Human Research Ethics Committee (CEISH)

What is the Human Research Ethics Committee?
The Human Research Research Ethics Committee, CEISH-USFQ, is a multidisciplinary body, which is part of the Universidad San Francisco de Quito, which is governed by national regulations for CEISHs in the country (Ministerial Agreement No. 00 4889 published in Official Registry Supplement No. 279 of July 1, 2014). It is responsible: for the technical evaluation from the bioethical approach, for the approval of studies involving human subjects; of the follow-up of clinical studies approved by the CEISH-USFQ..

What is the purpose of the Human Research Ethics Committee?
Its primary function is to evaluate the ethical, legal, scientific, and social aspects of any research project that involves human beings, submitted to this committee for review and approval. In addition, the CEISH-USFQ offers advice and training on issues related to ethics in scientific research.

Does the Human Research Ethics Committee only deal with medical and health research?
NO. The Human Research Ethics Committee is responsible for reviewing research requests in all areas of knowledge that relate to human subjects. The Committee is equivalent to an Institutional Review Board (IRB) in other countries. According to the Research Manual, published by the Research Dean of the USFQ, it is mandatory to request the approval of the Committee before conducting any research with human subjects.

What does the CEISH-USFQ do?
The Committee conducts a technical review from a bioethical approach, to ensure that research proposals comply with the principles of autonomy, justice, beneficence and non-maleficence, that is to say that:

• The risks associated with the voluntary participation of subjects in the research are minimal, or are justified because the benefits resulting from the study are greater;
• Consent and / or informed consent forms are used to inform participating subjects about what the study will do, how it will do it, when, where, how long it will take, the risk-benefits, and the options you have before make the decision to participate.
• Processes have been designed to keep the confidentiality and security of the information collected during all phases of the study.

The CEISH-USFQ also reviews that the design, methodology, processes, and instruments to be applied within the study comply with national and international standards for research ethics and with local laws.

What should a researcher do to request the review and approval of the Human Research Ethics Committee?
A researcher belonging to the USFQ community should review both the "USFQ Research Manual" as well as the "Investigator's Manual", Standard Working Procedures (SOPs) for clinical trials and observational studies with biological samples - if applicable - flow charts of CEISH-USFQ processes, to know how to request a review and the process that will be followed after receiving the documents.
External researchers: independent researchers, national universities, foreign universities, private or multinational companies, must:

• Consult the CEISH-USFQ review-approval costs for external studies at: comitebioetica@usfq.edu.ec
• Make the transfer and send a copy of it.
• Fill out the documents relevant to your study: "forms"
• Submit all documents digitally to comitebioetica@usfq.edu.ec

What are the costs of reviewing a study for external researchers?
Consult the CEISH-USFQ review-approval costs for external studies at: comitebioetica@usfq.edu.ec

How long does a review take?
Depending on the level of complexity and risk of a study, it is classified as exempt, expedited and in plenary session. The preparation of review reports for:

• Exempt studies, it takes between 8 and 15 days.
• Expedited studies, takes between 15 and 30 days.
• Full Board Studies, takes between 30 and 45 days.

These times may be extended depending on the number of requests for review-approval received by CEISH-USFQ, and the availability of active members and external consultants who will perform the review and approval of the documents.

Who are members of the Human Research Ethics Committee?
Review “about us: members and organization chart”.

What kind of studies require CEISH approval?
Any study that:

• Include direct intervention with humans
• Collect information from human beings, either primary or secondary (sample records)
• Collect biological samples from humans

If my study is not risky or the risk is minimal for participants, should I submit it for CEISH review?
Yes. The level of risk is not determined by the researcher but by CEISH, once the protocol and all its documents have been thoroughly reviewed and analyzed. Although a study is of minimal risk, CEISH must evaluate that the bioethical processes and aspects of the study are well described, clear, complete and feasible.

Do all investigations require the same type of review by the Committee?
No. The number of reviewers, the review parameters, and the level of analysis depth varies according to the risk level of the study:

• Minimum (exempt): Review form for minimal risk studies. Internal review of the management coordination and the president of CEISH. Immediate approval once the responses to all observations sent to the investigator are received, to the satisfaction of the committee. Eg: observational studies without direct intervention; studies with secondary information.
• Greater than the minimum (expedited): Form for expedited studies. Management coordination forecast, and review of at least two active members and -or an external consultant. Approval after evidencing that all the observations sent to the investigator were answered or justified. Eg: Studies with direct intervention with adult human subjects who voluntarily decide to participate, without collecting biological samples.
• High (Full Board): Form for reviewing high-risk studies. Prerevision and review of at least four active members of the committee, representatives of the areas of: research methodology, legal, bioethics and civil society, with approval in ordinary or extraordinary session of the Board in plenary session. Eg: Studies that test drugs, devices or products for human use and that require sanitary registration; studies that collect biological samples as part of the research; studies with vulnerable population.

What do the CEISH-USFQ observations consist of?
They are suggestions for modifications-clarifications to improve the quality of the protocol and-or the requirement of additional documents.
The lead investigator has three options when receiving observations that are included in the review report: 

1. Receive the observations and make the pertinent modifications in the documents.
2. Justify why the observation is not accepted.
3. Ignore the observations and not respond to them, before which the CEISH-USFQ will stop the review process and archive the proposal.

The researcher must fill out the document “response to CEISH-USFQ observations”, attach the modified versions of all documents, and send them to: comitebioetica@usfq.edu.ec