**5. Weaknesses of ethical review**

Current trend of ethical review seems likely to make ethical approval less efficient and less sustainable both in terms of time and money [12]. We can identify potential types of weakness in different places and in different areas of the pathway of ethical review.

Ethics is not an exact science, including several lines of thought, from Aristotelian virtue to Kantian deontology, the deterministic theories, the situational view, the Buberian relational perspective, and many others. Different decisions may arise from different points of view [7].

The most frequent hazards in clinical investigation are the breach of confidentiality, the adequacy of informed consent, and the protection of personal data. Patients are often the weakest link in the research project, unable to control most of the procedures in the protocol. But they may be also the strongest piece as they have the power to drop off, conditioning a potential bias able to weaken the interpretation of the outcomes. It's crucial to implement good strategies to safeguard voluntary informed consent, allowing the responsible freedom of the participants, based on effective information, especially when researchers are involved in their healthcare assistance [14].

Nowadays, many researchers use a standardized form to submit their study proposals to research ethics committees. The form overcomes the problem of inconsistencies in the paperwork required by different committees or, sometimes, by different members of the same committee. However, this procedure is time-consuming, and many times a work overloads, forcing the researchers to adapt their study protocol to a closed predefined form. Instead of the original idea of simplifying the process, there's a real risk of increasing the paperwork.

The informed consent is the key to legitimate the inclusion of the participants. However, its necessity may introduce some bias in the research. In primary care, socio-epidemiologic studies are common, and surveys frequently used methodological strategies. The requirement for a written consent will overload the paperwork

and may withdraw some participants, leading to lower response rates and conditioning the results [15].

One of the most important fundamental and central aspects of ethical review is the essential information necessary for ethical approval. That information can be written in form of questions [15]:


Another weakness commonly appointed to the ethical committees is the lack of expertise in specific scientific domains or in certain methodological approaches. The deliberations of research ethics committees require knowledge not only of ethical principles but also of different study designs and research topics. It is true that single members of research ethics committees usually do not have expertise in all of these domains for a given application. The way to prevent this weakness is to increase the number and the interdisciplinarity of the members of each research ethical committee. Portuguese health minister made recently an actualization of the regulation of health and research ethical committees, increasing the number of members to a maximum of 11 and imposing the obligation to integrate people from different areas such as medicine, justice, philosophy/ethics, theology, nursing and pharmacy, or even others as necessary [16].

There are also some concerns about the time to answer. One reason is the bureaucratic issues inherent to its internal functioning, not always well understood, many times perfectly expendable, but always present in our experience. The main reason, however, is more relevant. Some projects raise doubts that require further reflection and imply to postpone the decision, giving time to mature each one's opinions, based on each knowledge, sensitivities, experiences, and values, extended by self-education and, if needed, by consulting other experts.

There is a tendency to normalize the vision of the human being and his nature, leading to preconceived technical decisions, type "ready to wear." This is more common as the time goes by and the routine settles in. The decision must be always case by case. Each project requires specific consideration, which extends over time in the implementation process.

The most important factor for weakness in ethical committees, as in many other organizations, is the inability to recognize their own limitations. This blindness results in the lack of self-criticism and the affirmation that the decision is so perfect that everyone should accept without reservation. The solution is to maintain a deliberative environment in the ethical committees, with open dialog and real discussion on the different points of view, and the capacity to create consensus more that resorting to the decision by imposed suffrage.

#### **6. Conclusion**

Scientific inquiry and the production of new knowledge are central factors in the development of medicine and in improving the quality and quantity of life. It allows the generation of evidence about technologies and procedures offering information

**101**

*Evaluation of the Research Protocol by Ethical Committee*

useful for health reasoning and decision, whether with and for patients as individu-

Thus, the emergence of a research question that does not yet have an established answer (often in the context of the clinical evaluation on medical consultation) is an opportunity to create new knowledge with the potential to improve the current

Methodological strategies for hypothesis testing and for attainment of answers driven by research questions are known. Such procedures are expected to be suf-

Good practices require the submission of a protocol to an ethical committee

Ethical committees are sometimes seen as an obstacle to the work of researchers. The most common criticisms arise from the difficulty in perceiving some scientific concepts due to a lack of training in that specific topic and a tendency to overvalue prejudices that lead to a certain paternalistic attitude towards patients and distrust towards researchers. The historically established police character of ethical commit-

On the other hand, researchers have a tendency to facilitate processes based on their perception of excellence of the expected results and to forget (or even not

Ethical committees are a fundamental instrument of self-regulation that seek a balance between the benefit of research and its results (that may be translated into more and better health) and the respect for the participant has a human being in his

In its Greek genesis, ethics derives from *ēthikós*, which means relating to one's character. Thus, ethics refers to the ability to live with you and with others respecting individual freedom and its limits by realizing that any act on our part will have a

This may be the key to solve the apparent dilemma. Introducing this consideration in the design and implementation of the research turns it into an ethical

This chapter is based on our experience as members of the ethical committee of Northern Regional Health Administration of Portuguese Health Minister. We thank all other members in which their daily work allowed us to learn and practice the

The authors declare no conflict of interest regarding the contents of this chapter.

significant influence on the other and therefore must always be weighed.

ficiently described and structured in the investigation protocol.

*DOI: http://dx.doi.org/10.5772/intechopen.92265*

prior to the start of participants' inclusion.

tees also contributes to this depreciation.

know) current regulations and laws.

biopsychosocial dimensions.

investigation that we all agree on.

ethical appraisal of a research protocol.

**Acknowledgements**

**Conflict of interest**

als either for the population.

situation.

*Bioethics in Medicine and Society*

tioning the results [15].

written in form of questions [15]:

remaining hazards result in harms?

pharmacy, or even others as necessary [16].

implementation process.

and may withdraw some participants, leading to lower response rates and condi-

One of the most important fundamental and central aspects of ethical review is the essential information necessary for ethical approval. That information can be

• Can the research protocol be modified to reduce potential hazards, without

• Can the protocol study include solutions to minimize the chances that the

• Are the hazards or the risk of resulting in harm disproportionately great in comparison to the importance of the new knowledge to be gained?

There are also some concerns about the time to answer. One reason is the bureaucratic issues inherent to its internal functioning, not always well understood, many times perfectly expendable, but always present in our experience. The main reason, however, is more relevant. Some projects raise doubts that require further reflection and imply to postpone the decision, giving time to mature each one's opinions, based on each knowledge, sensitivities, experiences, and values, extended

There is a tendency to normalize the vision of the human being and his nature, leading to preconceived technical decisions, type "ready to wear." This is more common as the time goes by and the routine settles in. The decision must be always case by case. Each project requires specific consideration, which extends over time in the

The most important factor for weakness in ethical committees, as in many other organizations, is the inability to recognize their own limitations. This blindness results in the lack of self-criticism and the affirmation that the decision is so perfect that everyone should accept without reservation. The solution is to maintain a deliberative environment in the ethical committees, with open dialog and real discussion on the different points of view, and the capacity to create consensus

Scientific inquiry and the production of new knowledge are central factors in the development of medicine and in improving the quality and quantity of life. It allows the generation of evidence about technologies and procedures offering information

by self-education and, if needed, by consulting other experts.

more that resorting to the decision by imposed suffrage.

Another weakness commonly appointed to the ethical committees is the lack of expertise in specific scientific domains or in certain methodological approaches. The deliberations of research ethics committees require knowledge not only of ethical principles but also of different study designs and research topics. It is true that single members of research ethics committees usually do not have expertise in all of these domains for a given application. The way to prevent this weakness is to increase the number and the interdisciplinarity of the members of each research ethical committee. Portuguese health minister made recently an actualization of the regulation of health and research ethical committees, increasing the number of members to a maximum of 11 and imposing the obligation to integrate people from different areas such as medicine, justice, philosophy/ethics, theology, nursing and

compromising its ability to answer the research question?

**100**

**6. Conclusion**

useful for health reasoning and decision, whether with and for patients as individuals either for the population.

Thus, the emergence of a research question that does not yet have an established answer (often in the context of the clinical evaluation on medical consultation) is an opportunity to create new knowledge with the potential to improve the current situation.

Methodological strategies for hypothesis testing and for attainment of answers driven by research questions are known. Such procedures are expected to be sufficiently described and structured in the investigation protocol.

Good practices require the submission of a protocol to an ethical committee prior to the start of participants' inclusion.

Ethical committees are sometimes seen as an obstacle to the work of researchers. The most common criticisms arise from the difficulty in perceiving some scientific concepts due to a lack of training in that specific topic and a tendency to overvalue prejudices that lead to a certain paternalistic attitude towards patients and distrust towards researchers. The historically established police character of ethical committees also contributes to this depreciation.

On the other hand, researchers have a tendency to facilitate processes based on their perception of excellence of the expected results and to forget (or even not know) current regulations and laws.

Ethical committees are a fundamental instrument of self-regulation that seek a balance between the benefit of research and its results (that may be translated into more and better health) and the respect for the participant has a human being in his biopsychosocial dimensions.

In its Greek genesis, ethics derives from *ēthikós*, which means relating to one's character. Thus, ethics refers to the ability to live with you and with others respecting individual freedom and its limits by realizing that any act on our part will have a significant influence on the other and therefore must always be weighed.

This may be the key to solve the apparent dilemma. Introducing this consideration in the design and implementation of the research turns it into an ethical investigation that we all agree on.
