Category Archives: Research Ethics

TCPS 2 (2014) – Revisions for Public Consultation

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In keeping with its mandate to ensure that the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans is a living document, the Panel on Research Ethics is proposing revisions to TCPS 2 (2014). These proposed revisions are the result, in large part, of the work of two sub-committees of the Panel. The Chapter 11 sub-committee was mandated to review the scope of Chapter 11 – Clinical Trials and to update its guidance. Assistance on the implication of the proposed broader scope was provided by a group of social sciences researchers whose work would be covered under the proposed revisions.

The Population and Public Health Research Advisory Committee (PPHRAC) was established by the Panel in response to comments received from public health and epidemiology researchers in the course of consultations on TCPS 2 in 2010. PPHRAC considered how the guidance in TCPS 2 could be enhanced or adapted to address ethics issues specific to population and public health research.

In addition to the proposals generated by these groups, the Panel is also presenting revisions based on requests for interpretation of TCPS 2 that it has received over the last two years. Finally, some of the proposed changes involved re-organizing parts of the guidance based on changes to Chapter 11. In particular, a number of provisions were moved to the earlier chapters of TCPS 2 where general guidance is provided. A guide to the recommendations is provided in Highlights of Changes.

Comment Submissions

To promote the transparency of this public engagement process, the Panel requests that you include your name and the following demographics with your submission:
1. Province or territory
2. Affiliation: university, hospital, college, community organization, other
3. Capacity in which you are submitting the comments: REB member, researcher, student, administration, research participant, representative of a group or organization.
4. Your main discipline: Behavioural Sciences, Biomedical, Engineering, Health Sciences, Humanities, Interdisciplinary, Natural Sciences, Social Sciences, other.

All comments received (including identifiable information) will be posted to the Panel’s website after the closing of the comment period. If you do not wish to have your comments posted, please indicate that clearly at the beginning of your submission.

Please e-mail your comments by January 31, 2017 or mail them to:
E-mail: secretariat@rcr.ethics.gc.ca
Secretariat on Responsible Conduct of Research
16th Floor Mailroom
350 Albert Street
Ottawa, ON K1A 1H5

The TCPS was developed in 1998 by the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or “the Agencies,” to provide harmonized guidance on the ethical conduct of research involving humans. The Agencies formed the Panel in 2001 to interpret and promote the TCPS.

New TCPS2 Educational Resources – Available Fall 2016

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The Panel on Research Ethics and the Secretariat on Responsible Conduct of Research are creating new educational resources in support of TCPS 2 (2014). Reference: http://www.pre.ethics.gc.ca/eng/resources-ressources/news-nouvelles/nr-cp/2015-12-22/

Education — The TCPS 2 tutorial, Course on Research Ethics (CORE), provides an applied approach to guidance on TCPS 2. It features interactive exercises and multi-disciplinary examples in a media-rich format. An update to CORE is being developed, and it will incorporate policy revisions introduced in TCPS 2 (2014). It is expected to launch in late fall 2016. CORE will be further enhanced by the addition of two new modules: Multi-Jurisdictional Research, and Research Involving the First Nations, Inuit and Métis Peoples of Canada. Both modules will be posted in PDF format until the launch of the revised CORE tutorial.

Interpretations
As part of its ongoing interpretation service, the Secretariat continues to respond to individual requests. A new set of TCPS interpretations will be posted in January 2016.

Evolution
TCPS is revised periodically in order to provide relevant guidance that keeps pace with emerging ethical issues. TCPS 2 was revised in December 2014, and work continues on areas such as population and public health, clinical trials, material incidental findings, and the appropriate review of cell line research.

The Secretariat continues to support two Panels – the Panel on Research Ethics (PRE) and the Panel on Responsible Conduct of Research (PRCR). For additional information on either panel, new educational resources, or further revisions to TCPS 2 and the RCR Framework, please contact:

Secretariat on Responsible Conduct of Research
350 Albert Street
Ottawa, ON K1A 1H5 Canada

 

 

image source: cohdra, morguefile

Western TSC Learning Session–Research Ethics from a Research on Teaching and Learning Perspective

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In this session, Research Ethics from a Research on Teaching and Learning Perspective, Grace Kelly (Western Ethics Officer – Non-Medical REB & Health Sciences REB Delegated) will discuss common research ethics issues that arise for faculty members who do research on their teaching and ways that you can best address these issues before submitting your ethics protocol. She will also outline recent changes to Western’s REB processes and how they will effect your submissions. Please join us for this discussion of ethical issues in research on teaching and learning.

Monday, October 19, 2015
10:30 am – 12:00 pm
Teaching Support Centre, Room 122, The D.B. Weldon Library, Western University campus

Register at: https://www.lib.uwo.ca/tsc/calendar/view_program.php?id=765 

Brescia Research Ethics Board – Important Updates

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New templates and template guidelines (effective July 14, 2015)

  1. When completing a new BREB application from this moment forward, applicants must use updated templates and guidelines for the Letter of Information, Consent and any other forms required for the study (email/telephone scripts, recruitment posters etc.). The BREB uses Western’s templates/guidelines for these documents and these have been recently updated by Western. Templates will be updated with the Brescia logo and available on the BREB intranet page by late Summer. For now, please replace the Western logo with the Brescia logo on the letterhead.
  2. Links to the templates and guidelines can be found in the BREB application itself, on the BUC REB Intranet page: https://intranet.bresciauc.ca/faculty-resources/brescia-research-ethics-board-reb/ , and on Western’s Research Ethics website:

New BREB Forms (effective July 14, 2015)

In addition to the new templates and guidelines, the BREB has developed two new forms:

  1. Annual Status Report—to be used for a request for study renewal or closure. For end of study status (closure), the Research Officer will send a reminder to applicants in advance letting them know their approved protocol is nearing expiration. The email reminder will include the Annual Status Form as an attachment to be completed by the principal investigator of the study. For renewals, please submit at least 2 weeks in advance for review.
  2. Request for Changes to Approved Protocol—to be used for any changes to an approved ethics protocol. Must be submitted at least 2 weeks in advance for review.

Both forms are located on the BUC BREB intranet page: https://intranet.bresciauc.ca/faculty-resources/brescia-research-ethics-board-reb/

Any questions can be directed to the Research Officer, Elizabeth Russell-Minda, elizabeth.minda[at]uwo.ca

Revised Version of the 2nd Edition of TCPS 2 (2014)

The Presidents of the three federal research agencies — Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) announce the release of the revision of the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or TCPS 2 (2014). The revised version replaces TCPS 2 (2010) as the official human research ethics policy of the Agencies.

Changes include increased emphasis on the participant’s decision-making capacity, more detailed guidance about alterations to consent requirements, and the full integration of CIHR’s Guidelines for Human Pluripotent Stem Cell Research. The inclusion of the Guidelines addresses the Agencies’ goal of making TCPS 2 the single Agency policy for the ethics of research involving humans.

Please consult the Panel on Research website for additional information on the Panel, Highlights of Changes and to download your copy of TCPS 2 (2014). For questions on changes to the TCPS 2 (2014) or to request a hard copy version of the TCPS 2 (2014), please contact: secretariat@rcr.ethics.gc.ca.