Request Policy
Types of Applications
Initial Evaluation: This is the process by which the Research Ethics Committee (REC) reviews a submitted research protocol to assess its quality and its compliance with ethical principles and applicable regulations. During this evaluation, it is verified that the research protocol includes the necessary information, such as the objectives of the research, the proposed methodology, the target population, and the potential risks and benefits of the research. It also verifies that informed consent has been obtained from the participants and that rigorous ethical and scientific procedures have been followed. The IRB may make recommendations to modify the research protocol if necessary before final approval. The initial review is an important step in protecting the rights and wellbeing of research participants and in ensuring the quality and integrity of scientific research.
Amendment Review: The process by which a proposed modification to the research protocol originally approved by a research ethics committee is analyzed and evaluated. This review is necessary to ensure that any changes to the protocol comply with the ethical and scientific requirements established in the applicable regulations and standards.
The amendment review involves a careful evaluation of the nature of the proposed modifications, as well as the risks and benefits associated with them. Depending on the nature and extent of the modifications, the amendment review may require a thorough evaluation similar to the initial evaluation of the research protocol.
In general, the amendment review of a research protocol is intended to ensure that any proposed modifications are appropriate, ethically and scientifically sound, and that the rights and safety of research participants are protected.
Annual re-approval: is a process that is carried out to renew the approval of the research protocol by the research ethics committee after it has been approved for the first time. This process is necessary to ensure that the research protocol continues to meet the required ethical and scientific standards.
During the annual reapproval, the committee reviews the progress of the research and evaluates any changes made to the research protocol. The safety of the participants is also evaluated and informed consent procedures are verified. If the committee determines that the research protocol still meets ethical and scientific standards, approval to continue the research is renewed. If problems are found, recommendations may be made to modify the protocol or discontinue the research. Annual re-approval is an important process to ensure that the rights and wellbeing of research participants are protected.
Assignment of rights: This involves transferring the intellectual property of the research protocol from the original authors to another entity or person. This means that the new owners will have the exclusive rights to use, modify and distribute the research protocol, as well as any results obtained from it. The assignment of rights is accomplished through a legal agreement in which the original authors agree to transfer their intellectual property rights to the designated entity or person. This practice is common in situations where the research has been funded by an organization, such as a university or a company, and the results are expected to be the exclusive property of that organization.
Special Meeting: A meeting that is convened at a date other than the regularly scheduled meeting date to discuss and make decisions on an important matter that cannot wait until the next scheduled meeting. This type of meeting is called in emergency situations, such as the occurrence of unforeseen ethical issues related to a research protocol, or when urgent decisions need to be made to ensure the safety and wellbeing of study participants. Extraordinary meetings may be called by the committee chair, the research director, or any committee member.
