Approval of Ethics Committees for Research in Human Beings (CEISH) – Ministry of Public Health

2023-06-09 18:54:29

Description

Procedure aimed at approving the formation of Human Research Ethics Committees (CEISH), which are linked to universities or public or private health establishments.

Who can access the service?

• Universities in which research involving human beings and/or using human biological samples is carried out.
• Second and third level health care establishments that have teaching and research services.
• research centers

USE: Consider that NO it is mandatory that the CEISH include within its scope, the review and approval of ALL the types of research (observational, intervention or clinical trials). In other words, the committee can analyze the relevance of adding in its internal regulations, according to its resolution capacity or availability of resources, the approval and follow-up of one or more types of studies. For example: it can desist from regulating the approval of clinical trials and it can function as a committee focused on observational and/or intervention studies.

Requirements for the approval of a CEISH

1. CVs of each of the people proposed to be part of the Committee (Annex 1)
2. Declaration letters from each of the people proposed to be part of the CEISH in which they commit to actively participate in the Committee, keep the information to which they have access confidential, declare that they have no conflict of interest that could interfere with the function to ensure compliance with ethical principles and the safeguarding of people’s rights and voluntarily exclude their participation in the treatment of issues in which they could anticipate a conflict of interest (Annex 2)
3. Committee annual training plan (Annex 3
4. Standardized Work Procedures in accordance with the provisions of Section 25 of Chapter III of Ministerial Agreement 00005-2022 (Annex 4)
5. Internal operating regulations of the CEISH. which must be signed by all members and approved by the highest authority of the institution or its delegate.

Steps to access the process virtually

This is a free procedure and it is carried out in the Single Portal for Citizen Procedures GOB.EC:

1. Go to the online procedure for Ethics Committees in the following links:
   Human Research Ethics Committees: tramites/4397/webform
2. Attach all the requirements requested on the page
   Procedure form for CEISH (Click here)

3. Verify the information sent to your email with the status of the process.
4. The response to this procedure will be received via email sent by the Single Portal for Citizen Procedures GOB.EC, in which you will receive:

• • In the case of approval, the certificate of «Ethics Committee Approval»
  • Otherwise, you will receive «Observation evaluation report»

For questions, suggestions, reports and complaints

• In case of doubts about this service you can send an email to [email protected]([phone] – extension 5267, Mayra Paola Cueva Rojas
• To improve the health service with your requirements, disagreements and/or congratulations, you can contact number 171 option 3, free call.
• Remember that we also have one-stop-shops for customer service at district offices, zonal coordination offices, or at the central plant of the Ministry of Public Health to attend to or resolve all kinds of queries or disagreements.