● Introduction ● Vaccine and immunization research [ver] ● Research chapter in the AEP Immunization Manual online [ver] ● Informed consent [ver] ● Informed assent [ver] ● Importance of informed consent and assent [ver] ● More information on this website [ver]
In a few words ● The chapter of the AEP Online Immunization Manual dedicated to research has been updated, expanding with a new section dedicated to informed consent and assent.
● Vaccine research is a long, complex, and rigorous process that goes from identifying potential candidates to conducting human clinical trials.
● It is essential to guarantee the safety and efficacy of vaccines, and this cannot be achieved without the voluntary and conscious participation of the study subjects, participation that is ratified through informed consent.
● Informed consent is the fundamental tool that ensures that anyone participating in a vaccine clinical trial is fully informed about the potential risks and benefits of the research.
● In the case of clinical trials involving minor adolescents, it is also required that they sign an informed assent.
● Informed consent and assent protects the rights of participants, ensures ethical research, and contributes to public confidence in vaccines and medical research in general.
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Introduction
The chapter of the AEP Online Immunization Manual dedicated to research has been updated, expanding with a new section dedicated to informed consent and assent.
Vaccine and immunization research
Vaccine research is a fundamental pillar of modern medicine and Public Health. Throughout history, vaccines have proven to be one of the most effective tools for preventing serious disease and saving lives.
Vaccine research is a long, complex, and rigorous process that involves numerous steps, from identifying potential candidates to conducting human clinical trials. During each stage of this process, it is essential to guarantee the safety and efficacy of the vaccines, and this cannot be achieved without the voluntary and conscious participation of the study subjects, participation that is ratified through informed consent.
Research chapter in the AEP Immunization Manual online
The content of the recently updated chapter dedicated to research is:
Introduction [ver]. Why do we research and why is research necessary? The randomized clinical trial (RCT) as a paradigm of scientific evidence [ver]. General characteristics of an RCT [ver]. Classification of RCTs [ver]. Research ethics in RCTs [ver]. Codes of ethics: the standards of good clinical practice (GCP) of the International Conference on Harmonisation (I) [ver]. People and entities involved in the development of an RCT on vaccines [ver] (drug regulatory authority; sponsor; investigator; ethics committee; trial participants). Consent and informed assent in RCTs of vaccines [ver]. Informed consent [ver] (key elements; documentation). informed assent [ver] (application in RCT of vaccines in minors; ethical and legal importance). How is research done on vaccines?: the RCT applied to the field of prevention through vaccination [ver]. Phases of a clinical trial in vaccine research: phase I studies; phase II; phase III; phase IV [ver]. Bibliography [ver]. Links of interest [ver]. update history [ver]. Table and figure included in the chapter. Summary of the characteristics of the different phases of the vaccine clinical trial. General design of the research process.
informed consent
Informed consent is the fundamental tool that ensures that anyone participating in a vaccine clinical trial is fully informed about the potential risks and benefits of the research. This information must be provided in an understandable manner and without undue pressure from the study investigator. The main purpose of consent is to provide all available information so that participants understand the potential benefits and risks of their participation. When a minor participates in a vaccine clinical trial, it is the parents or legal guardians who must receive all the information available through the researcher, through this informed consent.
informed assent
In addition to consent, in the case of clinical trials involving adolescent minors, they are required to sign an informed assent. Informed assent implies that, in addition to the consent of the parents or legal guardians, the minor child or adolescent must also express their agreement to participate. This document should be written in a manner appropriate to their age and level of understanding. Informed assent is essential to ensure that even the most vulnerable participants have the opportunity to express their opinion and participate as much as possible in the decision-making process.
Importance of informed consent and assent
The importance of consent and informed assent in vaccine research is high. It protects the rights and dignity of participants, ensures that research is ethical and meets the highest scientific and ethical standards, and contributes to public confidence in vaccines and medical research in general.
In addition, vaccine research not only benefits individuals participating in clinical trials, but has a global impact by providing knowledge and effective tools to prevent diseases and epidemics. Without a robust system of informed consent and assent, vaccine research could not proceed ethically or efficiently.
In summary
In summary, vaccine research is an asset of great value for Public Health, but its success depends to a large extent on ethical integrity and the voluntary participation of study subjects through informed consent and assent.
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More information on this website
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2023-08-31 05:06:29
#Immunization #Manual #Updated #Research #Chapter
