Ethical guidelines and qualitative research on health


Diretrizes éticas e pesquisas qualitativas em saúde



Rosa Maria Stefanini de Macedo

Nucleus of Research in Family and Community, Catholic University of São Paulo (PUC/SP). romacedo@pcsp.br



This article aims to debate the excellent study carried out by Guerriero and Dallari1, about "the necessity of ethical guidelines adequate for qualitative research on Health" publicized in the previous pages of this magazine,

Above all, I must say I consider this study an extremely worthy piece of work that meets the difficulties experienced by researchers and also by members of Ethics in Research on Human Beings Committees. In this aspect, it is a profound investigation searching for reasons that justify the construction of ethical parameters for research on human beings adequate to the diversity of paradigms able to guide the research plan and its execution.

This because 196/962, resolution from the Health National Council - Conselho Nacional de Saúde - that sets ethical principles to guide research in the health field in Brazil to amplify the conception of research of the International Council of Medical Science Organizations (ICMSO)3.

This conception3 defines research as a group of activities aiming to develop or contribute to generalizable knowledge.

Generalizable knowledge consists of theories, principles or relations, or in the storage of data collection which they are based on, that can be asserted by recognized scientific methodology of observation and inference1.

Based on this definition, however, the national rule in the CNS Resolution 196/962 sees that the procedures mentioned to produce generalizable knowledge, counting on principles or relations or in gathering up data in their foundations asserted by recognized scientific methodology of observation and inference [...], are applicable to procedures of any nature; such as instrumental, environmental, nutritional, educational, sociological, economic, physical, psychic, or biological one not mattering if they are pharmacologic, clinical or surgical with preventive, diagnostic or therapeutic purposes1.

Well, when we amplify the application scope of those ethical rules, the Resolution in question paradoxically plasters the research on human beings to the fields of human, social and health sciences. I say this because noticeably the world view and therefore the science's which the announcement is based on, did not take into consideration the plurality of possible scientific paradigms, identifying itself with the premises of positivists paradigms focused on the universalization of knowledge (generalizable) confirmed by scientific methods of observation (mensurable) and therefore, able of being standardized4.

That the 196/962 Resolution has the biomedical area among its first concerns is understandable, but to stretch the same recommendations given to the first area mentioned, under a positivist or post positivist paradigm, to other areas of knowledge, as if all of them followed the steps of the same paradigm, is to go far beyond disregarding the richness, diversity, complexity of knowledge improvement and also the existence of scientific paradigms that observed other worldviews.

In the United States the Belmont Report, important document from 19795, which rules and protects human beings in biomedical and behavioral research, acknowledges that the social research can substantially differ from the previous ones, therefore a specific commission is necessary to define the policies for procedures that fit them better. It would be desirable that the Brazilian rule did at least the same1.

Defending the need to recognize different possible paradigms under the conception of reality, thus under the scientific activity, we can just remember, for instance, how the comprehension of the Universe evolved, from an absolute truth until Copernicus, Kepler Galileo to contemporary Physics and Astronomy.

What can be instantaneously deduced is the fragility of a certainty based on universal, absolute, fixed truths apart from the observer. This affirmation has been excessively demonstrated by results of experiences in very different disciplines so to say Biophysics (Von Foerster, 1981), Psychology (Von Glasersfeld, 1984) Neurophysiology and Biology (Maturana e Varela, 1987) Communication ( Krippendorff, 1982), Physics (Prigogine, 1980), Cybernetics (Wiener, 1948) 6.

Consistently, the studies carried out by these scientists with an origin on a systemic view of the universe went through clearly recognizable stages:

a) From the conception stage where systems from a homeostatic mechanism keep their stability and self regulation of their structure.

b) to the conception where a system out of its balance finds alternatives of its own to self regulate its structures through creative, learning or evolutive resources, eliminating the stability idea as something static and,

c) finally concluding by the unpredictability, complexity, uncertainty and subjectivity that rules the comprehension of irreducible systemic phenomena to objective criteria of analyses and description.

Different ways to see reality necessarily imply different paradigms and consequently distinctive recommendations and ethical procedures not only concerned about the autonomy of the participants and their rights, but also with the possibility of carrying out the research.

This is because theories, principles or relations that constitute knowledge must answer basic questions about the "being" and about knowledge (ontological and epistemological) and how knowledge acquisition occurs (methodological). Therefore, the method to know comes from what is believed to be the object of knowledge (onto) and from the procedure of acquiring it (epistemic). In this way, the planning of any acts which aim knowledge, as research does, has to adequate itself to the conceptions of reality and to the process of knowing this reality with methods compatible with such conceptions in order to access them in a coherent and adequate form.

Thus the conception of reality as something given; that is there, able to be known in an objective way through quantitative methods of observation and mensuration (positivism) is applicable to the study of many phenomena, such as the ones that intend to survey the present state of a certain episode in a population and have the purpose to outline adequate intervention policies.

Researching human behavior with almost experimental approach, however, a change in the positivist paradigms comes out – the post positivist – which introduces a slight modification according to the ontological and epistemological point of view. It is admitted that the reality is given, it is there, but it can only be known in terms, partially, because its view depends on the perception of the observer. This one continues apart from the observed object, that is why there are so many recommendations about the researcher impartiality, the control of his or her subjectivity and the control of the research variables in order not to "contaminate" the results obtained in the procedure.

A question could be raised then when drawing up a test, a questionnaire. In accordance with the theory which seems to the researcher the most reasonable one isn't he subjectively choosing pre-defined aspects of the phenomenon to be observed? If this isn't enough, when he ranks answers in descriptions measured by frequency, isn't he judging the answers obtained from the participants through subjective values?

These difficult epistemological issues have been putting the science field, mainly the human and social sciences at some impasses, and they justify a feverishly intellectual activity among tenacious researchers dealing with a plural reality. Some of them cited above.

This activity doesn't represent any specific school with unifying pretensions.

This pragmatic change of position, which the systemic-cybernetic perspective puts mainly on the human sciences, gives evidence to a necessity to reflect about the human subjectivity capable of being approached under qualitative methods7.

Under the paradigmatic approach this view responds to ontological, epistemological and methodological questions, stating that reality is only capable of being understood through the comprehension of the individual who gives names to it and therefore realizes and gives meaning to it.

In this way the paradigm's ontological and epistemological dimensions don't differ. Knowledge subject and object can't be put apart, since to know something is to construct reality aiming to describe and give it meaning. Then, we have that the act of knowing is endowed with value as observers select, according to their perception of reality aspects, describing and giving them names which match their life experiences, context, society, culture and the linguistic community they live in. The paradigm that favors the theory of experimentation is deconstructed and an alternative based on intersubjectivity is constructed.

In that, qualitative investigation finds its space between explaining and comprehending, requiring a sympathetic and equitable ethical attitude which sets researchers and participants in positions of exchangeable and reversible power.

The polysemic nature of the discourse is highlighted as well as the importance of the dialogue during the construction of meaning and the subjective aspect of this construction that will be negotiated among participants. In such a way reality is constructed by ordering and organizing our experience, making it conceptual because it is defined by language and understood as signification7.

Given the importance of the context, the dialogue and the negotiation of meaning among members (researcher and participant) the knowledge acquired is transferable (not generalizable) to other groups, other situations that share similarities. However, because of the multiplicity of possible contexts and the variability of people characteristics, the results are seen as an incomplete text, always capable of having finishing touches.

What about the concept of "value" and "truth" then?

How is it possible to construct a framework of valid scientific knowledge to a specific historical moment, to a society, to a community of pairs?

If the construction of reality depends on the perception of each one, will there be as many truths as the number of individuals? Do they weigh the same?

What about the value of knowledge, the respect for the other, and the scientist's responsibility?

In order to avoid misunderstandings, it is very important to let clear that although knowledge is coined intersubjectively in the relations, it is only socially legitimized in an individual-cultural recursive process where the individual is conceivable as socially defined and society is seen as a system of individuals "There are no individuals without society and no society without individuals"8.

Then, the research on human behavior based on the reality construction paradigm or on its interpretation (hermeneutics, phenomenology, ethnography, constructivism, and constructionism) can only be guided by values, as the researcher is part of the researched issue, ethics is intrinsic to research.

It means to say that the objectivist paradigm can accept objective criteria of the good (which is accepted in a conventional way without any criticism). Inside constructive and interpretative paradigms as there is no obligation to reproduce the social reality in question, the mandatory aspect of it is the researcher's awareness about the influence that occurs during the research and in the co-construction of reality that belongs to the participants. Therefore, knowledge produced in this way implies into a responsibility that presupposes integrity and a personal sense of values, in other words: ethics.

What institution do we want to develop? What health care do we want to provide?

How to act to fulfill community needs?

Following Ravn's6 proposition, and taking into consideration the recommendations given by many authors involved with new paradigms and subjectivity9, the freedom to search a large number of possible alternatives in different perspectives gives rise to a need to accept the implicit limits of ones' own choices, what leads us straight to the ethics domain.

In this way, the researchers' attitudes are compromised with their choices and they are responsible for them towards the scientific community and towards the society in general in view of the consequences of the results the research obtains.

The major criticism to constructivist and interpretative paradigms based on qualitative research, however, is the truth relativity, the uncertainty, the unpredictability and the lack of control of the objective research. This relativity, however, doesn't nullify the concept of truth or certainty, in the same way that it doesn't deny the existence of a real world, concrete, where we live in. Such criticism is the result of an absolutist misinterpretation of the knowing process. With the purpose to explain better this conception of reality construction through interpretation and conjoined elaboration of signification giving meaning to the world, Ravn6 suggests a pair of propositions: The Unity and the Diversity as ethical principles. For instance, he says, a city seen in a variety of perspectives looks different in each one. However, those different universes are nothing more than different perspectives of the same universe.

An ontology that says the world is a unit of perspectives may seem unusual, given the prevailing atomic ontology of modern science, says Ravn6. However, he says, in epistemological terms this statement could be expressed in this way: we notice the world under different perspectives although the world we see is always the same.

So the city is a unity, the total system can be seen from many different points (sub-systems) all of them related to the major one, unique in the perspective they are seen but different from each other.

Transferring this example to reality construction we conclude that the world is essentially a unit that cannot be perceived in its totality due to the limitation of the perceiver, his or her characteristics and their context, giving then birth to different ways of seeing it.

In the research field, the phenomenon is the same, the cut-outs we make in accordance with our paradigms, our theories, lead us to different ways of approaching them, obtaining different results, where one doesn't exclude the other, they are simply different readings of several aspects of the same event.

However, in order to avoid extremities: the nihilist approach which denies any possibility of knowing and the absolute-relativism approach which attributes to any knowledge the same value without any distinction or any value strictly speaking, the construction of reality should be guided with some advantages by the already mentioned ethical principles: Unit and Diversity.

These principles should be seen as inclusive ones and not as mutually exclusive ones. The experience of unit is the one where one can experience the world in such a way that each part of it seems to evoke or to be in touch with a wider totality or unit. Each act put the individuals in contact with a greater proposal or meaning revealed in each activity, in each role they play6.

Diversity is the experience that different parts of the world can have different views (of the same world). This experience applies to individual and social life. A person with such attitude thinks that the activities and objectives of other people simply express different aspects of life, such as our own when we put ourselves in different points of view6.

Unit and Diversity express distinctive moments but complementary ones according to the epistemology of complexity10 opposing to the simplifying linearity of the positivism, where the disjunctive thought contributes to place individuals in extreme paradoxical positions that make intermediary hues, which are part of the observed event, difficult to be contemplated. However both experiences are useful, the problem is settled when one happens to the total detriment of the other.

Depending on the intensity of the variation between Unit and Diversity, different positions are produced even some distortion can be produced. On the one hand, the maximum of Unit with any Diversity leads to absolutism, we can see it in the following statement: I have the truth; I am right; the world is in this way and there is only one way to truth". On the other hand, no Unit and the maximum of Diversity leads to total relativism. "In this position the affirmations go around of: everything is the same thing, it doesn't matter to think in a way or another, everything is true, and all goes". This posture nullifies moral values standards of any origin or priority, as it doesn't consider the quality of different affirmations and the responsibility of the one who declares them.

In the search of the good and best practices, the core of ideal ethics, the desirable position is the one which contemplates Unit inside Diversity.

This is to say that the meaning of our lives, our purposes (unit) agree with different actions and positions we take in view of specific objectives in each moment of our lives (diversity).

The basic principle of the position Unit – Diversity or Diversity – Unit in life as well as in the research is "compromise".

The balance between Unit-Diversity is essential when people / researchers revealed themselves compromised with the truths they built, when they are responsible for them according to the life track they chose, giving meaning to their acts, and at the same time accepting and respecting the others / people / researchers who have chosen different objectives and followed different paths, although not less worthy than their own. In this aspect, the community of pairs, the society has a fundamental role: to legitimate the truths which were built, through the dialogue, discussion, agreements and assent.

This posture is desirable not to be taken only by people throughout their lives but also by societies, organizations and institutions, needless to say by the scientific community along with the activities scientists and researchers perform.

Besides the arguments presented by Guerriero and Dallari1, to highlight the peculiarity of qualitative research based on other paradigms than the positivist one, I am confident that the adoption of the ethical principle of Unit-Diversity offers us room to reflection about ethical recommendations following research models respecting paradigms diversity and justifies the necessary changes of the 196/962 Resolution. I truly believe that this principle can help us to have more flexibility in research under the social-human and health sciences scope in constructive and interpretative paradigms.

That reflection, in our opinion, is much more adequate to the true scientific spirit: to recognize and respect differences, consequential of different ways to see the world, but adequately built upon the researchers' compromise, their moral judgment, their ethics, their acceptation of their pairs in accordance with social and moral rules of the culture they belong to, leading the ones in charge of legislating to act accordingly.

I do hope that the considerations here presented will contribute to widen the debate about moral principles in scientific research as I have proposed in the beginning, transferring it to the process of knowledge, to methods and procedures able to access them in a more proper way and consequently to raise the awareness that each model of research and each situation to be researched need specific ethical rules.

Certainly, this would make the scientific activity of the researchers and of the committees of ethics in research, a lot easier, contributing to a higher develop-ment of knowledge as inadequate models of judg-ment bring dissonant aspects, which can in turn provoke major difficulties to some projects to be approved.



1. Guerriero I, Dallari S. A necessidade de diretrizes éticas adequadas às pesquisas qualitativas em Saúde. Rev C S Col 2007. No prelo 2007.         

2. Brasil. Ministério da Saúde. Conselho Nacional de Saúde – Resolução nº 196 de 10 de Outubro de 1996. [acessado 2007 Jul 7]. Disponível em: http://conselho.saude.gov.br/docs/resolução/peso196.doc         

3. Council for International Organization of Medical Sciences/World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS/WHO; 1993. p. 47-50.         

4. Chauí M. Público, privado, despotismo. In: Novaes A, organizador. Ética. São Paulo: Companhia das Letras; 1992. p. 345-390.         

5. The National Commission for the Protection on Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Washington, D.C.; 1979. [cited 2007 Jul 7]. Available from: http//ohrs. od.nih.gov/mpa/Belmont.php3         

6. Ravn I. What Should Guide the Reality Construction? In: Steier F, editor. Research and Reflexivity London: Sage; 1991. p. 96-114.         

7. Macedo R, Kublikowski I, Grandesso M. Interpretação em pesquisa qualitativa: a construção do significado. Anais da I Cibrapeq – I Conferência Internacional do Brasil de Pesquisa Qualitativa; 2004 Mar; Taubaté (SP).         

8. Maturana H, Varela F. A árvore do conhecimento. São Paulo: Palas Athena; 2001.         

9. FriedSchnitman D, organizadora. Nuevos paradigmas, cultura y subjetividad. Buenos Aires: Paidós; 1994.         

10. Morin E. O problema epistemológico da complexidade. Lisboa: Publicação Europa – América; 1983.         

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