- Describe how subjects will be
- Explain how recruitment materials will be used (for example, announcements, flyers, telephone calls).
- If relevant, address any concern related to the privacy of the subjects during the recruitment process.
7.Consent and documentation process:
- Describe who will obtain the informed consent of participants, how, when and where it will be obtained.
- If the study involves vulnerable populations (e.g. children, prisoners, people with special needs, subjects who do not speak Spanish, etc.) the efforts that will be done to their understanding of the study and additional protections that will be in operation to ensure their voluntary participation must be described.
- Describe the arrangements made to receive and respond to questions and complaints from participants or their representatives during the study.
- If a waiver of consent or a waiver or alteration of signed consent is requested, provide justification for the waiver / alteration, and describe alternative procedures to inform participants about the study.
- Describe any risks associated with the study and its procedures, including physical, psychological, emotional, social, legal or economic.
- Describe the steps to be taken for reducing those risks.
- Describe the burden in which the study participants will be involved, including time, inconvenience, expenses,
- When including sensitive questions in interviews, describe how the privacy of participants will be protected during data collection.
- Describe the potential direct benefits to the participants for participating in the study (does not include payment for participation).
- Describe the possible social benefits that may derive from the study.
- Describe the form, the amount and timing of payments to participants.
- Include the potential total remuneration and the consequences of not completing all phases of the study.
11.Plan for reporting unanticipated problems / adverse events:
- Describe the plan for reporting to the Committee and if necessary to the sponsor.
- Describe the criteria for suspending or completely terminate research.
Measures for compensation / treatment in case of injury / disability / death of the participant attributable to participation in research
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