**4. Common mistakes**

The ethics committee of the Northern Regional Health Administration of Portuguese Health Minister was created in 2009 as the first ethical committee in primary care in Portugal. The Northern Regional Health Administration covers a population of about 3.5 million people and have about 9000 collaborators (2776 physicians and 2829 nurses). We have a large experience, counting over 1200 processes evaluated till the end of 2018 (95% research projects in primary care settings). Also we contributed to ethical education among providers implementing several courses on ethical topics, particularly focusing ethics in research.

During this period the discussion on ethical issues increased considerably among physicians and researchers, accompanying Portuguese legislative changes in ethical committees and access and protection of personal data. Ethics does not belong to any one in special: it is a commitment of all. Nevertheless, belonging to an ethical committee forces us to think globally and to decide case by case. In our monthly meeting, we have evolved continuously both in knowledge and in practice. Every project is a challenge for discussion, and every problem is an opportunity to think over about the way to improve ethical awareness, in an increasingly globalized and informed world, but somehow with less time to stop and think. As a result, more than 80% of projects were approved without ethical constraints.

However, many of the projects submitted for appreciation showed ethical constraints, reflecting the distance between research methods and ethical details:


**99**

*Evaluation of the Research Protocol by Ethical Committee*

cedure to mitigate "p-hacking" practices [12].

6.Absence of a well-defined statistical analytical plan. Quantitative studies may have an exploratory approach to data with all the limitations that poses for causal inference. Still, an exploratory approach may be helpful for theory generation. For the purpose of theory testing, prespecification of statistical analysis is warranted. Researchers should identify all variables in the study and specify the statistical modeling and testing that will be used. This is an important pro-

7.Lack of feedback to the participants. Researchers should commit with the obligation of informing participants if they identify a health or social problem that needs intervention, during the investigations. Whenever it is appropriate, a definition of adverse event and a procedure for reporting and managing

8.Declaration of conflicts of interest. Although there's a general acceptance about the definition of conflicts of interest in its several dimensions of financial ties, academic commitments, personal relationships, political or religious beliefs, and institutional affiliations, many times researchers opt by an individual assessment choosing which characteristics are more prone to set up a conflict in the particular case. Everyone has some kind of conflicts of interest

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

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

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

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

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

[13]. The transparency and truth is also an ethical duty.

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

adverse events is expected.

**5. Weaknesses of ethical review**

arise from different points of view [7].

process, there's a real risk of increasing the paperwork.

healthcare assistance [14].

of ethical review.

*Bioethics in Medicine and Society*

**4. Common mistakes**

The ethics committee of the Northern Regional Health Administration of Portuguese Health Minister was created in 2009 as the first ethical committee in primary care in Portugal. The Northern Regional Health Administration covers a population of about 3.5 million people and have about 9000 collaborators (2776 physicians and 2829 nurses). We have a large experience, counting over 1200 processes evaluated till the end of 2018 (95% research projects in primary care settings). Also we contributed to ethical education among providers implementing

During this period the discussion on ethical issues increased considerably among physicians and researchers, accompanying Portuguese legislative changes in ethical committees and access and protection of personal data. Ethics does not belong to any one in special: it is a commitment of all. Nevertheless, belonging to an ethical committee forces us to think globally and to decide case by case. In our monthly meeting, we have evolved continuously both in knowledge and in practice. Every project is a challenge for discussion, and every problem is an opportunity to think over about the way to improve ethical awareness, in an increasingly globalized and informed world, but somehow with less time to stop and think. As a result,

However, many of the projects submitted for appreciation showed ethical constraints, reflecting the distance between research methods and ethical details:

1.Lack of informed consent. Some researchers think the informed consent is expendable. Others think that informed consent is just a signature in a paper sheet, overlooking the relevance of the information and the explanation to give

2.The invitation to participate in the study. It's hard for a patient assisted in a clinic to refuse the participation in a study when invited by his/her doctor or nurse. It is not forbidden, but this vulnerability forces researchers to be more cautious in the way they include their patients in the study, for example, by asking another member of the team to talk with the patient. This is particularly relevant in the primary care due to the proximity of doctor-patient relationship.

3.Data collection. Clinical files keep a lot of health data of interest for research. However, these data are available for healthcare and not so much for investigation. The reuse of data implies a legitimacy that does not derive directly from assistance. The free informed consent of the patient or his/her agent is the right way to do it. Nevertheless, under certain circumstances, ethical committee may excuse the explicit consent, but special care must be taken to mini-

4.Variables under study. It's common to see data collection forms including

5.Use of questionnaires of other authors. Many questionnaires are protected by copyright and must be authorized by their owners. Even if they are on the public domain, the questionnaire has an intellectual property that should be respected. It's appropriate to obtain prior authorization from the original authors.

identification variables such as the patient's name, birth date, or health system number. This potentially jeopardizes the anonymization and confidentiality of the database. Rarely these variables are relevant for research and should be

mize, anonymize, and secure data.

avoided or duly justified [11].

participants the capacity of accepting consciously and freely [11].

several courses on ethical topics, particularly focusing ethics in research.

more than 80% of projects were approved without ethical constraints.

**98**

