Privacy legislation and research
Research in Nova Scotia must comply with both the Personal Information International Disclosure Act (PIIDPA) and the Personal Health Information Act (PHIA).
The Personal Information International Disclosure Protection Act (PIIDPA) came into effect in 2006. It protects privacy by restricting the disclosure of personal information outside Canada, as other countries may not have equivalent data protection laws. Personal information (including participants’ personal health information and researchers’ CVs) may be stored or accessed outside Canada only with the consent of the individual.
The Personal Health Information Act (PHIA) came into force on June 1, 2013. This legislation, similar to that in existence in other provinces, deals with the collection, use, disclosure, retention, disposal, and destruction of personal health information. PHIA introduces new requirements for research in Nova Scotia, which has led to modifications to many procedures, practices and forms at the Nova Scotia Health Authority.
Personal Health Information Act and Research
Research Standards and Regulations
- Biologics, Radiopharmaceuticals and Genetic Therapies
- Compliance and Enforcement
- Drugs and Health Products: Legislation and Guidelines
- Regulations Amending the Food and Drug Regulations Division 5
- Medical Devices
- Natural Health Products
- Clinical Trials: Frequently Asked Questions
Inter-agency Advisory Panel on Research Ethics
- CIOMS International Ethical Guidelines for Biomedical Research
- ICH Guidance E6: Guideline for Good Clinical Practice
- ICH Guidance E8: General Considerations for Clinical Trials
- Nuremberg Code
- Belmont Report
- World Medical Association Declaration of Helsinki
- World Health Organization
- Running Clinical Trials (FDA)
- Clinical Trial Guidance Documents (FDA)
- Office for Human Research Protection (OHRP)
- FDA Information for Clinical Investigators
- U.S. Food and Drug Administration
Resource Documents and Tools
- Supports for Investigator-Sponsored Clinical Trials
Institutional Accreditation Certificates
- CH Accreditation Certificate 2010-2013
- CH Accreditation Certificate 2013-2017
- CH Accreditation Certificate Exemplary Standing 2013-2017
- NOVHA Accreditation Status 2015 Letter
- NSHA Accreditation Certificate 2017-2021
- Delegation and Signature Log Template (word doc)
- Aneroid Sphygmomanometer Maintenance
- BME Requirements for Implementing Technology in the Clinical Research Setting
- HPF Compliance with FDA Title 21 Part 11 2014-02-24 (Word doc)
- Letter to FDA regarding Electronic Signature
- Research Policy Review Checklist -- Investigators 2016 (word doc)
- Research Policy Review Checklist -- Research Employees 2016 (word doc)
Standard Operating Procedures and Guidelines
The Research Quality Program is pleased to introduce and release several institutional Standard Operating Procedures (SOPs) for Health Canada regulated clinical trials. The goal of these SOPs is to provide consistency and efficiency for research groups.
We recognize that many groups have created existing departmental SOPs. Research teams are not required to replace their current SOPs with institutional SOPs provided their current SOPs contain the components as described in the attached institutional SOPs. Our aim is to create SOPs that are required for ICH-GCP compliance within Health Canada regulated clinical trials and also to align REB and institutional requirements.
Non-regulated clinical trials are encouraged, but not required, to have SOPs in place. These trials must be able to show, in the Ethics Application Form for REB submission, that their consenting and privacy practices align with TCPS and privacy legislation. Feel free to adopt any of the Health Canada institutional SOPs or use them as a guide for completing appropriate sections in the EAF for REB submission.