1. OBJECTIVE
The regulations contained in various research calls require that projects involving:
- a. Research on human subjects, use of their personal data, or biological samples of human origin.
- b. Animal experimentation.
- c. Use of biological agents.
- d. Use of genetically modified organisms (GMOs).
Not only comply with the requirements established in each case by current legislation, but also have the express authorization issued by the Research Ethics Committee of the Catholic University of San Antonio.
Beyond this obligation, the Catholic University of San Antonio, as a research and teaching institution, is aware of its responsibility to society and, consequently, has established the Research Ethics Committee to provide a swift and effective response to the needs that arise regarding scientific research conducted within its scope, in order to protect fundamental human rights, animal welfare, and the environment, and to respect the bioethical principles and commitments assumed by the scientific community and the University's own regulations on this matter.
2. RESPONSIBILITIES
The Research Ethics Committee of the Catholic University of San Antonio (hereinafter, the Committee) has the following functions within its area of competence:
- A. To issue reports requested by institutions and researchers on research projects or studies involving human subjects, the use of their personal data or biological samples of human origin, animal experimentation, or the use of biological agents or genetically modified organisms (GMOs).
- B. To assess any other research project that may directly affect fundamental human rights, animal welfare, and interests related to the defense and protection of the environment.
- C. To ensure compliance with good research and experimentation practices, in relation to the rights and interests referred to in the previous section.
- D. To prepare reports for the University's governing bodies on ethical issues related to the previous sections that may arise from research and teaching.
- E. To promote debate within the university community on bioethical issues of general interest.
- F. Any other functions assigned to it by current legislation or the University's Governing Council.
- The Vice-Rectorate for Research will be responsible for archiving the Committee's documents.
- This archive will contain a copy of all reports, as well as any other documentation generated during the information and evaluation process. This archive may be consulted by any member of the Committee.
- To facilitate filing and documentation, all projects will be assigned an identification number.
3. COMPOSITION AND APPOINTMENT
- The Committee is composed of eight members from different areas of expertise, belonging to the Teaching and Research Staff of UCAM.
- The appointment and removal of Committee members, as well as the appointment of the Chairperson, is the responsibility of the Governing Council, following a proposal from the Vice-Rectorate for Research.
- The Chairperson of the Committee will designate one of the remaining members to serve as Secretary.
- The Committee will be renewed every four years.
- No member may delegate their duties or be substituted during Committee meetings.
- The Committee may establish Subcommittees to study projects related to human and animal experimentation and biosafety when the number, deadlines, or nature of the reports to be produced so require.
4. OPERATION
- The operation of the Committee will be governed by the provisions of these regulations.
- The Vice-Rectorate for Research, on behalf of the President, will convene the Committee with sufficient advance notice when research project calls so require.
- The Committee may hold extraordinary meetings when required.
- The Committee will work in Plenary Session and in Subcommittees. Subcommittees will be composed of at least two members and will carry out any functions delegated to them by the Plenary Session. The Plenary Session may assume jurisdiction over any matter.
- The presence of at least four members is required for the Plenary Session of the Committee to be constituted. Committee decisions will be adopted by simple majority.
- Committee members are obligated to maintain confidentiality regarding both the discussions and the reports.
- Committee members must abstain from proceedings affecting projects in which they participate as researchers or in other cases where conflicts of interest may arise.
- When the Committee so decides
- The Committee may, as it deems appropriate, seek the opinion of external experts, who will also be bound by the principle of confidentiality.
- The Committee has the authority to request any additional information it considers necessary from the researchers of a project under evaluation.
- The Chair of the Committee may cast the deciding vote to resolve a tie, which may only be exercised when such a tie occurs.
5. PROCEDURE
- The documentation for projects or research requiring a report from this Committee must be submitted to the Vice-Rectorate for Research fifteen days prior to the closing date of the corresponding call for proposals.
- The documentation submitted to the Vice-Rectorate for Research will be forwarded to the Committee at least ten days before the meeting is convened by the Vice-Rectorate for Research, which will then call the plenary session.
- Each member of the Committee will submit their ethical assessment report for the project under evaluation to the Chair before the meeting.
- Once the submitted documentation has been reviewed, a decision will be sent to the Principal Investigator of the evaluated project through the Vice-Rectorate for Research. Research projects or papers submitted to the Committee for evaluation will be rated in one of the following ways:
- a) Favorable report.
- b) Favorable report conditional upon the correction of formal defects or the submission of the additional documentation expressly requested.
- c) Unfavorable report.
- A positive evaluation of the bioethical aspects involved in the research project or paper will result in the issuance of a favorable report. If the evaluation is not positive, the Committee will issue a reasoned unfavorable report.
- When the research project or paper is positively evaluated, subject to the correction of any formal defects or the submission of additional documentation demonstrating compliance with the applicable requirements, a favorable report conditional upon such correction will be issued. In this case, the Committee will request, through the Vice-Rectorate for Research, that the deficiency be corrected or that the supplementary documentation be provided by the principal investigator. Strict compliance with the request, which will be verified by the Committee Secretary with the approval of its Chair, will have the effects stipulated in the previous section. The decisions thus adopted will be reported to the Committee Plenary at its next meeting.
6. DOCUMENTATION TO BE SUBMITTED | APPENDICES