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

• 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

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

• 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

Hot Topic: Multi-jurisdictional Research

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)

• 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

• 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

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

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

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?

Question 1 posted under Research Involving FNIM1.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

Questions & Answers

Education resources

• On-line tutorial • Webinars • Interpretation service

Please get in touch

PANEL ON RESEARCH ETHICS

350 Albert StreetOttawa, ON K1A 1H5

Tel.: 613 996-0072

secretariat@rcr.ethics.gc.ca

www.pre.ethics.gc.ca