Research, along with education and clinical care are the three essential activities of the Health Centre. The Research Ethics Baord (REB) serves to assist members of the research community to conduct ethically acceptable research involving humans.
All research that involves human subjects, their information or their tissue, requires review and approval by the REB before it my begin. Research proposals are assessed for ethical acceptability using regional and international guidelines. The IWK Health Centre 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 informtion on the Board's operations and requirements of investigators and research staff. The SOP's should be read in conjunction with these guidelines.
The IWK has partnered with NSHA in the implementation of the ROMEO Research Portal. This latest edition of the Research Services database 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 or NSHA.
Access the ROMEO database through the Researcher Portal
System features include:
- Online development of new study applications, facilitating team member edits and collaboration with comprehensive edit tracking and logs
- Full electronic initial submission
- Integrated REB review and approval forms and processes
- Electronic submission of amendments, annual renewals, SAE reporting and other ongoing REB notification activities.
- Single site access to every study you are named on as a Primary Investigator, Team Member or Reviewer
To facilitate the review process 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.
Investigators are invited to make a short (10 minutes) informal presentation of the research study and REB Members may followup with a few clarifying questions. The REB reivew and Summary of REB issues will follow in the usual manner. Investigators will not be in attendance during the review of their submisissions.
Case Report Review
Consent, Authorization and Assent Documents - guidelines
Consent and Authorization Documents General Requirements (Minimal Risk)- guidelines
Diagnostic Imaging Review
Industry Sponsored Research - Ethics Review Fee - guidelines
Industry Sponsored Research - Requisition for Ethics Review - form
Letter of Support Template
Registering in the ROMEO Researcher Portal and Introduction to Managing Study Review Activities
Self Declared Income Statement for Research Participants - form
Telephone Consent - script and guidelines
Tissue or Biological Samples for Research Purpose
Personal Health Information for Research Guidelines - PHIA
Application for Access to Personal Health Information for Research Purposes - use for previously approved studies only
Waiver of Consent - EAS Addendum (Old Submissions) - use for previously approved studies only
SAE Reporting SOP
SAE Reporting - memo September 2009
Serious Adverse Event Initial Report
Serious Adverse Event Follow Up Report
SAE Summary Table
Major Study Violation Reporting Form
Minor Study Deviation Reporting Form
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.
Tri-Council Policy Statement (TCPS2)
Centre of Genomics and Policy (CGP), Maternal Infant Child and Youth Network (MICYRN) - Best practices for health research involving children and adolescents
The Belmont Report (USA)
Nuremberg Code (USA)
Interagency Adisory Panel on Research Ethics (PRE)
The Governance of Health Research Involving Human Subjects (HRIHS)
Good Clinical Practice: Consolidated Guideline
Health Canada: Food and Drug Act, Division 5
World Medical Association Declaration of Helsinki
International Ethics Guidelines for Biomedical Research Involving Human Subjects
Canadian Bioethics Society
Office for Human Research Protection
Updated December 2016Share
The IWK Health Centre is respected for its world-class research into disorders and diseases affecting women, children, youth and families and is home to many leading research centres.
Learn more about our research centres by visiting one of the links below.
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