NATIONAL AUTONOMOUS UNIVERSITY OF MEXICO (UNAM*) NATIONAL SCHOOL OF NURSING AND OBSTETRICS (ENEO*) COMMITTEE ON RESEARCH RESEARCH ETHICAL PRINCIPLES AT ENEO May, 2013 Written by the ethical sub-committee Alfredo Bermúdez González Margarita Cárdenas Jiménez Victoria Fernández García Reyna Matus Miranda Iñiga Pérez Cabrera Sandra S. Olvera Arreola Gloria Rodríguez Díaz Rosa A. Zárate Grajales *for its acronym in Spanish CONTENTS page 1. Introduction……………………………………………………………………………...3 2. Research ethical principles at ENEO………………………………………………...4 3. Ethical responsibility of ENEO researchers…………………………………………7 Related to persons………………………………………………………………………..9 Related to institutions………………………………………………………………..….10 Related to authorship…………………………………………………………………...12 Related to the results………………………………………………………………..…. 13 Related to the publication……………………………………………………………....13 4. Instrument for the ethical elements assessment of the projects…..…………….16 5. Procedure for resolution on projects with no evident risk……………………......16 6. Procedure for resolution on projects with evident risk which require further assessment by ethics or bio-ethics research experts…………………...…..18 7. Establishment of External Integrants…………………………………………….…21 8. References……………………………………………………………………….……22 2 1. INTRODUCTION Considered a public asset, derived from the discussion of ideas, created and shared with veracity, and oriented towards the common benefit, in today’s basedon-knowledge society, science becomes a strategic value. As a result, universities have a fundamental role of promoting and developing research, and modeling qualified professionals who can lead ethically-valued projects, all to foster the development of societies. Under this scheme, the National Autonomous University of Mexico (UNAM) - National School of Nursing and Obstetrics (ENEO) develops research projects within the academic and health services areas responding to the call of the Health Secretary - National Commission on Bioethics, a decentralized organ, to bring different social sectors together to discuss and propose solutions to the bioethics problems though systematic and sustainable research in order to benefit society. Within this context, and considering the corresponding scope of the university legislation, the ENEO Research Committee (RC) went further to reflect and discuss on making explicit the principles which point towards the human rights related to research within the areas of care and education – main objects of study of the ENEO academic community – this with the purpose of having a decision-making guide related to issues on research; nonetheless, since several years ago, it has been the function of the ENEO Research Committee to assess the projects in terms of their methodological and ethical dimensions so that, these research activities are conducted within an ethical frame, and their results are diffused with the conviction that they are the product of responsible work which privileges the individual well-being over the interests of science. This document, which we have denominated Ethical principles for research at ENEO will be considered an annex to the document: Guidelines for the research organization and functioning at ENEO, document approved by the honorable University Technical Council (agreement No. 223/2012) and founded on documents from national and international federal and academic organisms, which is responsible for guiding and regulating the related underlying ethics and research issues. 3 2. RESEARCH ETHICAL PRINCIPLES AT ENEO The ENEO-UNAM Research Committee, in its intention to assume ethics-based research which secures the person’s rights, has considered taking as reference diverse concepts on decision-making used by committees on ethics within the health area, and which have been proposed by authors such as Beauchamp and Childress, who introduced Principlism, a widely diffused approach in Bioethics (1). Principlism ethics takes the human rights and the scientific studies development regulatory legal aspects as its foundations, including the fundamental value of life, and the principles of therapeutic totality, freedom, responsibility, and socialization (2). These concepts are complemented with the concept of ethics of minimums proposed by Adela Cortina (3), who argues that norms in society are to regulate coexistence by taking into consideration the interests of all, favoring equality, and not conforming with previously-manipulated factual pacts in which, not everybody access the same level of resources, information, and culture – in other words, by making human equality a normative discourse in our daily acts. In general, research processes in nursing require a sound foundation of ethical principles to protect human dignity, as well as the physical, psychological, social and spiritual well-being of every person participating in these quantitative-orqualitative-in-nature processes. Therefore, for a good practice of ethical conduct guidance, it is necessary to regard the corresponding principles and concepts into a code observed by the Ethical Committee in order to protect all participants. The National Autonomous University of Mexico and National School of Nursing and Obstetrics take on the ethical responsibility of preserving the freedom, the values, the human rights, and the respect for the living beings as an essential part of the integral formation of its professionals, academicians, and undergraduate and graduate students. The public common-good becomes the human development interest, especially for those most vulnerable in our society. While generating new knowledge on care, links with other areas such as environment, labor, education, and other related disciplines (medicine, social work, psychology, and etcetera) will be developed. The National Autonomous University of Mexico includes in its legislation a Scientific Research Technical Council internal guideline which applies to the Sciences Faculty and the Institutes and Centers for Research. The Schools and other Faculties are prone to be integrated from the determination of this Council (Art. 12, Legislation, Chap. V, 88). At ENEO, it is usual to conduct research whose subjects are registered students and academicians. Because of this, it is necessary to emphasize the obligation to protect these individuals from any unlawful pressure by respecting their legitimate 4 and voluntary decisions to participate in any research, which moreover, must be ethically-acceptable. In the area of related-to-care clinical research practice, nursing faces permanent diverse difficult challenges including: the observations related to making gynecologic explorations, the associated pain related to making vein punctures to neonates, the sexual life etcetera - a situation which also evokes the need to debate on ethical principles. The professors of nursing at ENEO must consult the basic principles which backup every process of every research, including their design, proposal, approval, development and diffusion of results, all in order to protect the participating individuals, the hosting institution, and the responsible researchers as well. These normative guidelines do not limit the legal consequences which might arise from any civil or penal felonies, and/or any other unethical conduct unforeseen by this document. The general principles or ethical guidelines of action are: autonomy, no badintention, benefit, and justice (2). The principle of autonomy establishes that within the scope of research, the priority lies on the subject’s values, criteria, preferences, and postures. This is applied in the Informed Consent Document (CI), through which, participants receive clear and sufficient information to, without any abuse, take reasoned decisions regarding the possible benefits and costs resulting from their participation. The principle of no bad-intention enforces the obligation to avoid hurting others by privileging some benefit, even while having in consideration the therapeutic responses that a specific health care could imply. The principle of benefit points towards the gains derived from the participation. In order to take less controversial decisions, mediation around the values implied by the principles of autonomy and justice becomes necessary. The principle of justice enforces the right to equity-treatment, privacy, anonymity, and confidentiality. It also refers to the social gains which are expected from the research. The Research Committee is responsible for watching over the enforcement of these ethical principles and guidelines, as well as for prompting the measures to be taken when these principles and guidelines are broken by unethical conducts throughout the research. Therefore, the Research Committee declares: 5 In every nursing research, the fundamental value of life and the wellbeing of all persons, families and communities must prevail over the interest of science and/or any other technological, economical, political or social convenience. Every nursing research must be based on the universal values, the human rights, the patient rights, and the nursing professional rights; as well as on the National Autonomous University of Mexico Research Issues Security and Coordination Health Code. Every nursing research must make the principles of autonomy, no badintention, benefit, and justice clearly explicit to all directly-and-indirectly involved participants of the scientific study. In nursing research, the rights of those more sensible and vulnerable participants should be protected by the researcher, as well as by additional ethical and legal procedures. Examples of these are children and persons with physical, mental or emotional disabilities. Every research must follow the internally-accepted procedures established by the Operation Norms of the Ethics and Research Committee of the National School of Nursing and Obstetrics, which in turn respond to the institutional regulations with the referenced methodological rigor and the disciplinary and national health issues priority focus. 6 3. ENEO RESEARCHERS’ ETHICAL RESPONSIBILITY As a preamble, some topic-relevant issues are here commented. A long time ago, the concept of person was coined, however today it is necessary to recover what Boecio, making reference to what Saint Thomas said about that individual substance of rational nature, which today we know is applicable to the critical, judging, and assertive person. The person cannot be considered only as nature since this nature is rational and therefore, it has moral requirements. In today’s modern times, when the person has acquired certain maturity and development, from those relations which the person is establishing in his/her surroundings, these experiences will give the person stability through the holistic spheres. This orientation to the person will advance the knowledge being generated from nursing; but in order to clarify this, we would need to proceed from an epistemology to the object of study, the care, which includes the subject of study of the profession itself, and thus, the commitment to the unit which the person is. Therefore, from the stand point of the institutions and the role which they have in favor of societies, we will have to acknowledge and recover, and in the better of the cases, de-construct the de-virtualized conception of person from-the-academiaitself. This concern about recovering the ethical essence of the academia’s research activity comes from a federal proposal to hospital-related and educative institutions, to always maintain the common wellbeing of society –final goal of every professional action - as the convergence point of all the joint efforts. It is the task of this sub-commission to leave a strong message on those ethical advances which put in first plane those ethical questions with the persons and institutions, a situation which in other times was not the case. Many times, ethical issues are practical ideas which not only complement the versed actions of the professional from any discipline, but also which lead us to notice that the person is recovering terrain. If we do not understand that the person needs the attention from the so called society of knowledge, and that the actions in favor of the person are the key elements to the ethical issues, every action of research is condemned to failure; then, we should acknowledge a research, regardless of its degree of pragmatism only if its epistemological, ethical-institutional, and ethical-personal knowledgebases are preserved. 7 From this approach, the reason which supports this warning is that, if the materialobject of ethical science lies on human action, it is easy to understand that every ethical proposal must have as its foundation a human basic model and overall, with respect to behavior and decision-making. Because of this, human action, analyzed from different perspectives, suggests a new focus whose fundamental characteristic is not to be restrictive towards the action approach and, consequently towards ethics (4). In other words, the theoretical aspects that in this document are included are only a starting point to walk manner-congruently from an epistemic posture, which is academically-oriented to guarantee, from ethics, the questions on the discipline actions related to favor the person and not the methodological walls, being these quantitative or qualitative. If we want ethics to be the forming element in our every day researching activities, and not a mere series of theoretical actions for some moments, we need to devote our efforts in reading more, finding time and appropriate situations to learn and reflect on ethics. There is nothing like reading to shake us from the indifference and make us sensible to the ethical issues - action to illustrate and educate consciousness. But we also have to keep a level of exigency for ourselves and therefore discard any action which goes against our principles as the responsible subjects in the research. In other words, we have to learn to think, decide, write, speak, and act according to the ethical principles because this is the truth-embracing integral attitude to life. From this optic, there are fundamental aspects to initiate a good research practice, and which have repercussions on the researcher’s responsibility and on the persons and institutions: First, to guarantee that the quality of the protocols is improved; something which can be achieved though multi-disciplinary groups reviews - with the possibility to include external evaluators – and through the honest conflict of interests declaration, when this be the case (1). Second, the skills of the researcher should be considered. Jamenton (cited by Fouka and Mantzorou) (5), proposes 3 important elements on this: the researcher’s competency, the innovation and worthiness levels of the design, and the expected results. 8 Related to the Persons Considerations Before beginning a research, and in order to reduce the risks on persons (1), it needs to be considered that the relation of the nursing professionals to the persons has to be based on respect and human dignity, and within a holistic scheme, and that its main concern should be the social wellbeing – as the procurement and preservation of health through actions towards satisfying sanitary and social needs of the community. Therefore we have to comply with the following: Informed consent Confidentiality Data protection Right to abandon Potential benefits Potential risks Before persons are recruited for a research, they have to be informed on the research objectives, benefits, and potential risks, and they have to grant their participation consent voluntarily. At no moment, the individual will be forced to participate in a research study, or be biased by a reward promise. The persons must be conscious about the risks in which they might incur as a result of their participation. The Informed Consent Document (IC) is the basic ethical pillar of the research, and through this, it is guaranteed that the person has voluntarily expressed his/her will to participate in a research study, after having understand the given information related to the benefits, possible risks, alternatives, rights and responsibilities. The person must freely grant his/her IC before he/she can be included in any research study. The IC is a formal procedure which allows applying the principle of autonomy and must gather at least three elements: will, information, and comprehension. The voluntary attribute could be re-structured when this is requested by persons in a position of great authority or influence. The IC requires that the information related to the project be transparent, and in a language which the participant can understand. It must be verbal and written and clearly state the time which the activities and procedures will take. It is important that the persons take their time to decide. 9 Nursing professionals who are not part of the research team should not assume the responsibility of recruiting and asking for the participants’ IC, unless they have been explicitly prepared to do so, and they accept to do it. This delegation procedure must be documented. These professionals could further defend and help participants should they needed more, or did not understand the information. It is acknowledged that a person is competent when he/she can take his/her decisions according to his/her knowledge, values scale, and professional goals. In a case where the subject is not competent, a substitution-consent is requested. In general, it is recommendable that the confidentiality and anonymity of the research participants be preserved by means of data codification, or by assigning an alias to the persons. All confidential data must be kept from unauthorized access, and must have a specific time frame in which they can be used. Every person, even after having accepted to participate and becomes part of the study, will always have the right to abandon the study, and this without any prejudice, harm or any benefit, as in the case of the students. Diverse authors point out the difficulty to compare risks versus benefits; however the ethical method offers tools for a systematic analysis from the protocols (3). Nevertheless, sometimes qualitative research deals with delicate themes, a situation which could potentially cause emotional stress and harm to the persons (1). Some organizations have developed policies for the vulnerable persons, and in this regard, the ethics committees can request the researchers to perform potential skills tests on the participants. Related to the Institutions A social institution is a set of persons, relations among persons, objects, concepts and resources, and which responds to a social demand. The first virtue of every institution is justice, according to John Rawls (as cited by Lolas). Lolas states that institutions often transform ideals into practical principles, and the ideas into actions, and cites the example of how new conceptions released from the academic institutions influence onto the social projects by means of the persons, who transform them with the inspiration of their acts (6). Because of that, it is fundamental that research conducted ENEO observe its responsibilities towards the institutions, a concept which has to be plainly identified and contextualized by thinking the institution as an instance which is created with 10 the aim of giving common benefits among all its servers and the persons, motive by which research projects should be conducted. The projects approved by the research committee, when another institution is also involved, should be followed up in order to verify their corresponding approval, prior to commencing the research. This will assure the respect to the institutional normative which focuses on the care of persons. We also have to avoid research projects tending to move the public resources towards private-profiled destinations - this as part the justice and the guarantee of fulfilling the issues on “Carta Magna” related to the respect to the person and the right to health, always contextualizing through a focus of ethics of maximums and minimums, which must be protected by the institutions. The results of the research conducted by researchers from ENEO should share the results and credits with institutions and collaborators as the retribution of the benefits towards the persons, the institutions, and the projects themselves. Related to Authorship, Results, and Publication Considerations The ethical norms are to be personally accepted and go beyond the legal scope. Because of this, the declaration of principles will be presented only pretending to establish a set of guidelines for the ethical behaviors which would be expected from those who aspire to publish the results of research studies carried out. This consideration is fundamental to conduct a research project with honesty regarding the generation, management, and publication of data, and to respect the contributions of each participant - giving balanced credit to those previous findings consulted in the scientific literature (including those which might have opposing results). In this regard, the ethical handling of the information to be diffused will be specifically contextualized around the elaboration and sending of manuscripts susceptible of being assessed and published by diverse journals, because the readers expect that the authors and editors of these journals are honest and trustworthy. Under this frame, the manuscripts created by those who carry out research at ENEO should consider initially, among other points: 11 The adequate acknowledgement regarding the contributions of those who participated in the project, being these either technical of intellectual, including the right to co-authorship. The meticulous acknowledgement of previous findings from other colleagues by means of proper citations of the references in the scientific literature, including those which do not support the findings of their own. Avoid the plagiarism, including data and texts. The adequate supervision of the work of students and other participants involved in a project of research. Related to Authorship 1) 2) 3) 4) The authorship of published articles will be according to the level of participation of each integrant of the research group, this with previous written work agreements and communications to establish, among other, the criteria for the assignation of authorship (8), and the order of the articles produced, procuring to fulfill what has been denominated “good authorship practices” (9), and under no circumstance grant the gift authorship (10). The search for financing, the data collection, or the general supervision of the research group does not justify an authorship (11). If it is desired, these aspects can be included in the thankfulness section (which can be at the end of the article) but this does not make these collaborators co-authors of the research (12). For the acknowledgement of the authors, it will be compulsory: that they have substantially collaborated for the design and accomplishment of the research and the collection of data and their statistical analysis and interpretation; that they have critically reviewed the final research in the search for intellectual improvements; and that they have corrected research errors, all of the previous, in order to achieve a final approval for the research publication (13). The authors of published articles (14), (15) should conduct themselves with responsibility, property, and honesty, in other words, ethically (16), and avoid inappropriate conducts, particularly trying to make others believe something which is uncertain (17). Manuscripts should be original and not redundant, and should also grant the corresponding credits to all information sources utilized (13), (18). 12 Related to the results Authors should always keep in mind: 5) 6) 7) 8) 9) The obligation of publishing studies even with negative results (7). Not to exclude results which “are not in agreement” with the expected results, and to carry out “more-advantageous” statistical analysis is a publication bias (8), (19). Not to fabricate or falsify data (9). To always cite the sources of materials, including those library-related, maps, images, statistics, among other, which have truly been utilized, and this in agreement with the guidelines of the publishing journal (10). Not to communicate, in a premature or sensationalist form, the results of a research study, before their publication in scientific journals because this can cause confusion and false expectations about some exploratory technique or treatment (11). Related to Publication 10) 11) 12) Never send a manuscript for assessment or publication to more than one journal or media (12). To know and follow the guidelines, editorial policies, and instructions for authors stipulated by the desired-to-publish-in journal. To acknowledge in the manuscript to be assessed the support and sponsorship from persons, institutions and/or organizations which fostered the research study, and also the existence of any conflict of interest (10), (13). 13 DEFINITION OF TERMS (Authorship, results, and publication) Within this section, it was important to show some of the terms giving foundation to this proposal. Author: In Mexico, from a legal point of view, an Author is the physical person who has created a literary and artistic work (21). In the research field, an author is generally considered someone who has made a substantial intellectual contribution to a study. In this type of publication, the contribution of every participant is acknowledged, at least within the principal research work (7). Unjustified authorship: It is the warrantless authorship attribution of other persons’ authorship. Thus, “the authorship should be based only on the essential contributions referred to as: a) the conception and design of the study, or the analysis and interpretation of the data; b) the drafting of the article or the critical review of its important intellectual contents; and c) the approval of the final version which will be published. These conditions (a, b, and c) must always be fulfilled” (8). Plagiarism: Literal copy of text, results, graphics or illustrations belonging to another author, without expressing the corresponding credit through an explicit bibliographical reference (13). It is important to point out that this includes any kind of paraphrasing other authors’ works such as taking whole paragraphs, and changing words or sentence orders, and this also includes the self-plagiarism. This also occurs when the reference does not adequately delimit the literal copy boundaries (11, 18). According to the World Association of Medical Journal Editors ( WAME ) it is the use of ideas or words ( or other intellectual property) published or unpublished by others, without their permission or recognition, presenting them as your own and original instead of recognizing that come from other source.(12) Multiple publishing: In its simplest definition, it refers to the publication of an article in two different journals. It also includes simultaneously sending the same manuscript to two or more journals to begin an editorial review process, this with the intention of choosing to publish it in the first-accepting journal. The above is objectionable because of the editorial resource(s) waste of magazine(s) that the manuscript is removed from. Repetitive, duplicate, or redundant publishing: This issue refers to the publishing of an article which considerably overlaps with another already published article on a press or electronic media. 14 Peer review: This is the process of research works reviewing and assessing by the experts in the field and object of study (8). The previous is important because the integrity of the publication is based on a good review to avoid any fraud. Editors should maintain the scientific integrity, gain readers, operate without loses, assure the ethical standards and the confidentiality of the participants. Considering the reviewers case, it is important to maintain the confidentiality while not allowing any misuse of the reviewed material, and also to present informs in a timely manner while avoiding that any jealousness or professional rivalry interfere with the analysis of the manuscripts. Data Falsifying: This refers to the data or procedures manipulation to avoid possible undesirable outcomes from the research (15), and also to the data, or results changes or omissions so that the research outcomes become unrepresentative (20). Data fabrication: This refers to the creation and presentation of fictitious data in a scientific research (18), with the objective of keeping or publishing them (11). Conflict of interest: When an author, reviewer, or editor has personal or financial issues which could inappropriately influence his/her actions. These acts can vary from making negative statements to excessively-positive judging a research work; however, not all relations among those involved in the making, acceptance, and publication of a scientific article necessarily represent a conflict of interest. Because of this, the author must reveal all his/her economical or personal relations which could generate a bias in the work. This should be stated on a page dedicated to conflict of interests (10). Publishing Bias: This is defined as the tendency of the researchers, reviewers, and director or editors of the journals, to propose or accept the publication of articles in function of the direction or impact of the study results (14). 15 4. INSTRUMENT FOR THE REVIEW OF PROJECTS WHICH INTEGRATES THE ETHICAL ELEMENTS Consult on the Assessment guides for the research projects resolution on the ENEO web page, in the Graduate section: Formats for the operation of its functions. 5. PROCEDURE OF RESOLUTION OF PROJECT WITHOUT EVIDENT RISK The projects without evident risk can be reviewed and approved through the usual procedure established by the ENEO Research Committee. The researcher, on the instrument defined for that purpose, will state in the corresponding box if the project is considered without risk, clearly explaining his/her reasons for this. This type of projects can be those which have been approved by research and ethics committees other than the ENEO, as long as they do not affect, discriminate, or stigmatize the participants, and the groups and individuals involved. It is necessary to mention that every project which goes through the assessment of the ENEO Research Committee must include the Informed Consent Document (IC) in its protocol. The Informed Consent Document (IC) is the document on which the ethical responsibility, fundamental in every process related to scientific research with human beings, is stated. The IC must be understood and documented as a continuous process and not as a format single transaction. Through the IC, all involved persons must be appropriately informed on the relevance of the research study, as well as the associated risks and benefits. Through the IC, the following issues are recommended to the ENEO’s professors: a) The professor will establish contact with the persons participating in the study in order to let them know the objectives, methods, and possible risks and benefits, assuring that they have understood all of these. b) After being informed, the involved persons will be handed the IC written in clear and accessible language. They also must have enough time to reflect on it, and if it is the case, consult with their families or other persons, before taking their final decision. A person who decides to participate in a research project must sign the IC along with the signature of the researcher, and the signature of two witnesses, one of these being preferably a relative or a friend of the person involved. c) It is very important to consider the autonomy of participants and to establish the necessary conditions for their right to decide. 16 d) When a study participant is unable of taking decisions (age, mental state, intellectual deficit, a especial social, economical, educational, hierarchical condition, or an severe illness), the IC must be handed in by the legal agent or mentor. e) During the interview and the IC signing, Confidentiality and Privacy must be assured at all times. f) It is the duty of the researcher to inform the participants that they can leave the study when they desire. g) The IC must contain at least these domains: Title of the research project; identification of the responsible; and identification of the participating institutions, and these must include names and phones of those who the participants can communicate with when they have doubts regarding their participation. 17 6. PROCEDURE OF PROJECT RESOLUTION WITH EVIDENT RISK THAT REQUIRES AN ASSESSMENT FROM EXPERTS ON RESEARCH ETHICS OR BIOETHICS The risk is the probability that some danger is materialized and some physical or psychological damage is generated. This risk is undisputable. In the nursing discipline, it is understood as research with evident risk that research in which the probabilities of a person being affected are significant (22). This is applicable to those research activities involving experimental and quasiexperimental studies (clinical, field and communitarian) with persons, subjects of nursing research, and the researchers themselves who could run any risk, from the minimum nuisance to any damage, particularly from experimental manipulations. This also includes those studies which put in danger the identity or integrity of the persons by any means, particularly by the probability of causing prolonged lesions, including the irreparable damages which might result from nursing interventions, test care, diagnostic, and therapeutic manipulations (early stimulation, physical therapy, alternative care, use of topical heat or cold, medication authorized for professional nursing, etcetera). For purposes of risk assessment will be assessable only those related to the same research and not derived from the disease itself or the simultaneous medical treatment to nursing care. The recommended procedure is: 1) Assessment of the understood evident risk (22): a. Minimum risk. This is carried out with a register of data through routine diagnostic procedures (physical or psychological) and with transient impact to the health and comfort. b. Greater risk. This is carried out on experimental studies with a probability of affecting the person putting them in danger the life, identity or integrity of the person. 2) Assessment of the control and experimental groups on the type of risk which they might run into. 3) Projects will be analyzed and approved from without evident risk to the greatest risk by the researcher or nurse, contemplating the undesirable effects as a result of the research and the protocols on attention and contingency care. The undesirable effects can be physical, psychoemotional, economical or social. 4) The research project must always note the individual and collective benefits which it can generate to persons families and communities, and the society as a whole, both nationally and internationally. 18 5) In a clinical nursing research which uses diagnostic, free-access procedures, medications or therapies, coercive actions which might be considered “perverse incentives” which imply any kind of manipulation by the research will be absolutely avoided. 6) Just as with other research works, the participants’ confidentiality will be maintained; and only with their authorization, a scientific disclosure can take place. The project or protocol of research will point out the measures to obtain, keep, and safeguard all the related information, and only the main researcher will have access to the properly elaborated, codified, and identified files. 7) The identities of the researched persons will be protected in the research results (22). Because the research projects are performed with human beings as the subjects of study, other societal values such as the human rights and the respect to persons, are as well involved. At least three ethical levels can be considered in the research. a) On the one hand, that related to the treatment of the subjects of the experimental and human studies; b) on the other hand, that related to the members of our community who interact, collect, and store; and c) that related to those who analyze the data resulting from their research activities. Therefore, it is fundamental to adopt in a permanent manner a prudent and responsible behavior which considers as the priority the protection of the rights and wellbeing of the individuals who participate in the research projects. The Research Evaluation Committee must differentiate between research and audit. Research implies obtaining new knowledge, discover what is or can be a good practice. The clinical audit is related to quality and knowing if the best practices have been adopted using the evidence-based nursing method. Clearly the distinction is not absolute, thus the necessity of assessment from the Research Evaluation Committee cannot be defined with precision. A possible focus could be a concentration on three key questions (24): a) ¿Has the proposed project as objective to try to improve the quality of patient care in the local scope? b) ¿Would the project imply comparing the practice with standards? c) ¿Would the project imply doing to the patient something different from what would have been part of the regular routine treatment? 19 If the answers to the first and second questions is “yes” and the answer to the third is “no”, then the project is probably a clinical audit; otherwise, it is probably a research. These concepts on understood evident risk, between what minimum risk and greater risk are and the ethical consideration regarding the implementation of values and human rights will be most useful to follow an adequate procedure by the Research Evaluation Committee to assess and emit a better resolution. 20 7. ESTABLISHMENT OF EXTERNAL INTEGRANTS External evaluators will be assigned, from the recommendation of the committee and in accordance to the thematic and methodology of the project: A. The external committee will be integrated at least by 3 persons with acknowledged prestige in the ambits of ethics and health research. B. The integrants must be proposed by integrants of the Research Committee and approved by the plenary. C. The integrants of the external committee will individually hand in their resolution and the Research Committee will integrate them to the project evaluation for the final resolution. 21 8. REFERENCES 1. Beauchamp TM, Childress JF. Principios de Ética Biomédica. Barcelona: Masson, 1991. 2. Pallalazzani L. Bioética de los principios y bioética de las virtudes: el debate actual en los Estados Unidos. Revista Medicina y Ética 1992;(4):3:441-475 3. Cortina A. Ética mínima. 6ª ed. Madrid: Tecnos, 2000. P139 4. Rodríguez A, Aguilera JC. 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