions • 135 so far in 2013 • 144 in 2012 • Questions thatraise new issues or suggestpolicyrevisions are discussed by PRE • Responses to questions of generalinterestvetted by PRE and published on PRE website • 35 entries and growing Note: PRE/SRCR cannot serve as an appeal body for specific REB decisions

  4. Objectives of Interpretation Service • To enhanceunderstanding and consistency in applying TCPS 2 • To inform the need for revisions to TCPS 2 • interpretationrequests help identifyrecurrent issues or gaps in guidance • To better direct TCPS 2 educational initiatives to issues of relevance to the researchcommunity

  5. Hot Topic: Multi-jurisdictional Research • Whatis multi-jurisdictionalresearch? • Involves multiple REBs and/or institutions withjurisdiction over the research • Question 5 postedunderGovernance If a researcher obtains REB approval at his/her own institution to gather data from participants who are members of other institutions, is it necessary to obtain REB approval at each of the other institutions that employ the participating members?

  6. Hot Topic: Multi-jurisdictional Research Considerations for each institution: 1 or more researchers affiliated with the institution Research approved by an REB covered by a reciprocal or delegated review agreement Delegated or reciprocal review is possible (but consider local participant issues) The research is within the jurisdiction of the institution = REB Review Institution resources needed for recruitment Institution resources needed for data collection

  7. Hot Topic: Research vs Non-research activities • Is it research? • an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation • Does it involve human participants? • individuals whose data, or responses to interventions, stimuli … are relevant to answering the research question • Research and non-research activities confusion: • When activities and research employ similar methods and techniques • When participants are recruited for a dual purpose

  8. Hot Topic: Research vs Non-research activities • Is it research? • an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation • Does it involve human participants? • individuals whose data, or responses to interventions, stimuli … are relevant to answering the research question • Research and non-research activities confusion: • When activities and research employ similar methods and techniques • When participants are recruited for a dual purpose Key determining factor: Intended purpose of the undertaking

  9. Hot Topic: Research vs Non-research activities Posted interpretations – under ‘Scope’ • Does publishing the results of a quality assurance study in a journal determine whether it is research, and whether it requires REB review?   Example: • An evaluation of an administrative approach to improving hospital staff morale following a series of challenging events. • The hospital administration publishes the results in a quality assurance journal to show how the approach helped improve staff morale

  10. Hot Topic: Research vs Non-research activities Posted interpretations – under ‘Scope’ • Is it ethically acceptable to recruit participants for a dual purpose: a quality improvement study and research?  Example • An independent survey company asks post-secondary institutions to administer a student well-being questionnaire to their student population. • The institutions intend to use the results for quality assurance and evaluation of their student outreach programs. • The company intends to pool the data from all of the institutions to answer specific research questions about factors that affect student well-being.

  11. Hot Topic: Community Engagement Most frequent question: Why does the guidance in chapter 9 (particularly the guidance on community engagement) apply only to First Nations, Inuit, and Métis communities? 2nd most frequent question: When is community engagement required and to what extent?

  12. Hot Topic: Community Engagement Question 1 postedunder Research InvolvingFNIM • Can guidance in Chapter 9 for research involving FNIM peoples also apply to other communities? (March 2012) Chapter 9: • acknowledges the unique status of the Aboriginal peoples of Canada • was designed to guide research involving those communities • may also be an important source of guidance for research involving other distinct communities. Therefore: • Research ethics boards and researchers can apply the articles of Chapter 9 that are relevant to the particular community involved in the research.

  13. Questions & Answers

  14. Education resources • On-line tutorial • Webinars • Interpretation service

  15. Please get in touch PANEL ON RESEARCH ETHICS 350 Albert Street Ottawa, ON K1A 1H5 Tel.: 613 996-0072 secretariat@rcr.ethics.gc.ca www.pre.ethics.gc.ca

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