General study information, including:
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- Financial sponsorship
- Key personnel
- Performance sites
- Study dates
- Study abstract/summary
- Research design (including specific aims, background/prior research, methodology, analysis plan, etc.)
- Benefits to subjects from participation
- Risks to subjects
- Recruitment methods and description of subject population
- Informed consent procedures
- Data confidentiality provisions
- Conflicts of interest
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Discussion of special considerations, for example:
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- Procedures used to obtain consent to interview minors or other populations that require special consent (e.g., if interviewing minors, describe procedures for obtaining parental consent and include child assent and parental consent forms/oral protocols)
- Compensation and costs involved in participation for study subjects
- Procedures for handling biological samples, such as blood or saliva
- Proposal to conduct genetic typing/analysis from biological samples
- Considerations in conducting epidemiological or public health research
- Use of deception
- Use of internet/email for research
- Consent procedures for audio or video recording of interviews
- International research considerations
- Protocols for viewing of images or listening to recorded material
- Secondary data analysis
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Forms, including:
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- Copy of the grant/contract application
- Consent protocols/scripts/forms
- Copy of the questionnaire
Other forms (as appropriate):
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- Cognitive interview protocol
- Focus group moderator guide
- Recruitment flyers or emails
- Study brochure/fact sheet
- Letter(s) to be sent to respondents
- Data use agreement (for use of secondary data from third party sources)
- Documentation of review from other ethics review boards
- Documentation of training in research ethics for study staff
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