Memo regarding staffing & other changes in the Office of Human Research Ethics

January 7, 2016

Please see this document regarding staffing and other changes in the Office of Human Research Ethics:  OHRE Memo-Jan 6 2016


Upcoming Research on Teaching and Learning Event

October 7, 2015

You are invited to an upcoming research on teaching and learning session –

Research Ethics from a Research on Teaching and Learning Perspective

Monday, October 19,  10:30 am – 12:00 pm
Teaching Support Centre, Room 122, Weldon Library

In this session, Grace Kelly (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 impact your submissions. Please join the Teaching Support Centre for this discussion of ethical issues in research on teaching and learning.

Enrolment is limited.  Please register at https://www.lib.uwo.ca/tsc/calendar/view_program.php?id=765


Research Ethics – Tips to Speed up the Approval Process

October 6, 2015
Tips for a Successful Ethics Application
Thursday, October 15, 2015
12:00 pm – 2:00 pm
Faculty of Education Building, Community Room 1139

The session will begin with greetings from Mark Daley, Acting AVP of Research. Panel members will present, and there will be time for questions/discussion. Steve Bird, Faculty of Education’s Associate Dean of Research, will MC and act as Moderator.

Panel members:
Riley Hinson, Chair, Non-Medical Research Ethics Board
Erika Basile, Director, Research Ethics
Grace Kelly, Ethics Officer
Faculty of Education Research Ethics Board Members

Although organized by the Faculty of Education, it is open to, and will be of interest to all Western University Researchers submitting ethics applications to the Non-Medical Research Ethics Board.

Feel free to bring your lunch; we will provide coffee and cookies. Please RSVP to tbeynen@uwo.ca


Data Storage Requirements – Ethics Applications

August 10, 2015

The Office of Research Ethics has recently posted the following guideline for data storage requirements (Confidentiality and Data Security).

http://www.uwo.ca/research/_docs/ethics/nmreb_guidelines/NMREB%20Initial%20Application%20-%20Confidentiality%20and%20Data%20Security%20v04Aug2015.pdf


Updates at the Office of Research Ethics and for ROMEO (Ethics Applications)

August 10, 2015

The Office of Research Ethics (ORE) has been working to streamline processes to improve efficiency and to improve current review timelines. Below are some key updates that have/will be implemented:

Application Form
1. Effective August 1, 2015 the ORE rolled out an updated Non-Medical (NM) REB application form on Romeo. The previous application form was de-activated as of July 30, 2015 at 11:59 pm. If you were completing a NMREB application form before this date and did not submit it or save it as a word file BEFORE July 30, 2015 your information was lost.

Templates
1. The following templates/guidance documents are available on the website to help aid researchers with their application
a. An updated Letter of Information/Consent form. This will include helpful options for the various types of research projects.
b. Assent
c. Telephone script
d. Poster (Ad) for recruitment
e. Recruitment email, Reminder email
f. Debriefing form
g. Community Engagement form
h. Photographic Release Form

NM REB Reviewers
1. Effective June 1 only 1 reviewer + an Ethics Officer (EO) will be assigned to review all delegated submissions. The assigned REB member is responsible for the submission approval. The reviewer will be an REB member from within the Faculty of that submission who confirms no conflict of interest.
2. Initial review process:
. The Ethics Officer (EO) will review the initial submission with 4 business days of the submission date,
. The EO will email the reviewer requesting if they can review the submission (review must be done within 5 business days). Included in the email will be the EO’s review (preliminary recommendations). The REB member will review the submission, add their recommendations to ROMEO (if applicable), review the EO’s recommendations and confirm if they can be sent to the researcher. Correspondence will be done via email.
. This will cut down on back and forth between the reviewer and the ORE. NOTE: this timeline is subject to change if the ORE is unable to find an REB member.

Pilot project:
1. The ORE and FIMS have been working together to pilot a system that allows a representative from a department / faculty to internally review a protocol before it is submitted to the REB.
NOTE: The idea of having the submission reviewed by a representative within the department/faculty is to:
a. Ensure quality of the submission and to minimize the number of common errors found in many submissions (e.g., comprehension, grammar, spelling, etc.) that result in unnecessary delays in approval;
b. The department / faculty representative may be an REB member and therefore, their initial review is already completed and they only have to approve the preliminary recommendations (if any) issued by the EO’s (that should be completed within 3 days of the initial submission to the ORE).

NOTE for Faculty of Education Researchers – Karen Kueneman is available to pre-review all submissions to ROMEO. Please save a copy of the application and accompanying documents (letters of Information, etc) in Word and email to Karen, kueneman@uwo.ca, at least one week ahead of the date you wish to submit to ethics.

Other important updates
1. The ORE is hiring additional staff to help offset volume and review timelines
2. The ORE is looking at assessing the current REB management system (ROMEO) and the potential need for a more effective and efficient system.

Message to researchers
1. In order to ensure that you receive REB approval before your intended start date, please allow at least 2 months for the approval process. While the process may not take the full 2 months it should provide more than enough time to go through the review process (especially if your submission is to be reviewed at a full board NMREB meeting which only meet once a month).
2. If students are submitting a research proposal, the PI is responsible for proof reading and correcting any errors before the proposal is submitted to the REB (provide the same level of review as done for grant applications). As the PI you are ultimately responsible for the project and its oversight.
3. If you have any questions about your project please contact the ORE before you submit your proposal.

If you have any questions/concerns in general please contact Erika Basile, Director (Research Ethics) at ebasile@uwo.ca or ext 86764 or Grace Kelly (Lead Ethics Officer for the Non-Medical REB) at grace.kelly@uwo.ca or ext 84692.


Launch of the Revised Version of the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or TCPS 2 (2014)

January 5, 2015

The Presidents of the three federal research agencies–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)– 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). TCPS 2 (2014) 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), please contact secretariat@rcr.ethics.gc.ca.


Research Ethics – New forms and procedures

December 19, 2014

Effective January 1, 2015 Western’s Office of Research Ethics will be rolling-out a new Non-Medical Research Ethics Board (NMREB) Continued Ethics Review (CER) Form  & NMREB Revision Form. Current forms will be de-activated as of December 31, 2014 at 11:59 pm. If you are currently completing a NMREB CER Form or NMREB Revision Form, please be sure to submit them via Romeo BEFORE December 31, 2014 to ensure  your information is not lost.

New Continued Ethics Review (CER) Process for Non-Medical Research Ethics Board (NMREB)

To mitigate confusion surrounding the procedures of completing the annual Continuing Ethics Review (CER) form and extending the study end date, effective January 1, 2015 Western’s Office of Research Ethics (ORE) approves studies on an annual basis. If your study is ongoing for more than one year, the ORE will issue approval for one year at a time.  When your study has ended you are required to submit an End-of-Study Form.

NOTE: This change results in the following:

  1. Investigators/study team members will no longer be required to submit amendments for study end date extensions as all studies will be approved on an annual basis.  Review and approval of the annual CER forms will result in REB re-approval for the following year; and
  2. The ORE will no longer be processing Updated Approval submissions as approval letters will be issued for CER submissions on an annual basis.