Signed consent must be obtained when doing human subject research. Subjects, or their legally authorized representatives, must have the opportunity to consider their participation without the possibility of coercion.
Consent forms should:
- Begin with a concise summary
- State that study involves research
- Explain purpose of the research
- State expected duration of subjects participation
- Describe procedures to be followed (experimental procedures identified)
- Describe foreseeable risks/discomforts
- Describe benefits to subject or others (if compensation, state amount)
- Explain how anonymity/confidentiality/privacy of records will be maintained
- State who has access to records
- State name and contact information for person to contact with questions about research
- State participation is voluntary – refusal or decision to quit will have no penalty/loss benefits
- Clearly state use of findings
When appropriate include:
- Subject criteria: age, gender, medical condition, profession
- Statement that participation may involve unforeseeable risks to subject/embryo/fetus
- Statement that can skip a question in a survey/interview
- When participation may be terminated without subject’s consent
- Consequences/procedures for withdrawal/termination
- Additional costs to the subject from participation
- If more than minimal risk, describe any compensation/treatments available if injured
- Disclose appropriate alternative procedures (if none, say so)
- Potential conflicts of interest for the investigator (Ex. Financial, …)