Research in biomedical engineering: importance of the risk/benefit ratio

The application of knowledge and knowledge of the Biomedical Engineering for the protection and improvement of individual and public health is increasingly essential. A utilitarian view (the end justifies the means) in achieving this goal is not in line with current ethical and legal requirements. Therefore, special attention should be paid to risk/benefit weightingespecially in i projectsbiomedical engineering research involving the human experimentation.

Therefore, ethics and justice are called to be a guiding light in the navigation and in the arrival of research projects in the field of biomedicine. The program of Masters in Biomedical Research which offers the VIA University helps generate proposals with an impact on community health needs. This center trains professionals and researchers who will have a positive impact on the technological, economic, cultural and social development of the nation with equity and justice. This topic delves into the Master's Degree in Biomedical Engineering with a focus on research STREET.

The challenges of research in biomedical engineering

In addition to making sure the scientific solidity and social value of a biomedical research project, all the actors involved in its approach, design, development and execution must synergistically articulate to provide solutions to the healthcare area (in the scientific, technological or administrative field). In this way any direct or collateral risks are minimized. All the more considering that the biomedical researchgenerally use invasive procedures or used to address specific needs of project participants.

Essential ethical principles in biomedical research

Researchers, sponsors, research ethics committees and government authorities must know, respect and promote the following fundamental ethical principles. These have been internationally recognized and have a positive background in instruments such as the Nuremberg Code, the World Medical Association Declaration of Helsinki or the International Guidelines of the Council of International Organizations and Sciences (CIOMS):

  1. Apply for a particular project must first receive all relevant and pertinent information on the foreseeable risks associated with research. They should also be made aware of the potential benefits of doing so. Therefore, your decision to participate will be free, aware, express and voluntary; without any coercion. Respect for the autonomy of the will of the investigated subject materializes with the informed consent. In any case, it is preferable that it be granted in writing. This can be omitted only in interventions with risk classified as "minimal" and with the prior favorable opinion of the research ethics committee.
  2. During the project, in its preliminary and subsequent phases, respect for the human rights of the participants and the members of their communities must be guaranteed in a real and effective way. Personal data and other sensitive information must be kept confidential. The object of investigation study must be seen in relation to its context and environment and not in isolation, since human dignity is a right which cannot be affected under any circumstances. Cruel, inhuman or degrading treatment is not permitted.
  3. Since every proposal carries risks, burdens and costs, an ethical and legal guideline is determine if the risk/benefit ratio is favourable. This will be an essential criterion of the legitimacy and justification of carrying out an investigation. The benefit to be obtained must be quantitatively or qualitatively measurable. Example of an advantage would be provide relevant information and relevant to pathologies of high complexity or priority treatments for a specific community, otherwise impossible to reach. When the contribution resulting from the research is scientifically relevant, it becomes a central facility for future biomedical research or in related fields.
  4. The subjects under investigation who find themselves in conditions of vulnerability must have guarantees that prevent its abuse and exploitation. Some circumstances of vulnerability may arise from social or economic factors. Population groups in a subordinate relationship in hierarchical organizations are also found in this category. On the other hand, children and people with psychosocial mental disorders have unprotected circumstances that need to be taken into account, especially in decision making. Of course, not only individuals but also Whole communities can be exploited and degrading treatment. As a result, they end up bearing the brunt of the research and receive little or no benefit from their products and results.
  5. Promote risk minimisation associated with research, on the assumption that they can always occur. These risks must be reasonable and proportionate depending on the characteristics and objectives of the project. The rigor of the methodology and an appropriate participant selection process can help reduce the risks.
  6. act correctly and loyal in the aspects related to accessibility, use and impact of the results and other products obtained as a result of the research carried out, both for those who participated and for the community in general. But, above all, in those communities with scarce resources or in vulnerable conditions. For example, can these populations be guaranteed continuity of care? The equitable distribution of the benefits and burdens of research It is vitally important, it is not an optional matter.
  7. The equitable distribution of risks and burdens per se includes the type of population that is chosen for participation in the project. It is essential not to over-investigate individuals or communities in condition of vulnerability or marginalization. In selecting the participants, the criteria of objectivity, reasonableness and proportionality must be used. Including a diverse group of people on most occasions enriches the quality of research and prevents biased study.
  8. The vulnerable population must not be categorically excluded from biomedical engineering research. Rather, the team and others involved need to take additional steps and strategies to ensure your physical and mental well-being. Every individual must be protected from exploitation by powerful individuals or groups.
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Risk/benefit weighting

at the time of weigh or execute the risk/benefit balance, it is essential to understand the risk in its individual and collective dimensions. For example, the impact that the study would have on the networks and social groups closest to the researcher, such as his family, friends, neighbors or co-workers. Risk as the likelihood of harm, impairment, detriment or injury is not just physical in nature.
Thus, there are other categories, such as moral damage or social, emotional and financial impact. That's why it's essential evaluate the probability of risk and characterize it. This can be minimal, low, medium and high (depending on the magnitude, importance and impact of the hazard). Those investigations with a high level of risk usually represent an individual benefit for the patient and are focused on improving his health status or quality of life.
In that sense, the human experimentation It must have certain limits. There are risks that cannot be justified, regardless of the scientific and social value that the possible research result promises. A classic example from the scientific literature is presented below to better illustrate this. A research that aims to infect healthy patients with Ebola would be unacceptable (from an ethical point of view), since the risk of mortality is very high, even when the benefit could lead to the development of an effective vaccine or treatment.
AS, the ethical balance of the risk/benefit ratio It is not a physical formula, rigid, immutable, applicable to all cases. On the contrary, it requires a conscientious questioning of all factors and components of the investigation and a detailed study of the foreseeable risks (probability and magnitude) and the possible or potential benefits (social and individual value and scientific contribution). The risks must be less than the expected benefits.
Also, the acceptable risks and benefits they can also be conditioned by the values ​​and preferences of a given community. The most evident benefits are the improvement of health systems, the quality of life, the reduction of costs and the optimization of resources.
Always considering what the likely risks are and assessing their level and impact on the patient is key to verifying the feasibility of this type of project. The greater and more severe the foreseeable risks, the greater the potential benefits must be. These risks can be direct or collateral.
For this reason we must not forget the importance of minimizing risks and optimizing results in a realistic and reasonable way. An adequate formulation of the problem to be solved and an execution of the project oriented towards respect for ethical principles lead to results of optimal, fair and just research. This topic delves into the Master's Degree in Biomedical Engineering with a focus on research STREET. This is an educational institution with high quality accreditation and, obviously, committed to the biomedical engineering research developed according to the principles of ethics and justice.

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