The Institutional Ethics Committee of the INCAP (IEC) establishes the following requirements for submission of an application and evaluation of a research project:

1.       Present and submit the following paperwork to the Secretary of IEC-INCAP:

q Letter to the President of the IEC-INCAP presenting the research project and requesting review and approval.

q Protocol completed and signed by the Principal Researcher, including 6 copies for reviewers.

q Detailed description of the material to be used in the study, including advertisements for recruitment of potential research participants.

q Informed consent, clearly identified and dated, in Spanish and when necessary, in other languages. Ensure simple language writing and include the following sections: purpose of the study, procedures, benefits, confidentiality, potential risks, participation / voluntary retirement and contacts. Space should be provided for the signature of the participant and the two witnesses

q The consent (children), in Spanish, and when necessary, in other languages.

qDiary of Patients, case report forms, note cards, calendars or daily formats and questionnaires for participants in research.

q Curriculum Vitae of researchers with the necessary records, citing academic degree, specialty, place of work, work position, research projects and publications. Attach current approval certificate of course Protection of Human Subjects. If it's a controlled clinical trial (CCT) certificate of Good Medical Practices must be attached too.

q Commitment letter to the IEC-INCAP to comply with:

-               Standards for Protection of Human Subjects (and Good Clinical Practice in clinical              intervention studies) to develop research work.

-                Report the date that the first participant enrolled.

-                Submit a semi-annual report detailing the progress of research.

-                Report serious adverse events within 24 hours and send a detailed report no later than        72 hours.

-                Inform in writing the completion or termination of the study and the reasons for it.

-                Report the final publication of the results of the study.

-                Availability to answer any call or direct supervision of members of the CIE-INCAP on           the study

qLetter from the sponsor supporting its role as a researcher.