Human Research Ethics Committee (CEISH)

The Human Research Research Ethics Committee, CEISH-USFQ, is the body responsible for evaluating the bioethical, methodological, and legal aspects of all research involving human beings that requests review-approval by this committee, as well as approving the protocol and other documents related to the study.

The objective of the CEISH-USFQ is "to protect the dignity, rights, well-being, and security of human beings" participating in a research study (Ministerial Agreement No. 00 4889 published in the Official Registry Supplement No. 279 of July 1, 2014, Art 5). For this reason, the approval of a study is conditioned on compliance with the principles of autonomy, beneficence, justice, and non-maleficence within research with human beings.

Before sending a study for review, please review the different links that we detail below, especially the flow charts, which detail not only the process but the documents to be submitted.

In "frequently asked questions," you can answer your questions about which studies require committee approval.
In "documents" you can:

  • Access the documents that govern the internal investigation processes: "USFQ investigation manual"
  • Access standardized work processes for clinical trials and observational studies with biological samples.
  • Know the processes and regulations that a researcher must follow: "Investigator's Manual"
  • Know the review-approval processes of a study: “Flow Charts

In “forms”, there are all the standard formats approved to request a revision-approval from CEISH, the same ones that are available in “Word” to facilitate its use.

Training” describes the process to access one of the benefits that the CEISH-USFQ offers its researchers, which is to access, free of charge, the training of the CITI program (Collaborative Institutional Training Initiative).

About Us

CEISH-USFQ President: Iván Sisa, MD, MPH, MS

CEISH-USFQ Secretary: Mauricio Maldonado Muñoz, LLM, PhD

The CEISH-USFQ is made up of 11 active members representing four areas:

  • Health professionals experts in research methodology
  • Health professionals who are experts in bioethics
  • Legal professionals
  • Representatives of civil society (community)

It also has 11 external consultants in different areas of "expertise".

Organigrama

Organigrama comité bioética

Frequently Asked Questions

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:

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

Documents

CEISH-USFQ Statutes 2015

 DOWNLOAD DOCUMENT

Investigator's Manual 2017

 DOWNLOAD DOCUMENT

PNT for clinical trials

 DOWNLOAD DOCUMENT

PNT for observational studies with biological sample

 DOWNLOAD DOCUMENT

Flowchart for internal studies review

 DOWNLOAD DOCUMENT

Flowchart for review of external studies

 DOWNLOAD DOCUMENT

Flowchart of the review process of clinical studies or observational studies with biological samples

 DOWNLOAD DOCUMENT

Flowchart of the process to request renewals

 DOWNLOAD DOCUMENT

Flowchart of the process to request modifications

 DOWNLOAD DOCUMENT

Flowchart for requesting an appeal

 DOWNLOAD DOCUMENT

Forms

Before filling out any forms, please review: the Investigator's Manual; and the flow charts for the process you require (link: documents)

1.1 REQUEST FOR PROTOCOL OF THE INVESTIGATION EXEMPT-EXPEDITED STUDIES

1.2 REQUEST FOR A RESEARCH PROTOCOL FOR OBSERVATIONAL STUDIES WITH BIOLOGICAL SAMPLES AND-OR VULNERABLE POPULATION

1.3 REQUEST RESEARCH PROTOCOL FOR CLINICAL TRIAL

2.1 WRITTEN INFORMED CONSENT FORM

2.2 INFORMED CONSENT FORM FOR USE OF CLINICAL INFORMATION AND-OR BIOLOGICAL SAMPLES PREVIOUSLY COLLECTED

2.3 WRITTEN INFORMED CONSENT FORM FOR DATA STORAGE AND USE OF BIOLOGICAL SAMPLES IN FUTURE INVESTIGATIONS

2.4 INFORMED CONSENT FORM

2.5 MODIFICATION FORM OF THE WRITTEN INFORMED CONSENT FORM

2.6 JUSTIFICATION FOR THE NON-APPLICATION OF THE INFORMED CONSENT

3.1 RESEARCHER LIFE SHEET FORMAT

3.2 LETTER OF COMMITMENT FROM THE PRINCIPAL INVESTIGATOR OF A STUDY THAT HAS REQUESTED THE REVIEW-APPROVED OF THE CEISH-USFQ

3.3 CONFIDENTIALITY AGREEMENT FOR THE PRINCIPAL INVESTIGATOR OF A PROTOCOL APPROVED BY THE CEISH-USFQ

3.4 ABSENCE OF CONFLICT OF INTEREST STATEMENT FOR THE PRINCIPAL INVESTIGATOR OF A PROTOCOL SUBMITTED FOR REVIEW-APPROVAL OF THE CEISH-USFQ

4.1 REQUEST FOR RENEWAL OF APPROVED PROTOCOLS

4.2 REQUEST FOR MODIFICATION OF PREVIOUSLY APPROVED DOCUMENTS

For internal or external clinical studies, the same MSP forms will be used, which can be downloaded directly from the ARCSA website www.controlsanitario.gob.ec; For the convenience of researchers whose studies have been approved by this Committee, they are included below:

YELLOW CARD FORMAT MSP, TO REPORT ADVERSE REACTIONS TO MEDICINES

YELLOW CARD MSP FORMAT, TO REPORT SERIOUS ADVERSE EVENTS

Training

Every USFQ member or student has free access to courses on good practices and protection of human subjects in an investigation. To access this training they must follow the steps included in the instructions for the CITI training.

INSTRUCTIONS TO ACCESS THE COURSE ON BIOETHICS

  1. Access the electronic address: www.citiprogram.org
  2. The page is in English. If you prefer Spanish or another language, you must select the language at the top Left.
  3. New users must register by taking the following steps:
    • Click on the "Register" button
    • Write: "USFQ" as your participating Institution. Then click on “Continue to step 2”
    • Fill out Personal Information. Then click on “Continue to Step 3”
    • Create a Username and Password. Additionally, a security question must be selected and the answer to that question must be written. Then click on “Continue to step 4”
    • Select the Country of Residence, Gender, Ethnicity, and race. Then click on “Continue to step 5”
    • Complete the requested information. Then click on “Continue to step 6”
    • Complete the information requested by the University. Then click on “Continue to step 7”
    • Complete three modules: "Human Subjects", "Responsible Behavior Research", and "Good Clinical Practices". Optionally, other modules can be completed.
    • In the student menu, in the course book, four options are compulsory, including exams, for which you will receive a grade of 100%. It is suggested to take all the options of the Module "Human Subjects", although they do not count to pass this training, only the first four, starting with "Guarantee of integrity".
    • After completing the modules, a certificate is generated and will be sent to your email account.

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