Ethics - Research
Nova Scotia Health Authority Research Ethics Board
At the Nova Scotia Health Authority, all research projects involving patients, staff, resources or data are reviewed by our Research Ethics Board (REB) before the research begins.
This requirement also applies to research involving human participants, human biological materials as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.
The Nova Scotia Health Authority Research Ethics Board (NSHA REB) has the authority and resources to review research protocols that will be conducted within the Nova Scotia Health Authority. Board membership includes representatives from each zone who meet via video conference on a weekly basis. The NSHA REB is a paperless enterprise and the ROMEO database is the platform for on-line submissions to complete the research ethics review process.
The goals of the NSHA REB are to:
- Meet the requirements of the Tri-Council Policy Statement Guidelines, ICH-GCP Guidelines, and Health Canada Division 5 Food and Drug Regulations which protect the safety and well being of research participants
- Reduce review timelines and simultaneously maintain a high quality research ethics review
- Increase the capacity throughout the province to conduct health research of all kinds
- Attract and retain health professionals interested in research throughout the province
- Create a competitive research environment that attracts research to Nova Scotia
NSHA REB Submission Process Information
The NSHA REB has moved to an electronic submission process, accessed through an electronic portal.
If you are a new research person, you must click on the Register button to create your account. Your username should be your primary email address. Once you have registered, you will receive an email with instructions on setting your password.
If you have previously submitted a study to either the IWK or the former CDHA/Multisite REBs, you will already have an account within the system.
If you are the principal investigator of a non-interventional study and you do not have a NSHA affiliation, you must have a Supervising Investigator who is affiliated with the NSHA and who will accept the overall clinical and supervisory responsibility during the conduct of the study.
If the study is a clinical trial, the principal investigator must be affiliated with the NSHA.
Here are the User Guides for Researchers and Research Coordinators on how to use to the electronic portal:
- ROMEO Research Portal Users Guide for Researchers
- ROMEO Research Portal Users Guide for Research Coordinators
Please refer to policy Research Ethics Board Jurisdiction RS 02-001.
Note: If you require access to custodial databases, please refer to procedures for obtaining access to HDNS data. For access to data held by the Nova Scotia Department of Health and Wellness, complete the application form.
NSHA REB meeting dates and submission deadlines have been set for 2015.
For more information, contact:
Ken Jenkins, REB Manager
Nadine Gillam, Administrative Coordinator
Study Feasibility Assessment
- Amended Protocols, Consent Forms, Addendums 2015-04-01
- Annual Approval Request - Additional Documents 2015-04-01
- Annual Approval Request - Clinical Trials 2015-04-01
- Annual Approval Request - Non-Interventional Studies 2015-04-01
- DSMB Safety Alert Reporting Form (CTs) 2015-04-01
- Local Serious Unexpected Adverse Reaction - Follow-up 2015-04-01
- Local Serious Unexpected Adverse Reaction - Initial Report 2015-04-01
- Major Study Violation 2015-04-01
- Minor Study Deviations (CTs) 2015-04-01
- Periodic Safety Update Reports (CTs) 2015-04-01
- Premature Study Termination 2015-04-01
- Product Information 2015-04-01
- Study Closure - Clinical Trials 2015-04-01
- Study Closure - Non-Interventional Studies 2015-04-01
- Supporting Materials 2015-04-01
- Abbreviated CV for Research - Sample Template 2015-04-01
- Addendum Informed Consent 2016-01-08
- Advertisement Template 2015-04-01
- Access Personal Health Information Consent Form
- Consent for Case Reports 2015-04-01
- Consent for Database/Registry Studies 2015-04-01
- Consent Clinical Trials Template 2016-01-12
- Consent Non-Interventional Studies Template 2016-01-12
- Researchers Commitments: Site Investigator
- Consent Preparation and Use 2015-04-01
- EAS form F2 section RMU wording 2015-04-01
- Radiological Review Information
- Research Protocol Guidelines 2015
Reviewer's Assessment Forms
- Reviewer's Assessment Clinical Trials Protocol 2015-04-01
- Reviewer's Assessment Non-Interventional Trials Protocol 2015-04-01
- Reviewer's Assessment Risk 2015-04-01
- Reviewer's Assessment Form Consent 2015-04-01
- Risk Assessment Guide 2015-04-01
Ethics Board Meetings
- Interagency Advisory Panel on Research Ethics (PRE)
- The Governance of Health Research Involving Human Subjects (HRIHS)
- Tri-council Policy Statement: Ethical Conduct for Research Involving Humans
- Good Clinical Practice: Consolidated Guideline
- Health Canada: Food and Drugs Act, Division 5
- World Medical Association Declaration of Helsinki
- The Belmont Report (USA)
- Nuremberg Code (USA)
- Code of Federal Regulations (USA)
- International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Canadian Bioethics Society
- Office for Human Research Protections (USA)