№ files_lp_4_process_2_58293
Guidance document outlining institutional and regulatory requirements for obtaining and documenting electronic written informed consent from participants in human research and clinical trials.
Organization: CHEO Research Ethics Board (REB)
Country: Canada
Document type: Guidance document
Subject: Electronic written informed consent in human research
Related policy: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2-2018)
Legal framework: Canada Evidence Act; Personal Information Protection and Electronic Documents Act (PIPEDA); US Code of Federal Regulations Title 21 Part 11
Applicable sector: Human research and clinical trials
Target audience: Researchers and investigators conducting human participant research
Key topics: electronic consent procedures, digital signatures, participant identity verification, consent documentation, privacy and confidentiality requirements
Special context: COVID-19 pandemic procedures for remote consent
Research setting: Clinical trials and health research involving human participants
Document components: consent procedures, electronic signature requirements, study protocol documentation, email consent attestation template
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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