*for its acronym in Spanish NATIONAL AUTONOMOUS

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).
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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:
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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
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