of Ethics Online Collection: 2002
Code of Good Scientific Practices
A. Foreword
A.1. The Code of Good Scientific Practice applied in
the centres of the Barcelona Biomedical
Research Park (PRBB) represents a set of recommendations and commitments governing
scientific activities. The aim is to create an environment conducive to quality
research and
prevent problems from arising in relation to the integrity of scientists in
their work. The
recommendations set forth complement current legal regulations.
A.2. The Code of Good Scientific Practice constitutes
a framework for self-regulation. The
content has been supervised and updated as part of the remit of the Scientific
Commission
of the PRBB, made up of the directors and scientific staff of the Municipal
Institute of
Medical Research (IMIM), the Department of Experimental and Health Sciences
of the
Universitat Pompeu Fabra (UPF), the Centre for Genomic Regulation (CRG), the
Barcelona
Centre for Regenerative Medicine (CMRB), the Institute of Advanced Technology
(IATPRBB),
and the Centre for Research in Environmental Epidemiology (CREAL).
A.3. The Committee for Research Integrity (CRI) is
an independent body at the service of
the scientific community whose main role is to promote greater awareness of
the Code
of Good Scientific Practice within the PRBB and to respond to enquiries or
arbitrate
conflicts that might arise. The CRI is made up of members nominated by the
Scientific
Commission of PRBB. (Details of the functions and composition of the CRI are
provided
in Section 9.)
A.4. As evidence of the acceptance of the contents
of the Code of Good Scientific
Practice, the directors of the PRBB centres publicly sign an original copy
and commit to
promoting dissemination and adherence to its contents within the centres in
Barcelona
on 13 February 2007.
Miguel López-Botet, Municipal Institute of Medical
Research (IMIM-IMAS)
Fernando Giráldez, Department of Experimental
and Health Sciences (UPF)
Miguel Beato, Centre for Genomic Regulation (CRG)
Juan Carlos Izpisúa, Barcelona Centre for Regenerative
Medicine (CMRB)
Francisco J Fernández, Institute for Advanced
Technology (IAT-PRBB)
Josep M Antó, Centre for Research in Environmental
Epidemiology (CREAL)
Jordi Camí, Barcelona Biomedical Research Park
(PRBB)
B. Commitment to Dissemination and Implementation
B.1. The directorate of each centre will distribute
a copy of the new Code of Good
Scientific Practice to all personnel and will provide a copy to any new members
when
they join the centre. In both cases, individuals will be required to confirm
receipt of their
copy. The centres will maintain a record of the provision of the Code of Good
Scientific
Practice, including the date of receipt and the name of the individual. This
record will be
made available to the CRI. Likewise, the centres will post a link to the current
contents
of the Code of Good Scientific Practice on their webpage so that they will
be readily
available and can be freely consulted.
B.2. The PRBB will provide the centres with a sufficient
number of copies of the Code
of Good Scientific Practice and will make sufficient resources available for
them to be
effectively disseminated and implemented, including provision of the means
needed to
support the activities of the CRI.
B.3. The CRI will oversee the regular analysis and
discussion of the contents of the Code
of Good Scientific Practice as part of postgraduate studies and activities
undertaken by
trainee scientists affiliated with PRBB centres.
C. Contents
1. Supervision of researchers in training
2. Preparation of research protocols
3. Recording, documentation, storage, custody, and sharing of data and biological
or chemical materials arising from research
4. Research projects funded by the healthcare industry or other commercial
enterprises
5. Publication and communication practices
6. Authorship of scientific articles, other publications, and patents
7. Peer review
8. Main legal requirements affecting scientific activities
9. The Committee for Research Integrity
1. Supervision of researchers in training
1.1 Assignment of a mentor All individuals linked to
a PRBB centre either through a
contract or grant in order to receive some form of training[1] will be assigned
a mentor.[2]
[1] Training as a scientist or
research technician; this includes
undergraduate students,
postgraduates, individuals with
diploma-level education, and others.
[2] The term mentor will also be used
to refer to a tutor or thesis/project
supervisor.
1.2. Responsibilities of mentors The mentor defines
the objectives and takes
responsibility for the education of the individual in training, and should
advise and guide
the individual in order that the expectations of the initially proposed training
may be
fulfilled within the time allotted. Furthermore, the mentor must provide the
individual with
the best possible conditions for the development of his or her future scientific
career.
1.3. Limits to the number of individuals assigned to a single
mentor The total number
of trainees for whom a single mentor is responsible should be appropriate and
compatible
with the extent of the mentor’s obligations and commitments.
1.4. Rights and obligations of individuals in training Trainees
have rights and
obligations that differ from those of contracted individuals in the centre.
The mentor should
be especially diligent in ensuring that trainee scientists are not involved
in performing
tasks outside those prescribed by their training. Trainees should not participate
in projects
with commercial restrictions on the publication of results or that involve
delays beyond
those associated with procedures necessary for the commercial protection of
the results
obtained.
1.5. Obligations of mentors The specific obligations
of mentors are as follows: a)
to interact personally with trainees for whom they are responsible on a regular
basis
in order to supervise the tasks with which the trainees are entrusted and ensure
that
those tasks are completed; b) to encourage regular meetings to discuss the
progress
of the assigned tasks and contribute to the scientific and technical development
of the trainees; c) to monitor the working conditions of trainees and ensure
that they receive appropriate health and safety training; and d) to provide
trainees with
up-to-date information regarding legal requirements affecting scientific activities
(see
Section 8).
2. Preparation of research protocols
2.1. Written projects subject to scrutiny by outside parties Prior
to their initiation,
all research projects must be formulated in a written protocol. If the protocol
directly
involves humans, experimental animals, or human embryonic material, the text
must have
been independently assessed by an ethics committee on clinical research and/or
animal
experimentation.[3] The text of the protocol generally coincides with the written
proposal
necessary to obtain approval and funding.[4]
[3] See Section 8.
[4] A research protocol must include,
as a minimum requirement, the
background to the proposal, the
specific objectives, the methods to
be used, a work plan including a
predicted time scale, available and
necessary resources, and the names
of persons in the participating team.
According to the type of study to
be undertaken, the protocol should
also include ethical and legal
components and safety provisions.
It is useful to include a plan for the
communication of the results of the
study in the research protocol.
2.2. Unacceptability of secret research Under no circumstances
should a protocol, or
any part of a protocol, remain secret. This stipulation differs from temporarily
restricted
access to certain protocols or parts thereof for reasons of competition and
confidentiality.
2.3. Extension or modification of the research protocol The
development of an
unexpected or additional research question will require preparation of a corresponding
complementary written protocol prior to initiating research in that direction.
If the implications
of the new research question so require, the protocol must follow established
procedures
for external authorization and supervision. This is indispensable when the
research directly
involves human subjects, experimental animals, or human embryonic material,
and in some
cases of extension or alteration of the primary objectives of the research.[5]
[5] This would be the case, for
instance, when stored biological
material that is associated with
identifying information on the source
individuals is used for purposes
other than those predicted in the
original protocol.
2.4. Exceptionally urgent research When situations
relating to public health or safety
require the immediate establishment and implementation of a research project,
the
initiation of research activities must nevertheless be supported by a protocol
describing
the procedures involved, albeit in a simplified form; this is especially applicable
when that
research involves human subjects or experimental animals. As far as possible,
simplified
protocols or protocols to be initiated urgently should nevertheless be externally
reviewed
and processed according to the normally required procedures for research protocols.
2.5. Use of external equipment or facilities All research
protocols that involve the use
of health service facilities or equipment, either associated with the research
group or
external to it, or of any research facilities or equipment not designated for
the exclusive
use of the research group, will require prior consent from the head of the
corresponding
organization, hospital, or centre, or the individual responsible for the facility
or equipment
that is to be used.
2.6. Collaborative research When a planned research
project involves the participation
of several groups from the same or different centres, the limits and terms
of the
collaboration must be formalized in writing.[6]
[6] An appendix to the research
project should include the following:
criteria defining the relationships
between the different researchers
involved and governing the exchange
of information during the course of
the project; the explicit distribution
of responsibilities, rights, and
obligations of the participating
groups both in relation to the tasks
to be undertaken and the results
obtained; a plan for the presentation
and communication of the results;
procedures for the storage and
distribution of data and samples;
prediction of possible commercial
implications; and stipulations relating
to funding and resolution of conflicts.
3. Recording, documentation, storage, custody, and sharing of
data and biological
or chemical material arising from research
3.1. Data collection and storage All research protocols
must include a system for collection
of data, registries, and biological or chemical material arising from the research,
along with a plan relating to their custody and storage.
3.2. Recording of data and alterations Without exception,
all data arising from
experiments or research observations must be recorded. That information must
remain
permanently recorded in databases, registered notebooks,[7] or other appropriate
format,
in a condition that facilitates external review. The records must also include
changes;
errors; and negative, unexpected, or conflicting results; as well as an indication
of the
person who performed the experiment or made the observation.
[7] The PRBB provides registered
notebooks free of charge to all personnel
belonging to its
constituent centres.
3.3. Storage of data The necessary means and infrastructure
must be provided for
correct storage and safekeeping of all documentation and biological or chemical
material resulting from a research project. In the case of data recorded on
electronic
media, a specific plan will be included for the preparation and physical storage
of
backup copies.
3.4. Custody and access to collected data All individuals
who belong to the research
group must be able to access information on the data obtained and their interpretation.
The individual responsible for the research will have a single record of the
locations of
all the different data-collection instruments (registered notebooks, databases,
etc.) and
samples that must be accessible to third parties.
3.5. Ownership of data and samples All primary documentation
(registered data collection
notebooks, databases, etc.) and biological or chemical material obtained
in the course of a research project is the property of the centre to which
the person
responsible for the research is affiliated. Recording, storage, and safekeeping
of that
material are the responsibility of the individual responsible for the project.
Should a
researcher change institutions, the individual responsible for the project
will be able
to make available a photocopy of part or all of the records, a copy of the
existing
electronic information, a photocopy of the data-collection notebooks, or aliquots
of
available biological or chemical materials, provided such sharing is necessary.
When
the change involves the person responsible for the research, the director of
the centre
will take responsibility for supervising this process.
3.6. Sharing of data and samples with outside parties Data
and materials arising
from a research project must be publicly available and in a condition to be
shared
with outside parties, except in cases where restrictions have been established
on the
basis of possible future commercial use. Provision of data or materials will
require that
information be provided on the intended use by the person who has requested
them,
that the research group is aware of the request, that there is a material or
data transfer
agreement with the approval of the individual responsible for the research,
and that the
person making the request is willing to pay all possible costs of production
and shipping.
Sharing may be restricted for reasons of availability, competition, or confidentiality.
Material or data obtained from human subjects must be shared in such a way
that
the subjects can not be identified; if identification of individual subjects
is possible,
those individuals must first consent.
3.7. Length of storage of data and samples All original
primary information and
biological and chemical material arising from a research project must be stored
for a
minimum of 10 years from the date of the first publication of the results,
except in those
cases in which the law allows shorter storage periods or requires longer periods
to be
applied. If the centre allows, the primary information and material may remain
stored
for longer periods, provided their final destination meets the approval of
the person
responsible for the research.
4. Research projects funded by the healthcare industry or other
commercial
enterprises
4.1. Transparency and priority of interests When knowledge
and technology is
exchanged or provided to private enterprises, public interests must always
take
priority, and therefore, complete transparency must be maintained in all agreements.
In addition, the directors of the centres will establish the necessary limits
to protect the
intellectual freedom of their researchers and avoid excessive confidentiality
agreements
or unjustified publication restrictions on the results obtained.
4.2. Industrial property rights When researchers who
participate in a project
promoted by industry make essential contributions to its design and execution,
the
necessary agreements will be established with the promoting organization to
share the
corresponding industrial and intellectual property rights. Under those conditions,
the
promoting organization will have exclusive access to all results for a period
of up to 90
days in order to assess their commercial potential.
4.3. Intellectual property rights When a research group
offers a technical service or
researchers participate exclusively in the collection of data as part of a
protocol developed
by a third party, the conditions for communication and publication of the results
obtained will be established by mutual agreement with the promoting entity,
taking into
account the principles indicated in Section 5.1.
4.4. Economic compensation All commitments involving
the funding body and the
centre or centres on which the person or persons responsible for the research
depend
will be recorded in the corresponding agreement (or agreements). The agreement
must
include all aspects of economic compensation directly or indirectly relating
to the research.
These contracts shall be accessible to the organizations, committees, and individuals
with responsibilities relating to the matters under agreement.
5. Publication and communication practices
5.1. Peer review of results The results of scientific
research must always be subject to
peer scrutiny. Thus, publication of results in journals or other media that
apply a process
of peer review is an essential part of the research protocol.
5.2. Protection of results with possible commercial interest If
the results
of research could lead to inventions or applications that may be subject to
protection
on the basis of their commercial interest, the individual responsible for
the research project is obliged to communicate this information to the directorate
of the
centre and manage the publication of the results in scientific journals accordingly.
5.3. Unpublished results The failure to publish results
or the excessive delay in publishing
them may constitute a serious offence relating to misuse of resources. The
publication
of results constitutes an ethical imperative for clinical studies in which
human
subjects have participated.
5.4. Negative results In clinical studies and certain
epidemiological studies it is equally
necessary to publish negative results or results that differ from those predicted
in the
research project.
5.5. Fragmented publication Fragmented publication
of a single piece of research is
unacceptable. Fragmentation is only justified by extension of the research.
5.6. Duplicate publication Duplicate or redundant publication
is considered to be an
unacceptable practice. Secondary publication is only acceptable under the terms
established
in the guidelines of the International Committee of Medical Journal Editors
(‘Vancouver Group’).[8]
[8] See the criteria for acceptable
secondary publication in the
Uniform Requirements for
Manuscripts Submitted to
Biomedical Journals: Writing and
Editing for Biomedical Publication
Updated February 2006 International
Committee of Medical Journal
Editors, http://www.icmje.org/
5.7. Bibliographic references to third parties Both
in publications and in patent applications
or utility models, it is necessary to cite all work directly related to a given
piece of research and, in turn, to avoid unjustified or honorary citations.
Reference to
the work of others must include sufficient recognition of the value of that
work.
5.8. Acknowledgements The Acknowledgements section
of a publication must follow
strict principles. The individuals or institutions mentioned have the right
to deny permission
to be included. Some journals require that written authorization be obtained
from
individuals acknowledged. The same principle is applicable to references to ‘personal
communication’.
5.9. Institutional affiliation and acknowledgement of support In
conference
presentations and all other types of presentation of results prior to definitive
publication,
the following must be declared: a) the institutions or centres to which the
authors belong,
or belonged, and in which the research was undertaken; b) whenever applicable,
the
independent ethics committees who supervised the research protocol and the
specific
permission obtained; and c) details of all funding received.
5.10. Presentation in the mass media The presentation
of results in the mass media
must always include an appropriate level of explanation for a non-specialist
audience or
a part of the presentation that has been adapted for the general public. In
such presentations,
the names of the authors must always be linked to their institutions and, wherever
possible, financial support and help received should be mentioned.
5.11. Premature communication through the media The
communication of research
results in the media prior to scrutiny by other scientists through peer review—in
other
words, prior to acceptance for publication or presentation in certain types
of conference—
is considered unacceptable.
5.12. Urgent reporting The early or premature reporting
or publication of results is only
justified in exceptional cases on public health grounds. In such cases, the
authors must
ensure that the results will simultaneously be under rapid review for scientific
publication.
Likewise, they should inform the editors of the journals in which definitive
publication of
the results is intended of the scope of the prior communication.
5.13. Use of publication record for purposes of research assessment In
assessments
of individuals or groups involving analysis of scientific publications for
the purposes
of promotion or other forms of compensation, evaluation will always be based
on the
quality and potential importance of the scientific output, not simply on the
number of
publications.
6. Authorship of scientific articles, other publications, and patents
6.1. Who may be an author? The status of author is
not dependent upon belonging to
a given profession or on hierarchical position, nor to employment status, but
rather to the
contribution made by the individual to the research.
6.2. Who should be an author? To fully meet the criteria
of author of a publication or
patent, an individual must a) have made a substantial contribution to the creative
process,
that is, to the conception and design of the study, or to the analysis and
interpretation
of the data; b) have contributed to the preparation of the communications,
reports, or
publications that have arisen; and c) be able to present in detail his or her
contribution to
the project and to discuss the main aspects of the overall research. Authors
must provide
signed acceptance of the final version of original manuscripts submitted for
publication
or registration.
6.3. Provision of data, expert reports, or experimental subjects Mere
participation
in obtaining resources or in data collection, such as, for example, the provision
of routine
data or experimental subjects, does not necessarily justify the condition of
author,
although such involvement should be recognized in the Acknowledgements section.
In
studies involving the use of samples, analysis, or expert reports provided
by third parties,
it is advisable to establish a prior plan relating to communication and authorship
in which
the potential intellectual contribution to the project is taken into account
along with any
other elements relating to rights to authorship.
6.4. Partial authorship When an author of a publication
cannot take responsibility for all
of its content, his or her specific contribution should be indicated separately,
except in
those cases in which this question is already addressed by editorial guidelines.
6.5. Honorary and ghost authorship Any person linked
to a research group who requests
inclusion as an author on the basis of hierarchical position or professional
relationship
violates the principles of academic freedom and commits an act of injustice,
if not abuse
of authority. Likewise, the omission of names of any individuals who have made
proven
contributions according to the criteria in Section 6.2 represents an act of
misappropriation
of intellectual property on the part of the other authors.
6.6. Indication of authorship in reports The preparation
of memoranda, technical or
work reports, or other written documents for the attention of outside parties
must always
indicate the authors of the research, the centre or centres with which they
are affiliated,
and the support received, in the same way as if the document were a scientific
publication
or patent.
6.7. Order of authorship As a general rule, the order
in which authors appear in scientific
publications should be as follows: a) the first author should be the person
who has made
the greatest contribution to the study and has prepared the first draft of
the article; b) the
senior author who directed or has final responsibility for the research protocol
appears
as the last author; and c) the remaining authors may appear in order of importance
and, in certain cases, in alphabetical order. The corresponding author is responsible
for
dealing with the editorial process and future correspondence arising from the
publication
of the study.
6.8. Shared main authorship The right exists in scientific
publications to justify the order
in which authors appear and some journals request this as a condition of publication.
When two or more authors have made an equal contribution to the same study
and have
shared responsibility for preparation of the manuscript, they will be considered
as equal
first authors. This condition will be made clear in the publication of the
article. The same
criteria may be applied to intermediate or senior authors.
6.9. Curriculum vitae should be signed In the preparation
of a personal Curriculum vita,
the author is responsible for the accuracy of its content. Consequently, such
a document
should always be signed by the individual who presents it. In the case of a
group CV, it is
sufficient for the document to be signed by the individual responsible for
presenting it.
7. Peer Review
7.1. The concept of peer review Peer review is understood
as all requests to an
individual in their position of expert or similar status to undertake a specific
assessment,
examination, or evaluation of a manuscript submitted for publication, an individual
or
group grant proposal, a clinical or experimental protocol subject to assessment
by an
ethics committee, or a report arising from an on-site visit to a laboratory
or centre.
7.2. Conflicts of interest Reviews must be objective
and based on scientific criteria
rather than personal opinion. Reviews should be declined in the event of a
conflict of
interest—for instance, when there is a direct relationship between the
author(s) and the
reviewer or when the reviewer is in direct competition with the authors—or
if the invited
reviewer does not consider that he or she is sufficiently prepared to perform
the review.
7.3. Use and fate of documentation submitted for assessment Reports
and written
documents that are subject to review are always confidential and represent
privileged
information. As a consequence, such documentation a) may not be used for the
benefit
of the reviewer until the information has been published; b) may not be shared
with other
colleagues except in specific circumstances or with the explicit permission
of the editor or
research organization; and c) may not be retained or copied except where this
is allowed
by those responsible for the editorial process or the research organization
for whom the
review is requested. Common practice is to destroy or return the material once
the review
process is completed.
8. Main legal requirements affecting scientific activities
8.1. Responsibilities of the centres The directors
of the centres must provide assurances
to personnel that the infrastructure complies with legal requirements and that
they have
the relevant authorization to undertake any scientific activity that is subject
to specific
regulations. In addition to the procedures that regulate scientific research
involving
human subjects, experimental animals, or human embryonic material, the centres
will pay
attention to regulations on the use of, exposure to, and storage of radioactive
material,
genetically modified organisms, or any other potentially dangerous biological
agent.[9]
[9] Spanish Royal Decree 178/2004
of January 30 (Official State Journal
[BOE] number 27, January 31)
approving the regulations of general
applicability for the development
and practice of Spanish Law
9/2003 of April 25 governing the
restricted use, voluntary release,
and commercialization of genetically
modified organisms.
Ministerial Order of March 25, 1998,
adapting to technical
progress Royal Decree 664/1997 of
May 12 on the protection of workers
against workplace exposure to
biological agents (BOE number 76
of March 30, 1998). Royal Decree
665/1997 of May 12 (BOE number
124 of May 24) on the protection
of workers against the risks of
workplace exposure to biological
agents. Law 31/1995 of November
8 on prevention of workplace risks
(BOE number 269 of November 10,
1995).
8.2. Research involving human subjects All research
protocols involving the direct
participation of human subjects or based on any form of information or biological
samples
obtained from such subjects must always have received, as a minimum requirement,
approval from the corresponding clinical research ethics committee.[10] When
research
involves patients, members of the research team who are not responsible for
treating
the study participants must collaborate and not interfere with any decisions
made by the
physician responsible for treatment.
[10] Royal Decree 223/2004 of
February 6 regulating clinical
drug trials (BOE number 33 of
February 7). Decree 406/2006
of October 24 regulating the
requirements and procedures for
accreditation of ethics committees
on clinical research (Official Catalan
Government Gazette, 26/10/2006).
The ethics committee on clinical
research with responsibility for
PRBB centres is that of the IMAS.
11 Spanish Law on Biomedical
Research, currently being
considered in parliament.
8.3. Genetic research All research protocols that include
the collection, manipulation,
and/or storage of biological samples for the purposes of genetic analysis will
be prepared
according to the current legislation.11 In particular, the privacy of the subjects
and their
right to be informed about their personal results must be guaranteed.
8.4. Common requirements in all research involving human subjects Particular
diligence is required in relation to all information regarding the purpose,
potential
discomfort/inconvenience and risks, and the benefits of the research, in obtaining
the express, specific, and written consent of the participants, and in attending
to the
confidentiality of data, samples, and results obtained. In addition, given
that in clinical
research the process of data collection is complex and cannot always be repeated,
the
research group must pay particular attention to the quality of data collection
and the
procedures for data storage.
8.5. Consent for genetic research The consent of the
participating subjects can foresee
the use of samples in other projects related to the initially proposed research.
Consent must
be renewed whenever biological samples are to be used for purposes other than
those
indicated at the time they were donated.[12]
[12] Summary of the various rules
drafted in the Spanish Law on
Biomedical Research, which is
currently being considered in
parliament.
8.6. Research involving human embryonic material All
research protocols that involve
collection, manipulation, and/or storage of human embryonic material must receive
the
corresponding permission from the Spanish Ministry of Health,[13] following
acceptance by
the appropriate ethics committee for clinical research.[14]
[13] Committee on the Donation and
Use of Human Cells and Tissues,
assigned to the Instituto de Salud
Carlos III and drafted in the Law on
Biomedical Research, currently being
considered in parliament.
[14] In Catalonia, the only ethics
committee on clinical research with
responsibility for this type of study
is that of the CMRB, according
to Decree 406/2006 of October
24, 2006, which regulates the
requirements and procedures for the
accreditation of ethics committees
on clinical research (Official Catalan
Government Gazette, 26/10/2006).
8.7. Protection of personal data All research protocols
that involve the use of institutional
computer records or the preparation of databases containing information relating
to
individuals must guarantee the anonymity of the participants and be subject
to current
regulations on data protection.[15]
[15] Spanish Organic Law 15/1999 of
December 13, 1999, which regulates
the protection of personal data (BOE
number 298, December 14). Decree
29/1995 of January 10 regulating
electronic files that contain personal
data in the Department of Health
and Social Security (Official Catalan
Government Gazette number
2013, 17/2/1995). Law 23/1998 of
December 30, relating to statistics
for Catalonia (Official Catalan
Government Gazette number 2801,
8/1/1999) and Law 12/1989 on public
statistics (BOE number 112 of May 12).
8.8. Research involving experimental animals All procedures
involving experimental
animals must be approved by the ethics committee for animal research.[16]
[16] Royal Decree 1201/2005 of
October 10 (BOE number 252 of
October 21) on the protection of
animals used for experimentation
or other scientific purposes. Decree
214/1997 of July 30 regulating the
use of animals for experimentation
and other scientific purposes (Official
Catalan Government Gazette number
2450, 7/8/1997). In our case, the ethics
committee for animal experiments is
the committee for the PRBB.
8.9. Good laboratory practice Non-clinical studies
intended to test health or environmental
safety and in which results must be presented to the competent regulatory authorities
must
be performed according to the principles of good laboratory practice.[17]
[17] Royal Decree 1369/2000 of July
19, updating Royal Decree 822/1993
of May 28, which establishes
the principles of good laboratory
practice and their application
in non-clinical studies involving
chemical substances and products.
9. The committee for research integrity
9.1. Definition The CRI is a body established by the
Scientific Committee of the PRBB and
made up of members of its constituent centres who sit on the committee voluntarily.
Its
role is to promote awareness and internal implementation of the Code of Good
Scientific
Practice and to address queries and arbitrate in the event of conflicts. The
CRI acts
independently in the service of the staff of the PRBB centres and with the
only objective
of supporting research quality and contributing to the preservation of research
integrity.
9.2. Functions The functions of the CRI are as follows:
a) to monitor observance of the
Code of Good Scientific Practice and compliance with its recommendations; b)
to act as
an arbitrating body in the case of uncertainties or conflicts that may arise
in relation to
research integrity—the decisions of the CRI will be binding for all persons
who submit
conflicts for arbitration; c) to inform and raise awareness in the scientific
community of the
PRBB regarding events, needs, and information relating to ethical considerations
affecting
biomedical research; and d) to remain alert and sensitive to new problems relating
to
research integrity and to propose updates to the content of the Code of Good
Scientific
Practice to the Scientific Commission of the PRBB. The CRI will prepare its
own bylaws.
9.3. Procedures In relation to its mentioned roles,
the CRI will guarantee at all times the
diligence of its activities, the independence of its decisions, the anonymity
and confidentiality
of personal information, the authority of the information generated, the impartiality
of its deliberation, and the fairness of its resolutions, as well as the opportunity
to appeal
against those decisions.
9.4. Contacting the CRI The committee can be contacted
at cir@prbb.org. When the
concern is one of a doubt about interpretation or of a possible conflict, it
is advisable to
first make informal contact with a member of the CRI from a researcher’s
own centre. This
is particularly recommended prior to initiating any type of formal communication
with the
CRI. Members of the CRI are obliged to respect the anonymity and confidentiality
of personal
details or of any information received even in the case of informal contacts.
9.5. Composition of the CRI
Chairman: Jordi Camí (PRBB and UPF)
Secretary: Jaume Marrugat (IMIM, UAB)
Members: Carme de Bolós (H Mar/IMIM), Montserrat Bordes (UPF Dep. Humanities),
David Comas (DCEXS/UPF), Juan Domingo (IAT)
Cristina Fillat (CRG), Judit García (IMIM and CREAL), Joaquín
Rodríguez León (CMRB),
Andrea Sáez (DCEXS/UPF), Montserrat Torà (IMIM)

