of Ethics Online Collection: 2007
Code of Good Scientific Practice
Contents
Foreword
Code of good scientific practice
1. Supervision of the research worker in training
2. Development of research protocols
3. Documentation, storage, custody and sharing of the data, records
and biological or chemical material resulting from the research work
4 Research projects sponsored by the healthcare industry or by
any other profit-making institution
5. Practice of publication
6. Authorship of scientific work
7. Practice of peer review
Committee for the integrity of scientific research
Foreword
In order to conduct scientific research with quality and in accor-dance with
accepted ethical standards, there is a need for consensus amongst scientists
with regard to their attitudes and the procedures involved in planning and
developing and in the communication of all matters related to the scientific
practices and production. One way to achieve this consists in providing a Code
of Good Scientific Practice (CGSP) and the possibility that researchers could
appeal to a Committee for the Integrity of Scientific Research (CISR).
At the present time, there is wide consensus in the international scientific
community in respect to the most important components of what constitutes Good
Scientific Practice. The two main purpo-ses of the Code of Good Scientific
Practice are to improve the quality of science and to prevent problems related
to integrity in research. These consists of a series of rules and obligations
that go beyond these established by legal principles and expand some of the
aspects already included in specific guidelines for the practice of science.
The present document sets out the Code of Conduct that has been adopted as
a personal commitment by the scientific personnel of the following three institutions:
the Municipal Institute of Medical Research (IMIM) and IMAS, the Health and
Experimental Sciences Department of the Universitat Pompeu Fabra and the Center
of Genomic Regulation (CGR). Following its initial publi-cation in the year
2000, we present a second edition which inclu-des new criteria on the handling
of biological samples for genetic tests and an updating of the CISR composition.
Beyond the satisfaction and responsability deriving from the exis-tence of a Code of Good Scientific Practice, we also renew with this new edition our commitment to promote its maximum application.
Jordi Camí, Municipal Institute of Medical Research (IMIM-IMAS)
Miguel López-Botet, Department of Health and Experimental Sciences (UPF)
Miguel Beato, Center of Genomic Regulation (CGR)
Barcelona, June 2002
Code of good scientific practice
1. Supervision of the research worker in training
1.1. Everyone regularly associated with our institutions, training either as
a scientific research worker or technical research support assistant (university
student, graduate, pre-doctoral, diploma or other students), will be provided
with a mentor 1 . Said mentor shall be responsible for the individual education
of the person in training, and shall counsel and guide the latter towards fully
achieving his/her training goals, in line with his/her original objectives
and calendar, and shall ensure the best possible conditions to guarantee the
individual’s future career in science.
1.2. The person training as a scientific research worker or technical research support assistant, whether the association be by way of rese-arch grant or otherwise, shall not merely be considered an extra hand in the mentor’s laboratory, group, unit, service or department, and his/her priority tasks must always be those related to his/her training.
1. From hereafter considered the equi-valent of a tutor, director of thesis or project.
1.3. The mentor’s tasks are the following:
a) The mentor shall supervise the work and accomplishments of the person in training by way of regular, face-to-face interaction with the latter.
b) The mentor must ensure that the person in training has regular access to discussion meetings, studying and reviewing the progress made on the assigned scientific tasks, and suggesting any literature that could be of interest with respect to current lines of research.
c) The mentor must be particularly diligent with his/her staff in trai-ning, ensuring that they do not become excessively involved in tasks not relevant to their training during the course of their association, especially if such tasks are related to healthcare industry promoted research work with restrictions regarding the publication of results.
d) The mentor must be responsible for teaching his/her staff in trai-ning all of the elements of good scientific practice, from the ethical standards of human or animal experimentation, through to the con-tent of the present Code of GSP.
2. Development of research protocols
Concerning the definition of the protocol
2.1. A research protocol is a written document about the study of a hypothesis comprising a minimum of the following: a back-ground to the proposal, the specific objectives, the methodology to be employed, the work plan and calendar, the resources available and those that will be needed, and the composition of the team involved.When dealing with animal or human studies, it shall also include all ethical issues and safety measures.
2.2. Any research protocol or part thereof, which is, or should be kept, secret, for whatever reason, is unacceptable. However, for rea-sons of confidentiality or competition, the distribution of protocols may be limited.
2.3. Questions regarding additional or supplementary research work for an established project, involving human beings and provi-ding for traumatic procedures in experimental animals and which represents a change in the objectives of the protocol (for example, when a biological or chemical component developed by specific research is to be used for purposes other than those defined in the original protocol) shall require the drafting of the corresponding research protocol, prior to proceeding with such use. If the conse-quences of the new question or discovery so require, the revised protocol shall have to undergo all of the established procedures for external authorization and supervision.
2.4. When circumstances require the immediate start-up of research work, and/or the establishment of a simplified protocol in research projects involving human beings or experimental animals, there shall never be any justification for the absence of a written proto-col, nor for the drafting of such protocol not to be in line with the most basic standards. Simplified or emergency protocols shall be subject to parallel external review, in line with all of the procedures established for a regular protocol.
2.5. It is recommended that all research protocols be independently examined by third parties, except in those cases in which such exa-mination is compulsory and institutionalized (application for rese-arch grants, protocols involving animals or human beings). Concerning statutory requirements
2.6. No research protocol involving studies with human beings shall ever be employed without first having obtained the approval of the CREC (Clinical Research Ethics Committee) 2 .
2.7. No research protocol involving animal experimentation shall ever be employed without first having obtained the approval of the AEEC (Animal Experimentation Ethics Committee) 3 .
2.8. All research protocols involving the obtention and/or conser-vation of biological samples shall guarantee the donor’s confidentia-lity, independently of the identification stage in which the samples are conserved.When non-anonymous samples to carry out geneti-cal tests are conserved, the consent shall be renewed whenever new tests, different from those approved in the initial protocol, are carried out.
2.9. The head researcher, and his/her collaborators, in a human research project, must faithfully and exclusively follow the approved research protocol, most specifically with respect to all matters rela-ting to obtaining the informed consent of the subjects participating therein, and the confidentiality of the data, samples and results.
2. Royal Decree 561/1993 dated April 16, establishing
the Requirements for the Performance of Clinical Trials with Medicines.
Order dated October 26, 1992 concerning the accreditation the Clinical
Research Ethics Committees.
3. Decree 214/1997 dated July 30, regula-ting the use of ani-mals for experimen-tation
or other scien-tific purposes.
2.10. All research protocols involving the use of institutional com-puter files or the development of data bases containing personal information, shall guarantee the anonymity of all participants, and shall be subject to the existing regulations concerning the keeping of data bases 4 .
Concerning the responsibilities of the researcher/s
2.11. With respect to any application for a research grant, the individual responsible for the report shall be the person responsible for ascertaining the true availability of the resources committed thereto.
2.12. Any research protocol involving the use of healthcare equip-ment or facilities, pertaining or not to the institution, or any other of the institution’s common research equipment or facilities, shall require the approval of the head of the institution, facilities or equipment.
2.13. It is recommendable for the head researcher, alongside the other researchers, to draw up a plan of communication and publi-cation for any results that may emerge from their research work.
2.14. On preparing his/her personal Curriculum Vitae (CV), the author is responsible for the veracity of the content thereof. As proof of said veracity, the CV should be signed; in the case of a collective CV, the individual handling the application will be held responsible.
4. Organic Law 5/1992 dated October 29, regula-ting the computer processing of perso-nal information. Decree 29/1995, dated January 10, regulating Department of Health and Social Security computer files containing per-sonal information. Law 17/87 concer-ning Statistics and Law 12/89 concer-ning Public Functions.
2.15. It is recommendable to avoid grant applications for new research projects if there is a delay in the publication of the results of previously completed projects.
2.16. As the process of data collection in clinical research is com-plex, and not always repeatable, the head researcher and his /her collaborators shall pay special attention to reflect the quality and custody of data when drafting the research protocol.
2.17. The head researcher and his /her collaborators in research projects are not responsible for the clinical course of the disease of the participants, and thus are obliged not to interfere with any decision of the doctors in whose care the subjects of the study are placed. Concerning collaborative projects
2.18. When a single research project is scheduled to involve diffe-rent groups from the same or different centres, it is advisable to for-malize a protocol that covers the terms under which the different groups agree on their joint contribution
2.19. The agreement on joint contribution shall contain all the requirements covered by a research protocol, in addition to:
a) an unambiguous drafting of all matters relating to the research plan provided for within the framework of said joint contribution.
b) the criteria by which progress of the research will be updated between the various participating groups or centers.
c) the explicit distribution of the responsibilities, rights and obliga-tions of the groups and centers that participate, both with respect to the work to be carried out and the results obtained thereby, inclu-ding the determination of the custody and storage of the data or samples obtained,
d) a draft of the plan for the presentation and communication of the results,
e) the procedures for the storage and distribution of the data and samples, and for the safeguarding of identity and,
f) all other matters considered pertinent and all possible potential commercial implications, in addition to questions relating to finan-ce and conflict resolution 5 .
3. Documentation, storage, custody and sharing of the data, records and biological or chemical material resulting from the research work
3.1. All research protocols must include a specific plan for the collection of the data, records and biological or chemical samples resulting from the research, and for the custody and preservation thereof.
3.2. The head researcher and his/her collaborators are obliged to record each and every one of the details of the research experiments or observations.All information, of whatever kind, shall be indelibly written, and incorporated in the record or ad hoc data collection books defined. Thus any intermediate or final data shall be correspondingly recorded in the original documents, as would be the case with the medical records of a patient participating in clinical trials. All experiments and observations must include the number of peo-ple participating and explicit details regarding the time and cir-cumstances under which they were made. Neither error, negative or unexpected or discordant results should be omitted.Any corrections should be clear to follow and their author should be systematically identified.
5. As a guideline for a joint protocol, we recommend the “Guideline for agree-ments at the initiation of research projects” developed by the Danish Committee on Scientific Dishonesty – Guidelines for Good Scientific Practice published on http://www.forsk.dk /eng/uvvu/publ/gui delines98/kap3.htm
3.3. The head researcher shall make clear provision for the different media required for the proper custody and preservation of the dif-ferent documentation and biological or chemical material obtained from the experiments or observations. Likewise, a log shall be kept tracking the different record or ad hoc data collection books and the banks of chemical or biological material. All electronic primary data records shall be built around a protocol, establishing a specific data storage and backup plan to safeguard against incidents that may occur with the hardware, affecting the custody or access to the data.
3.4. All documentary data records, or samples in a biological or chemical material bank, obtained during the course of the research work, shall always be made available to all the members of the rese-arch team. All of the members of a research team have a mutually binding undertaking with respect to the providing of information on all of the results obtained, the processing and interpretation the-reof.
3.5. All the documentation (record books, data collection books, etc.) and biological or chemical material obtained during the cour-se of a research project is the property of the institution, where it shall be duly guarded, in line with the criteria of the head researcher for the project. If a collaborator from a research group changes institution and demands to take information obtained during the course of a research project with him/her, the head researcher may provide photocopies of part or all of the record books, copies of the electronic information available, photocopies of the data collection books, or aliquots of the biological or chemical material available. When such change concerns the head researcher of a project, copies of all of the documentation or samples of biological or chemical material shall be facilitated thereto, under the supervision of the management of the centre.
3.6. All primary, original information shall remain in store for a period of at least ten years after the first publication of the results, except for those cases in which the law requires longer periods of time. At all events, all biological or chemical material stored as the result of research work, shall not be destroyed any sooner than ten years after the first publication of the results, except for those cases in which the law requires longer periods of time. It may remain sto-red for longer periods of time and, whatever its fate, such shall always require the approval of the head researcher.
3.7. The use of the biological or chemical material or digital data resulting from a research work should be made available to the public and may be shared by other researchers, except in those cases in which restrictions are made with a view to future marketing pur-poses. The transfer requires that those who have made such request are qualified to make good use thereof, that the original researchers that generated the material are informed, that there is a transfer pro-tocol approved by the head researcher responsible for said material and, if applicable, that the applicant is prepared to cover the costs of production and dispatch. Such transfer may be limited for reasons of availability, competition or confidentiality (all material and data must remain anonymous or, if not, informed consent must again be obtained before any such transfer shall be possible).
4 Research projects sponsored by the healthcare industry or by any other profit-making institution
4.1. Regarding the research that is carried out in the public sector with sponsorship from private institutions, it is important to take into account the following considerations:
a) it is essential for industry to carry out certain research work at public institutions, most especially in the area of experimental or technological development,
b) research work sponsored by industry is necessary and recom-mendable, given that it fosters the transfer of technology and can provide important economic resources
c) in scientific relations with industry, all the constraints necessary shall be established to ensure that the principles and purpose of intellectual freedom are not compromised and,
d) with respect to the members of institutions that benefit from public money and credibility, the former have the obligation to develop scientific discoveries in accordance with the general inte-rests of the public.
4.2. Although the researchers may often require access to prior information of a confidential nature from the sponsoring organization, such access shall not in any way limit their ability to publish the new results obtained, unless such be subject to the restrictions specified below.
4.3. The researchers that participate in a research project promoted by a company are responsible for the design and planning of said research work (see section 4.4). The publication of the results of research work sponsored by industry constitutes an ethical impera-tive. Agreements may be made to permit the promoting organiza-tion to examine the manuscripts or discoveries, with a view to the commercial potential thereof as well as to formalize under the terms of the agreement established, the sharing of intellectual property rights.To such ends, the promoting organization may have exclusi-ve access to all of the results obtained up to 90 days in advance.
4.4. When the researchers exclusively participate in the data collec-tion stage of a previously protocol developed by another group or institution, the terms of the communication and publication of the results obtained shall be established under the terms of an agree-ment between the promoting organization and the researcher.
4.5. All agreements regarding financial, or any other form of recompense, directly or indirectly related to the research work, esta-blished between the sponsoring organization and the researcher or research group, shall be provided for in a single agreement between the promoter and the institution to which the researchers are ans-werable. All financial agreements established should be made availa-ble to all the committees, bodies and individuals whose areas of competence extend into such matters.
5.1. The publication of the results forms an integral, inescapable part of any kind of research work. It constitutes the only standardi-zed mechanism by which the results may be subject to peer scru-tiny. The non-publication of the results of a research work, or an unwarranted delay therein, shall be considered to constitute the misappropriation of the resources employed therein.
5.2. The publication of the results of a research work involving human beings is considered an ethical imperative.
5.3. The publication of negative results, or results other than those expected for the research project, is likewise an inescapable part of the research work undertaken.
5.4. Notwithstanding dissemination in scientific spheres (meetings or congresses and publications), is considered the final stage of a spe-cific research project. Publication represents the beginning of a pro-cess by which the scientific community is able to substantiate and correct the results obtained, and develop new conclusions with res-pect thereto.
5.5. Any reference to the work of third parties must sufficiently acknowledge the merit of others. The work included shall be directly pertinent to the research project in hand and any super-fluous or gratuitous references shall be avoided. 5.6. The acknowledgements made in a publication shall be rigorous and shall not include gratuitous or marginal mentions. Those ack-nowledged have the right to decline the mention of their name in the section and, to such ends, the authors shall, whenever possible, attempt to obtain written permission there from.The same is appli-cable to acknowledgements referenced as “personal communica-tion”.
5.7. In the final publication of the results, the following must be specifically stated:
a) the names of the institutions or centres to which the author/s belong and the names of the institutions or centres at which the research work was carried out;
b) the names of the independent ethics committees that have super-vised the research protocol and the explicit permits granted by the authorities for the research work to be carried out;
c) any financial aid that has been received, or any other form of sponsorship that either partially or totally has enabled the research work to be carried out, or the individual participation of any of the authors of the study.
It is also advisable to report such details in conference communica-tions or other kind of presentations previous to the final publica-tion, especially when human beings or experimental animals have been involved in the research and when financial aid has been recei-ved from companies with commercial interests.
5.8. There shall be no communication or dissemination of the results of the research work to the media prior to their publication in scientific journals. Prior or early dissemination or publication of the results may, as an exception, be justified in the interests of public health. In such cases, the author/s shall assess the possibility of the results being simultaneously, urgently reviewed in a scientific jour-nal, or shall agree as to the extent of such early communication with the editor/s of the journal in which the final version of the results is to be published.
5.9. Fragmentary publication of a single piece of research work shall be avoided. Such serialization shall only be justified in the case of a very extensive piece of work.
5.10. Redundant or dual publication is considered an unacceptable practice. Secondary publication shall only be justified under the terms established in the “Standards of the Vancouver Group”.
5.11. In those cases of individual or group assessment in which scientific publications are taken into account (for the purposes of promotion or any other form of compensation or recompense), the researchers of such institutions shall demand that such assessment always be made on the basis of the content of the scientific pro-duction, and never on the number.
6. Authorship of scientific work
6.1. To be considered an author, the individual does not have to pertain to any particular profession or specific hierarchical or other working position.
6.2. To be fully considered the author of a research work the indi-vidual shall:
a) have substantially contributed to the creative process, that is, the concept and design, or to the analysis and interpretation of the data,
b) have substantially contributed to the preparation of the resulting communications and publications and,
c) be capable of making a detailed presentation of his/her personal contribution to the research and of discussing the main aspects of the contribution of others.
6.3. All authors must give their written approval of the final draft of the manuscript to be published.
6.4. Mere participation in the obtaining of resources or data collec-tion, such as the supply of routine data or experimental subjects, shall be acknowledged in the “acknowledgements” section but shall not be considered in any way authorship.
6.5. If an individual associated to the group by way of his/her hie-rarchical, or any other position, demands the right to “ex officio” authorship, it shall be considered a breach of the principles of aca-demic freedom and justice. On the other hand, the omission of an individual who has contributed to the communications or publica-tions deriving from a research work constitutes the clear misappro-priation of intellectual property.
6.6. In the case of review articles, all of the authors shall have par-ticipated in the critical review of the literature cited.
6.7. All internal drafts, general reports, working reports, technical reports or any other document addressed to third parties, shall include the names of the author/s of the research work or investi-gation, in the same way as they would be included in a scientific publication.
6.8. With respect to the order in which the authors are listed, the general rule is as follows:
a) the first author is he/she who has made the greatest contribution to the research work and has made the first draft of the main arti-cle to be published;
b) the “senior” participant, that is, he/she who directs the work and/or who has ultimate responsibility for the research protocol shall be the last of the authors;
c) the remaining authors shall comprise all the other contributors and participants, often listed in order of importance and, at times, in alphabetical order;
d) the author responsible for correspondence shall be the person with the ultimate responsibility, both in the process of publication and in all future interactions deriving from the publication of such work.
6.9. When an author is unable to accept full responsibility for the entire content of a publication, he/she shall specifically identify his/her own contribution, unless such is already provided for by editorial standards.
6.10. The meaning of the order in which the authors of a work are listed may be explained, if applicable, by a footnote to the manuscript. To such ends, when more than one author has contributed equally to the work and to the preparation of the manuscript, all shall be considered principal authors and such shall be explicitly sta-ted in the final publication of the original piece. The above is like-wise applicable to senior authors.
7.1. The practice is considered to include any examination or cri-ticism entrusted to experts or peers, be it of a manuscript to be published, a report to support application for individual or collecti-ve grants, a clinical or experimental protocol to be submitted to an ethics committee, or a report to be made “in situ”.
7.2. All review shall be objective and based on scientific criteria, not on the opinion or ideas of individuals. Any review in which a con-flict of interests is involved must be rejected, e.g., when there is a direct link with the author/s, when there is a situation of close com-petition or when the reviewer is not considered to have sufficient expert knowledge.
7.3. The reports and other documents to be reviewed shall always be considered confidential, privileged information. Consequently any such documentation shall:
a) not be used to the benefit of the reviewer, until such time as the information is published,
b) not be shared with any other colleagues, other than for specific issues, unless explicitly permitted by the editor or agency and,
c) not be retained or copied unless those responsible for the process of publication, or the agency, have explicitly given permission so to do (normally, at the end of the process the material is either shred-ded or returned).
Committee for the integrity of scientific research
The Committee for the Integrity of Scientific Research (CISR) is a body constituted freely and voluntarily by the researchers of the IMIM, Hospital Del Mar and other health centres of the IMAS, the Department of Health and Experimental Sciences of the UPF and the Center for Genomic Regulation.Acts independently and at the complete service of the researchers and the scientific community with the unique interest of giving support to the quality of research and to contribute to its integrity.
Functions:
1. To supervise the general, constant, and complete fulfillment of guidelines of the code of Good Scientific Practice in our centres.
2. To act as an arbitration body for uncertainties or conflicts that may arise in relation to research integrity matters. Its decisions are binding for those researchers submitting their conflicts to the CISR.
3. To provide information and to continuously sensitize with regard to events, necessities and orientations related to ethical and deonto-logical aspects of biomedical research.The Committee has the compromise to request from the Governing Bodies of the centres, the resources and measures that will contribute to the development of this function.
4. To be receptive to new problems related to research integrity, to propose their discussion to our institutions and, consequently, to update the code of Good Scientific Practice as needed.
5. In relation to the functions mentioned above, the Committee will guarantee by all means its managerial diligence, independence of action, anonymity and confidentiality in the treatment of personal data, solvency of the information generated, impartiality in the delibe-ration process and equity of resolutions as well as possible allegations.
6. Communications to the CISR should be addressed to one of the following e-mail addresses: cir@imim.es or cir@grup.upf.es or cir@crg.es. It is also possible for those who are interested in con-tacting the CISR to approach any members of such committee in order to obtain information.
Composition of CISR
President: Dr. Norbert Bilbeny (professor of Political and Moral Philosophy at UB)
Secretary: Dr. Jaume Marrugat (researcher of IMIM, UAB)
Members:
Mrs. Aida Andrés (grant holder of the Dep. of CEXS, UPF)
Dr. Cristina Fillat (researcher of CGR)
Dr. Joaquim Gea (researcher of Hospital del Mar, UPF)
Dr. Anna Pérez Lezaun (technician, UPF)
Dr. Olga Pol (postdoctoral researcher of IMIM)
Dr. Jordi Sunyer (researcher of IMIM, UPF)
Dr. Miguel Valverde (researcher of Dep. of CEXS, UPF)
