**4. Capacity/competence**

Capacity and competence criteria have traditionally been reviewed in the field of informed consent. The Nuremberg Code identifies voluntary consent as necessary and essential for the conduct of investigations with persons. Considering the capacity and competence in the discussion of special populations is relevant because precisely their evaluation allows the researcher and the Bioethics Committee to establish whether they have the minimum conditions for obtaining valid informed consent and what kind of additional protective devices should be implemented.

the distortion in the assessment of risks and benefits added to the explosion of a plethora of economic incentives that can make that transition in the gray scale from nonvulnerable to

Nature of Vulnerability in Biomedical and Psychosocial Research

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A terrain where the slippery slope of bioethics becomes steeper is that of healthy volunteers. They often participate in research where they are exposed to new drugs or procedures without responding to the reality of a disease or condition that is their own. While recognizing their altruism in exposing their well-being, it is questionable when economic or other rewards motivate their link. The reflection points to the fact that the researcher and the Bioethics Committees recognize in these subjects their vulnerability, despite precisely being "normal." The issue of vulnerability lies essentially in the area of autonomy and respect for people with diminished autonomy, while that of the risk-benefit relationship corresponds to distributive justice. When applying the principle of justice, it should also be understood that the objectives of the research and its likely outcomes account for a problem that affects the level of well-being and health conditions of vulnerable individuals included. In this way, the expectation of interventions and procedures, which directly benefit their health, would justify their participation.

If we use the principle of beneficence, the researcher and his work group must maximize benefits and reduce risks. However, research with special and vulnerable populations requires additional effort to identify and prevent risks before, during and after the intervention. Precisely the vulnerability increases when the study has concluded the individuals present

In an attempt to circumvent the difficulties involved in obtaining valid informed consent in special populations, the concept of minimum risk has been introduced to justify interventions or research procedures that have no possibility of direct benefit to their health "Minimum risk means that the probability and magnitude of the predicted harm or discomfort in the research are no greater in themselves than those commonly encountered in daily life or during routine

At this point, it should be noted that even if the investigative intervention is of minimal risk, or slightly exceeds, this does not exempt from seeking the available channels obtaining consent or assent, if any, for the beginning of the same. Any sign of rejection or desire to leave should be respected without having to request rigorous or extensive explanations about it. In addition, the researcher should question about psychosocial risks such as breach of confidentiality, invasion of privacy, or stigmatization and not focus exclusively on physiological organic risk. The informed consent process must therefore be particularly rigorous so that individuals or their legal representatives have the option of adequately assessing the benefits of linking them

To summarize, special populations have to be evaluated in the convergence of the criteria of vulnerability condition, level of dependency, capacity/competence, and risk-benefit ratio. With these elements in mind, it is possible to continue the discussion on each particular popu-

some damage in their integrity and do not find who respond for damages.

physical or psychological examinations or tests" [2].

to research in the face of risks.

lation group.

vulnerable.

Capacity refers to "the necessary physiological, mental and emotional integrity required to make decisions, and therefore to be considered legally competent" [2]. Capacity is a medical term that results from the evaluation that the investigator or a specialized physician performs, among others, the spheres of mental functioning and the organic state in general.

Capacity may be compromised by fluctuations in a chronic disease or by the intensity of an acute event such as encephalocranial trauma. Similarly, states of limited capacity may be medically induced as during general anesthesia or the use of sedative medication in agitated patients. The ability also refers to the proper integration of external stimuli with the internal mental reality and the behaviors that are executed accordingly. To understand, even more, the concept of capacity is required to integrate variables, which, although they make the analysis more complex, enrich the criteria that base a conclusion, in this order are psychophysiological maturity and sociocultural influences.

For its part, the Competition, a legal term, is "a construction that indicates that a person has the necessary capacity to deal with legally defined acts such as signing contracts, witnessing, being prosecuted or accepting medical interventions." The link between capacity and competence guides the basic conditions that a researcher must have when working with people belonging to special populations and with vulnerability.
