What is a clinical research ethics committee?
- The Ethics Committee is an organization responsible for ensuring the protection of the rights, safety and well-being of the human subjects involved in a study.
- All research conducted on human subjects must be evaluated and approved by the Ethics Committee.
- All IRB members must have completed the Good Clinical Practices course.
By: Sebastián López Henao
Member of the CREICEC Ethics Committee (Regional Committee of Ethics in Clinical Research of the Eje Cafetero).
If Hobbes’ reflections are kept in mind and applied to the current biotechnological and scientific context, in the framework of which health professionals encounter patients who suffer and die, which leads to teamwork, meeting in groups of specialists, and even collectively publishing the results of research.
“Such is the character of men that, however they may acknowledge that many others are more ingenious, more eloquent, or more learned than themselves, they find it hard to believe that there are many whose wisdom is superior to their own, for they see their wit at hand, and that of others afar off.”The warning against arrogance that Thomas Hobbes launches in his Leviathan, published in 1651.
As has been noted, it is also not uncommon for scientists and health professionals to serve on various formal committees in their own institutions or communities or, as specialized consultants, at the regional and national levels.
These activities are indicative of the fairly recent practice of meeting in groups; when these are formalized, committees, commissions and councils are created.
The tension between advancing science and protecting research subjects has been a concern since the late 19th century.
Violations of the human rights of clinical research participants have contributed to the development of a complex, if insufficient, regulatory framework (Homedes and Ugalde, 2014).
A bioethics committee is responsible for systematically and continuously addressing the ethical dimension of:
- Medical and health sciences
- Life sciences
- Innovative health policies
The term “bioethics committee” denotes a group of individuals (a chairperson and members) who meet to address issues that are not only factual, but also deeply normative in nature.
“In other words, they do not meet to simply determine the state of the art in a given area of interest.
What decision should we make and how should we act?
A committee is not concerned only with the factual dimension of the empirical data; it is set up to answer the question equally:
“What decision should I make and how should I act?” and to the more general question “What decision should we make and how should we act?”.
Thus, we move from ethics, which is traditionally a branch of philosophy, to politics: “How should a government act?
Bioethics committees therefore ask questions from a normative perspective, i.e., as a group, they ask themselves and look closely at certain individual or societal values, which is tantamount to examining not only their own conduct, but also that of others.
The members of these committees focus their work on the principles, norms and values that prevail in the field of health care, in relation to which not only personal behavior, but also the conduct of health professionals (and sometimes that of patients), must be under constant scrutiny, even formal supervision.
Bioethicists do not claim to provide a single, correct ethical answer to any moral conundrum that arises, for there are no ready-made answers; bioethical dilemmas are not akin to a mathematical problem that lends itself only to an individual solution.
Types of Ethics Committees:
Institutional Ethics Committee (CEI)
An independent organization composed of medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of the human subjects involved in a study by, among other things, reviewing, approving and constantly revising the study design and amendments to the documentation and informed consent of the study subjects.
Independent Ethics Committee
An independent organization (a review board or an institutional, regional, national, or supranational committee) composed of medical/scientific professionals and nonmedical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. Provide public assurance of that protection of rights, through, among other things, review and approval/favorable opinion of the study design, the competence of the investigator(s), and the adequacy of the facilities, methods, and material to be used in obtaining and documenting informed consent from study subjects.
In general The Ethics Committee is an organization responsible for ensuring the protection of the rights, safety and well-being of the human subjects involved in a study.
Ongoing review, approval and follow-up of the research project and amendments to the documentation along with informed consent of the study subjects.
This evaluation should always be focused on the integrity of the study participant, above the feasibility of conducting a research study in a center or IPS.
All research conducted on human subjects must be evaluated and approved by the Ethics Committee.
research team, informed consent form (document explaining the purpose of the research, including the risks and benefits to potential participants), known information about the drug (including reports of unexpected and expected adverse events), and any potential publicity planned to obtain potential participants. In addition, any changes to the protocol, no matter how insignificant.
Research projects of institutions that do not have an Institutional Ethics Committee must be approved by an Ethics Committee of another institution that has a certificate of compliance with Good Clinical Practices, issued by the National Institute for Drug and Food Surveillance (INVIMA).
The national regulations that frame the ethics committees are Resolution 8430 of 1998, the Technical Annex to Resolution 2378 of 2008, and the Guide issued by INVIMA in 2015.
Each of the RECs must draw up their operating manuals based on the provisions of these documents and the Good Clinical Practices. According to Resolution 2378/08, RECs must have a multidisciplinary composition, with a balance of gender and age, and a minimum of 5 members.
All IRB members must have completed the GCP course.
Members should include a physician, someone who does not have a scientific background in health sciences, and someone independent of the institution or center where the clinical trials are conducted. IRBs cannot meet without the presence of a community representative.
The guide also indicates that the CEI
“It must guarantee all the minimum competencies necessary to assess a research project” and The IRB members must have adequate and sufficient time for the analysis and evaluation of the established tasks” (INVIMA, Guide for IRBs, Point 7ª, page 4).
For this reason, the Ethics Committee is the highest authority within the research center regarding the maintenance of the integrity of the research subject.
By: Sebastián López Henao
Member of the Ethics Committee CREICEC (Regional Committee of Ethics in Clinical Research of the Eje Cafetero).