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 individual interpretation questions  135 so far in 2013  144 in 2012 Questions that raise new issues or suggest policy revisions are discussed by PRE Responses to questions of general interest vetted 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 enhance understanding and consistency in applying TCPS 2 To inform the need for revisions to TCPS 2  interpretation requests help identify recurrent issues or gaps in guidance To better direct TCPS 2 educational initiatives to issues of relevance to the research community

5. What is multi-jurisdictional research? –Involves multiple REBs and/or institutions with jurisdiction over the research Question 5 posted under Governance 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? Hot Topic: Multi-jurisdictional Research

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

7. 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 Hot Topic: Research vs Non-research activities

8. 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 Hot Topic: Research vs Non-research activities Key determining factor: Intended purpose of the undertaking

9. Posted interpretations – under ‘Scope’ 7.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 Hot Topic: Research vs Non-research activities

10. Posted interpretations – under ‘Scope’ 8.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. Hot Topic: Research vs Non-research activities

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 M étis communities? 2 nd most frequent question: When is community engagement required and to what extent?

12. Question 1 posted under Research Involving FNIM 1.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. Hot Topic: Community Engagement

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