Research, education, and clinical care are the three essential activities of IWK Health. The Research Ethics Board (REB) serves to help members of the research community to conduct ethically-acceptable research involving humans.
On this page:
- Introduction to the REB
- REB Membership
- REB Submission and Meeting Dates
- REB Submissions Requiring Delegated Review (minimal risk)
- The ROMEO Research Portal
- Guidelines and Templates
- Tutorials
- Recommended Reading
- Research Review
Introduction to the REB
All research that involves human subjects, their information, or their tissue, requires review and approval by the REB before it may begin. Research proposals are assessed for ethical acceptability using regional, national and international guidelines. The IWK Health Research Ethics guidelines and operating procedures provide direction in regard to research involving IWK families and personnel. Since research ethics is a continually evolving subject, these guidelines may be modified from time to time. It is the responsibility of the reader to ensure that they are using the most recent version.
The REB Standard Operating Procedures (SOP) also provides important information on the Board's operations and requirements of investigators and research staff. The SOP’s should be read in conjunction with these guidelines. Guidelines, SOPs and related notices are regularly updated.
To facilitate the review of Full Board REB Submissions, Principal Investigators (or their designate) may be invited to attend the REB meeting. Investigators will be notified of the time and location of the REB meeting 10 days prior to the meeting date if their attendance is requested.
Investigators will be invited to make a short (10 minute) informal presentation of the research study and REB members may follow up with a few clarifying questions. Additionally, investigators may volunteer to come to the REB to briefly present their REB submission. This can be particularly helpful with unique or complex projects. Simply contact the research ethics office 10 days prior to the meeting to be added to the agenda.
The REB review and Summary of REB Issues will follow in the usual manner. Investigators will not be in attendance during the review of their submission.
IWK Responsible Conduct of Research Policy
The Responsible Conduct of Research policy establishes expectations for the responsible conduct of research at the IWK and outlines processes for handling allegations of research misconduct.
IWK Research Ethics Board Membership (January 2024)
Megan Thomas, MD, PhD – Chair – Clinical Researcher, Developmental Pediatrics
Carol Digout – Vice Chair – Executive Director, APPHON
Eleanor Fitzpatrick, MN – Executive Chair – Clinical Researcher, Nursing
Angela Arseneault, MEd – Privacy Consultant, Mara Consulting
Steven Beyea, PhD – Innovation Strategic Advisor, Office of the VPRI
Christopher Blackmore, MD – Clinical Researcher, Pediatric Surgery
David Conrad, MD - Clinical Researcher, Hematopathology
Kellie Davis, MD – Clinical Researcher, Medical Genetics
Zara Forbrigger - Research Assistant, Hematology/Oncology
Isabelle French, LL.M. – Legal Representative, Dalhousie University
Katie Hollis, MHA, RPh – Director of Pharmacy, IWK Health
Richard Huntsman, MD - Clinical Researcher, Neurology
Emily MacLeod - Research Manager, Centre for Pediatric Pain Research
Amanda Morvan, BCom - Lay Representative
Jill Mutch - Director of Clinical Operations, Canadian Center for Vaccinology
Kara Redden, M.Sc., RN - Research Manager, Canadian Center for Vaccinology
Kelly Ann Trask, M.Sc. - Research Coordinator, Emergency Medicine
Submission & Meeting Dates
Submission dates
January 30, 2024 for the February REB meeting
February 27, 2024 for the March REB meeting
March 26, 2024 for the April REB meeting
April 30, 2024 for the May REB meeting
May 28, 2024 for the June REB meeting
June 25, 2024 for the July REB meeting
August - no REB meeting
August 27, 2024 for the September REB meeting
September 24, 2024 for the October REB meeting
October 29, 2024 for the November REB meeting
November 26, 2024 for the December REB meeting
Meeting dates
January 16, 2024 – REB Retreat
February 20, 2024
March 19, 2024
April 16, 2024
May 21, 2024
June 18, 2024
July 16, 2024
August – no meeting held in August
September 17, 2024
October 15, 2024
November 19, 2024
December 17, 2024
REB Submissions Requiring Delegated Review (minimal risk)
These may be submitted at any time.
REB review comments are normally provided to the investigator within four weeks of submission.
It’s recommended that investigators avoid the deadline dates noted above when submitting delegated (minimal risk) projects, as reviews may be delayed if received on the deadline date for full board submissions.
Delegated submissions may be delayed during holiday periods or when the REB is experiencing increased volume, for example Summer Studentship applications. Please be sure to get your submissions in early!
RESOURCES
The ROMEO Research Portal
The IWK REB uses the online ROMEO Research Portal for the management of ethics applications and grant/award applications. The Research Portal provides researchers and study team members including co-investigators, research coordinators, and other study staff, the ability to see and manage the submission and approval process for their research studies. Through a single login, you may review all existing projects underway at the IWK and NSHA.
If you require an Investigator Profile to gain access to ROMEO, please take a few moments to fill out the form below. Note that we process the forms Monday to Friday (8am-4pm); please plan ahead.
New User - Registration Request
The IWK has several user guides to help with the management of your study:
Registering in ROMEO & Intro to Managing Study Review Activities
Registering in ROMEO & Intro to applying to IWK Research Programs
Amendment or New Ethics Application Guidelines
ROMEO Training:
If you would like to schedule a training session on using the Research Portal, please email Joanne Street at joanne.street@iwk.nshealth.ca.
Questions: If you have any questions regarding ROMEO and the Research Portal, please email Joanne Street, Ethics Coordinator, Research & Innovation Advancement at joanne.street@iwk.nshealth.ca.
Guidelines and Templates
New Applications
Consent and Authorization Documents - General Requirements - Guidelines
Consent and Authorization Documents General Requirements (Minimal Risk) - Guidelines
Industry Sponsored Research - Ethics Review Fee - Guidelines
Industry Sponsored Research - Requisition for Ethics Review - Form
Registering in ROMEO & Intro to Managing Study Review Activities
Self-Declared Income Statement for Research Participants - Form
Privacy
PHIA – Personal Health Information for Research Guidelines
Pledge of Confidentiality (on Pulse)
Privacy Impact Assessment (on Pulse) - use the assessment tool to find out if you need a PIA for your research
Waiver of Consent - EAS Addendum (Old Submissions) - use for previously approved studies only
REB Reviewers' Tools
Tutorials
TCPS2 Tutorial - Self-paced course featuring interactive exercises and multi-disciplinary examples.
CITI Online Courses - Collaborative Institutional Train Initiative (CITI) online training courses.
NIH Funded Projects - All researchers receiving NIH funding MUST complete the NIH intramural on-line module.
Office for Human Research Protections (OHRP) - Human Subject Assurance Training.
Recommended Reading
Tri-Council Policy Statement (TCPS2)
Interagency Advisory Panel on Research Ethics (PRE)
The Governance of Health Research Involving Human Subjects (HRIHS) (abridged version - full version available here)
Good Clinical Practice: Consolidated Guideline
Health Canada: Food and Drugs Act and Regulations, Division 5
World Medical Association Declaration of Helsinki
International Ethics Guidelines for Biomedical Research Involving Human Subjects
Office for Human Research Protections (USA)
Research Review
Our Primary Purpose:
The IWK is committed to the health and well-being of women, children, youth and families. From a research perspective, the population we serve is an integral part of how we investigate, implement and evaluate how we deliver care. As important stakeholders, we are committed to our research participants by ensuring that research is carried out with their interests and safety at the forefront. The Research Review (formerly referred to as the Research Ethics Audit) is designed to ensure that as researchers we are engaging in due diligence and complying with the ethical standards laid out by the Tri-Council.
The Review process is intended to fulfill the commitment of Research & Innovation Advancement (RIA) to ensuring the safety and privacy of our research participants, but also to ensure that IWK Health:
consistently conducts research with high quality scientific and ethical standards,
complies with the requirements that are laid out locally, nationally and internationally, and
maintains internal systems that are comprehensive and sensitive enough to guarantee the highest quality of ethical standards in research.
The Review should not be considered a penalty but rather a quality assurance process through which both RIA and the Research Team can benefit.
If your project is selected for audit you will receive notification several weeks in advance of the scheduled date and time. Every effort will be made to accommodate your schedule. The Principal Investigator is invited to attend the Audit session but research assistants or coordinators are also encouraged to take part.
The document linked below provides further information about the IWK REB Audit Committee and process. Feel free to contact RIA if you have any questions.
Email Address: researchethicsIWK@iwk.nshealth.ca