Frequently asked questions – CEAS – Ministry of Public Health

2023-06-09 19:25:51

What is the difference between a health care ethics committee and one for research in human beings?
There are two types of health ethics committees, ethics committees for research in human beings, are bodies linked to a public or private institution, responsible for carrying out the ethical, methodological and legal evaluation prior to its execution, in which they participate. human beings, that use human biological samples, that involve the participation of vulnerable populations or use confidential information of people; as well as to carry out the follow-up of the approved investigations during their development until their completion and their respective publication of the results obtained.
While the Health Care Ethics Committees are deliberative bodies of multidisciplinary composition, at the service of professionals, users and management teams of health establishments, created to analyze and advise on ethical issues that arise in practice. care.

That regulations are in force for the formation of Ethics Committees in the country?
Currently, the country is in force under Ministerial Agreement No. 0005-2022, published in the Fifth Supplement to Official Gazette No. 118 of August 2, 2022, “Regulations for the approval and follow-up of the Ethics Committees for Research in Human Beings (CEISH) and the Health Care Ethics Committees (CEAS)»
Additionally, the related regulations in the country must be taken into account.

For CEISH:

For CEAS:

What is a Healthcare Ethics Committee (CEAS)?
Health Care Ethics Committees are multidisciplinary deliberation bodies, at the service of professionals, users and management teams of health establishments, created to analyze and advise on ethical issues that arise in care practice.

What should be included in the Internal Regulations of the Health Care Ethics Committee?

• Basic principles of CEAS.
• CEAS objective.
• CEAS scope of action.
• Functions, in accordance with the general functions defined in the previous articles of these regulations.
• Conformation: the criteria for the election of president, secretary and members will be included.
• Loss of Membership.
• Procedures for replacement of members.
• Functions of the president, the secretary and members.
• Operating rules:
  • Conflict of interest statement
  • Confidentiality of information
  • Reception of requests for evaluation by the committee.
  • Periodicity of ordinary and extraordinary meetings.
  • Call for sessions.
  • Registration of attendance and quorum.
  • Mechanism for calling third parties to CEAS meetings.
  • Evaluation of cases and issuance of reports and/or responses.
  • Content of the minutes and their approval mechanism.
  • Query response mechanism.
  • File and custody of documents.
  • Institutional linkage, human resources, materials and equipment.
• Mechanisms to reform the internal regulations.
• Procedure for the execution of the annual training plan for its members.
• CEAS management reports.

Who can form the Health Care Ethics Committees (CEAS)?
The CEAS will be made up of health personnel from the institution to which it is linked, who will make up a multidisciplinary team of at least five (5) people, always considering that it is an odd number of members. Of the minimum conformation of five (5) people at least three (3) will have the following basic operating profiles: a legal professional, a health professional (doctors, nurses, social workers, psychologists, technologists) with knowledge in bioethics, and a representative of civil society. In the case of legal professionals, they may belong to another institution, if this professional profile does not exist in the establishment requesting CEAS approval.

Who is and what does the civil society representative do in the Health Care Ethics Committees (CEAS)?
The civil society representative should not have specific training in areas related to health, medical care or law. His participation must express the point of view of the users of health care. In addition, it is recommended that you not be in a dependency relationship with the institution to which the CEAS belongs.

When is the status of member of a CEAS lost??
CEAS membership may be lost for the following reasons:

• By administrative transfer.
• Dissociation from the institution to which the Committee belongs.
• In the case of the president or secretary who delegates his position for more than three (3) months, without justification of the delegation.
• By own will expressed in a request addressed to the president of CEAS.
• For unjustified absence to more than three (3) ordinary or two (2) extraordinary sessions.
• For non-compliance with the obligations assumed as a member of the Committee or its operating rules.
• Hold positions of Manager, Medical Director or any other managerial position in the establishment to which CEAS is linked.
• Failure to maintain the confidentiality of the information provided.
• Expulsion agreed by the members of CEAS.
• End of the period for which you were elected a member.

At what time is the registration of new members in CEAS enabled?
The DIS will issue the observation or approval report, as appropriate, of the new member(s) requested within twenty (20) days from receipt of the request. In the event that the CEAS receives a report with observations, it will forward the corrected observations to the DIS within twenty (20) days, otherwise the request will be archived.

How do you lose your CEAS membership?
CEAS membership may be lost for the following reasons:

• By administrative transfer
• Dissociation from the institution to which the Committee belongs.
• In the case of the president or secretary who delegates his position for more than three (3) months, without justification of the delegation.
• By own will expressed in a request addressed to the president of CEAS.
• For unjustified absence to more than three (3) ordinary or two (2) extraordinary sessions.
• For non-compliance with the obligations assumed as a member of the Committee or its operating rules.
• Hold positions of Manager, Medical Director or any other managerial position in the establishment to which CEAS is linked.
• Failure to maintain the confidentiality of the information provided.
• Expulsion agreed by the members of CEAS.
• End of the period for which you were elected a member.

Who should attend CEAS sessions?
The CEAS sessions will be ordinary and extraordinary. Ordinary sessions will be held monthly, and extraordinary sessions when agreed. The sessions will have at least 50% plus one (1) of the members, the presence of the president, secretary (or those who formally replace them), being mandatory. as well as the members who cover the basic operating profiles.

The Committee must keep minutes of the sessions it holds, which must be duly signed by the president, secretary and all members participating in them.

The CEAS will establish the convening mechanism, in the event that the Committee considers it necessary to invite third parties such as specialists or experts in
finished themes. These third parties must sign a confidentiality agreement and a declaration of not having a conflict of interest, prior to their participation in the sessions to which they are invited.

What happens if a CEAS loses its validity?

In the event that the CEAS does not send the request for renewal of the Committee’s approval within the established term and loses the validity of the approval, it will immediately cease its functions and activities. However, you must send the DIS within thirty (30) days from notification, the annual management report.

This annual report must be evaluated and approved by the DIS or whoever acts as such, and will serve as a prerequisite for the Committee to submit a new application for approval.

The National Health Authority, through the National Directorate of Health Intelligence, may request the information it deems pertinent for the evaluation and approval of the report sent by the CEAS that has lost its validity.