Dear researchers, it is an honor for CEISH - UEES that you have decided to send your research protocol to be approved by this collegiate body. We thank you for your confidence.
Please consider the following general instructions for the submission of your protocol:
a) Letter of request for evaluation of the study signed by the principal investigator, stating the name and signature of the investigators responsible for each research center of the study.
b) Form for the submission of clinical trial protocols.
c) Statement of responsibility of the principal investigator(s) of the research center(s), including the commitment that during the execution of the study he/she will comply with the stipulations of the CEISH and with national and international bioethical standards.
d) Letter of declaration of institutional interest (letter of interest) in the subject of the study, signed by the highest authority of the health facility or facilities or institutions where the research is proposed to be carried out.
e) Resume of the principal investigator(s) and investigator(s) of each research center, evidencing their experience in the area of study or development of clinical trials.
f) Research protocol or amendment in the original language of the sponsor (when applicable) and in Spanish.
g) Clinical trials fact sheet.
h) Informed consent form in Spanish and/or translated into the ancestral languages of the peoples or nationalities involved in the study.
i) Investigator's manual according to Good Clinical Practices, including the flowchart for the management of adverse events and reactions.
j) Procedures and instruments for recruiting subjects to participate in the study (flyers, posters, web page, other materials).
k) All instruments to be used in the research as in the case of data collection involving the use of questionnaires, surveys or similar instruments.
m) Certificate of training and experience of the participating investigators related to the subject of the study, and in research bioethics.
n) The principal investigator must be at least registered with SENESCYT as a natural person related to research and/or technological development activities as stipulated in Agreement No. SENESCYT-2018-029 published in Official Gazette No. 540 of September 14, 2018, or regulations replacing it.
o) Available information on the safety of the experimental drug, when applicable.
p) In the case of multicenter studies, the investigator must submit the letter of approval from the Ethics Committee of the country where the sponsor of the study is located.
q) Copy of the contract signed between the study sponsor and the investigators.
r) Clinical trial monitoring plan.
s) Participant's safety plan.
Exemption Request (Download here)
Submit a letter addressed to the CEISH president justifying the
reasons for considering the protocol exempt from review.
Protocol Form (Download hereí)
Complete and send the corresponding form.
Research Instruments
Attach all the materials necessary for the research, such as
data sheets, interviews, surveys, manuals, and guides, according to
corresponds.
Letter of Interest from Establishments (Download here)
If the research is carried out in public or private health institutions, the research will be carried out in
submit a letter of interest signed by the authority
maximum of the corresponding establishment or coordination.
Request for evaluation. (Download here)
Submit the formal request for the evaluation of the study.
Protocol form. (Download here)
Complete and submit the research protocol submission form.
Informed consent (Download here)
For adults: include the informed consent document.
For minors: present consent of legal representatives and informed consent according to age and cognitive capacity.
In indigenous communities in Ecuador: translate these documents into ancestral languages when appropriate.
Comprehensive Informed Consent (Download here)
If your study will collect samples or data that will be used for future research, your research participants will be asked to complete and sign a comprehensive informed consent form.
Community Consent (if applicable)
In research with indigenous communities, submit collective consent signed by their legitimate leader, reflecting free, prior and informed consultation.
Research instruments
Attach data sheets, interviews, surveys, guides and any other necessary material.
Confidentiality Commitment (By each investigator and on the letterhead of the sponsoring institution. All together in a single document)
In studies involving human biological samples, vulnerable subjects or sensitive data, all investigators must sign a confidentiality agreement.
Conflict of Interest Statement (By each investigator and on the letterhead of the sponsoring institution. All together in a single document)
In studies involving biological samples, vulnerable subjects or sensitive data, submit a conflict of interest statement signed by the investigators.
Curriculum Vitae of Researchers (Download here)
Attach the CV of each participating researcher.
Letter of Interest from Establishments (Download here)
If the research is carried out in public or private institutions, submit a letter of interest signed by its highest authority.
