MINISTRY OF HEALTH
OPERATING MANUAL OF THE NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH
San Salvador, March 2017.
one
Ministry of Health Vice Ministry of Health Policy Higher Council of Public Health
Directorate of Health Regulation and Legislation National Committee for Health Research Ethics
“OPERATING MANUAL OF THE NATIONAL COMMITTEE OF RESEARCH ETHICS
IN HEALTH"
SAN SALVADOR, EL SALVADOR 2017
two
CATALOG SHEET
2017 Ministry of Health
All rights reserved. The partial or total reproduction of this work is allowed, provided that the
source and not for sale or other commercial purpose.
The official documentation of the Ministry of Health can be consulted through:
http://asp.salud.gob.sv/regulacion/default.asp
OPERATING MANUAL OF THE NATIONAL COMMITTEE OF ETHICS OF THE
HEALTH RESEARCH ”
Printing:
Edition and Distribution Ministry of Health
Vice Ministry of Health of Health Policies Higher Council of Public Health
Arce Street No. 827, San Salvador. Telephone: 22 05 70 00 Official page: http://www.salud.gob.sv
Graphic project design:
Diagramming:
Printed in El Salvador by:
Ministry of Health. Vice Ministry of Health Policies. Higher Council of Public Health. Direction of
Regulation and Legislation in Health. National Committee for Health Research Ethics. San Salvador, El
Savior. AC
3
AUTHORITIES
Dr. Elvia Violeta Menjívar Escalante Minister of Health
Mr. Pedro Rosalío Escobar President of the Higher Council of Public Health
Dr. Eduardo Espinoza Fiallos Vice Minister of Health Policy
Dr. Julio Oscar Robles Ticas Deputy Minister of Health Services
4
TECHNICAL TEAM
Dr. Mario Ernesto Soriano Lima
President, National Committee of Health Research Ethics CSSP-MINSAL
Dr. David Torres
Vice President, National Committee for Health Research Ethics CSSP-MINSAL
Lic. Yeny Acosta
Secretary, National Committee for Health Research Ethics CSSP-MINSAL
Reviewers and update team
Ing. Tito Orlando Llanes Vocal
Dr. Gerardo Antonio Godoy Vocal Licda. Miriam Irene Meléndez Vocal Licda. Help Euphemia Stop
Vocal Licda. María Delsy Menjivar Vocal
Dr. Wilfrido Clará Vocal
Ms. Ángela de Rivas Administrative Assistant
5
INDEX
AGREEMENT
7
INTRODUCTION
8
I. LEGAL FRAMEWORK
9
II. MANUAL OBJECTIVES
10
III. CNEIS DESCRIPTION AND OPERATION
1. Nature
10
2. Dependency
10
3. Mission
eleven
4. Vision
eleven
5. Objectives of the committee
eleven
6. Ethical principles for health research 11
7. Requirements to become a member
12
8. Conformation
12
9. Attributions
13
10. Meetings
14
11. Functions of the President
14
12. Functions of the Vice President 15
13. Functions of the Secretary
fifteen
14. Roles of other members 16
15. Responsibilities of CNEIS 16
16. Training of members 18
17. Monitoring through the Higher Council of Public Health, (CSSP). 18
18. Removal of members
twenty
19. Conflict of interest
twenty
20. Financial Resources
twenty
21. Local Ethics Committees
twenty-one
IV. REVISION AND UPDATE OF THE MANUAL 22
V. VALIDITY
22
Annexes
2. 3
6
MINISTRY OF HEALTH
AGREEMENT No. 382
San Salvador, March 1, 2017.
THE EXECUTIVE BODY IN THE HEALTH BOARD CONSIDERING:
I. That in accordance with Articles 40 and 41 numeral 2 of the Health Code this Secretariat of
State, is the agency responsible for determining, planning, executing and issuing the relevant regulations, as well as
organize, coordinate and evaluate the execution of health related activities.
II. That Article 16 numeral 3 and 67 of the Internal Regulations of the Executive Branch establishes that it is
faculty of the Holder of this State Portfolio, approve and enforce the Manuals of
organization; as well as determine the administrative structure and operation of this Secretary of State.
III. That it is necessary to order and systematize the operation of the National Ethics Committee of research in
health, in order to develop the functions in an agile and timely manner.
THEREFORE: In use of its legal powers, AGREES to issue the following:
OPERATING MANUAL OF THE NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH ”
7
INTRODUCTION
The realization of clinical studies in all the countries of our continent, as in the rest of the
world, you must follow strict ethical and scientific principles. These principles are universal, above
of any difference between people, in order to safeguard the physical and psychic integrity of
the subjects involved, as stated in the declaration of the rights of the people of Helsinki.
In 2005, and due to the regulatory vacuum to evaluate biomedical research in humans in El
Salvador, the Higher Council of Public Health (CSSP) and the Ministry of Health (MINSAL), created the Committee of
National Bioethics, later called the National Committee for Clinical Research Ethics and, currently, the Committee
National Health Research Ethics (CNEIS).
In that period 2005-2010, a group of health and social science professionals from the country discussed and
approved the document Organization and Operation Guide of the National Research Ethics Committee in
Health, based on the fundamental principles established in the Nuremberg Code, the Declaration of Helsinki,
document subsequently amended (64th General Assembly, Fortaleza, Brazil, October 2013), and guides
proposed by the Council of International Organizations of Medical Sciences (CIOMS) and the
World Health Organization (WHO). Three basic ethical principles of similar moral strength respect for
people, charity and justice permeate all the principles of good clinical practice (PCB)
In this sense, the current health reform process involves the creation of legal technical instruments that
guarantee the protection of people, as well as the guiding tools in the ethical aspects of
research with a potential for innovations that can be generated from the research process, which
suppose scientific advances for medical sciences, going from the analysis of the biologiscist aspects and that
transcend the approach to social determination in health.
These facts highlight the need for a National Research Ethics Committee in
Health, as part of the set of regulatory authorities that promote uniform standards for
local committees of the country and, under any system, the sponsors of an investigation and the institutions that
Hiring researchers should allocate sufficient resources for the evaluation process.
This manual describes the process of organization and operation of the National Research Ethics Committee in
health, considering the laws and regulations in force in the country related to research, as well as
current international standards, which protect people who participate in health research.
8
I. LEGAL FRAMEWORK
Constitution of the Republic Article 79, states that “The State shall provide the necessary resources and
indispensable for the permanent control of the quality of chemical, pharmaceutical and
veterinarians, through surveillance agencies ”.
Helsinki Declaration of the World Medical Assembly Ethical principles for medical research
in human beings, during the 64th General Assembly, Fortaleza, Brazil, October 2013, described in its principles
ethical the following:
• The investigation protocol must be sent, for consideration, comment, advice and approval
to the relevant research ethics committee before beginning the study. This committee must be transparent.
in its operation, it must be independent of the researcher, the sponsor or any other type of
undue influence and must be properly qualified. The committee must consider laws and regulations
in force in the country where the research is carried out, as well as current international standards, but not
they should be allowed to reduce or eliminate any of the protections for people participating in the
investigation established in this Statement.
• The committee has the right to monitor ongoing trials. The researcher has the obligation to provide
control information to the committee, especially on any serious adverse incident. No amendment should be made in
the protocol without the consideration and approval of the committee. After the study is over, the
researchers must submit a final report to the committee with a summary of the results and conclusions
of the study.
Guide to Good Clinical Practices of Research in Human Health, Document of the Americas, revised in the IV
Pan American Conference for the Harmonization of Pharmaceutical Regulation, dated March of
2005, defines in its chapter the organization of the Research Ethics Committee or Review Committee
Institutional (CEI / CRI), structure, composition, functions and procedures.
International Ethical Guidelines for Biomedical Research in Human Beings Prepared by the Council
of International Medical Sciences Organizations (CIOMS) in collaboration with the World Organization of
Health, reviewed in Geneva, in 2012, orient, especially to low-income countries, in the
definition of national guidelines on biomedical research ethics, applying ethical standards in conditions
local, and establishing or redefining appropriate mechanisms for the ethical evaluation of research
in human beings, including in Guideline 2, related to the Ethics Evaluation Committee,
expressing the following: “All proposals to conduct research in human beings must be submitted
to one or more scientific evaluation and ethical evaluation committees to examine their scientific merit and acceptability
ethics. The evaluation committees must be independent of the research team, and any benefits
direct, financial or material that they could obtain from the investigation, should not depend on the result
of the evaluation. The researcher must obtain approval or authorization before conducting the investigation. The
Committee of
9
ethical evaluation should perform the additional revisions that are necessary during the investigation, including
Track your progress.
II. OBJECTIVES OF THE MANUAL
A. General
Standardize the procedures for the organization and operation of the National Research Ethics Committee in
Health (CNEIS) and Local Committee for Health Research (CEIS) of El Salvador, to ensure quality
of the processes of protection of the rights, security and well-being of the participating human beings
voluntarily in health research projects, in accordance with scientific and ethical principles
internationally approved.
B. Specific
1. Describe the nature and dependence of the Health Research Ethics Committee.
2. Detail the procedures for the organization of the Health Research Ethics Committee.
3. List the functions of the committee and its members.
III. CNEIS DESCRIPTION AND OPERATION
1. Nature
The National Committee for Health Research Ethics, hereinafter CNEIS is a useful body
public, independent and autonomous in the exercise of its functions, composed of technical experts
competent multidisciplinaries, responsible for protecting the rights, security and welfare of human beings
voluntarily participating in health research projects, in accordance with principles
internationally approved scientists and ethicists.
2. Dependency
The CNEIS was created on April 27, 2005 by the Ministry of Health and the Higher Council of Public Health, date in
which took the protest of law to the owners and alternate members elected on February 25 of the same
year. The CNEIS depends organically on the Ministry of Health, hereinafter MINSAL and administratively on the
Higher Public Health Council, hereinafter CSSP, and operates autonomously to ensure that all
research involving human beings in the country is conducted based on ethical principles
fundamental respect for people, considering the laws and regulations in force in the country,
as well as the current international norms established in the Declaration of Helsinski.
10
3. Mission
Ensure respect for the rights and safety of the participants involved in the activities of the
scientific research, seeking an independent, competent and timely evaluation of the ethical aspects of the
Health research
4. Vision
To be the national committee, with regional recognition, that provides professional services and
technicians in the evaluation of the ethical considerations of the investigation, to the scientific community of the country, in
special to the community that participates in health research projects, in order to help safeguard the
dignity, rights, security and welfare of all research participants.
5. Objectives of the National Committee for Health Research Ethics
to. general
Review the quality and integrity of research projects carried out in the country, for the
protection of people who participate as volunteers in a health research.
b. Specific
to. Supervise the proper protection of subjects involved in health research conducted in the country and the
ethical safeguards of the studies carried out.
b. Verify the application of international guidelines for the guarantee of Good Clinical Practices of
Research in Human Health.
c. Provide support to researchers in the ethical aspects of their projects.
6. Ethical principles for health research
All health research must be carried out in accordance with established ethical principles:
a) Principle of beneficence: research contributes to the well-being of people;
b) Principle of non-maleficence: the investigation must not cause deliberate or perverse harm to the
participants and people in general;
c) Principle of autonomy: research must protect the rights and dignity of participants and their
capacity for self-determination to make decisions. Your participation must be voluntary and based on the
informed consent;
d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
correct and appropriate; and to distributive justice, which
eleven
establishes the equitable distribution of burdens and benefits to research participants;
e) Principle of privacy, anonymity and confidentiality: all information and data of the participants obtained
Directly or indirectly they are confidential.
7. Requirements to become a member
To be a member of the CNEIS, the following requirements must be met:
a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
b) Be of notorious honesty;
c) Have professional and private conduct based on moral principles;
d) Have proven expertise in the field of research and the field of your profession;
e) Commitment and interest to participate actively in the activities of the Ethics Committee;
f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
their relatives in second degree of consanguinity or first of affinity;
g) Not be a member of organizations responsible for health research, or directors, officials,
employees or shareholders of pharmaceutical companies and their relatives in second degree of consanguinity or first
of affinity
8. Conformation
The CNEIS will be made up of eleven to thirteen proprietary members, of which five to seven will be professionals of
Health Sciences, four from the Social Sciences, one with experience in the area of ​​human rights and one with
training and leadership in theology, constituted in a way that ensures a competent evaluation and review of the
scientific, medical and ethical aspects of the study, as well as to achieve that their goals can be
executed free of bias and influence that could affect their independence. CNEIS members will be elected
by the Minister of Health and the President of the Higher Council of Public Health, through a
public call issued three months in advance that stipulates the requirements established to be
member of the Ethics Committee. For this, the acting Ethics Committee will prepare a list of selected candidates
by contest of merits based on the Curriculum Vitae and personal interview.
The members of the CNEIS will last three years in their functions, being able to be appointed for one more period.
The CNEIS will be composed of the President who will preside, a Vice-President, a Secretary and so many
Members as members have been registered in the Committee.
12
The President, the Vice President and the Secretary of the CNEIS will be appointed by majority vote of the members of the
Ethics Committee.
9. Attributions
For the purposes of the attributions of CNEIS, research in humans includes:
a) Studies of physiological, biochemical or pathological processes, or of the response to an intervention
specific-physical, chemical or psychological in patients or healthy subjects;
b) Controlled trials of diagnostic, preventive or therapeutic interventions in large groups of
people, designed to demonstrate a specific generalizable response against a background of biological variation
individual;
c) Studies designed to determine the consequences of specific preventive or therapeutic interventions for
individuals and communities;
d) Studies on human behavior related to health in various circumstances and environments.
Likewise, investigations can be classified into three categories according to risk:
a) Risk-free research: those in which intervention is not necessary
Some in the participating individuals. Data is collected through questionnaires, interviews, review of
clinical records and others;
b) Interventions with minimal risk: these are the investigations that use procedures
common for recording data, such as physical and psychological exams, or routine treatments in
clinical practice;
c) Interventions with higher risk: those that employ methods that can affect the
individuals, such as radiological studies, trials with commercial medications or in
development and studies that include surgical procedures and genetic studies.
Risk-free or minimal risk interventions will be evaluated by local ethics committees created in the
academic or health institutions and registered annually in the CNEIS. Investigations with higher risk should
be reviewed by local ethics committees, but registered and definitively approved by the CNEIS.
Taking into account the above, the attributions of the National Ethics Committee of Health research
They are as follows:
a) Issue an opinion to ensure that the rights and well-being of people included in health research
be properly protected;
13
b) Ensure that the researcher achieves the free consent of the people participating in the study,
and that the information obtained be confidential;
c) Ensure that there is a balance between risk and potential benefits in any study supported by
the CNEIS;
d) Ensure that researchers and sponsors of human studies comply with the principles
internationally accepted scientists and ethicists.
10. Meetings
The Ethics Committee will meet ordinarily every fifteen days, and extraordinarily when convened by the
Chairman of the Committee on his own initiative, or when requested by more than fifty percent of the
representation of its members.
In order for the CNEIS to hold a valid session, the attendance of the President, and / or the
Vice President, and / or Secretary and five of its members. The resolutions of the Ethics Committee are
they will take half plus one of the members that make up the quorum.
11. Functions of the President
The Chairman of the Ethics Committee will have the following functions:
a) Represent the CNEIS before the different national academic and scientific bodies and
foreigners involved in human research;
b) Chair the ordinary and extraordinary sessions of the Ethics Committee;
c) Represent and be a spokesperson for the Ethics Committee before the CSSP and MINSAL;
d) Coordinate together with the Secretary the scientific and ethical evaluation meetings of the projects of
health research submitted to the Ethics Committee for consideration;
e) Prepare the Annual Work Plan together with the members of the Committee;
f) Direct the Financial and Human Resources Administration of the Committee;
g) Coordinate and monitor the evaluation process of research projects in
health evaluated;
h) Authorize access to the relevant documentation of the projects evaluated to national organizations and
internationals that sponsor the use of medicines;
i) Manage and coordinate with other national and international organizations, clinical research activities,
research ethics and bioethics;
14
j) Support the creation of ethics committees at the national level, and promote the exchange of experiences with the committees
National and international;
k) Manage financial resources for the operation and training of Committee members
Ethics with the CSSP and MINSAL authorities;
l) Manage before the CSSP and MINSAL the call to elect a new Committee three months before
the period of the acting Ethics Committee has ended;
m) Keep the inscription of the Institute Review Board (IRB) and of the Federal Wide Assurance (FWA) updated before
the Office of Protection of Human Subjects in Research (OHRP), of the Department of Health of the States
United; Y
n) Direct the self-evaluation of the CNEIS every six months (Annex 1).
12. Functions of the Vice President
Assume all the responsibilities of the president during his absence or other specific activity that is
delegated by it.
13. Functions of the Secretary
The Secretary of the Ethics Committee shall have the following functions:
a) Act as Secretary of the Ethics Committee, where he participates with voice and vote;
b) Convene the meetings of the Ethics Committee 3 days in advance;
c) Coordinate and monitor the evaluation process of research projects in
health evaluated;
d) Write the Minutes of the Ethics Committee sessions;
e) Certify with its signature and that of the President the resolutions and agreements of the Ethics Committee;
f) Prepare with the President the Agenda to be discussed in the sessions of the Ethics Committee;
g) Notify interested parties of the resolutions issued by the Ethics Committee;
h) Collaborate in the preparation of the Annual Report of the Ethics Committee;
i) Perform the functions assigned by the President of the Ethics Committee;
j) Support to the President in the administration of the Ethics Committee funds; Y
fifteen
k) Keep updated the database of the projects analyzed by the Ethics Committee, which contains the following
Basic information on the status of each project:
- Number and name of the protocol.
- Code.
- Researcher data.
- Date of request and evaluation of the protocol.
- Dates of the first, second and third evaluation.
- Evaluation result code.
- Date and type of safety report.
- Closing date of the evaluation.
- Date of transfer to the central archive.
-     Observations.
14. Roles of the other members
a) Attend ordinary and extraordinary meetings when called;
b) Evaluate research protocols according to established operating procedures, and give their opinion
on compliance with ethical requirements;
c) Collaborate in the preparation of the Annual Work Plan and the Committee's Work Report;
d) Assume responsibility for the activities delegated by the Chairman of the Committee; Y
e) Send electronically the observations issued to the protocols assigned for the
Review of ethical considerations, three days before the ordinary session.
15. Responsibilities of CNEIS
a) The responsibility of a Research Ethics Committee in evaluating an investigation in
health is to contribute to safeguard the dignity, rights, security and well-being of all participants
current and potential research; special attention should be given to studies that may
involve vulnerable people;
b) A cardinal principle of research involving human beings is to respect the dignity of people.
The goals of research, while important should never go beyond health, well-being and
care of research participants;
c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
and disadvantages of the research are distributed equally among all groups and
classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
16
d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
proposed;
e) The CNEIS is responsible for acting in the full interest of the potential participants of the
research and of the communities involved, taking into account the interests and needs of
researchers, as well as the requirements of regulatory agencies and applicable laws;
f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
regular evaluation of developing studies that received a positive decision at intervals
appropriate according to the degree of risk to people, at least once a year;
g) The CNEIS has the authority to approve, request modifications (prior to approval),
refuse, or suspend a clinical study;
h) To fulfill its functions, the CNEIS must receive and have available all the documentation
related to the study: protocol, amendments thereto, informed consent forms and
updates to it, updated researcher's curriculum vitae, recruitment procedures,
patient information, investigator manual, available safety information, and payment information
to patients, information on patient compensation, and any other document than CNEIS
may need to fulfill their responsibilities;
i) The CNEIS must consider the competence of the investigator to conduct the proposed study, as documented
in the Curriculum Vitae and in all other relevant documentation requested by the CNEIS;
j) The CNEIS must review both the amount and the method of payment to individuals to ensure that they do not exist
coercion problems or bad influence on study subjects. Payments to the person must be assigned
and not depend on the subject finishing the study;
k) The CNEIS must ensure that information regarding the payment to individuals, including methods,
quantities and programming is stipulated in the form of written informed consent, as well as any
other written information provided to subjects. You must specify the way it will be
assigned payment.
17
16. Training of members
The CNEIS will promote the continuous training of its members in the following subject: courses on
research and ethics methodology, expert conferences, workshops, conferences and diplomas (Magister
in Bioethics). These trainings can be extended to the members of the local ethics committees.
17. Monitoring through the Higher Council of Public Health, (CSSP).
The objectives of monitoring a study are to verify that:
a) The rights and welfare of human beings are protected;
b) The reported data of the study are complete, accurate and can be verified from the source documents; Y
c) The conduct of the study is in accordance with the protocol / amendments, approved, with the
Guidelines for Good Clinical Practices (BPC) in establishments where they are carried out
research or clinical trials involving people. (adaptation of the harmonized tripartite guide of
the international harmonization conference iche 6r1).
A written monitoring plan must be available and for the selection of studies that will receive monitoring
the scope and nature of monitoring should be determined based on considerations such as the objective,
design, complexity, blind studies, size, study measurement points, adverse effects report
Serious, EAS or SUSAR.
The actions to be carried out during monitoring are the following:
a) Verify that the researcher is qualified and has adequate resources and they
maintain during the study that the facilities, including the laboratory, equipment and the
staff are suitable to conduct the study safely and appropriately and are maintained in this way
during it;
b) Verify with respect to the product under investigation that:
i. storage times and conditions are acceptable and supplies are
sufficient during the study the research product is provided only to the subjects that are
eligible to receive it and at the doses specified in the protocol;
ii. subjects are provided with the necessary instructions on the use, handling, storage and return
appropriate research product;
iii. the reception, use and return of the product under investigation at the sites where the
study is controlled and properly documented; Y
18
iv. The disposition of the unused research product, at the sites where the study is conducted,
Comply with applicable regulatory requirements and be in compliance with the sponsor.
c) Verify that the investigator follows the approved protocol and all the approved amendments, if the
would have
d) Verify that the written informed consent of each subject has been obtained before participating in
the study;
e) Ensure that the researcher receives the current Investigator Manual, all documents and documents
study supplies needed to properly conduct the study and to
comply with applicable regulatory requirements;
f) Ensure that the researcher and that the investigator's study staff are adequately informed about
the study;
g) Verify that the investigator's study staff are carrying out the specific functions
of the study in accordance with the protocol and with any other written agreement between the sponsor and
the researcher / institution and that they have not delegated;
h) Verify that the investigator is only accepting eligible subjects;
i) Report the recruitment rate of subjects;
j) Verify that the data source / document and other records of the investigation are accurate, complete
keep updated and preserved;
k) Verify that the researcher provides all reports, notifications, requests and
required submissions and that these documents are accurate, complete, timely, legible, are
dated and identify the study;
l) Inform the investigator of any error, omission or illegibility in the protocol data. The
Monitor should ensure that corrections, additions or relevant erasures are made,
date and an explanation is given (if necessary) and initialized by the investigator or a member of the team
investigation of the study that is authorized to make and initialize changes in the protocol instead
of the researcher. This authorization must be documented;
m) Determine if all adverse events (EAS) are properly reported within the periods of
time required according to the respective legal technical instrument; Y
n) Communicate deviations from the protocol and regulatory requirements applicable to the researcher and take the
appropriate measures to prevent a recurrence of the detected deviations.
19
Post-monitoring procedures are:
a) Submit a written report to the President of the Higher Council of Public Health and the National Ethics Committee of
the Investigation, after each visit to the place where the study is carried out or a communication related to the
study;
b) The report must include the date, place, name of the monitor and name of the investigator or other individuals to whom
has been contacted; Y
c) The reports must include a summary of what the monitor reviewed as well as statements
concerning findings / facts, significant deviations, conclusions, actions taken or by
Take and / or recommended actions to ensure compliance.
18. Removal of members
Causes for dismissal of the members of the Ethics Committee are considered:
a) Unexcused absences to five consecutive Committee sessions;
b) Lack of confidentiality of the evaluation processes of research projects; Y
c) Acts of corruption proven by enforceable judgment.
19. Conflict of interest
An investigator may be a member of the CNEIS but is not allowed to participate in the initial evaluation and review
after a study in which you have a conflict of interest (for example if you are part of the study in some way).
At the time of selecting the members of the CNEIS, these potential conflicts of interest must be considered.
consider. These members must refrain from intervening in the deliberations of the CNEIS and in the voting of the
studies in which the conflict of interest situation arises.
The main decision makers of the entity that create the CNEIS, or of any organization that
sponsors or conducts research examined by the CNEIS (as the director of an institution or its
representative), cannot be members of the CNEIS or preside over it.
20. Financial Resources
The National Committee for Health Research Ethics (CNEIS), will periodically receive support services from the
CSSP, including technical and administrative assistance, information technology, and infrastructure. As well as financial management
of the funds obtained by the ethical evaluation services, through a special account created to
such end, based on
twenty
“Guidelines for the management of the circulating funds of fixed amount of the CSSP”, as well as the regulation of the “Law of
Acquisitions and Contracting of the Public Administration ”, as appropriate.
The functioning of CNEIS members for the ethical evaluation of research
It is ad-honorem.
The economic resources obtained from the tariff for the ethical evaluation services required by the studies
clinical, will be destined to reinforce the budget of the CNEIS, according to the source of sponsorship. Which will be
used for food services, transfers, staff training, furniture, computer equipment,
telephony, stationery, knowledge management activities, participation in activities inside and outside the country
related to the functioning of the committee.
The fee for the ethical evaluation of investigations is as follows:
• International pharmaceutical companies: US $ 1,500.00;
• National pharmaceutical companies: US $ 1,000.00;
• Non-profit non-governmental organizations and foreign universities:
US $ 500.00;
• Local private universities: US $ 400.00
• Without sponsorship and state sources: the case will be evaluated to exempt payment;
• Annual renewals of ethical authorizations: one third of the annual amount.
21. Local Ethics Committees
For the organization and operation of the Local Health Research Ethics Committee, CEIS, must
apply the mechanisms described in this Manual and in other legal technical instruments that are
consider relevant.
For the formation of local Committees, it must be considered that at least one of the members must be not
scientist and in the case of an Institutional Committee must include an external member (who does not have
relationship with some official or staff of the institution). It is also recommended that one of the members
possess knowledge of biostatistics and / or research methodology.
The CNEIS may register local Ethics Committees at the written request of the academic or health institutions
upon request (Annex 2). For this, applicants must submit the creation documents
respective:
a) Certificate of formation;
b) Specific registration request form;
c) Regulations or regulations of the organization and operation of the local Committee; Y
d) Curriculum vitae of the members of the local Committee.
twenty-one
The CNEIS will designate an ad-hoc commission to visit the institution requesting registration, whose report will be
discussed by the Ethics Committee and the resolution sent to the CSSP, MINSAL and institution authorities
applicant.
All registration must be updated every period that the local committee is renewed, for which the local Committee
will send the following information:
a) Letter of application for updating the registration;
b) Specific form for said process; Y
c) Curriculum vitae of the active members of the local committee.
The CEIS must send reports of evaluated studies, as well as resolutions made to the CNEIS, with a periodicity
annual, as a mechanism for exchanging information between the CEIS and the CNEIS. According to Annex 3, Control Matrix of
research protocols
IV. REVISION AND UPDATE OF THE MANUAL
This Manual should be reviewed and updated periodically, when required according to the needs
MINSAL institutions.
V. VALIDITY
This Manual will become effective as of this date. COMMUNICATE
GOD UNION AND FREEDOM
22
APPENDIX 1
CEIS SELF-ASSESSMENT QUESTIONNAIRE (CHECKLIST)
This questionnaire is useful for reviewing / reconsidering the procedures and operations of a CEIS. Most
the items are also applicable to committees not affiliated with an institution. Written procedures may
Audit to verify compliance.
Three response categories were established for each item in relation to written procedures: Yes, No or NA (no
applicable), as appropriate.
DOES THE CEIS HAVE PROCEDURES OR WRITTEN POLICIES THAT DESCRIBE THE FOLLOWING ITEMS?
1) Do you have authorization from the institution to establish the CEIS?
Yes  No  NA 
2) Do you have defined the objective (s) of the CEIS (for example, to protect the patients who participate in
clinical research)
Yes  No  NA 
3) Do you have principles that govern the CEIS for the protection of patients' rights and well-being in
investigation?
Yes  No  NA 
4) Scope of the ethics committee authority
a) Do you have defined the type of clinical trials you evaluate?
Yes  No  NA 
b) Do you have the authority to approve, disapprove or modify a clinical study based on the protection of subjects
humans?
Yes  No  NA 
c) Authority to request written reports of the progress / progress of the study by researchers and
to monitor the conduct of the study?
Yes  No  NA 
d) Authority to suspend or terminate a previously granted authorization?
Yes  No  NA 
2. 3
e) Authority to set restrictions in a study?
Yes  No  NA 
5) The CEIS has defined relations with:
a) administration of the institution
Yes  No  NA 
b) other committees or department headquarters
Yes  No  NA 
c) clinical researchers
Yes  No  NA 
d) regulatory authorities
Yes  No  NA 
6) Do you have the requirements of the members defined?
a) Number of members
Yes  No  NA 
b) Qualification of members
Yes  No  NA 
c) Diversity of members
c.1) at least one member of an area of ​​non-scientific interest
Yes  No  NA 
c.2) men and women
Yes  No  NA 
c.3) at least one independent member of the institution where the study will be carried out
Yes  No  NA 
d) Alternative / alternate members
24
Yes  No  NA 
7) Administration of the ethics committee
a) Chairman of the ethics committee
a.1) selection and designation process Yes  No  NA  a.2) period of service
Yes  No  NA 
a.3) obligations / responsibilities
Yes  No  NA 
a.4) removal process
Yes  No  NA 
b) The members of the ethics committee b.1) selection and designation process Yes  No 
NA  b.2) service period
Yes  No  NA 
b.3) obligations / responsibilities
Yes  No  NA  b.4) attendance / presence requirements Yes 
No  NA  b.5) removal process
Yes  No  NA 
c) Do you have defined the training of the President and the members of the committee? c.1) orientation or initial indications
Yes  No  NA 
25
c.2) continuing education
Yes  No  NA 
c.3) reference / reference materials (library)
Yes  No  NA 
d) Compensation of committee members
Yes  No  NA 
e) Liability coverage of the members of the ethics committee
Yes  No  NA 
f) Use of external consultants / consultants
Yes  No  NA 
g) Obligations of administrative / secretarial staff
Yes  No  NA 
h) Do you have defined what resources you need to have? (physical meeting place, phone, files,
equipment, computers, etc.)
Yes  No  NA 
i) Do you have a conflict of interest policy defined?
i.1) No selection of CEIS members by the investigator
Yes  No  NA 
i.2) Is the prohibition on participating in the deliberations and voting of researchers defined?
Yes  No  NA 
8) Functions of the ethics committee
a) Do you have defined the initial and continuous evaluation of the studies?
Yes  No  NA 
b) Do you have defined the form of written report of findings and actions to be taken directed at the researcher and the
institution?
26
Yes  No  NA 
c) Do you have defined studies that require more frequent verification than the annual review?
Yes  No  NA 
d) Do you have identified studies that require verification from other sources, apart from the researcher, for the
Review of changes that may have occurred since the prior evaluation of the ethics committee?
Yes  No  NA 
e) Do you have established that the changes in the approved study are not implemented without the review and approval of the
CEIS, except when it is necessary to eliminate immediate damage?
Yes  No  NA 
f) Do you have defined the immediate report to the CEIS and regulatory agencies of:
f.1) previously unidentified problems that put the study patients at risk?
Yes  No  NA 
f.2) serious failure to comply with current regulations or CEIS requirements?
Yes  No  NA 
f.3) suspension or cancellation of the approval given by the CEIS?
Yes  No  NA 
f.4) identification of studies with devices that carry significant risks?
Yes  No  NA 
9) Operational functioning of the ethics committee
a) Schedule meetings
Yes  No  NA 
b) Distribution to members of information on the place and date of the meeting, agenda, study materials a
check, etc.
27
Yes  No  NA 
c) Has a review / evaluation process that ensures
c.1) That all members receive the study documentation to be evaluated (or only some who will discuss it later)
with the Committee in full)
Yes  No  NA 
Or what:
c.2) One or more evaluators (primary / secondary) receive full documentation to review, report
to the Committee and lead the discussions. In case other members review the summary, those members should have access
to the complete documentation
Yes  No  NA  c.3) Role of any CEIS subcommittee Yes 
No  NA 
c.4) emergency notifications and reporting processes
Yes  No  NA 
c.5) expedited evaluation procedures for approval of studies or changes (studies already approved) that involve
minimal risks
Yes  No  NA 
d) Approval criteria by the ethics committee that contain all the requirements
Yes  No  NA 
e) Voting requirements e.1) quorum required
Yes  No  NA 
e.2) Quorum diversity requirements (for example, the requirement that at least one of
voting members be a doctor, for review of studies with products in development)
Yes  No  NA 
e.3) percentage required to approve or reject a study
Yes  No  NA 
28
e.4) voting rights of the evaluating members
Yes  No  NA 
e.5) no acceptance of written or telephone votes
Yes  No  NA 
e.6) prohibition of voting in case of conflict of interest
Yes  No  NA 
f) Further approvals or revisions by other parties within the institution
Yes  No  NA 
g) CEIS communications
g.1) to the investigator, informing the decision of the CEIS
Yes  No  NA 
g.2) to the hospital administration, informing the decision of the CEIS
Yes  No  NA 
g.3) to the research sponsor, informing the decision of the CEIS
Yes  No  NA 
h) Appeal of CEIS decisions h.1) Appeal criteria
Yes  No  NA  h.2) to whom the appeal is directed Yes 
No  NA 
h.3) how the appeal is resolved (rejection of a disapproval is prohibited)
Yes  No  NA 
10) Documentation requirements / records of the CEIS
a) List of members describing their qualifications
29
Yes  No  NA 
b) Written procedures and standards
Yes  No  NA 
c) Report of the meetings
Yes  No  NA 
c.1) members present (consultants / advisors and visits registered separately)
Yes  No  NA 
c.2) summary of discussions on the issues discussed (record of decisions taken by the CEIS)
Yes  No  NA 
c.3) registration of the vote (votes in favor, against and abstentions)
Yes  No  NA 
d) Retention / archiving of the evaluated protocols and approved consent documents
Yes  No  NA 
e) Communication to and from the CEIS
Yes  No  NA 
f) Report of adverse reactions and documentation of the review of such reports by the CEIS
Yes  No  NA 
g) Records of continuous evaluations by the CEIS
Yes  No  NA 
h) Required time to file records
Yes  No  NA 
i) Registration of budgets and accounting
Yes  No  NA 
30
j) Reports for use in emergencies
Yes  No  NA 
k) Declarations of new significant findings communicated to patients / subjects
Yes  No  NA 
11) Information submitted to the CEIS by the researcher
a) Background / qualifications that support it to carry out clinical research (including a description of the
necessary services and equipment for research)
Yes  No  NA 
b) Clinical study protocol that includes b.1) study title
Yes  No  NA 
b.2) objective of the study (including the benefits expected from the study, once
accomplished)
Yes  No  NA 
b.3) study sponsor
Yes  No  NA 
b.4) results of previous related investigations
Yes  No  NA 
b.5) ​​inclusion and exclusion criteria
Yes  No  NA 
b.6) justification for the use of any population of patients or special or vulnerable subjects (for
example, people who cannot make a decision or children)
Yes  No  NA 
b.7) study design (including, if necessary, a discussion of the acceptability of the methods of
investigation)
Yes  No  NA 
31
b.8) description of the study procedures
Yes  No  NA 
b.9) management of adverse events
Yes  No  NA 
b.10) procedures related to consent, including the place, autonomy of the subject, difficulties of the
language, vulnerable populations, etc.
Yes  No  NA 
b.11) procedures for the documentation of the Informed Consent, which includes any procedure
for obtaining it by minors, use of witnesses, translators and how these are preserved
documents
Yes  No  NA 
b.12) compensation of patients for their participation
Yes  No  NA 
b.13) compensation in case of patients who have suffered damage in the study
Yes  No  NA 
b.14) protection of the privacy of the patient / subject
Yes  No  NA 
b.15) extra costs for patients / subjects derived from their participation.
Yes  No  NA 
c) Researcher Monograph (if any)
Yes  No  NA 
d) Case report record [FRC / CRF] (if any)
Yes  No  NA 
e) Proposed Informed Consent Document e.1) all requirements are met
32
Yes  No  NA 
e.2) translations of consent documents, considering patient populations that require it
Yes  No  NA 
f) Request for amendments to the study, after initiation
Yes  No  NA 
g) Report of unexpected adverse events
Yes  No  NA 
h) Progress / progress report
Yes  No  NA 
i) Final report
Yes  No  NA 
j) Institutional reports / reports
Yes  No  NA 
12) Exception of Informed Consent in emergency situations
a) Guarantee of compliance with the non-approval of this type of studies in the institution
Yes  No  NA 
b) The ethics committee must inform immediately, in writing, if it decides not to approve a study, including
reasons
Yes  No  NA 
c) To approve a consent exception, the committee must have and document the following:
c.1) that the subjects are in a life-threatening condition, that there are no treatments available
or satisfactory for that condition and that the need to obtain / gather scientific evidence is necessary
Yes  No  NA 
c.2) that it is not possible to obtain consent because
33
c.2.1) the medical condition prevents consent
Yes  No  NA 
c.2.2) there is not enough time to obtain the consent of the authorized legal representative
Yes  No  NA 
c.2.3) because identifying the legal representative is unreasonable
Yes  No  NA 
c.3) that there are expected benefits for the subjects because c.3.1) the life-threatening situation needs to be treated
Yes  No  NA 
c.3.2) the previous data guarantee the benefit for the patients
Yes  No  NA 
c.3.3) the risk / benefit of the standard and proposed treatment is reasonable
Yes  No  NA 
c.4) an exceptional situation is necessary to carry out the study
Yes  No  NA 
c.5) a therapeutic window is defined in which the researcher will make all the necessary efforts to
Obtain consent instead of starting without consent. A summary of all efforts made will be
documented and delivered to the ethics committee, during the continuous review of the study (by CEIS).
Yes  No  NA 
c.6) CEIS evaluates and approves the consent process and its documentation. The CEIS evaluates and approves the
procedures in case of objection by the family
Yes  No  NA 
c.7) additional protective behaviors, including at least c.7.1) consultation with community representatives
3. 4
Yes  No  NA 
c.7.2) make plans, benefits and risks available to the public
Yes  No  NA 
c.7.3) make the results of the study available to the public
Yes  No  NA 
c.7.4) ensure that an Independent Data Monitoring Committee has been established
Yes  No  NA 
c.7.5) summary of the family member's objection for continued review
Yes  No  NA 
c.8) ensure the implementation of procedures to inform as quickly as possible the inclusion of the
patient to study (participation may in these cases be discontinued). Procedures to inform the
family that the patient was in the study, if he died.
Yes  No  NA 
c.9) CEIS disapproval must be documented in writing and sent to the researcher and the sponsor of the
study. The sponsor must report this to its regulatory authority, other researchers and other CEIS
involved
Yes  No  NA 
35
APPENDIX 2
REGISTRATION OF LOCAL HEALTH RESEARCH ETHICS COMMITTEES (CEIS) BEFORE THE NATIONAL COMMITTEE OF ETHICS OF
HEALTH RESEARCH (CNEIS)
[] New file [] Renewal
Institution in which the CEIS operates:
Address to send correspondence:
Director of the institution where the CEIS operates: Names:
Surnames:
Degrees:
Telephone fax:
E-mail:
Address:
President of the CEIS Names:
Surnames:
Degrees:
Telephone fax:
E-mail:
Address:
Registration number (in case of renewal):
CEIS operating data
to. Has your Committee been accredited by an international body?
36
[   ] If not
If yes, provide the name of that accrediting organization:
Accreditation Date:
Number:
Total number of active protocols (approximately):
Approximate number of people hired for the administrative activities of the Committee:
Does the Committee evaluate international financing studies?
[   ] If not
Approximate number of active studies with funding from international organizations:
Approximate number of active studies with funding from transnational pharmaceutical companies:
Approximate number of local studies (of your institution) active:
Approximate number of active expedited evaluation studies:
Active protocols that involve (check all that apply):
[] medications [] food additives
[] medical devices [] coloring additives
[] biological products [] other
Do Committee members receive a certain type of continuing education in research ethics? [] Yes
[   ]Do not
37
Table of members of the CEIS
Member's Name (Last Name, First Name)
Gender M / F
Academic degree
Primary scientific or non-scientific specialty
Affiliation * with the institution Yes / No
Comments Place “**” to the substitutes
* Affiliate means that the person is hired to work with the institution.
What is the duration of the period of its members?
Do they have updated internal regulations?
[   ] If not
Do they have standardized operating procedures?
[   ] If not
Do you have a calendar of ordinary meetings?
[   ] If not
Submit this application accompanied by: Certificate of formation
Internal regulations
Summary curriculum of Committee members
38