By Sharan Sidhu, 06 AUG 2014.
Since observational studies do not involve the administration of investigational products, they are not subject to Health Canada’s and the Food and Drug Administration’s (FDA) clinical trial regulations. Although these studies do not require regulatory approval from Health Canada or the FDA, they do need Institutional Review Board (IRB) approval in both Canada and the USA to ensure ethical conduct. This requirement ensures that ethical standards are maintained while streamlining the process for conducting observational research.
Key Considerations
Institutional Review Board (IRB) Approval: Any observational study involving human subjects must receive IRB approval to ensure ethical standards are met, including informed consent, privacy protection, and risk minimization
Ethical Considerations: Despite not requiring FDA and HC approval, researchers must adhere to ethical guidelines and regulations, including the Common Rule (45 CFR 46), which governs human subject research in the U.S. and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) in Canada. This includes ensuring voluntary participation, informed consent, and confidentiality of participant information.
Data Privacy: Adherence to privacy laws is essential when handling personal health information in observational studies. In Canada compliance with the Personal Information Protection and Electronic Documents Act (PIPEDA) is required and in the US compliance with the Health Insurance Portability and Accountability Act (HIPAA) is essential when handling protected health information (PHI) in observational studies.
In conclusion, while observational studies do not require the same regulatory approval as controlled trials, they do require ethical oversight. This may seem daunting for small and medium-sized businesses that lack the infrastructure to “sponsor” a study. To address this, Salix Sciences has developed a comprehensive policy and plan package to help you get started and guide you in the right direction.
See also:
Can Observational Studies Provide Statistical Significant Data?
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