79C3C34C52B45572883A05D425EB0F82
Manual on the Functioning of the Health Research Ethics Committee
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / vulnerable
Searching for indicator vulnerable:
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p.000014: fifteen
p.000014: k) Keep updated the database of the projects analyzed by the Ethics Committee, which contains the following
p.000014: Basic information on the status of each project:
p.000014: - Number and name of the protocol.
p.000014: - Code.
p.000014: - Researcher data.
p.000014: - Date of request and evaluation of the protocol.
p.000014: - Dates of the first, second and third evaluation.
p.000014: - Evaluation result code.
p.000014: - Date and type of safety report.
p.000014: - Closing date of the evaluation.
p.000014: - Date of transfer to the central archive.
p.000014: - Observations.
p.000014: 14. Roles of the other members
p.000014: a) Attend ordinary and extraordinary meetings when called;
p.000014: b) Evaluate research protocols according to established operating procedures, and give their opinion
p.000014: on compliance with ethical requirements;
p.000014: c) Collaborate in the preparation of the Annual Work Plan and the Committee's Work Report;
p.000014: d) Assume responsibility for the activities delegated by the Chairman of the Committee; Y
p.000014: e) Send electronically the observations issued to the protocols assigned for the
p.000014: Review of ethical considerations, three days before the ordinary session.
p.000014: 15. Responsibilities of CNEIS
p.000014: a) The responsibility of a Research Ethics Committee in evaluating an investigation in
p.000014: health is to contribute to safeguard the dignity, rights, security and well-being of all participants
p.000014: current and potential research; special attention should be given to studies that may
p.000014: involve vulnerable people;
p.000014: b) A cardinal principle of research involving human beings is to respect the dignity of people.
p.000014: The goals of research, while important should never go beyond health, well-being and
p.000014: care of research participants;
p.000014: c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
p.000014: and disadvantages of the research are distributed equally among all groups and
p.000014: classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
p.000016: 16
p.000016: d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
p.000016: proposed;
p.000016: e) The CNEIS is responsible for acting in the full interest of the potential participants of the
p.000016: research and of the communities involved, taking into account the interests and needs of
p.000016: researchers, as well as the requirements of regulatory agencies and applicable laws;
p.000016: f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
p.000016: regular evaluation of developing studies that received a positive decision at intervals
p.000016: appropriate according to the degree of risk to people, at least once a year;
p.000016: g) The CNEIS has the authority to approve, request modifications (prior to approval),
p.000016: refuse, or suspend a clinical study;
...
p.000029: Yes No NA
p.000029: c.2) summary of discussions on the issues discussed (record of decisions taken by the CEIS)
p.000029: Yes No NA
p.000029: c.3) registration of the vote (votes in favor, against and abstentions)
p.000029: Yes No NA
p.000029: d) Retention / archiving of the evaluated protocols and approved consent documents
p.000029: Yes No NA
p.000029: e) Communication to and from the CEIS
p.000029: Yes No NA
p.000029: f) Report of adverse reactions and documentation of the review of such reports by the CEIS
p.000029: Yes No NA
p.000029: g) Records of continuous evaluations by the CEIS
p.000029: Yes No NA
p.000029: h) Required time to file records
p.000029: Yes No NA
p.000029: i) Registration of budgets and accounting
p.000029: Yes No NA
p.000030: 30
p.000030: j) Reports for use in emergencies
p.000030: Yes No NA
p.000030: k) Declarations of new significant findings communicated to patients / subjects
p.000030: Yes No NA
p.000030: 11) Information submitted to the CEIS by the researcher
p.000030: a) Background / qualifications that support it to carry out clinical research (including a description of the
p.000030: necessary services and equipment for research)
p.000030: Yes No NA
p.000030: b) Clinical study protocol that includes b.1) study title
p.000030: Yes No NA
p.000030: b.2) objective of the study (including the benefits expected from the study, once
p.000030: accomplished)
p.000030: Yes No NA
p.000030: b.3) study sponsor
p.000030: Yes No NA
p.000030: b.4) results of previous related investigations
p.000030: Yes No NA
p.000030: b.5) inclusion and exclusion criteria
p.000030: Yes No NA
p.000030: b.6) justification for the use of any population of patients or special or vulnerable subjects (for
p.000030: example, people who cannot make a decision or children)
p.000030: Yes No NA
p.000030: b.7) study design (including, if necessary, a discussion of the acceptability of the methods of
p.000030: investigation)
p.000030: Yes No NA
p.000031: 31
p.000031: b.8) description of the study procedures
p.000031: Yes No NA
p.000031: b.9) management of adverse events
p.000031: Yes No NA
p.000031: b.10) procedures related to consent, including the place, autonomy of the subject, difficulties of the
p.000031: language, vulnerable populations, etc.
p.000031: Yes No NA
p.000031: b.11) procedures for the documentation of the Informed Consent, which includes any procedure
p.000031: for obtaining it by minors, use of witnesses, translators and how these are preserved
p.000031: documents
p.000031: Yes No NA
p.000031: b.12) compensation of patients for their participation
p.000031: Yes No NA
p.000031: b.13) compensation in case of patients who have suffered damage in the study
p.000031: Yes No NA
p.000031: b.14) protection of the privacy of the patient / subject
p.000031: Yes No NA
p.000031: b.15) extra costs for patients / subjects derived from their participation.
p.000031: Yes No NA
p.000031: c) Researcher Monograph (if any)
p.000031: Yes No NA
p.000031: d) Case report record [FRC / CRF] (if any)
p.000031: Yes No NA
p.000031: e) Proposed Informed Consent Document e.1) all requirements are met
p.000032: 32
p.000032: Yes No NA
p.000032: e.2) translations of consent documents, considering patient populations that require it
p.000032: Yes No NA
p.000032: f) Request for amendments to the study, after initiation
p.000032: Yes No NA
p.000032: g) Report of unexpected adverse events
p.000032: Yes No NA
p.000032: h) Progress / progress report
p.000032: Yes No NA
p.000032: i) Final report
p.000032: Yes No NA
p.000032: j) Institutional reports / reports
p.000032: Yes No NA
p.000032: 12) Exception of Informed Consent in emergency situations
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Health / Drug Dependence
Searching for indicator dependence:
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p.000008: local, and establishing or redefining appropriate mechanisms for the ethical evaluation of research
p.000008: in human beings, including in Guideline 2, related to the Ethics Evaluation Committee,
p.000008: expressing the following: “All proposals to conduct research in human beings must be submitted
p.000008: to one or more scientific evaluation and ethical evaluation committees to examine their scientific merit and acceptability
p.000008: ethics. The evaluation committees must be independent of the research team, and any benefits
p.000008: direct, financial or material that they could obtain from the investigation, should not depend on the result
p.000008: of the evaluation. The researcher must obtain approval or authorization before conducting the investigation. The
p.000008: Committee of
p.000009: 9
p.000009: ethical evaluation should perform the additional revisions that are necessary during the investigation, including
p.000009: Track your progress.
p.000009: II. OBJECTIVES OF THE MANUAL
p.000009: A. General
p.000009: Standardize the procedures for the organization and operation of the National Research Ethics Committee in
p.000009: Health (CNEIS) and Local Committee for Health Research (CEIS) of El Salvador, to ensure quality
p.000009: of the processes of protection of the rights, security and well-being of the participating human beings
p.000009: voluntarily in health research projects, in accordance with scientific and ethical principles
p.000009: internationally approved.
p.000009: B. Specific
p.000009: 1. Describe the nature and dependence of the Health Research Ethics Committee.
p.000009: 2. Detail the procedures for the organization of the Health Research Ethics Committee.
p.000009: 3. List the functions of the committee and its members.
p.000009: III. CNEIS DESCRIPTION AND OPERATION
p.000009: 1. Nature
p.000009: The National Committee for Health Research Ethics, hereinafter CNEIS is a useful body
p.000009: public, independent and autonomous in the exercise of its functions, composed of technical experts
p.000009: competent multidisciplinaries, responsible for protecting the rights, security and welfare of human beings
p.000009: voluntarily participating in health research projects, in accordance with principles
p.000009: internationally approved scientists and ethicists.
p.000009: 2. Dependency
p.000009: The CNEIS was created on April 27, 2005 by the Ministry of Health and the Higher Council of Public Health, date in
p.000009: which took the protest of law to the owners and alternate members elected on February 25 of the same
p.000009: year. The CNEIS depends organically on the Ministry of Health, hereinafter MINSAL and administratively on the
p.000009: Higher Public Health Council, hereinafter CSSP, and operates autonomously to ensure that all
p.000009: research involving human beings in the country is conducted based on ethical principles
p.000009: fundamental respect for people, considering the laws and regulations in force in the country,
p.000009: as well as the current international norms established in the Declaration of Helsinski.
p.000010: 10
p.000010: 3. Mission
p.000010: Ensure respect for the rights and safety of the participants involved in the activities of the
...
Health / Drug Usage
Searching for indicator influence:
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p.000010: Directly or indirectly they are confidential.
p.000010: 7. Requirements to become a member
p.000010: To be a member of the CNEIS, the following requirements must be met:
p.000010: a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
p.000010: b) Be of notorious honesty;
p.000010: c) Have professional and private conduct based on moral principles;
p.000010: d) Have proven expertise in the field of research and the field of your profession;
p.000010: e) Commitment and interest to participate actively in the activities of the Ethics Committee;
p.000010: f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
p.000010: their relatives in second degree of consanguinity or first of affinity;
p.000010: g) Not be a member of organizations responsible for health research, or directors, officials,
p.000010: employees or shareholders of pharmaceutical companies and their relatives in second degree of consanguinity or first
p.000010: of affinity
p.000010: 8. Conformation
p.000010: The CNEIS will be made up of eleven to thirteen proprietary members, of which five to seven will be professionals of
p.000010: Health Sciences, four from the Social Sciences, one with experience in the area of human rights and one with
p.000010: training and leadership in theology, constituted in a way that ensures a competent evaluation and review of the
p.000010: scientific, medical and ethical aspects of the study, as well as to achieve that their goals can be
p.000010: executed free of bias and influence that could affect their independence. CNEIS members will be elected
p.000010: by the Minister of Health and the President of the Higher Council of Public Health, through a
p.000010: public call issued three months in advance that stipulates the requirements established to be
p.000010: member of the Ethics Committee. For this, the acting Ethics Committee will prepare a list of selected candidates
p.000010: by contest of merits based on the Curriculum Vitae and personal interview.
p.000010: The members of the CNEIS will last three years in their functions, being able to be appointed for one more period.
p.000010: The CNEIS will be composed of the President who will preside, a Vice-President, a Secretary and so many
p.000010: Members as members have been registered in the Committee.
p.000012: 12
p.000012: The President, the Vice President and the Secretary of the CNEIS will be appointed by majority vote of the members of the
p.000012: Ethics Committee.
p.000012: 9. Attributions
p.000012: For the purposes of the attributions of CNEIS, research in humans includes:
p.000012: a) Studies of physiological, biochemical or pathological processes, or of the response to an intervention
p.000012: specific-physical, chemical or psychological in patients or healthy subjects;
p.000012: b) Controlled trials of diagnostic, preventive or therapeutic interventions in large groups of
p.000012: people, designed to demonstrate a specific generalizable response against a background of biological variation
p.000012: individual;
p.000012: c) Studies designed to determine the consequences of specific preventive or therapeutic interventions for
p.000012: individuals and communities;
...
p.000016: e) The CNEIS is responsible for acting in the full interest of the potential participants of the
p.000016: research and of the communities involved, taking into account the interests and needs of
p.000016: researchers, as well as the requirements of regulatory agencies and applicable laws;
p.000016: f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
p.000016: regular evaluation of developing studies that received a positive decision at intervals
p.000016: appropriate according to the degree of risk to people, at least once a year;
p.000016: g) The CNEIS has the authority to approve, request modifications (prior to approval),
p.000016: refuse, or suspend a clinical study;
p.000016: h) To fulfill its functions, the CNEIS must receive and have available all the documentation
p.000016: related to the study: protocol, amendments thereto, informed consent forms and
p.000016: updates to it, updated researcher's curriculum vitae, recruitment procedures,
p.000016: patient information, investigator manual, available safety information, and payment information
p.000016: to patients, information on patient compensation, and any other document than CNEIS
p.000016: may need to fulfill their responsibilities;
p.000016: i) The CNEIS must consider the competence of the investigator to conduct the proposed study, as documented
p.000016: in the Curriculum Vitae and in all other relevant documentation requested by the CNEIS;
p.000016: j) The CNEIS must review both the amount and the method of payment to individuals to ensure that they do not exist
p.000016: coercion problems or bad influence on study subjects. Payments to the person must be assigned
p.000016: and not depend on the subject finishing the study;
p.000016: k) The CNEIS must ensure that information regarding the payment to individuals, including methods,
p.000016: quantities and programming is stipulated in the form of written informed consent, as well as any
p.000016: other written information provided to subjects. You must specify the way it will be
p.000016: assigned payment.
p.000017: 17
p.000017: 16. Training of members
p.000017: The CNEIS will promote the continuous training of its members in the following subject: courses on
p.000017: research and ethics methodology, expert conferences, workshops, conferences and diplomas (Magister
p.000017: in Bioethics). These trainings can be extended to the members of the local ethics committees.
p.000017: 17. Monitoring through the Higher Council of Public Health, (CSSP).
p.000017: The objectives of monitoring a study are to verify that:
p.000017: a) The rights and welfare of human beings are protected;
p.000017: b) The reported data of the study are complete, accurate and can be verified from the source documents; Y
p.000017: c) The conduct of the study is in accordance with the protocol / amendments, approved, with the
p.000017: Guidelines for Good Clinical Practices (BPC) in establishments where they are carried out
p.000017: research or clinical trials involving people. (adaptation of the harmonized tripartite guide of
p.000017: the international harmonization conference iche 6r1).
p.000017: A written monitoring plan must be available and for the selection of studies that will receive monitoring
...
Health / Healthy People
Searching for indicator volunteers:
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p.000009: which took the protest of law to the owners and alternate members elected on February 25 of the same
p.000009: year. The CNEIS depends organically on the Ministry of Health, hereinafter MINSAL and administratively on the
p.000009: Higher Public Health Council, hereinafter CSSP, and operates autonomously to ensure that all
p.000009: research involving human beings in the country is conducted based on ethical principles
p.000009: fundamental respect for people, considering the laws and regulations in force in the country,
p.000009: as well as the current international norms established in the Declaration of Helsinski.
p.000010: 10
p.000010: 3. Mission
p.000010: Ensure respect for the rights and safety of the participants involved in the activities of the
p.000010: scientific research, seeking an independent, competent and timely evaluation of the ethical aspects of the
p.000010: Health research
p.000010: 4. Vision
p.000010: To be the national committee, with regional recognition, that provides professional services and
p.000010: technicians in the evaluation of the ethical considerations of the investigation, to the scientific community of the country, in
p.000010: special to the community that participates in health research projects, in order to help safeguard the
p.000010: dignity, rights, security and welfare of all research participants.
p.000010: 5. Objectives of the National Committee for Health Research Ethics
p.000010: to. general
p.000010: Review the quality and integrity of research projects carried out in the country, for the
p.000010: protection of people who participate as volunteers in a health research.
p.000010: b. Specific
p.000010: to. Supervise the proper protection of subjects involved in health research conducted in the country and the
p.000010: ethical safeguards of the studies carried out.
p.000010: b. Verify the application of international guidelines for the guarantee of Good Clinical Practices of
p.000010: Research in Human Health.
p.000010: c. Provide support to researchers in the ethical aspects of their projects.
p.000010: 6. Ethical principles for health research
p.000010: All health research must be carried out in accordance with established ethical principles:
p.000010: a) Principle of beneficence: research contributes to the well-being of people;
p.000010: b) Principle of non-maleficence: the investigation must not cause deliberate or perverse harm to the
p.000010: participants and people in general;
p.000010: c) Principle of autonomy: research must protect the rights and dignity of participants and their
p.000010: capacity for self-determination to make decisions. Your participation must be voluntary and based on the
p.000010: informed consent;
p.000010: d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
p.000010: correct and appropriate; and to distributive justice, which
p.000010: eleven
p.000010: establishes the equitable distribution of burdens and benefits to research participants;
...
Health / Motherhood/Family
Searching for indicator family:
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p.000032: Yes No NA
p.000032: c.2) that it is not possible to obtain consent because
p.000033: 33
p.000033: c.2.1) the medical condition prevents consent
p.000033: Yes No NA
p.000033: c.2.2) there is not enough time to obtain the consent of the authorized legal representative
p.000033: Yes No NA
p.000033: c.2.3) because identifying the legal representative is unreasonable
p.000033: Yes No NA
p.000033: c.3) that there are expected benefits for the subjects because c.3.1) the life-threatening situation needs to be treated
p.000033: Yes No NA
p.000033: c.3.2) the previous data guarantee the benefit for the patients
p.000033: Yes No NA
p.000033: c.3.3) the risk / benefit of the standard and proposed treatment is reasonable
p.000033: Yes No NA
p.000033: c.4) an exceptional situation is necessary to carry out the study
p.000033: Yes No NA
p.000033: c.5) a therapeutic window is defined in which the researcher will make all the necessary efforts to
p.000033: Obtain consent instead of starting without consent. A summary of all efforts made will be
p.000033: documented and delivered to the ethics committee, during the continuous review of the study (by CEIS).
p.000033: Yes No NA
p.000033: c.6) CEIS evaluates and approves the consent process and its documentation. The CEIS evaluates and approves the
p.000033: procedures in case of objection by the family
p.000033: Yes No NA
p.000033: c.7) additional protective behaviors, including at least c.7.1) consultation with community representatives
p.000033: 3. 4
p.000033: Yes No NA
p.000033: c.7.2) make plans, benefits and risks available to the public
p.000033: Yes No NA
p.000033: c.7.3) make the results of the study available to the public
p.000033: Yes No NA
p.000033: c.7.4) ensure that an Independent Data Monitoring Committee has been established
p.000033: Yes No NA
p.000033: c.7.5) summary of the family member's objection for continued review
p.000033: Yes No NA
p.000033: c.8) ensure the implementation of procedures to inform as quickly as possible the inclusion of the
p.000033: patient to study (participation may in these cases be discontinued). Procedures to inform the
p.000033: family that the patient was in the study, if he died.
p.000033: Yes No NA
p.000033: c.9) CEIS disapproval must be documented in writing and sent to the researcher and the sponsor of the
p.000033: study. The sponsor must report this to its regulatory authority, other researchers and other CEIS
p.000033: involved
p.000033: Yes No NA
p.000035: 35
p.000035: APPENDIX 2
p.000035: REGISTRATION OF LOCAL HEALTH RESEARCH ETHICS COMMITTEES (CEIS) BEFORE THE NATIONAL COMMITTEE OF ETHICS OF
p.000035: HEALTH RESEARCH (CNEIS)
p.000035: [] New file [] Renewal
p.000035: Institution in which the CEIS operates:
p.000035: Address to send correspondence:
p.000035: Director of the institution where the CEIS operates: Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: President of the CEIS Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: Registration number (in case of renewal):
p.000035: CEIS operating data
p.000035: to. Has your Committee been accredited by an international body?
p.000036: 36
p.000036: [ ] If not
p.000036: If yes, provide the name of that accrediting organization:
p.000036: Accreditation Date:
p.000036: Number:
p.000036: Total number of active protocols (approximately):
p.000036: Approximate number of people hired for the administrative activities of the Committee:
p.000036: Does the Committee evaluate international financing studies?
p.000036: [ ] If not
p.000036: Approximate number of active studies with funding from international organizations:
p.000036: Approximate number of active studies with funding from transnational pharmaceutical companies:
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Health / visual impairment
Searching for indicator blind:
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p.000016: quantities and programming is stipulated in the form of written informed consent, as well as any
p.000016: other written information provided to subjects. You must specify the way it will be
p.000016: assigned payment.
p.000017: 17
p.000017: 16. Training of members
p.000017: The CNEIS will promote the continuous training of its members in the following subject: courses on
p.000017: research and ethics methodology, expert conferences, workshops, conferences and diplomas (Magister
p.000017: in Bioethics). These trainings can be extended to the members of the local ethics committees.
p.000017: 17. Monitoring through the Higher Council of Public Health, (CSSP).
p.000017: The objectives of monitoring a study are to verify that:
p.000017: a) The rights and welfare of human beings are protected;
p.000017: b) The reported data of the study are complete, accurate and can be verified from the source documents; Y
p.000017: c) The conduct of the study is in accordance with the protocol / amendments, approved, with the
p.000017: Guidelines for Good Clinical Practices (BPC) in establishments where they are carried out
p.000017: research or clinical trials involving people. (adaptation of the harmonized tripartite guide of
p.000017: the international harmonization conference iche 6r1).
p.000017: A written monitoring plan must be available and for the selection of studies that will receive monitoring
p.000017: the scope and nature of monitoring should be determined based on considerations such as the objective,
p.000017: design, complexity, blind studies, size, study measurement points, adverse effects report
p.000017: Serious, EAS or SUSAR.
p.000017: The actions to be carried out during monitoring are the following:
p.000017: a) Verify that the researcher is qualified and has adequate resources and they
p.000017: maintain during the study that the facilities, including the laboratory, equipment and the
p.000017: staff are suitable to conduct the study safely and appropriately and are maintained in this way
p.000017: during it;
p.000017: b) Verify with respect to the product under investigation that:
p.000017: i. storage times and conditions are acceptable and supplies are
p.000017: sufficient during the study the research product is provided only to the subjects that are
p.000017: eligible to receive it and at the doses specified in the protocol;
p.000017: ii. subjects are provided with the necessary instructions on the use, handling, storage and return
p.000017: appropriate research product;
p.000017: iii. the reception, use and return of the product under investigation at the sites where the
p.000017: study is controlled and properly documented; Y
p.000018: 18
p.000018: iv. The disposition of the unused research product, at the sites where the study is conducted,
p.000018: Comply with applicable regulatory requirements and be in compliance with the sponsor.
p.000018: c) Verify that the investigator follows the approved protocol and all the approved amendments, if the
p.000018: would have
p.000018: d) Verify that the written informed consent of each subject has been obtained before participating in
p.000018: the study;
p.000018: e) Ensure that the researcher receives the current Investigator Manual, all documents and documents
p.000018: study supplies needed to properly conduct the study and to
p.000018: comply with applicable regulatory requirements;
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Social / Access to Social Goods
Searching for indicator access:
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p.000013: 10. Meetings
p.000013: The Ethics Committee will meet ordinarily every fifteen days, and extraordinarily when convened by the
p.000013: Chairman of the Committee on his own initiative, or when requested by more than fifty percent of the
p.000013: representation of its members.
p.000013: In order for the CNEIS to hold a valid session, the attendance of the President, and / or the
p.000013: Vice President, and / or Secretary and five of its members. The resolutions of the Ethics Committee are
p.000013: they will take half plus one of the members that make up the quorum.
p.000013: 11. Functions of the President
p.000013: The Chairman of the Ethics Committee will have the following functions:
p.000013: a) Represent the CNEIS before the different national academic and scientific bodies and
p.000013: foreigners involved in human research;
p.000013: b) Chair the ordinary and extraordinary sessions of the Ethics Committee;
p.000013: c) Represent and be a spokesperson for the Ethics Committee before the CSSP and MINSAL;
p.000013: d) Coordinate together with the Secretary the scientific and ethical evaluation meetings of the projects of
p.000013: health research submitted to the Ethics Committee for consideration;
p.000013: e) Prepare the Annual Work Plan together with the members of the Committee;
p.000013: f) Direct the Financial and Human Resources Administration of the Committee;
p.000013: g) Coordinate and monitor the evaluation process of research projects in
p.000013: health evaluated;
p.000013: h) Authorize access to the relevant documentation of the projects evaluated to national organizations and
p.000013: internationals that sponsor the use of medicines;
p.000013: i) Manage and coordinate with other national and international organizations, clinical research activities,
p.000013: research ethics and bioethics;
p.000014: 14
p.000014: j) Support the creation of ethics committees at the national level, and promote the exchange of experiences with the committees
p.000014: National and international;
p.000014: k) Manage financial resources for the operation and training of Committee members
p.000014: Ethics with the CSSP and MINSAL authorities;
p.000014: l) Manage before the CSSP and MINSAL the call to elect a new Committee three months before
p.000014: the period of the acting Ethics Committee has ended;
p.000014: m) Keep the inscription of the Institute Review Board (IRB) and of the Federal Wide Assurance (FWA) updated before
p.000014: the Office of Protection of Human Subjects in Research (OHRP), of the Department of Health of the States
p.000014: United; Y
p.000014: n) Direct the self-evaluation of the CNEIS every six months (Annex 1).
p.000014: 12. Functions of the Vice President
p.000014: Assume all the responsibilities of the president during his absence or other specific activity that is
p.000014: delegated by it.
p.000014: 13. Functions of the Secretary
p.000014: The Secretary of the Ethics Committee shall have the following functions:
p.000014: a) Act as Secretary of the Ethics Committee, where he participates with voice and vote;
...
p.000026: Review of changes that may have occurred since the prior evaluation of the ethics committee?
p.000026: Yes No NA
p.000026: e) Do you have established that the changes in the approved study are not implemented without the review and approval of the
p.000026: CEIS, except when it is necessary to eliminate immediate damage?
p.000026: Yes No NA
p.000026: f) Do you have defined the immediate report to the CEIS and regulatory agencies of:
p.000026: f.1) previously unidentified problems that put the study patients at risk?
p.000026: Yes No NA
p.000026: f.2) serious failure to comply with current regulations or CEIS requirements?
p.000026: Yes No NA
p.000026: f.3) suspension or cancellation of the approval given by the CEIS?
p.000026: Yes No NA
p.000026: f.4) identification of studies with devices that carry significant risks?
p.000026: Yes No NA
p.000026: 9) Operational functioning of the ethics committee
p.000026: a) Schedule meetings
p.000026: Yes No NA
p.000026: b) Distribution to members of information on the place and date of the meeting, agenda, study materials a
p.000026: check, etc.
p.000027: 27
p.000027: Yes No NA
p.000027: c) Has a review / evaluation process that ensures
p.000027: c.1) That all members receive the study documentation to be evaluated (or only some who will discuss it later)
p.000027: with the Committee in full)
p.000027: Yes No NA
p.000027: Or what:
p.000027: c.2) One or more evaluators (primary / secondary) receive full documentation to review, report
p.000027: to the Committee and lead the discussions. In case other members review the summary, those members should have access
p.000027: to the complete documentation
p.000027: Yes No NA c.3) Role of any CEIS subcommittee Yes
p.000027: No NA
p.000027: c.4) emergency notifications and reporting processes
p.000027: Yes No NA
p.000027: c.5) expedited evaluation procedures for approval of studies or changes (studies already approved) that involve
p.000027: minimal risks
p.000027: Yes No NA
p.000027: d) Approval criteria by the ethics committee that contain all the requirements
p.000027: Yes No NA
p.000027: e) Voting requirements e.1) quorum required
p.000027: Yes No NA
p.000027: e.2) Quorum diversity requirements (for example, the requirement that at least one of
p.000027: voting members be a doctor, for review of studies with products in development)
p.000027: Yes No NA
p.000027: e.3) percentage required to approve or reject a study
p.000027: Yes No NA
p.000028: 28
p.000028: e.4) voting rights of the evaluating members
p.000028: Yes No NA
p.000028: e.5) no acceptance of written or telephone votes
p.000028: Yes No NA
p.000028: e.6) prohibition of voting in case of conflict of interest
p.000028: Yes No NA
p.000028: f) Further approvals or revisions by other parties within the institution
p.000028: Yes No NA
p.000028: g) CEIS communications
p.000028: g.1) to the investigator, informing the decision of the CEIS
p.000028: Yes No NA
p.000028: g.2) to the hospital administration, informing the decision of the CEIS
p.000028: Yes No NA
p.000028: g.3) to the research sponsor, informing the decision of the CEIS
p.000028: Yes No NA
p.000028: h) Appeal of CEIS decisions h.1) Appeal criteria
p.000028: Yes No NA h.2) to whom the appeal is directed Yes
p.000028: No NA
...
Social / Age
Searching for indicator age:
(return to top)
p.000010: Research in Human Health.
p.000010: c. Provide support to researchers in the ethical aspects of their projects.
p.000010: 6. Ethical principles for health research
p.000010: All health research must be carried out in accordance with established ethical principles:
p.000010: a) Principle of beneficence: research contributes to the well-being of people;
p.000010: b) Principle of non-maleficence: the investigation must not cause deliberate or perverse harm to the
p.000010: participants and people in general;
p.000010: c) Principle of autonomy: research must protect the rights and dignity of participants and their
p.000010: capacity for self-determination to make decisions. Your participation must be voluntary and based on the
p.000010: informed consent;
p.000010: d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
p.000010: correct and appropriate; and to distributive justice, which
p.000010: eleven
p.000010: establishes the equitable distribution of burdens and benefits to research participants;
p.000010: e) Principle of privacy, anonymity and confidentiality: all information and data of the participants obtained
p.000010: Directly or indirectly they are confidential.
p.000010: 7. Requirements to become a member
p.000010: To be a member of the CNEIS, the following requirements must be met:
p.000010: a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
p.000010: b) Be of notorious honesty;
p.000010: c) Have professional and private conduct based on moral principles;
p.000010: d) Have proven expertise in the field of research and the field of your profession;
p.000010: e) Commitment and interest to participate actively in the activities of the Ethics Committee;
p.000010: f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
p.000010: their relatives in second degree of consanguinity or first of affinity;
p.000010: g) Not be a member of organizations responsible for health research, or directors, officials,
p.000010: employees or shareholders of pharmaceutical companies and their relatives in second degree of consanguinity or first
p.000010: of affinity
p.000010: 8. Conformation
p.000010: The CNEIS will be made up of eleven to thirteen proprietary members, of which five to seven will be professionals of
p.000010: Health Sciences, four from the Social Sciences, one with experience in the area of human rights and one with
p.000010: training and leadership in theology, constituted in a way that ensures a competent evaluation and review of the
p.000010: scientific, medical and ethical aspects of the study, as well as to achieve that their goals can be
p.000010: executed free of bias and influence that could affect their independence. CNEIS members will be elected
p.000010: by the Minister of Health and the President of the Higher Council of Public Health, through a
p.000010: public call issued three months in advance that stipulates the requirements established to be
...
p.000014: - Date of transfer to the central archive.
p.000014: - Observations.
p.000014: 14. Roles of the other members
p.000014: a) Attend ordinary and extraordinary meetings when called;
p.000014: b) Evaluate research protocols according to established operating procedures, and give their opinion
p.000014: on compliance with ethical requirements;
p.000014: c) Collaborate in the preparation of the Annual Work Plan and the Committee's Work Report;
p.000014: d) Assume responsibility for the activities delegated by the Chairman of the Committee; Y
p.000014: e) Send electronically the observations issued to the protocols assigned for the
p.000014: Review of ethical considerations, three days before the ordinary session.
p.000014: 15. Responsibilities of CNEIS
p.000014: a) The responsibility of a Research Ethics Committee in evaluating an investigation in
p.000014: health is to contribute to safeguard the dignity, rights, security and well-being of all participants
p.000014: current and potential research; special attention should be given to studies that may
p.000014: involve vulnerable people;
p.000014: b) A cardinal principle of research involving human beings is to respect the dignity of people.
p.000014: The goals of research, while important should never go beyond health, well-being and
p.000014: care of research participants;
p.000014: c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
p.000014: and disadvantages of the research are distributed equally among all groups and
p.000014: classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
p.000016: 16
p.000016: d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
p.000016: proposed;
p.000016: e) The CNEIS is responsible for acting in the full interest of the potential participants of the
p.000016: research and of the communities involved, taking into account the interests and needs of
p.000016: researchers, as well as the requirements of regulatory agencies and applicable laws;
p.000016: f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
p.000016: regular evaluation of developing studies that received a positive decision at intervals
p.000016: appropriate according to the degree of risk to people, at least once a year;
p.000016: g) The CNEIS has the authority to approve, request modifications (prior to approval),
p.000016: refuse, or suspend a clinical study;
p.000016: h) To fulfill its functions, the CNEIS must receive and have available all the documentation
p.000016: related to the study: protocol, amendments thereto, informed consent forms and
p.000016: updates to it, updated researcher's curriculum vitae, recruitment procedures,
p.000016: patient information, investigator manual, available safety information, and payment information
p.000016: to patients, information on patient compensation, and any other document than CNEIS
p.000016: may need to fulfill their responsibilities;
p.000016: i) The CNEIS must consider the competence of the investigator to conduct the proposed study, as documented
...
Social / Child
Searching for indicator children:
(return to top)
p.000029: c.3) registration of the vote (votes in favor, against and abstentions)
p.000029: Yes No NA
p.000029: d) Retention / archiving of the evaluated protocols and approved consent documents
p.000029: Yes No NA
p.000029: e) Communication to and from the CEIS
p.000029: Yes No NA
p.000029: f) Report of adverse reactions and documentation of the review of such reports by the CEIS
p.000029: Yes No NA
p.000029: g) Records of continuous evaluations by the CEIS
p.000029: Yes No NA
p.000029: h) Required time to file records
p.000029: Yes No NA
p.000029: i) Registration of budgets and accounting
p.000029: Yes No NA
p.000030: 30
p.000030: j) Reports for use in emergencies
p.000030: Yes No NA
p.000030: k) Declarations of new significant findings communicated to patients / subjects
p.000030: Yes No NA
p.000030: 11) Information submitted to the CEIS by the researcher
p.000030: a) Background / qualifications that support it to carry out clinical research (including a description of the
p.000030: necessary services and equipment for research)
p.000030: Yes No NA
p.000030: b) Clinical study protocol that includes b.1) study title
p.000030: Yes No NA
p.000030: b.2) objective of the study (including the benefits expected from the study, once
p.000030: accomplished)
p.000030: Yes No NA
p.000030: b.3) study sponsor
p.000030: Yes No NA
p.000030: b.4) results of previous related investigations
p.000030: Yes No NA
p.000030: b.5) inclusion and exclusion criteria
p.000030: Yes No NA
p.000030: b.6) justification for the use of any population of patients or special or vulnerable subjects (for
p.000030: example, people who cannot make a decision or children)
p.000030: Yes No NA
p.000030: b.7) study design (including, if necessary, a discussion of the acceptability of the methods of
p.000030: investigation)
p.000030: Yes No NA
p.000031: 31
p.000031: b.8) description of the study procedures
p.000031: Yes No NA
p.000031: b.9) management of adverse events
p.000031: Yes No NA
p.000031: b.10) procedures related to consent, including the place, autonomy of the subject, difficulties of the
p.000031: language, vulnerable populations, etc.
p.000031: Yes No NA
p.000031: b.11) procedures for the documentation of the Informed Consent, which includes any procedure
p.000031: for obtaining it by minors, use of witnesses, translators and how these are preserved
p.000031: documents
p.000031: Yes No NA
p.000031: b.12) compensation of patients for their participation
p.000031: Yes No NA
p.000031: b.13) compensation in case of patients who have suffered damage in the study
p.000031: Yes No NA
p.000031: b.14) protection of the privacy of the patient / subject
p.000031: Yes No NA
p.000031: b.15) extra costs for patients / subjects derived from their participation.
p.000031: Yes No NA
p.000031: c) Researcher Monograph (if any)
p.000031: Yes No NA
p.000031: d) Case report record [FRC / CRF] (if any)
p.000031: Yes No NA
p.000031: e) Proposed Informed Consent Document e.1) all requirements are met
p.000032: 32
p.000032: Yes No NA
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000014: a) Attend ordinary and extraordinary meetings when called;
p.000014: b) Evaluate research protocols according to established operating procedures, and give their opinion
p.000014: on compliance with ethical requirements;
p.000014: c) Collaborate in the preparation of the Annual Work Plan and the Committee's Work Report;
p.000014: d) Assume responsibility for the activities delegated by the Chairman of the Committee; Y
p.000014: e) Send electronically the observations issued to the protocols assigned for the
p.000014: Review of ethical considerations, three days before the ordinary session.
p.000014: 15. Responsibilities of CNEIS
p.000014: a) The responsibility of a Research Ethics Committee in evaluating an investigation in
p.000014: health is to contribute to safeguard the dignity, rights, security and well-being of all participants
p.000014: current and potential research; special attention should be given to studies that may
p.000014: involve vulnerable people;
p.000014: b) A cardinal principle of research involving human beings is to respect the dignity of people.
p.000014: The goals of research, while important should never go beyond health, well-being and
p.000014: care of research participants;
p.000014: c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
p.000014: and disadvantages of the research are distributed equally among all groups and
p.000014: classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
p.000016: 16
p.000016: d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
p.000016: proposed;
p.000016: e) The CNEIS is responsible for acting in the full interest of the potential participants of the
p.000016: research and of the communities involved, taking into account the interests and needs of
p.000016: researchers, as well as the requirements of regulatory agencies and applicable laws;
p.000016: f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
p.000016: regular evaluation of developing studies that received a positive decision at intervals
p.000016: appropriate according to the degree of risk to people, at least once a year;
p.000016: g) The CNEIS has the authority to approve, request modifications (prior to approval),
p.000016: refuse, or suspend a clinical study;
p.000016: h) To fulfill its functions, the CNEIS must receive and have available all the documentation
p.000016: related to the study: protocol, amendments thereto, informed consent forms and
p.000016: updates to it, updated researcher's curriculum vitae, recruitment procedures,
p.000016: patient information, investigator manual, available safety information, and payment information
p.000016: to patients, information on patient compensation, and any other document than CNEIS
p.000016: may need to fulfill their responsibilities;
p.000016: i) The CNEIS must consider the competence of the investigator to conduct the proposed study, as documented
p.000016: in the Curriculum Vitae and in all other relevant documentation requested by the CNEIS;
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000010: participants and people in general;
p.000010: c) Principle of autonomy: research must protect the rights and dignity of participants and their
p.000010: capacity for self-determination to make decisions. Your participation must be voluntary and based on the
p.000010: informed consent;
p.000010: d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
p.000010: correct and appropriate; and to distributive justice, which
p.000010: eleven
p.000010: establishes the equitable distribution of burdens and benefits to research participants;
p.000010: e) Principle of privacy, anonymity and confidentiality: all information and data of the participants obtained
p.000010: Directly or indirectly they are confidential.
p.000010: 7. Requirements to become a member
p.000010: To be a member of the CNEIS, the following requirements must be met:
p.000010: a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
p.000010: b) Be of notorious honesty;
p.000010: c) Have professional and private conduct based on moral principles;
p.000010: d) Have proven expertise in the field of research and the field of your profession;
p.000010: e) Commitment and interest to participate actively in the activities of the Ethics Committee;
p.000010: f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
p.000010: their relatives in second degree of consanguinity or first of affinity;
p.000010: g) Not be a member of organizations responsible for health research, or directors, officials,
p.000010: employees or shareholders of pharmaceutical companies and their relatives in second degree of consanguinity or first
p.000010: of affinity
p.000010: 8. Conformation
p.000010: The CNEIS will be made up of eleven to thirteen proprietary members, of which five to seven will be professionals of
p.000010: Health Sciences, four from the Social Sciences, one with experience in the area of human rights and one with
p.000010: training and leadership in theology, constituted in a way that ensures a competent evaluation and review of the
p.000010: scientific, medical and ethical aspects of the study, as well as to achieve that their goals can be
p.000010: executed free of bias and influence that could affect their independence. CNEIS members will be elected
p.000010: by the Minister of Health and the President of the Higher Council of Public Health, through a
p.000010: public call issued three months in advance that stipulates the requirements established to be
p.000010: member of the Ethics Committee. For this, the acting Ethics Committee will prepare a list of selected candidates
p.000010: by contest of merits based on the Curriculum Vitae and personal interview.
p.000010: The members of the CNEIS will last three years in their functions, being able to be appointed for one more period.
p.000010: The CNEIS will be composed of the President who will preside, a Vice-President, a Secretary and so many
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000019: The CNEIS may register local Ethics Committees at the written request of the academic or health institutions
p.000019: upon request (Annex 2). For this, applicants must submit the creation documents
p.000019: respective:
p.000019: a) Certificate of formation;
p.000019: b) Specific registration request form;
p.000019: c) Regulations or regulations of the organization and operation of the local Committee; Y
p.000019: d) Curriculum vitae of the members of the local Committee.
p.000019: twenty-one
p.000019: The CNEIS will designate an ad-hoc commission to visit the institution requesting registration, whose report will be
p.000019: discussed by the Ethics Committee and the resolution sent to the CSSP, MINSAL and institution authorities
p.000019: applicant.
p.000019: All registration must be updated every period that the local committee is renewed, for which the local Committee
p.000019: will send the following information:
p.000019: a) Letter of application for updating the registration;
p.000019: b) Specific form for said process; Y
p.000019: c) Curriculum vitae of the active members of the local committee.
p.000019: The CEIS must send reports of evaluated studies, as well as resolutions made to the CNEIS, with a periodicity
p.000019: annual, as a mechanism for exchanging information between the CEIS and the CNEIS. According to Annex 3, Control Matrix of
p.000019: research protocols
p.000019: IV. REVISION AND UPDATE OF THE MANUAL
p.000019: This Manual should be reviewed and updated periodically, when required according to the needs
p.000019: MINSAL institutions.
p.000019: V. VALIDITY
p.000019: This Manual will become effective as of this date. COMMUNICATE
p.000019: GOD UNION AND FREEDOM
p.000022: 22
p.000022: APPENDIX 1
p.000022: CEIS SELF-ASSESSMENT QUESTIONNAIRE (CHECKLIST)
p.000022: This questionnaire is useful for reviewing / reconsidering the procedures and operations of a CEIS. Most
p.000022: the items are also applicable to committees not affiliated with an institution. Written procedures may
p.000022: Audit to verify compliance.
p.000022: Three response categories were established for each item in relation to written procedures: Yes, No or NA (no
p.000022: applicable), as appropriate.
p.000022: DOES THE CEIS HAVE PROCEDURES OR WRITTEN POLICIES THAT DESCRIBE THE FOLLOWING ITEMS?
p.000022: 1) Do you have authorization from the institution to establish the CEIS?
p.000022: Yes No NA
p.000022: 2) Do you have defined the objective (s) of the CEIS (for example, to protect the patients who participate in
p.000022: clinical research)
p.000022: Yes No NA
p.000022: 3) Do you have principles that govern the CEIS for the protection of patients' rights and well-being in
p.000022: investigation?
p.000022: Yes No NA
p.000022: 4) Scope of the ethics committee authority
p.000022: a) Do you have defined the type of clinical trials you evaluate?
p.000022: Yes No NA
p.000022: b) Do you have the authority to approve, disapprove or modify a clinical study based on the protection of subjects
p.000022: humans?
p.000022: Yes No NA
p.000022: c) Authority to request written reports of the progress / progress of the study by researchers and
...
Social / education
Searching for indicator education:
(return to top)
p.000022: b) other committees or department headquarters
p.000022: Yes No NA
p.000022: c) clinical researchers
p.000022: Yes No NA
p.000022: d) regulatory authorities
p.000022: Yes No NA
p.000022: 6) Do you have the requirements of the members defined?
p.000022: a) Number of members
p.000022: Yes No NA
p.000022: b) Qualification of members
p.000022: Yes No NA
p.000022: c) Diversity of members
p.000022: c.1) at least one member of an area of non-scientific interest
p.000022: Yes No NA
p.000022: c.2) men and women
p.000022: Yes No NA
p.000022: c.3) at least one independent member of the institution where the study will be carried out
p.000022: Yes No NA
p.000022: d) Alternative / alternate members
p.000024: 24
p.000024: Yes No NA
p.000024: 7) Administration of the ethics committee
p.000024: a) Chairman of the ethics committee
p.000024: a.1) selection and designation process Yes No NA a.2) period of service
p.000024: Yes No NA
p.000024: a.3) obligations / responsibilities
p.000024: Yes No NA
p.000024: a.4) removal process
p.000024: Yes No NA
p.000024: b) The members of the ethics committee b.1) selection and designation process Yes No
p.000024: NA b.2) service period
p.000024: Yes No NA
p.000024: b.3) obligations / responsibilities
p.000024: Yes No NA b.4) attendance / presence requirements Yes
p.000024: No NA b.5) removal process
p.000024: Yes No NA
p.000024: c) Do you have defined the training of the President and the members of the committee? c.1) orientation or initial indications
p.000024: Yes No NA
p.000025: 25
p.000025: c.2) continuing education
p.000025: Yes No NA
p.000025: c.3) reference / reference materials (library)
p.000025: Yes No NA
p.000025: d) Compensation of committee members
p.000025: Yes No NA
p.000025: e) Liability coverage of the members of the ethics committee
p.000025: Yes No NA
p.000025: f) Use of external consultants / consultants
p.000025: Yes No NA
p.000025: g) Obligations of administrative / secretarial staff
p.000025: Yes No NA
p.000025: h) Do you have defined what resources you need to have? (physical meeting place, phone, files,
p.000025: equipment, computers, etc.)
p.000025: Yes No NA
p.000025: i) Do you have a conflict of interest policy defined?
p.000025: i.1) No selection of CEIS members by the investigator
p.000025: Yes No NA
p.000025: i.2) Is the prohibition on participating in the deliberations and voting of researchers defined?
p.000025: Yes No NA
p.000025: 8) Functions of the ethics committee
p.000025: a) Do you have defined the initial and continuous evaluation of the studies?
p.000025: Yes No NA
p.000025: b) Do you have defined the form of written report of findings and actions to be taken directed at the researcher and the
p.000025: institution?
p.000026: 26
p.000026: Yes No NA
p.000026: c) Do you have defined studies that require more frequent verification than the annual review?
p.000026: Yes No NA
p.000026: d) Do you have identified studies that require verification from other sources, apart from the researcher, for the
p.000026: Review of changes that may have occurred since the prior evaluation of the ethics committee?
p.000026: Yes No NA
...
p.000035: REGISTRATION OF LOCAL HEALTH RESEARCH ETHICS COMMITTEES (CEIS) BEFORE THE NATIONAL COMMITTEE OF ETHICS OF
p.000035: HEALTH RESEARCH (CNEIS)
p.000035: [] New file [] Renewal
p.000035: Institution in which the CEIS operates:
p.000035: Address to send correspondence:
p.000035: Director of the institution where the CEIS operates: Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: President of the CEIS Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: Registration number (in case of renewal):
p.000035: CEIS operating data
p.000035: to. Has your Committee been accredited by an international body?
p.000036: 36
p.000036: [ ] If not
p.000036: If yes, provide the name of that accrediting organization:
p.000036: Accreditation Date:
p.000036: Number:
p.000036: Total number of active protocols (approximately):
p.000036: Approximate number of people hired for the administrative activities of the Committee:
p.000036: Does the Committee evaluate international financing studies?
p.000036: [ ] If not
p.000036: Approximate number of active studies with funding from international organizations:
p.000036: Approximate number of active studies with funding from transnational pharmaceutical companies:
p.000036: Approximate number of local studies (of your institution) active:
p.000036: Approximate number of active expedited evaluation studies:
p.000036: Active protocols that involve (check all that apply):
p.000036: [] medications [] food additives
p.000036: [] medical devices [] coloring additives
p.000036: [] biological products [] other
p.000036: Do Committee members receive a certain type of continuing education in research ethics? [] Yes
p.000036: [ ]Do not
p.000037: 37
p.000037: Table of members of the CEIS
p.000037: Member's Name (Last Name, First Name)
p.000037: Gender M / F
p.000037: Academic degree
p.000037: Primary scientific or non-scientific specialty
p.000037: Affiliation * with the institution Yes / No
p.000037: Comments Place “**” to the substitutes
p.000037: * Affiliate means that the person is hired to work with the institution.
p.000037: What is the duration of the period of its members?
p.000037: Do they have updated internal regulations?
p.000037: [ ] If not
p.000037: Do they have standardized operating procedures?
p.000037: [ ] If not
p.000037: Do you have a calendar of ordinary meetings?
p.000037: [ ] If not
p.000037: Submit this application accompanied by: Certificate of formation
p.000037: Internal regulations
p.000037: Summary curriculum of Committee members
...
Social / employees
Searching for indicator employees:
(return to top)
p.000010: capacity for self-determination to make decisions. Your participation must be voluntary and based on the
p.000010: informed consent;
p.000010: d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
p.000010: correct and appropriate; and to distributive justice, which
p.000010: eleven
p.000010: establishes the equitable distribution of burdens and benefits to research participants;
p.000010: e) Principle of privacy, anonymity and confidentiality: all information and data of the participants obtained
p.000010: Directly or indirectly they are confidential.
p.000010: 7. Requirements to become a member
p.000010: To be a member of the CNEIS, the following requirements must be met:
p.000010: a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
p.000010: b) Be of notorious honesty;
p.000010: c) Have professional and private conduct based on moral principles;
p.000010: d) Have proven expertise in the field of research and the field of your profession;
p.000010: e) Commitment and interest to participate actively in the activities of the Ethics Committee;
p.000010: f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
p.000010: their relatives in second degree of consanguinity or first of affinity;
p.000010: g) Not be a member of organizations responsible for health research, or directors, officials,
p.000010: employees or shareholders of pharmaceutical companies and their relatives in second degree of consanguinity or first
p.000010: of affinity
p.000010: 8. Conformation
p.000010: The CNEIS will be made up of eleven to thirteen proprietary members, of which five to seven will be professionals of
p.000010: Health Sciences, four from the Social Sciences, one with experience in the area of human rights and one with
p.000010: training and leadership in theology, constituted in a way that ensures a competent evaluation and review of the
p.000010: scientific, medical and ethical aspects of the study, as well as to achieve that their goals can be
p.000010: executed free of bias and influence that could affect their independence. CNEIS members will be elected
p.000010: by the Minister of Health and the President of the Higher Council of Public Health, through a
p.000010: public call issued three months in advance that stipulates the requirements established to be
p.000010: member of the Ethics Committee. For this, the acting Ethics Committee will prepare a list of selected candidates
p.000010: by contest of merits based on the Curriculum Vitae and personal interview.
p.000010: The members of the CNEIS will last three years in their functions, being able to be appointed for one more period.
p.000010: The CNEIS will be composed of the President who will preside, a Vice-President, a Secretary and so many
p.000010: Members as members have been registered in the Committee.
p.000012: 12
p.000012: The President, the Vice President and the Secretary of the CNEIS will be appointed by majority vote of the members of the
p.000012: Ethics Committee.
p.000012: 9. Attributions
...
Social / gender
Searching for indicator gender:
(return to top)
p.000035: Institution in which the CEIS operates:
p.000035: Address to send correspondence:
p.000035: Director of the institution where the CEIS operates: Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: President of the CEIS Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: Registration number (in case of renewal):
p.000035: CEIS operating data
p.000035: to. Has your Committee been accredited by an international body?
p.000036: 36
p.000036: [ ] If not
p.000036: If yes, provide the name of that accrediting organization:
p.000036: Accreditation Date:
p.000036: Number:
p.000036: Total number of active protocols (approximately):
p.000036: Approximate number of people hired for the administrative activities of the Committee:
p.000036: Does the Committee evaluate international financing studies?
p.000036: [ ] If not
p.000036: Approximate number of active studies with funding from international organizations:
p.000036: Approximate number of active studies with funding from transnational pharmaceutical companies:
p.000036: Approximate number of local studies (of your institution) active:
p.000036: Approximate number of active expedited evaluation studies:
p.000036: Active protocols that involve (check all that apply):
p.000036: [] medications [] food additives
p.000036: [] medical devices [] coloring additives
p.000036: [] biological products [] other
p.000036: Do Committee members receive a certain type of continuing education in research ethics? [] Yes
p.000036: [ ]Do not
p.000037: 37
p.000037: Table of members of the CEIS
p.000037: Member's Name (Last Name, First Name)
p.000037: Gender M / F
p.000037: Academic degree
p.000037: Primary scientific or non-scientific specialty
p.000037: Affiliation * with the institution Yes / No
p.000037: Comments Place “**” to the substitutes
p.000037: * Affiliate means that the person is hired to work with the institution.
p.000037: What is the duration of the period of its members?
p.000037: Do they have updated internal regulations?
p.000037: [ ] If not
p.000037: Do they have standardized operating procedures?
p.000037: [ ] If not
p.000037: Do you have a calendar of ordinary meetings?
p.000037: [ ] If not
p.000037: Submit this application accompanied by: Certificate of formation
p.000037: Internal regulations
p.000037: Summary curriculum of Committee members
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000012: Likewise, investigations can be classified into three categories according to risk:
p.000012: a) Risk-free research: those in which intervention is not necessary
p.000012: Some in the participating individuals. Data is collected through questionnaires, interviews, review of
p.000012: clinical records and others;
p.000012: b) Interventions with minimal risk: these are the investigations that use procedures
p.000012: common for recording data, such as physical and psychological exams, or routine treatments in
p.000012: clinical practice;
p.000012: c) Interventions with higher risk: those that employ methods that can affect the
p.000012: individuals, such as radiological studies, trials with commercial medications or in
p.000012: development and studies that include surgical procedures and genetic studies.
p.000012: Risk-free or minimal risk interventions will be evaluated by local ethics committees created in the
p.000012: academic or health institutions and registered annually in the CNEIS. Investigations with higher risk should
p.000012: be reviewed by local ethics committees, but registered and definitively approved by the CNEIS.
p.000012: Taking into account the above, the attributions of the National Ethics Committee of Health research
p.000012: They are as follows:
p.000012: a) Issue an opinion to ensure that the rights and well-being of people included in health research
p.000012: be properly protected;
p.000013: 13
p.000013: b) Ensure that the researcher achieves the free consent of the people participating in the study,
p.000013: and that the information obtained be confidential;
p.000013: c) Ensure that there is a balance between risk and potential benefits in any study supported by
p.000013: the CNEIS;
p.000013: d) Ensure that researchers and sponsors of human studies comply with the principles
p.000013: internationally accepted scientists and ethicists.
p.000013: 10. Meetings
p.000013: The Ethics Committee will meet ordinarily every fifteen days, and extraordinarily when convened by the
p.000013: Chairman of the Committee on his own initiative, or when requested by more than fifty percent of the
p.000013: representation of its members.
p.000013: In order for the CNEIS to hold a valid session, the attendance of the President, and / or the
p.000013: Vice President, and / or Secretary and five of its members. The resolutions of the Ethics Committee are
p.000013: they will take half plus one of the members that make up the quorum.
p.000013: 11. Functions of the President
p.000013: The Chairman of the Ethics Committee will have the following functions:
p.000013: a) Represent the CNEIS before the different national academic and scientific bodies and
p.000013: foreigners involved in human research;
p.000013: b) Chair the ordinary and extraordinary sessions of the Ethics Committee;
...
p.000014: e) Certify with its signature and that of the President the resolutions and agreements of the Ethics Committee;
p.000014: f) Prepare with the President the Agenda to be discussed in the sessions of the Ethics Committee;
p.000014: g) Notify interested parties of the resolutions issued by the Ethics Committee;
p.000014: h) Collaborate in the preparation of the Annual Report of the Ethics Committee;
p.000014: i) Perform the functions assigned by the President of the Ethics Committee;
p.000014: j) Support to the President in the administration of the Ethics Committee funds; Y
p.000014: fifteen
p.000014: k) Keep updated the database of the projects analyzed by the Ethics Committee, which contains the following
p.000014: Basic information on the status of each project:
p.000014: - Number and name of the protocol.
p.000014: - Code.
p.000014: - Researcher data.
p.000014: - Date of request and evaluation of the protocol.
p.000014: - Dates of the first, second and third evaluation.
p.000014: - Evaluation result code.
p.000014: - Date and type of safety report.
p.000014: - Closing date of the evaluation.
p.000014: - Date of transfer to the central archive.
p.000014: - Observations.
p.000014: 14. Roles of the other members
p.000014: a) Attend ordinary and extraordinary meetings when called;
p.000014: b) Evaluate research protocols according to established operating procedures, and give their opinion
p.000014: on compliance with ethical requirements;
p.000014: c) Collaborate in the preparation of the Annual Work Plan and the Committee's Work Report;
p.000014: d) Assume responsibility for the activities delegated by the Chairman of the Committee; Y
p.000014: e) Send electronically the observations issued to the protocols assigned for the
p.000014: Review of ethical considerations, three days before the ordinary session.
p.000014: 15. Responsibilities of CNEIS
p.000014: a) The responsibility of a Research Ethics Committee in evaluating an investigation in
p.000014: health is to contribute to safeguard the dignity, rights, security and well-being of all participants
p.000014: current and potential research; special attention should be given to studies that may
p.000014: involve vulnerable people;
p.000014: b) A cardinal principle of research involving human beings is to respect the dignity of people.
p.000014: The goals of research, while important should never go beyond health, well-being and
p.000014: care of research participants;
p.000014: c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
p.000014: and disadvantages of the research are distributed equally among all groups and
p.000014: classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
p.000016: 16
p.000016: d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
p.000016: proposed;
...
Economic / Economic/Poverty
Searching for indicator low-income:
(return to top)
p.000008: in its operation, it must be independent of the researcher, the sponsor or any other type of
p.000008: undueXinfluence and must be properly qualified. The committee must consider laws and regulations
p.000008: in force in the country where the research is carried out, as well as current international standards, but not
p.000008: they should be allowed to reduce or eliminate any of the protections for people participating in the
p.000008: investigation established in this Statement.
p.000008: • The committee has the right to monitor ongoing trials. The researcher has the obligation to provide
p.000008: control information to the committee, especially on any serious adverse incident. No amendment should be made in
p.000008: the protocol without the consideration and approval of the committee. After the study is over, the
p.000008: researchers must submit a final report to the committee with a summary of the results and conclusions
p.000008: of the study.
p.000008: Guide to Good Clinical Practices of Research in Human Health, Document of the Americas, revised in the IV
p.000008: Pan American Conference for the Harmonization of Pharmaceutical Regulation, dated March of
p.000008: 2005, defines in its chapter the organization of the Research Ethics Committee or Review Committee
p.000008: Institutional (CEI / CRI), structure, composition, functions and procedures.
p.000008: International Ethical Guidelines for Biomedical Research in Human Beings Prepared by the Council
p.000008: of International Medical Sciences Organizations (CIOMS) in collaboration with the World Organization of
p.000008: Health, reviewed in Geneva, in 2012, orient, especially to low-income countries, in the
p.000008: definition of national guidelines on biomedical research ethics, applying ethical standards in conditions
p.000008: local, and establishing or redefining appropriate mechanisms for the ethical evaluation of research
p.000008: in human beings, including in Guideline 2, related to the Ethics Evaluation Committee,
p.000008: expressing the following: “All proposals to conduct research in human beings must be submitted
p.000008: to one or more scientific evaluation and ethical evaluation committees to examine their scientific merit and acceptability
p.000008: ethics. The evaluation committees must be independent of the research team, and any benefits
p.000008: direct, financial or material that they could obtain from the investigation, should not depend on the result
p.000008: of the evaluation. The researcher must obtain approval or authorization before conducting the investigation. The
p.000008: Committee of
p.000009: 9
p.000009: ethical evaluation should perform the additional revisions that are necessary during the investigation, including
p.000009: Track your progress.
p.000009: II. OBJECTIVES OF THE MANUAL
p.000009: A. General
p.000009: Standardize the procedures for the organization and operation of the National Research Ethics Committee in
p.000009: Health (CNEIS) and Local Committee for Health Research (CEIS) of El Salvador, to ensure quality
p.000009: of the processes of protection of the rights, security and well-being of the participating human beings
p.000009: voluntarily in health research projects, in accordance with scientific and ethical principles
p.000009: internationally approved.
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000010: technicians in the evaluation of the ethical considerations of the investigation, to the scientific community of the country, in
p.000010: special to the community that participates in health research projects, in order to help safeguard the
p.000010: dignity, rights, security and welfare of all research participants.
p.000010: 5. Objectives of the National Committee for Health Research Ethics
p.000010: to. general
p.000010: Review the quality and integrity of research projects carried out in the country, for the
p.000010: protection of people who participate as volunteers in a health research.
p.000010: b. Specific
p.000010: to. Supervise the proper protection of subjects involved in health research conducted in the country and the
p.000010: ethical safeguards of the studies carried out.
p.000010: b. Verify the application of international guidelines for the guarantee of Good Clinical Practices of
p.000010: Research in Human Health.
p.000010: c. Provide support to researchers in the ethical aspects of their projects.
p.000010: 6. Ethical principles for health research
p.000010: All health research must be carried out in accordance with established ethical principles:
p.000010: a) Principle of beneficence: research contributes to the well-being of people;
p.000010: b) Principle of non-maleficence: the investigation must not cause deliberate or perverse harm to the
p.000010: participants and people in general;
p.000010: c) Principle of autonomy: research must protect the rights and dignity of participants and their
p.000010: capacity for self-determination to make decisions. Your participation must be voluntary and based on the
p.000010: informed consent;
p.000010: d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
p.000010: correct and appropriate; and to distributive justice, which
p.000010: eleven
p.000010: establishes the equitable distribution of burdens and benefits to research participants;
p.000010: e) Principle of privacy, anonymity and confidentiality: all information and data of the participants obtained
p.000010: Directly or indirectly they are confidential.
p.000010: 7. Requirements to become a member
p.000010: To be a member of the CNEIS, the following requirements must be met:
p.000010: a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
p.000010: b) Be of notorious honesty;
p.000010: c) Have professional and private conduct based on moral principles;
p.000010: d) Have proven expertise in the field of research and the field of your profession;
p.000010: e) Commitment and interest to participate actively in the activities of the Ethics Committee;
p.000010: f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
p.000010: their relatives in second degree of consanguinity or first of affinity;
...
p.000029: Yes No NA
p.000029: h) Required time to file records
p.000029: Yes No NA
p.000029: i) Registration of budgets and accounting
p.000029: Yes No NA
p.000030: 30
p.000030: j) Reports for use in emergencies
p.000030: Yes No NA
p.000030: k) Declarations of new significant findings communicated to patients / subjects
p.000030: Yes No NA
p.000030: 11) Information submitted to the CEIS by the researcher
p.000030: a) Background / qualifications that support it to carry out clinical research (including a description of the
p.000030: necessary services and equipment for research)
p.000030: Yes No NA
p.000030: b) Clinical study protocol that includes b.1) study title
p.000030: Yes No NA
p.000030: b.2) objective of the study (including the benefits expected from the study, once
p.000030: accomplished)
p.000030: Yes No NA
p.000030: b.3) study sponsor
p.000030: Yes No NA
p.000030: b.4) results of previous related investigations
p.000030: Yes No NA
p.000030: b.5) inclusion and exclusion criteria
p.000030: Yes No NA
p.000030: b.6) justification for the use of any population of patients or special or vulnerable subjects (for
p.000030: example, people who cannot make a decision or children)
p.000030: Yes No NA
p.000030: b.7) study design (including, if necessary, a discussion of the acceptability of the methods of
p.000030: investigation)
p.000030: Yes No NA
p.000031: 31
p.000031: b.8) description of the study procedures
p.000031: Yes No NA
p.000031: b.9) management of adverse events
p.000031: Yes No NA
p.000031: b.10) procedures related to consent, including the place, autonomy of the subject, difficulties of the
p.000031: language, vulnerable populations, etc.
p.000031: Yes No NA
p.000031: b.11) procedures for the documentation of the Informed Consent, which includes any procedure
p.000031: for obtaining it by minors, use of witnesses, translators and how these are preserved
p.000031: documents
p.000031: Yes No NA
p.000031: b.12) compensation of patients for their participation
p.000031: Yes No NA
p.000031: b.13) compensation in case of patients who have suffered damage in the study
p.000031: Yes No NA
p.000031: b.14) protection of the privacy of the patient / subject
p.000031: Yes No NA
p.000031: b.15) extra costs for patients / subjects derived from their participation.
p.000031: Yes No NA
p.000031: c) Researcher Monograph (if any)
p.000031: Yes No NA
p.000031: d) Case report record [FRC / CRF] (if any)
p.000031: Yes No NA
p.000031: e) Proposed Informed Consent Document e.1) all requirements are met
p.000032: 32
p.000032: Yes No NA
p.000032: e.2) translations of consent documents, considering patient populations that require it
p.000032: Yes No NA
p.000032: f) Request for amendments to the study, after initiation
p.000032: Yes No NA
p.000032: g) Report of unexpected adverse events
p.000032: Yes No NA
p.000032: h) Progress / progress report
p.000032: Yes No NA
p.000032: i) Final report
p.000032: Yes No NA
p.000032: j) Institutional reports / reports
p.000032: Yes No NA
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000026: e) Do you have established that the changes in the approved study are not implemented without the review and approval of the
p.000026: CEIS, except when it is necessary to eliminate immediate damage?
p.000026: Yes No NA
p.000026: f) Do you have defined the immediate report to the CEIS and regulatory agencies of:
p.000026: f.1) previously unidentified problems that put the study patients at risk?
p.000026: Yes No NA
p.000026: f.2) serious failure to comply with current regulations or CEIS requirements?
p.000026: Yes No NA
p.000026: f.3) suspension or cancellation of the approval given by the CEIS?
p.000026: Yes No NA
p.000026: f.4) identification of studies with devices that carry significant risks?
p.000026: Yes No NA
p.000026: 9) Operational functioning of the ethics committee
p.000026: a) Schedule meetings
p.000026: Yes No NA
p.000026: b) Distribution to members of information on the place and date of the meeting, agenda, study materials a
p.000026: check, etc.
p.000027: 27
p.000027: Yes No NA
p.000027: c) Has a review / evaluation process that ensures
p.000027: c.1) That all members receive the study documentation to be evaluated (or only some who will discuss it later)
p.000027: with the Committee in full)
p.000027: Yes No NA
p.000027: Or what:
p.000027: c.2) One or more evaluators (primary / secondary) receive full documentation to review, report
p.000027: to the Committee and lead the discussions. In case other members review the summary, those members should have access
p.000027: to the complete documentation
p.000027: Yes No NA c.3) Role of any CEIS subcommittee Yes
p.000027: No NA
p.000027: c.4) emergency notifications and reporting processes
p.000027: Yes No NA
p.000027: c.5) expedited evaluation procedures for approval of studies or changes (studies already approved) that involve
p.000027: minimal risks
p.000027: Yes No NA
p.000027: d) Approval criteria by the ethics committee that contain all the requirements
p.000027: Yes No NA
p.000027: e) Voting requirements e.1) quorum required
p.000027: Yes No NA
p.000027: e.2) Quorum diversity requirements (for example, the requirement that at least one of
p.000027: voting members be a doctor, for review of studies with products in development)
p.000027: Yes No NA
p.000027: e.3) percentage required to approve or reject a study
p.000027: Yes No NA
p.000028: 28
p.000028: e.4) voting rights of the evaluating members
p.000028: Yes No NA
p.000028: e.5) no acceptance of written or telephone votes
p.000028: Yes No NA
p.000028: e.6) prohibition of voting in case of conflict of interest
p.000028: Yes No NA
p.000028: f) Further approvals or revisions by other parties within the institution
p.000028: Yes No NA
p.000028: g) CEIS communications
p.000028: g.1) to the investigator, informing the decision of the CEIS
p.000028: Yes No NA
p.000028: g.2) to the hospital administration, informing the decision of the CEIS
p.000028: Yes No NA
p.000028: g.3) to the research sponsor, informing the decision of the CEIS
p.000028: Yes No NA
p.000028: h) Appeal of CEIS decisions h.1) Appeal criteria
p.000028: Yes No NA h.2) to whom the appeal is directed Yes
p.000028: No NA
p.000028: h.3) how the appeal is resolved (rejection of a disapproval is prohibited)
p.000028: Yes No NA
p.000028: 10) Documentation requirements / records of the CEIS
p.000028: a) List of members describing their qualifications
p.000029: 29
...
p.000031: language, vulnerable populations, etc.
p.000031: Yes No NA
p.000031: b.11) procedures for the documentation of the Informed Consent, which includes any procedure
p.000031: for obtaining it by minors, use of witnesses, translators and how these are preserved
p.000031: documents
p.000031: Yes No NA
p.000031: b.12) compensation of patients for their participation
p.000031: Yes No NA
p.000031: b.13) compensation in case of patients who have suffered damage in the study
p.000031: Yes No NA
p.000031: b.14) protection of the privacy of the patient / subject
p.000031: Yes No NA
p.000031: b.15) extra costs for patients / subjects derived from their participation.
p.000031: Yes No NA
p.000031: c) Researcher Monograph (if any)
p.000031: Yes No NA
p.000031: d) Case report record [FRC / CRF] (if any)
p.000031: Yes No NA
p.000031: e) Proposed Informed Consent Document e.1) all requirements are met
p.000032: 32
p.000032: Yes No NA
p.000032: e.2) translations of consent documents, considering patient populations that require it
p.000032: Yes No NA
p.000032: f) Request for amendments to the study, after initiation
p.000032: Yes No NA
p.000032: g) Report of unexpected adverse events
p.000032: Yes No NA
p.000032: h) Progress / progress report
p.000032: Yes No NA
p.000032: i) Final report
p.000032: Yes No NA
p.000032: j) Institutional reports / reports
p.000032: Yes No NA
p.000032: 12) Exception of Informed Consent in emergency situations
p.000032: a) Guarantee of compliance with the non-approval of this type of studies in the institution
p.000032: Yes No NA
p.000032: b) The ethics committee must inform immediately, in writing, if it decides not to approve a study, including
p.000032: reasons
p.000032: Yes No NA
p.000032: c) To approve a consent exception, the committee must have and document the following:
p.000032: c.1) that the subjects are in a life-threatening condition, that there are no treatments available
p.000032: or satisfactory for that condition and that the need to obtain / gather scientific evidence is necessary
p.000032: Yes No NA
p.000032: c.2) that it is not possible to obtain consent because
p.000033: 33
p.000033: c.2.1) the medical condition prevents consent
p.000033: Yes No NA
p.000033: c.2.2) there is not enough time to obtain the consent of the authorized legal representative
p.000033: Yes No NA
p.000033: c.2.3) because identifying the legal representative is unreasonable
p.000033: Yes No NA
p.000033: c.3) that there are expected benefits for the subjects because c.3.1) the life-threatening situation needs to be treated
p.000033: Yes No NA
p.000033: c.3.2) the previous data guarantee the benefit for the patients
p.000033: Yes No NA
p.000033: c.3.3) the risk / benefit of the standard and proposed treatment is reasonable
p.000033: Yes No NA
p.000033: c.4) an exceptional situation is necessary to carry out the study
p.000033: Yes No NA
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000014: involve vulnerable people;
p.000014: b) A cardinal principle of research involving human beings is to respect the dignity of people.
p.000014: The goals of research, while important should never go beyond health, well-being and
p.000014: care of research participants;
p.000014: c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
p.000014: and disadvantages of the research are distributed equally among all groups and
p.000014: classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
p.000016: 16
p.000016: d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
p.000016: proposed;
p.000016: e) The CNEIS is responsible for acting in the full interest of the potential participants of the
p.000016: research and of the communities involved, taking into account the interests and needs of
p.000016: researchers, as well as the requirements of regulatory agencies and applicable laws;
p.000016: f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
p.000016: regular evaluation of developing studies that received a positive decision at intervals
p.000016: appropriate according to the degree of risk to people, at least once a year;
p.000016: g) The CNEIS has the authority to approve, request modifications (prior to approval),
p.000016: refuse, or suspend a clinical study;
p.000016: h) To fulfill its functions, the CNEIS must receive and have available all the documentation
p.000016: related to the study: protocol, amendments thereto, informed consent forms and
p.000016: updates to it, updated researcher's curriculum vitae, recruitment procedures,
p.000016: patient information, investigator manual, available safety information, and payment information
p.000016: to patients, information on patient compensation, and any other document than CNEIS
p.000016: may need to fulfill their responsibilities;
p.000016: i) The CNEIS must consider the competence of the investigator to conduct the proposed study, as documented
p.000016: in the Curriculum Vitae and in all other relevant documentation requested by the CNEIS;
p.000016: j) The CNEIS must review both the amount and the method of payment to individuals to ensure that they do not exist
p.000016: coercion problems or bad influence on study subjects. Payments to the person must be assigned
p.000016: and not depend on the subject finishing the study;
p.000016: k) The CNEIS must ensure that information regarding the payment to individuals, including methods,
p.000016: quantities and programming is stipulated in the form of written informed consent, as well as any
p.000016: other written information provided to subjects. You must specify the way it will be
p.000016: assigned payment.
p.000017: 17
p.000017: 16. Training of members
p.000017: The CNEIS will promote the continuous training of its members in the following subject: courses on
...
p.000019: annual, as a mechanism for exchanging information between the CEIS and the CNEIS. According to Annex 3, Control Matrix of
p.000019: research protocols
p.000019: IV. REVISION AND UPDATE OF THE MANUAL
p.000019: This Manual should be reviewed and updated periodically, when required according to the needs
p.000019: MINSAL institutions.
p.000019: V. VALIDITY
p.000019: This Manual will become effective as of this date. COMMUNICATE
p.000019: GOD UNION AND FREEDOM
p.000022: 22
p.000022: APPENDIX 1
p.000022: CEIS SELF-ASSESSMENT QUESTIONNAIRE (CHECKLIST)
p.000022: This questionnaire is useful for reviewing / reconsidering the procedures and operations of a CEIS. Most
p.000022: the items are also applicable to committees not affiliated with an institution. Written procedures may
p.000022: Audit to verify compliance.
p.000022: Three response categories were established for each item in relation to written procedures: Yes, No or NA (no
p.000022: applicable), as appropriate.
p.000022: DOES THE CEIS HAVE PROCEDURES OR WRITTEN POLICIES THAT DESCRIBE THE FOLLOWING ITEMS?
p.000022: 1) Do you have authorization from the institution to establish the CEIS?
p.000022: Yes No NA
p.000022: 2) Do you have defined the objective (s) of the CEIS (for example, to protect the patients who participate in
p.000022: clinical research)
p.000022: Yes No NA
p.000022: 3) Do you have principles that govern the CEIS for the protection of patients' rights and well-being in
p.000022: investigation?
p.000022: Yes No NA
p.000022: 4) Scope of the ethics committee authority
p.000022: a) Do you have defined the type of clinical trials you evaluate?
p.000022: Yes No NA
p.000022: b) Do you have the authority to approve, disapprove or modify a clinical study based on the protection of subjects
p.000022: humans?
p.000022: Yes No NA
p.000022: c) Authority to request written reports of the progress / progress of the study by researchers and
p.000022: to monitor the conduct of the study?
p.000022: Yes No NA
p.000022: d) Authority to suspend or terminate a previously granted authorization?
p.000022: Yes No NA
p.000022: 2. 3
p.000022: e) Authority to set restrictions in a study?
p.000022: Yes No NA
p.000022: 5) The CEIS has defined relations with:
p.000022: a) administration of the institution
p.000022: Yes No NA
p.000022: b) other committees or department headquarters
p.000022: Yes No NA
p.000022: c) clinical researchers
p.000022: Yes No NA
p.000022: d) regulatory authorities
p.000022: Yes No NA
p.000022: 6) Do you have the requirements of the members defined?
p.000022: a) Number of members
p.000022: Yes No NA
p.000022: b) Qualification of members
p.000022: Yes No NA
p.000022: c) Diversity of members
p.000022: c.1) at least one member of an area of non-scientific interest
p.000022: Yes No NA
p.000022: c.2) men and women
p.000022: Yes No NA
p.000022: c.3) at least one independent member of the institution where the study will be carried out
p.000022: Yes No NA
p.000022: d) Alternative / alternate members
p.000024: 24
p.000024: Yes No NA
p.000024: 7) Administration of the ethics committee
p.000024: a) Chairman of the ethics committee
p.000024: a.1) selection and designation process Yes No NA a.2) period of service
p.000024: Yes No NA
p.000024: a.3) obligations / responsibilities
p.000024: Yes No NA
p.000024: a.4) removal process
p.000024: Yes No NA
p.000024: b) The members of the ethics committee b.1) selection and designation process Yes No
p.000024: NA b.2) service period
p.000024: Yes No NA
p.000024: b.3) obligations / responsibilities
p.000024: Yes No NA b.4) attendance / presence requirements Yes
p.000024: No NA b.5) removal process
p.000024: Yes No NA
...
p.000033: documented and delivered to the ethics committee, during the continuous review of the study (by CEIS).
p.000033: Yes No NA
p.000033: c.6) CEIS evaluates and approves the consent process and its documentation. The CEIS evaluates and approves the
p.000033: procedures in case of objection by the family
p.000033: Yes No NA
p.000033: c.7) additional protective behaviors, including at least c.7.1) consultation with community representatives
p.000033: 3. 4
p.000033: Yes No NA
p.000033: c.7.2) make plans, benefits and risks available to the public
p.000033: Yes No NA
p.000033: c.7.3) make the results of the study available to the public
p.000033: Yes No NA
p.000033: c.7.4) ensure that an Independent Data Monitoring Committee has been established
p.000033: Yes No NA
p.000033: c.7.5) summary of the family member's objection for continued review
p.000033: Yes No NA
p.000033: c.8) ensure the implementation of procedures to inform as quickly as possible the inclusion of the
p.000033: patient to study (participation may in these cases be discontinued). Procedures to inform the
p.000033: family that the patient was in the study, if he died.
p.000033: Yes No NA
p.000033: c.9) CEIS disapproval must be documented in writing and sent to the researcher and the sponsor of the
p.000033: study. The sponsor must report this to its regulatory authority, other researchers and other CEIS
p.000033: involved
p.000033: Yes No NA
p.000035: 35
p.000035: APPENDIX 2
p.000035: REGISTRATION OF LOCAL HEALTH RESEARCH ETHICS COMMITTEES (CEIS) BEFORE THE NATIONAL COMMITTEE OF ETHICS OF
p.000035: HEALTH RESEARCH (CNEIS)
p.000035: [] New file [] Renewal
p.000035: Institution in which the CEIS operates:
p.000035: Address to send correspondence:
p.000035: Director of the institution where the CEIS operates: Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: President of the CEIS Names:
p.000035: Surnames:
p.000035: Degrees:
p.000035: Telephone fax:
p.000035: E-mail:
p.000035: Address:
p.000035: Registration number (in case of renewal):
p.000035: CEIS operating data
p.000035: to. Has your Committee been accredited by an international body?
p.000036: 36
p.000036: [ ] If not
p.000036: If yes, provide the name of that accrediting organization:
p.000036: Accreditation Date:
p.000036: Number:
p.000036: Total number of active protocols (approximately):
p.000036: Approximate number of people hired for the administrative activities of the Committee:
p.000036: Does the Committee evaluate international financing studies?
p.000036: [ ] If not
p.000036: Approximate number of active studies with funding from international organizations:
p.000036: Approximate number of active studies with funding from transnational pharmaceutical companies:
p.000036: Approximate number of local studies (of your institution) active:
p.000036: Approximate number of active expedited evaluation studies:
p.000036: Active protocols that involve (check all that apply):
p.000036: [] medications [] food additives
p.000036: [] medical devices [] coloring additives
p.000036: [] biological products [] other
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000006: OPERATING MANUAL OF THE NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH ”
p.000007: 7
p.000007: INTRODUCTION
p.000007: The realization of clinical studies in all the countries of our continent, as in the rest of the
p.000007: world, you must follow strict ethical and scientific principles. These principles are universal, above
p.000007: of any difference between people, in order to safeguard the physical and psychic integrity of
p.000007: the subjects involved, as stated in the declaration of the rights of the people of Helsinki.
p.000007: In 2005, and due to the regulatory vacuum to evaluate biomedical research in humans in El
p.000007: Salvador, the Higher Council of Public Health (CSSP) and the Ministry of Health (MINSAL), created the Committee of
p.000007: National Bioethics, later called the National Committee for Clinical Research Ethics and, currently, the Committee
p.000007: National Health Research Ethics (CNEIS).
p.000007: In that period 2005-2010, a group of health and social science professionals from the country discussed and
p.000007: approved the document Organization and Operation Guide of the National Research Ethics Committee in
p.000007: Health, based on the fundamental principles established in the Nuremberg Code, the Declaration of Helsinki,
p.000007: document subsequently amended (64th General Assembly, Fortaleza, Brazil, October 2013), and guides
p.000007: proposed by the Council of International Organizations of Medical Sciences (CIOMS) and the
p.000007: World Health Organization (WHO). Three basic ethical principles of similar moral strength respect for
p.000007: people, charity and justice permeate all the principles of good clinical practice (PCB)
p.000007: In this sense, the current health reform process involves the creation of legal technical instruments that
p.000007: guarantee the protection of people, as well as the guiding tools in the ethical aspects of
p.000007: research with a potential for innovations that can be generated from the research process, which
p.000007: suppose scientific advances for medical sciences, going from the analysis of the biologiscist aspects and that
p.000007: transcend the approach to social determination in health.
p.000007: These facts highlight the need for a National Research Ethics Committee in
p.000007: Health, as part of the set of regulatory authorities that promote uniform standards for
p.000007: local committees of the country and, under any system, the sponsors of an investigation and the institutions that
p.000007: Hiring researchers should allocate sufficient resources for the evaluation process.
p.000007: This manual describes the process of organization and operation of the National Research Ethics Committee in
p.000007: health, considering the laws and regulations in force in the country related to research, as well as
p.000007: current international standards, which protect people who participate in health research.
p.000008: 8
p.000008: I. LEGAL FRAMEWORK
p.000008: Constitution of the Republic Article 79, states that “The State shall provide the necessary resources and
...
p.000008: • The investigation protocol must be sent, for consideration, comment, advice and approval
p.000008: to the relevant research ethics committee before beginning the study. This committee must be transparent.
p.000008: in its operation, it must be independent of the researcher, the sponsor or any other type of
p.000008: undueXinfluence and must be properly qualified. The committee must consider laws and regulations
p.000008: in force in the country where the research is carried out, as well as current international standards, but not
p.000008: they should be allowed to reduce or eliminate any of the protections for people participating in the
p.000008: investigation established in this Statement.
p.000008: • The committee has the right to monitor ongoing trials. The researcher has the obligation to provide
p.000008: control information to the committee, especially on any serious adverse incident. No amendment should be made in
p.000008: the protocol without the consideration and approval of the committee. After the study is over, the
p.000008: researchers must submit a final report to the committee with a summary of the results and conclusions
p.000008: of the study.
p.000008: Guide to Good Clinical Practices of Research in Human Health, Document of the Americas, revised in the IV
p.000008: Pan American Conference for the Harmonization of Pharmaceutical Regulation, dated March of
p.000008: 2005, defines in its chapter the organization of the Research Ethics Committee or Review Committee
p.000008: Institutional (CEI / CRI), structure, composition, functions and procedures.
p.000008: International Ethical Guidelines for Biomedical Research in Human Beings Prepared by the Council
p.000008: of International Medical Sciences Organizations (CIOMS) in collaboration with the World Organization of
p.000008: Health, reviewed in Geneva, in 2012, orient, especially to low-income countries, in the
p.000008: definition of national guidelines on biomedical research ethics, applying ethical standards in conditions
p.000008: local, and establishing or redefining appropriate mechanisms for the ethical evaluation of research
p.000008: in human beings, including in Guideline 2, related to the Ethics Evaluation Committee,
p.000008: expressing the following: “All proposals to conduct research in human beings must be submitted
p.000008: to one or more scientific evaluation and ethical evaluation committees to examine their scientific merit and acceptability
p.000008: ethics. The evaluation committees must be independent of the research team, and any benefits
p.000008: direct, financial or material that they could obtain from the investigation, should not depend on the result
p.000008: of the evaluation. The researcher must obtain approval or authorization before conducting the investigation. The
p.000008: Committee of
p.000009: 9
p.000009: ethical evaluation should perform the additional revisions that are necessary during the investigation, including
p.000009: Track your progress.
p.000009: II. OBJECTIVES OF THE MANUAL
p.000009: A. General
p.000009: Standardize the procedures for the organization and operation of the National Research Ethics Committee in
p.000009: Health (CNEIS) and Local Committee for Health Research (CEIS) of El Salvador, to ensure quality
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000014: IV. REVISION AND UPDATE OF THE MANUAL 22
p.000014: V. VALIDITY
p.000022: 22
p.000022: Annexes
p.000022: 2. 3
p.000006: 6
p.000006: MINISTRY OF HEALTH
p.000006: AGREEMENT No. 382
p.000006: San Salvador, March 1, 2017.
p.000006: THE EXECUTIVE BODY IN THE HEALTH BOARD CONSIDERING:
p.000006: I. That in accordance with Articles 40 and 41 numeral 2 of the Health Code this Secretariat of
p.000006: State, is the agency responsible for determining, planning, executing and issuing the relevant regulations, as well as
p.000006: organize, coordinate and evaluate the execution of health related activities.
p.000006: II. That Article 16 numeral 3 and 67 of the Internal Regulations of the Executive Branch establishes that it is
p.000006: faculty of the Holder of this State Portfolio, approve and enforce the Manuals of
p.000006: organization; as well as determine the administrative structure and operation of this Secretary of State.
p.000006: III. That it is necessary to order and systematize the operation of the National Ethics Committee of research in
p.000006: health, in order to develop the functions in an agile and timely manner.
p.000006: THEREFORE: In use of its legal powers, AGREES to issue the following:
p.000006: OPERATING MANUAL OF THE NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH ”
p.000007: 7
p.000007: INTRODUCTION
p.000007: The realization of clinical studies in all the countries of our continent, as in the rest of the
p.000007: world, you must follow strict ethical and scientific principles. These principles are universal, above
p.000007: of any difference between people, in order to safeguard the physical and psychic integrity of
p.000007: the subjects involved, as stated in the declaration of the rights of the people of Helsinki.
p.000007: In 2005, and due to the regulatory vacuum to evaluate biomedical research in humans in El
p.000007: Salvador, the Higher Council of Public Health (CSSP) and the Ministry of Health (MINSAL), created the Committee of
p.000007: National Bioethics, later called the National Committee for Clinical Research Ethics and, currently, the Committee
p.000007: National Health Research Ethics (CNEIS).
p.000007: In that period 2005-2010, a group of health and social science professionals from the country discussed and
p.000007: approved the document Organization and Operation Guide of the National Research Ethics Committee in
p.000007: Health, based on the fundamental principles established in the Nuremberg Code, the Declaration of Helsinki,
p.000007: document subsequently amended (64th General Assembly, Fortaleza, Brazil, October 2013), and guides
p.000007: proposed by the Council of International Organizations of Medical Sciences (CIOMS) and the
p.000007: World Health Organization (WHO). Three basic ethical principles of similar moral strength respect for
p.000007: people, charity and justice permeate all the principles of good clinical practice (PCB)
p.000007: In this sense, the current health reform process involves the creation of legal technical instruments that
p.000007: guarantee the protection of people, as well as the guiding tools in the ethical aspects of
p.000007: research with a potential for innovations that can be generated from the research process, which
p.000007: suppose scientific advances for medical sciences, going from the analysis of the biologiscist aspects and that
p.000007: transcend the approach to social determination in health.
p.000007: These facts highlight the need for a National Research Ethics Committee in
p.000007: Health, as part of the set of regulatory authorities that promote uniform standards for
p.000007: local committees of the country and, under any system, the sponsors of an investigation and the institutions that
p.000007: Hiring researchers should allocate sufficient resources for the evaluation process.
p.000007: This manual describes the process of organization and operation of the National Research Ethics Committee in
p.000007: health, considering the laws and regulations in force in the country related to research, as well as
p.000007: current international standards, which protect people who participate in health research.
p.000008: 8
p.000008: I. LEGAL FRAMEWORK
p.000008: Constitution of the Republic Article 79, states that “The State shall provide the necessary resources and
p.000008: indispensable for the permanent control of the quality of chemical, pharmaceutical and
p.000008: veterinarians, through surveillance agencies ”.
p.000008: Helsinki Declaration of the World Medical Assembly Ethical principles for medical research
p.000008: in human beings, during the 64th General Assembly, Fortaleza, Brazil, October 2013, described in its principles
p.000008: ethical the following:
p.000008: • The investigation protocol must be sent, for consideration, comment, advice and approval
p.000008: to the relevant research ethics committee before beginning the study. This committee must be transparent.
p.000008: in its operation, it must be independent of the researcher, the sponsor or any other type of
p.000008: undueXinfluence and must be properly qualified. The committee must consider laws and regulations
p.000008: in force in the country where the research is carried out, as well as current international standards, but not
p.000008: they should be allowed to reduce or eliminate any of the protections for people participating in the
p.000008: investigation established in this Statement.
p.000008: • The committee has the right to monitor ongoing trials. The researcher has the obligation to provide
p.000008: control information to the committee, especially on any serious adverse incident. No amendment should be made in
p.000008: the protocol without the consideration and approval of the committee. After the study is over, the
p.000008: researchers must submit a final report to the committee with a summary of the results and conclusions
p.000008: of the study.
p.000008: Guide to Good Clinical Practices of Research in Human Health, Document of the Americas, revised in the IV
p.000008: Pan American Conference for the Harmonization of Pharmaceutical Regulation, dated March of
p.000008: 2005, defines in its chapter the organization of the Research Ethics Committee or Review Committee
...
Orphaned Trigger Words
p.000006: State, is the agency responsible for determining, planning, executing and issuing the relevant regulations, as well as
p.000006: organize, coordinate and evaluate the execution of health related activities.
p.000006: II. That Article 16 numeral 3 and 67 of the Internal Regulations of the Executive Branch establishes that it is
p.000006: faculty of the Holder of this State Portfolio, approve and enforce the Manuals of
p.000006: organization; as well as determine the administrative structure and operation of this Secretary of State.
p.000006: III. That it is necessary to order and systematize the operation of the National Ethics Committee of research in
p.000006: health, in order to develop the functions in an agile and timely manner.
p.000006: THEREFORE: In use of its legal powers, AGREES to issue the following:
p.000006: OPERATING MANUAL OF THE NATIONAL COMMITTEE OF ETHICS OF HEALTH RESEARCH ”
p.000007: 7
p.000007: INTRODUCTION
p.000007: The realization of clinical studies in all the countries of our continent, as in the rest of the
p.000007: world, you must follow strict ethical and scientific principles. These principles are universal, above
p.000007: of any difference between people, in order to safeguard the physical and psychic integrity of
p.000007: the subjects involved, as stated in the declaration of the rights of the people of Helsinki.
p.000007: In 2005, and due to the regulatory vacuum to evaluate biomedical research in humans in El
p.000007: Salvador, the Higher Council of Public Health (CSSP) and the Ministry of Health (MINSAL), created the Committee of
p.000007: National Bioethics, later called the National Committee for Clinical Research Ethics and, currently, the Committee
p.000007: National Health Research Ethics (CNEIS).
p.000007: In that period 2005-2010, a group of health and social science professionals from the country discussed and
p.000007: approved the document Organization and Operation Guide of the National Research Ethics Committee in
p.000007: Health, based on the fundamental principles established in the Nuremberg Code, the Declaration of Helsinki,
p.000007: document subsequently amended (64th General Assembly, Fortaleza, Brazil, October 2013), and guides
p.000007: proposed by the Council of International Organizations of Medical Sciences (CIOMS) and the
p.000007: World Health Organization (WHO). Three basic ethical principles of similar moral strength respect for
p.000007: people, charity and justice permeate all the principles of good clinical practice (PCB)
p.000007: In this sense, the current health reform process involves the creation of legal technical instruments that
p.000007: guarantee the protection of people, as well as the guiding tools in the ethical aspects of
p.000007: research with a potential for innovations that can be generated from the research process, which
p.000007: suppose scientific advances for medical sciences, going from the analysis of the biologiscist aspects and that
p.000007: transcend the approach to social determination in health.
p.000007: These facts highlight the need for a National Research Ethics Committee in
p.000007: Health, as part of the set of regulatory authorities that promote uniform standards for
p.000007: local committees of the country and, under any system, the sponsors of an investigation and the institutions that
p.000007: Hiring researchers should allocate sufficient resources for the evaluation process.
p.000007: This manual describes the process of organization and operation of the National Research Ethics Committee in
p.000007: health, considering the laws and regulations in force in the country related to research, as well as
p.000007: current international standards, which protect people who participate in health research.
p.000008: 8
p.000008: I. LEGAL FRAMEWORK
p.000008: Constitution of the Republic Article 79, states that “The State shall provide the necessary resources and
p.000008: indispensable for the permanent control of the quality of chemical, pharmaceutical and
p.000008: veterinarians, through surveillance agencies ”.
p.000008: Helsinki Declaration of the World Medical Assembly Ethical principles for medical research
p.000008: in human beings, during the 64th General Assembly, Fortaleza, Brazil, October 2013, described in its principles
p.000008: ethical the following:
p.000008: • The investigation protocol must be sent, for consideration, comment, advice and approval
p.000008: to the relevant research ethics committee before beginning the study. This committee must be transparent.
p.000008: in its operation, it must be independent of the researcher, the sponsor or any other type of
p.000008: undueXinfluence and must be properly qualified. The committee must consider laws and regulations
p.000008: in force in the country where the research is carried out, as well as current international standards, but not
p.000008: they should be allowed to reduce or eliminate any of the protections for people participating in the
p.000008: investigation established in this Statement.
p.000008: • The committee has the right to monitor ongoing trials. The researcher has the obligation to provide
p.000008: control information to the committee, especially on any serious adverse incident. No amendment should be made in
p.000008: the protocol without the consideration and approval of the committee. After the study is over, the
p.000008: researchers must submit a final report to the committee with a summary of the results and conclusions
p.000008: of the study.
p.000008: Guide to Good Clinical Practices of Research in Human Health, Document of the Americas, revised in the IV
p.000008: Pan American Conference for the Harmonization of Pharmaceutical Regulation, dated March of
p.000008: 2005, defines in its chapter the organization of the Research Ethics Committee or Review Committee
p.000008: Institutional (CEI / CRI), structure, composition, functions and procedures.
p.000008: International Ethical Guidelines for Biomedical Research in Human Beings Prepared by the Council
p.000008: of International Medical Sciences Organizations (CIOMS) in collaboration with the World Organization of
p.000008: Health, reviewed in Geneva, in 2012, orient, especially to low-income countries, in the
p.000008: definition of national guidelines on biomedical research ethics, applying ethical standards in conditions
p.000008: local, and establishing or redefining appropriate mechanisms for the ethical evaluation of research
p.000008: in human beings, including in Guideline 2, related to the Ethics Evaluation Committee,
p.000008: expressing the following: “All proposals to conduct research in human beings must be submitted
p.000008: to one or more scientific evaluation and ethical evaluation committees to examine their scientific merit and acceptability
p.000008: ethics. The evaluation committees must be independent of the research team, and any benefits
p.000008: direct, financial or material that they could obtain from the investigation, should not depend on the result
p.000008: of the evaluation. The researcher must obtain approval or authorization before conducting the investigation. The
p.000008: Committee of
p.000009: 9
p.000009: ethical evaluation should perform the additional revisions that are necessary during the investigation, including
p.000009: Track your progress.
p.000009: II. OBJECTIVES OF THE MANUAL
p.000009: A. General
p.000009: Standardize the procedures for the organization and operation of the National Research Ethics Committee in
p.000009: Health (CNEIS) and Local Committee for Health Research (CEIS) of El Salvador, to ensure quality
p.000009: of the processes of protection of the rights, security and well-being of the participating human beings
p.000009: voluntarily in health research projects, in accordance with scientific and ethical principles
p.000009: internationally approved.
p.000009: B. Specific
p.000009: 1. Describe the nature and dependence of the Health Research Ethics Committee.
p.000009: 2. Detail the procedures for the organization of the Health Research Ethics Committee.
p.000009: 3. List the functions of the committee and its members.
p.000009: III. CNEIS DESCRIPTION AND OPERATION
p.000009: 1. Nature
p.000009: The National Committee for Health Research Ethics, hereinafter CNEIS is a useful body
p.000009: public, independent and autonomous in the exercise of its functions, composed of technical experts
p.000009: competent multidisciplinaries, responsible for protecting the rights, security and welfare of human beings
p.000009: voluntarily participating in health research projects, in accordance with principles
p.000009: internationally approved scientists and ethicists.
p.000009: 2. Dependency
p.000009: The CNEIS was created on April 27, 2005 by the Ministry of Health and the Higher Council of Public Health, date in
p.000009: which took the protest of law to the owners and alternate members elected on February 25 of the same
p.000009: year. The CNEIS depends organically on the Ministry of Health, hereinafter MINSAL and administratively on the
p.000009: Higher Public Health Council, hereinafter CSSP, and operates autonomously to ensure that all
p.000009: research involving human beings in the country is conducted based on ethical principles
p.000009: fundamental respect for people, considering the laws and regulations in force in the country,
p.000009: as well as the current international norms established in the Declaration of Helsinski.
p.000010: 10
p.000010: 3. Mission
p.000010: Ensure respect for the rights and safety of the participants involved in the activities of the
p.000010: scientific research, seeking an independent, competent and timely evaluation of the ethical aspects of the
p.000010: Health research
p.000010: 4. Vision
p.000010: To be the national committee, with regional recognition, that provides professional services and
p.000010: technicians in the evaluation of the ethical considerations of the investigation, to the scientific community of the country, in
p.000010: special to the community that participates in health research projects, in order to help safeguard the
p.000010: dignity, rights, security and welfare of all research participants.
p.000010: 5. Objectives of the National Committee for Health Research Ethics
p.000010: to. general
p.000010: Review the quality and integrity of research projects carried out in the country, for the
p.000010: protection of people who participate as volunteers in a health research.
p.000010: b. Specific
p.000010: to. Supervise the proper protection of subjects involved in health research conducted in the country and the
p.000010: ethical safeguards of the studies carried out.
p.000010: b. Verify the application of international guidelines for the guarantee of Good Clinical Practices of
p.000010: Research in Human Health.
p.000010: c. Provide support to researchers in the ethical aspects of their projects.
p.000010: 6. Ethical principles for health research
p.000010: All health research must be carried out in accordance with established ethical principles:
p.000010: a) Principle of beneficence: research contributes to the well-being of people;
p.000010: b) Principle of non-maleficence: the investigation must not cause deliberate or perverse harm to the
p.000010: participants and people in general;
p.000010: c) Principle of autonomy: research must protect the rights and dignity of participants and their
p.000010: capacity for self-determination to make decisions. Your participation must be voluntary and based on the
p.000010: informed consent;
p.000010: d) Principle of justice: ethical obligation to treat each person in accordance with what is considered morally
p.000010: correct and appropriate; and to distributive justice, which
p.000010: eleven
p.000010: establishes the equitable distribution of burdens and benefits to research participants;
p.000010: e) Principle of privacy, anonymity and confidentiality: all information and data of the participants obtained
p.000010: Directly or indirectly they are confidential.
p.000010: 7. Requirements to become a member
p.000010: To be a member of the CNEIS, the following requirements must be met:
p.000010: a) Be a Salvadoran citizen, of legal age and in full enjoyment of his rights;
p.000010: b) Be of notorious honesty;
p.000010: c) Have professional and private conduct based on moral principles;
p.000010: d) Have proven expertise in the field of research and the field of your profession;
p.000010: e) Commitment and interest to participate actively in the activities of the Ethics Committee;
p.000010: f) Not be an officer of the Executive, Legislative and Judicial Powers and of the Higher Council of Public Health and
p.000010: their relatives in second degree of consanguinity or first of affinity;
p.000010: g) Not be a member of organizations responsible for health research, or directors, officials,
p.000010: employees or shareholders of pharmaceutical companies and their relatives in second degree of consanguinity or first
p.000010: of affinity
p.000010: 8. Conformation
p.000010: The CNEIS will be made up of eleven to thirteen proprietary members, of which five to seven will be professionals of
p.000010: Health Sciences, four from the Social Sciences, one with experience in the area of human rights and one with
p.000010: training and leadership in theology, constituted in a way that ensures a competent evaluation and review of the
p.000010: scientific, medical and ethical aspects of the study, as well as to achieve that their goals can be
p.000010: executed free of bias and influence that could affect their independence. CNEIS members will be elected
p.000010: by the Minister of Health and the President of the Higher Council of Public Health, through a
p.000010: public call issued three months in advance that stipulates the requirements established to be
p.000010: member of the Ethics Committee. For this, the acting Ethics Committee will prepare a list of selected candidates
p.000010: by contest of merits based on the Curriculum Vitae and personal interview.
p.000010: The members of the CNEIS will last three years in their functions, being able to be appointed for one more period.
p.000010: The CNEIS will be composed of the President who will preside, a Vice-President, a Secretary and so many
p.000010: Members as members have been registered in the Committee.
p.000012: 12
p.000012: The President, the Vice President and the Secretary of the CNEIS will be appointed by majority vote of the members of the
p.000012: Ethics Committee.
p.000012: 9. Attributions
p.000012: For the purposes of the attributions of CNEIS, research in humans includes:
p.000012: a) Studies of physiological, biochemical or pathological processes, or of the response to an intervention
p.000012: specific-physical, chemical or psychological in patients or healthy subjects;
p.000012: b) Controlled trials of diagnostic, preventive or therapeutic interventions in large groups of
p.000012: people, designed to demonstrate a specific generalizable response against a background of biological variation
p.000012: individual;
p.000012: c) Studies designed to determine the consequences of specific preventive or therapeutic interventions for
p.000012: individuals and communities;
p.000012: d) Studies on human behavior related to health in various circumstances and environments.
p.000012: Likewise, investigations can be classified into three categories according to risk:
p.000012: a) Risk-free research: those in which intervention is not necessary
p.000012: Some in the participating individuals. Data is collected through questionnaires, interviews, review of
p.000012: clinical records and others;
p.000012: b) Interventions with minimal risk: these are the investigations that use procedures
p.000012: common for recording data, such as physical and psychological exams, or routine treatments in
p.000012: clinical practice;
p.000012: c) Interventions with higher risk: those that employ methods that can affect the
p.000012: individuals, such as radiological studies, trials with commercial medications or in
p.000012: development and studies that include surgical procedures and genetic studies.
p.000012: Risk-free or minimal risk interventions will be evaluated by local ethics committees created in the
p.000012: academic or health institutions and registered annually in the CNEIS. Investigations with higher risk should
p.000012: be reviewed by local ethics committees, but registered and definitively approved by the CNEIS.
p.000012: Taking into account the above, the attributions of the National Ethics Committee of Health research
p.000012: They are as follows:
p.000012: a) Issue an opinion to ensure that the rights and well-being of people included in health research
p.000012: be properly protected;
p.000013: 13
p.000013: b) Ensure that the researcher achieves the free consent of the people participating in the study,
p.000013: and that the information obtained be confidential;
p.000013: c) Ensure that there is a balance between risk and potential benefits in any study supported by
p.000013: the CNEIS;
p.000013: d) Ensure that researchers and sponsors of human studies comply with the principles
p.000013: internationally accepted scientists and ethicists.
p.000013: 10. Meetings
p.000013: The Ethics Committee will meet ordinarily every fifteen days, and extraordinarily when convened by the
p.000013: Chairman of the Committee on his own initiative, or when requested by more than fifty percent of the
p.000013: representation of its members.
p.000013: In order for the CNEIS to hold a valid session, the attendance of the President, and / or the
p.000013: Vice President, and / or Secretary and five of its members. The resolutions of the Ethics Committee are
p.000013: they will take half plus one of the members that make up the quorum.
p.000013: 11. Functions of the President
p.000013: The Chairman of the Ethics Committee will have the following functions:
p.000013: a) Represent the CNEIS before the different national academic and scientific bodies and
p.000013: foreigners involved in human research;
p.000013: b) Chair the ordinary and extraordinary sessions of the Ethics Committee;
p.000013: c) Represent and be a spokesperson for the Ethics Committee before the CSSP and MINSAL;
p.000013: d) Coordinate together with the Secretary the scientific and ethical evaluation meetings of the projects of
p.000013: health research submitted to the Ethics Committee for consideration;
p.000013: e) Prepare the Annual Work Plan together with the members of the Committee;
p.000013: f) Direct the Financial and Human Resources Administration of the Committee;
p.000013: g) Coordinate and monitor the evaluation process of research projects in
p.000013: health evaluated;
...
p.000014: b) Evaluate research protocols according to established operating procedures, and give their opinion
p.000014: on compliance with ethical requirements;
p.000014: c) Collaborate in the preparation of the Annual Work Plan and the Committee's Work Report;
p.000014: d) Assume responsibility for the activities delegated by the Chairman of the Committee; Y
p.000014: e) Send electronically the observations issued to the protocols assigned for the
p.000014: Review of ethical considerations, three days before the ordinary session.
p.000014: 15. Responsibilities of CNEIS
p.000014: a) The responsibility of a Research Ethics Committee in evaluating an investigation in
p.000014: health is to contribute to safeguard the dignity, rights, security and well-being of all participants
p.000014: current and potential research; special attention should be given to studies that may
p.000014: involve vulnerable people;
p.000014: b) A cardinal principle of research involving human beings is to respect the dignity of people.
p.000014: The goals of research, while important should never go beyond health, well-being and
p.000014: care of research participants;
p.000014: c) The CNEIS must take into consideration the principle of justice. Justice requires that the benefits
p.000014: and disadvantages of the research are distributed equally among all groups and
p.000014: classes of society, taking into account age, sex, economic status, culture and ethnic considerations;
p.000016: 16
p.000016: d) The CNEIS must provide an independent, competent and timely evaluation of the ethics of the studies
p.000016: proposed;
p.000016: e) The CNEIS is responsible for acting in the full interest of the potential participants of the
p.000016: research and of the communities involved, taking into account the interests and needs of
p.000016: researchers, as well as the requirements of regulatory agencies and applicable laws;
p.000016: f) The CNEIS is responsible for evaluating the proposed research before its start. You must also ensure
p.000016: regular evaluation of developing studies that received a positive decision at intervals
p.000016: appropriate according to the degree of risk to people, at least once a year;
p.000016: g) The CNEIS has the authority to approve, request modifications (prior to approval),
p.000016: refuse, or suspend a clinical study;
p.000016: h) To fulfill its functions, the CNEIS must receive and have available all the documentation
p.000016: related to the study: protocol, amendments thereto, informed consent forms and
p.000016: updates to it, updated researcher's curriculum vitae, recruitment procedures,
p.000016: patient information, investigator manual, available safety information, and payment information
p.000016: to patients, information on patient compensation, and any other document than CNEIS
p.000016: may need to fulfill their responsibilities;
p.000016: i) The CNEIS must consider the competence of the investigator to conduct the proposed study, as documented
p.000016: in the Curriculum Vitae and in all other relevant documentation requested by the CNEIS;
p.000016: j) The CNEIS must review both the amount and the method of payment to individuals to ensure that they do not exist
p.000016: coercion problems or bad influence on study subjects. Payments to the person must be assigned
p.000016: and not depend on the subject finishing the study;
p.000016: k) The CNEIS must ensure that information regarding the payment to individuals, including methods,
p.000016: quantities and programming is stipulated in the form of written informed consent, as well as any
p.000016: other written information provided to subjects. You must specify the way it will be
p.000016: assigned payment.
p.000017: 17
p.000017: 16. Training of members
p.000017: The CNEIS will promote the continuous training of its members in the following subject: courses on
p.000017: research and ethics methodology, expert conferences, workshops, conferences and diplomas (Magister
p.000017: in Bioethics). These trainings can be extended to the members of the local ethics committees.
p.000017: 17. Monitoring through the Higher Council of Public Health, (CSSP).
p.000017: The objectives of monitoring a study are to verify that:
p.000017: a) The rights and welfare of human beings are protected;
p.000017: b) The reported data of the study are complete, accurate and can be verified from the source documents; Y
p.000017: c) The conduct of the study is in accordance with the protocol / amendments, approved, with the
p.000017: Guidelines for Good Clinical Practices (BPC) in establishments where they are carried out
p.000017: research or clinical trials involving people. (adaptation of the harmonized tripartite guide of
p.000017: the international harmonization conference iche 6r1).
p.000017: A written monitoring plan must be available and for the selection of studies that will receive monitoring
p.000017: the scope and nature of monitoring should be determined based on considerations such as the objective,
p.000017: design, complexity, blind studies, size, study measurement points, adverse effects report
p.000017: Serious, EAS or SUSAR.
p.000017: The actions to be carried out during monitoring are the following:
p.000017: a) Verify that the researcher is qualified and has adequate resources and they
p.000017: maintain during the study that the facilities, including the laboratory, equipment and the
p.000017: staff are suitable to conduct the study safely and appropriately and are maintained in this way
p.000017: during it;
p.000017: b) Verify with respect to the product under investigation that:
p.000017: i. storage times and conditions are acceptable and supplies are
p.000017: sufficient during the study the research product is provided only to the subjects that are
p.000017: eligible to receive it and at the doses specified in the protocol;
p.000017: ii. subjects are provided with the necessary instructions on the use, handling, storage and return
p.000017: appropriate research product;
p.000017: iii. the reception, use and return of the product under investigation at the sites where the
p.000017: study is controlled and properly documented; Y
p.000018: 18
p.000018: iv. The disposition of the unused research product, at the sites where the study is conducted,
p.000018: Comply with applicable regulatory requirements and be in compliance with the sponsor.
p.000018: c) Verify that the investigator follows the approved protocol and all the approved amendments, if the
p.000018: would have
p.000018: d) Verify that the written informed consent of each subject has been obtained before participating in
p.000018: the study;
p.000018: e) Ensure that the researcher receives the current Investigator Manual, all documents and documents
p.000018: study supplies needed to properly conduct the study and to
p.000018: comply with applicable regulatory requirements;
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| blind | visual impairment |
| children | Child |
| cioms | cioms guidelines |
| dependence | Drug Dependence |
| education | education |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| gender | gender |
| helsinki | declaration of helsinki |
| influence | Drug Usage |
| low-income | Economic/Poverty |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| union | Trade Union Membership |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
developing
ethics
harm
justice
protect
protection
risk
self-determination
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input