for nightingale
billyjates88
em5_background_research_consent_forms.pptConsent forms for Research must include several elements
Identify Research
- The subject’s involvement must be identified as research
- The research must be described
- The purpose of the research must be explained
Risks
- Risks and consequences of the research activity must be clearly set forth
Benefits
- The benefits of the proposed research must be explained
Alternatives
- If the investigations is clinical, the diagnostic and therapeutic alternatives must be described
Research Records
- The mechanism and process of protecting privacy and maintaining confidentiality of records and data must be described
Compensation
- The availability of compensation for participation must be explained
- The availability of treatment in the event of injury must be explained
Contact Person
- The consent form must clearly identify the person to contact with questions, concerns, inquiries, or in the event of injury
Individual Rights
- The right of the individual to refuse participation or withdraw from the research must be explained
