Code of Good Research Practices (CBPI)

One of the priority objectives of the University of Valladolid is to carry out research work of the highest level in all fields of knowledge that can contribute, as a quality factor, to the progress of knowledge, to the improvement of the quality of life, to the preservation and improvement of the environment, to the disappearance of social and economic inequalities between individuals and between peoples, to the promotion of entrepreneurial activity, to the creation of employment, to technological development and, in general, to the progress of science and artistic creation, respecting equal opportunities between men and women. It should not be forgotten, however, that science, like any other human activity, must be subject to ethical principles, thanks to which it achieves its dignity as a specifically human action. These principles inspire the present Code of Good Practice in Research (CBPI).
The first of these principles is the recognition of the human being as a free and autonomous subject of research. This means that the interests of science must not take precedence over those of the human being, i.e., that science is at the service of society and not the other way around; also, that scientists and those who design scientific policies are obliged to morally justify their objectives and priorities.
The second is respect for the dignity of the human being, particularly when he or she is the object of experimentation. Whenever their health and rights are at stake, their consent must be obtained and freely given, after having been informed of the risks and possible consequences of the misuse or wrong use of science on their person.
The third is the assumption of responsibilities in the exercise of scientific activity. The scientist is responsible for respecting human rights, which are always inviolable. He is also responsible for respecting living organisms and the environment; he must avoid unnecessary suffering of the former and ensure the integrity and proper functioning of the Earth system. The present generations are responsible to future generations for the world we will leave behind, hence scientists must especially encourage ethical reflection so that the extraordinary possibilities derived from scientific research contribute to the improvement of living conditions in the future, and not to their deterioration.
The fourth principle is the recognition that research that threatens the health or dignity of human beings, such as those that justify racism or gender inequality, the denial of the Holocaust or the apology of terrorism, among others, should not be promoted in any field. Although the scientist and the University of Valladolid are not directly responsible for the use that could be made of the knowledge they contribute to the common heritage, they will avoid getting involved in projects and in the dissemination of information when it is suspected that they may have a high probability of being used for inappropriate purposes.
The fifth is to accept that research must be transparent. Scientists must always be willing to give an account of their work, since they recognize, on the one hand, the importance of the opinion of their peers for the assessment of their discoveries and, on the other, the social impact of scientific activity.
The sixth, in any case, must guarantee the relevance of the research taking into account the available knowledge.
This Code of Good Practice of the University of Valladolid is applicable to all members of the university community who carry out or collaborate in research work within the University, regardless of the discipline, area, center, etc. in which the research is framed.
Good Research Practices (GPR) are, essentially, an attitude towards research and constitute the path through which the approach and proposal of the research, the way in which it is carried out, the way in which the results are obtained, preserved and disseminated should flow. The BPI allow the verification of the quality and integrity of the research and are the basis for resolving conflicts or complaints of malpractice, fraud or inappropriate or dishonest conduct and promote the conduct of quality research.

The Code of Good Practices in Research is the document that establishes the guidelines for the conduct of research activities.
Its objectives are:

• Improve the quality of research in all fields.
• Establish mechanisms to ensure honesty, accountability, traceability and rigor in research.
• Provide formal training on Good Research Practices to research personnel in training.
• Acquire good scientific practices in the training stage of the researchers.

The University of Valladolid cannot, and should not, impose the approaches, methods or approaches that each researcher uses in his or her research work, but expects all researchers to observe and follow the following general principles.

Honesty

Researchers should be honest in their research activities, as well as in relation to the activities of other researchers. This applies to the entire research work, including the initial formulation of hypotheses, the methodological design to be carried out, the analysis of data, the publication of results, the acknowledgment of the contribution of other researchers, and the review and evaluation activities carried out under personal commission. Researchers should not infringe intellectual property rights, practice plagiarism, or manipulate the results.

Responsibility

Researchers must ensure that the research is carried out in accordance with the terms and conditions defined by the funding entity and/or agreed between the University of Valladolid and the funding agencies. This includes the need to ensure:
a)    That the research is carried out as stipulated in the original proposal document submitted to the funding entity, unless amendments to the original proposal have been subsequently negotiated and agreed upon.
b)    That the funding is used only for its intended purpose, except where authorization has been obtained from the funding entity for alternative uses.
c)     That the reports are submitted on time and accurately reflect the work performed.
d)     That the conditions relating to publication, authorship and intellectual property are complied with.

Rigor

Research, in any field of knowledge, aims to obtain data, ideas, certainties, etc. that facilitate the answers to the scientific questions that are formulated. For this reason, research must be carried out following well-designed work protocols that, if necessary, can be examined and understood by any researcher in the field. Experiments, data collection and observations must be carefully designed with rigor and intelligence, with the purpose of making the best use of the available resources and taking into account the work standards existing in the field at any given time. This is required to a greater extent when the object of the research is human beings or their data, laboratory animals, or when human or environmental safety may be at stake.

Conflicts of interest

Researchers must avoid conflicts of interest that may compromise the validity of the results of their research. The Research Committee will establish a declaration of interest form that must accompany the application for all research projects.

The complexity of current scientific research almost always requires teamwork and the use of common methodologies, human resources and infrastructures organized through research projects or programs.
The researcher who intends to lead a group must therefore assume the responsibilities that this leadership entails, both scientifically and in terms of organization and management. Ideally, these responsibilities and the composition of the research group are clearly established in the funding documents or allocation of resources to the project or programs that define it and must be strictly respected, except in cases of force majeure, throughout its life.
All members of a team, each in his or her assigned role, must abide by this commitment, renouncing initiatives that could jeopardize the proper development of the project.
In no case should the research work of possible competing groups be hindered, delaying the transmission of scientific results or avoiding their dissemination in seminars or scientific discussions. The researcher should always be open to criticism, doubts and comments expressed by other teams and colleagues.
The group leader should promote cooperation and exchange with other research groups or teams, both from the University of Valladolid and from other Spanish and foreign entities with the aim of favoring the exchange and contrast of ideas among the different researchers.
The leader of a research group will have the obligation to keep the whole team updated on the development of the project, giving the collaborators all the necessary information to carry out their work.

All research work must be formulated in a written document, called a research protocol. The text of the document may coincide with the report required to apply for funding of a research project through a public call for proposals.
The research protocol must include at least the following information: background information, specific objectives, methodology to be used and the team involved. The document should also contain a work plan with a timetable for each phase of the research, indicating the human and material resources to be used in each phase. Depending on the type of study, the ethical and legal aspects and the risk assessment should also be included. If the research directly involves human subjects, material of human origin or experimental animals, the document will be submitted for prior evaluation by the corresponding committee.

The training of young researchers should not be limited to the learning necessary to carry out their research work, but should include knowledge of good scientific practices, teamwork and coexistence within the research group, the Center and the Institution. Students and personnel in the training process must be adequately supervised to guarantee the quality of the results they generate.
Any person who joins the University of Valladolid by means of a contract or scholarship, with the purpose of acquiring some type of training, must have one or more directors or supervisors assigned to him/her, who must accept this assignment in writing.                                                                                      The duties of directors or supervisors include, among others:
a)    Perform their work in a way that sets an example for the researcher-in-training to follow.
b)    Provide the trainee researcher with the means and the appropriate scientific environment, taking into account his or her training needs and avoiding undue pressures.
c)    Inform you about safety and occupational risk prevention regulations, urging you to comply with them.
d)    Instill compliance with the Code of Best Practices.
Scientific.
e)    To foster a critical spirit in young researchers when evaluating their own work as well as the work done by others.
f)     Introduce you to discussion forums and scientific meetings and advise you for your future.
g)    Recognize the work of the researcher in training and be rigorous and fair in the authorship of publications.
h)    Agree with the researcher in training and the research group, the participation of the former in research projects, stays abroad, courses, etc.
i)     To be scrupulous with the tasks entrusted, so that they are exclusively related to his condition as a researcher in training.
j)     Provide good training in Good Clinical Practices and Good Laboratory Practices as a guarantee of the reliability and traceability of research processes.
The duties of trainees include, but are not limited to:
k)    To be fully integrated in the project assigned for their training.
l)     Follow the supervisor's advice and recommendations and inform him/her of your possible initiatives and the progress of your results. If you encounter difficulties in the performance of your work, you should report them as soon as possible.
m)   Be informed and follow the safety standards and procedures, as well as the Code of Good Scientific Practice.
n)    Participate in scientific activities, discussion forums, seminars, etc. related to the development of their work.
o)    Acknowledge the contribution of your supervisor in the oral or written dissemination of your results.
p)    Respect and value the necessary management, administration and tasks related to the research activity.
q)    Make good use of the material means and facilities that the University of Valladolid makes available.
r)    Report abusive or inappropriate entrustment by their supervisors.

In scientific research, data from experiments and observations and the materials used are the basis for results and publications. For this reason it is necessary, in case of doubt, to be able to reconstruct the experiments and to understand the basis for their interpretation. This implies that the experimental protocols and original data will have to be kept by the researcher, the research group and the Institution, for a certain period of time, which may depend on the disciplines, but cannot be less than five years.
The materials must also be retained or their origin clearly documented, bearing in mind that the ownership of the data always belongs to the Institution where the work has been carried out.
The Institution must provide the researchers and personnel in training with sufficient means and adequate supports to store the data obtained, in order to allow any expert in the field to understand and reproduce them.
All methodologies used in research protocols or projects must come from sources that ensure their reliability (reference methods, scientific publications, standards, etc.). In case the research itself involves the use of a new methodology, the process of fine-tuning and validation of the new methodology will be part of the research protocol and the investigators will have to have evidence to demonstrate its reliability.
All procedures and methods used in a research protocol should be adequately referenced and/or documented so that the process can be reviewed as accurately as possible at a later date.

All facilities should be suitable for carrying out the planned research activities, both from the point of view of the safety of the people working there and the quality of the results obtained.
When equipment is used to carry out research activities, investigators should ensure that it is suitable for the activities to be carried out and that the personnel who are to use it have adequate instructions to ensure its correct use. Instructions should be available in the form of properly documented procedures.
Any equipment used in research activities should be subject to preventive maintenance to avoid malfunctioning that could alter the results obtained. Likewise, researchers must guarantee, at all times, the reliability of the measurements provided by the equipment.
All the facilities and equipment acquired during the activities carried out by researchers belonging to the University of Valladolid will be the property of the latter, which may cede them in usufruct to them, under the conditions indicated in the corresponding agreement. Likewise, the institution may interrupt or modify this agreement when new circumstances and/or needs arise.

In order to have the full status of author of a published work it will be necessary:
a)    Have contributed substantially to the conception and design or analysis and interpretation of the data.
b)    To have contributed to the preparation of the resulting document.
c)    Be able to present in detail the personal contribution to the research and discuss the main aspects of the whole.
Any person who has contributed to the work in any other way should be acknowledged in the acknowledgements section.
The status of author does not depend on belonging to a particular profession or hierarchical position or on the nature of the employment relationship.
The person linked to the research group and who, because of his hierarchical position or employment relationship, requests to be listed as an author ex officio, violates academic freedom and the principles of justice. Conversely, the exclusion as author in the communications or publications of a research project of someone who has participated in the realization of the same is a misappropriation of the intellectual authorship.
All researchers must state in the published works, communications presented or any other format of dissemination of the results of the research carried out, their belonging to the University of Valladolid, in the manner established by the University. In the case of researchers attached to other research structures (Institutes, Technological Centers, etc.), their affiliation to the University of Valladolid must also be clearly identified.
All published works should explicitly include the independent ethical committees that have supervised the research protocol, as well as details of the grants, aids, sponsorships received, both from public and private sources. If research support services of the University of Valladolid have been used, this circumstance should also be adequately reflected, also indicating the service used.
The reference to the work of third parties must be sufficiently acknowledging their merit. Reference to work directly related to research should be included and unjustified references should be avoided.
Researchers should be aware of the University of Valladolid's policy regarding the protection of intellectual property and the promotion of the valorization and commercialization of research results.
Publication of results is an integral and unavoidable part of any research, since it is the only standardized means by which the results are subject to the scrutiny of scientific personnel with peer knowledge. Failure to publish the results of a research study or the exaggerated delay of such a study is considered a misappropriation of the resources employed.
A free society needs to have a high level of knowledge and to have and handle different objective elements for decision making, therefore the scientists of the University of Valladolid must:
a)    Disseminate and communicate to society the results of its research to contribute to the cultural advancement of the general public and the dissemination of knowledge, and to justify to society the resources it devotes to research and the dissemination of knowledge, and to justify to society the resources devoted to research.
b)    Make an effort to provide the non-specialized audience with an adequate level of knowledge, and avoid presenting premature, speculative and insufficiently contrasted results to the media.
c)    Dissemination involves using the same criteria that are required for the rest of the dissemination activities, such as truthfulness and sufficient scientific evidence.

The industrial and intellectual property of the results obtained through the research work of its members is vested in the University of Valladolid.
The University of Valladolid must encourage and promote an adequate management of the ownership of the results obtained through the research work of its members, establishing and disseminating an intellectual and industrial property policy that allows its effective evaluation, protection, valorization and commercialization. Likewise, it will adopt measures aimed at increasing the awareness and training of the research personnel in relation to intellectual and industrial property and its exploitation.
The research personnel who are going to execute and develop a collaborative research project, or under contract, must, in the course of negotiations, safeguard all pre-existing information and knowledge owned by the University of Valladolid. The appropriate contractual documents will be signed in which the different interests, tasks or contributions of the parties will be adequately reflected. Likewise, the obligation of secrecy and confidentiality assumed by the intervening parties, the assignment of ownership of the results generated within the framework of the project, contemplating the possibility of their adequate and effective legal protection and the conditions of their exploitation will be stipulated.
If the results obtained in a research project are susceptible to protection due to their potential commercial interest, they should not be disclosed as long as the Institution proceeds to their evaluation. Possible delays in disclosure, when industrial property protection is sought, should be kept to a minimum.

Researchers must be aware of the safety, occupational health and environmental protection measures that must be taken into account when carrying out research activities.
The University of Valladolid will ensure that the development of research is carried out guaranteeing the safety and health of the personnel involved and respect for the environment.
The research groups must guarantee that their activities are carried out within the framework of the occupational risk prevention and environmental protection policies of the University of Valladolid. Toxic and hazardous waste of all kinds will be handled appropriately, in accordance with the safety standards and protocols established by the University of Valladolid.
All research personnel of the University of Valladolid have the right to information and effective protection in terms of health and safety at work.
It shall be the duty of all research personnel of the University of Valladolid to know the safety rules of their center and to make appropriate use of the resources, means, facilities and services that the University of Valladolid makes available to them.Researchers must be familiar with and comply with the recommendations of the European Charter for Researchers. Code of Conduct for the Recruitment of Researchers.

Researchers who carry out research activities involving human subjects or who use biological samples of human origin must be especially rigorous in complying with the corresponding regulations. For all research projects involving human subjects or using biological samples of human origin, a favorable report from the Research Ethics Committee must be requested and obtained beforehand.
Researchers will have to request and obtain the express consent of the persons they wish to include in a research project -or of their supervisors or representatives, if that is the case- or who give biological samples, stating the information on the purpose and duration of the project, the expected benefits (either for the subject or for others), the foreseen risks or discomfort, the criteria for exclusion or inclusion in the project, and the methodology and criteria for completion of the project.
Researchers must make an explicit commitment to maintain due confidentiality about everything that may be known about the persons participating in a project, in accordance with the provisions of the regulations on personal data protection. In general, the anonymity of the participants must be guaranteed, both during the execution of the project and during the recording and conservation of the data obtained.
The investigators should make an explicit commitment not to transfer data or biological samples to other projects or other investigators without the authorization of the transferors or the corresponding Research Ethics Committee.
The investigators should specify, if applicable, the financial compensation to be received by the subjects participating in the project.
In the event that a project foresees the participation of students, it should be guaranteed that they will be included freely and measures should be taken to avoid adverse consequences for those who decline to take part or decide to withdraw.

All research activities carried out with experimental animals must be carried out in accordance with current legislation.
The personnel involved in research activities with animals for experimental and other scientific purposes will have to have the corresponding accreditation as researcher or experimenter, as the case may be. Likewise, researchers must request and obtain the authorization of the Ethical Committee on Animal Experimentation and Welfare (CEEBA) for each of the experimental procedures in which animals are used for experimentation and other scientific purposes. The CEEBA will provide the information and assistance necessary for researchers to comply with current legislation.
Research activities using animals for experimental and other scientific purposes should be governed, whenever possible, by the three concepts of replacement, reduction and refinement.

Material and economic resources must be used effectively and efficiently, administered correctly and responsibly, in such a way that they allow or facilitate the achievement of the planned objectives, avoiding their use for particular purposes and ensuring their conservation.

The researcher has the commitment to meet the demands of collaboration or knowledge raised explicitly to the Institution by both public and private entities.
The type of collaborations mentioned in the previous paragraph must be supervised and subscribed by the Institution by means of a contractual document: agreement, contract, etc. that in no case will contravene the regulations of the University of Valladolid. The clauses of the contractual document must stipulate all the obligations and rights that make it possible to reconcile the interests of all the intervening agents. All the agreements adopted between the entity requesting the work and those responsible for the execution of the research must be included in the contractual document.
The researchers involved in this type of collaboration will avoid possible conflicts of interest, both when negotiating the terms of the contract and when publishing, protecting or exploiting the results obtained.
When the institution provides means and facilities for the promotion and creation of Technology-Based Companies (TBC) as a result of the research work of a University group, care must be taken to avoid abuses in favor of the private interests of any of the participants in the TBC.

Science as a quest for knowledge is, as a matter of principle, the enemy of fraud. However, there is the possibility of deviations in the activity of researchers, who seek fame or undeserved merit, or even in some cases, personal or institutional economic benefits. These types of deviations constitute the greatest threat to the proper development of scientific practice and are the ultimate responsibility of the scientist who practices them. These can be, among others:
a)    Abusive interpretation of data.
b)    Falsification of data or evidence to fit the initial hypothesis.
c)    Fabulation of data and discoveries.
d)    Plagiarism of other people's work.
e)    Commercialization of pseudoscientific services.
The mechanisms to combat them effectively include, among others:
a)    The obligation of researchers to submit any new contribution to criticism through peer review, and the possibility of contrasting the results independently by other researchers.
b)   The commitment of the scientific community, both national and international, to denounce and combat fraud.
c)    Coordination of all agents, both national and international, involved in scientific research, fraud surveillance and systematic prosecution.
d)   Monitoring of unauthorized marketing activities.

Compliance with this Code will be monitored by the Research Ethics Committee (REC), which will be appointed by the Governing Council at the proposal of the Research Commission.
The Research Ethics Committee will act in the service of the research and researchers of the University of Valladolid with the aim of supporting the quality of research and contributing to maintain its integrity.

Functions

The IRB will ensure that the criteria and principles established in the CBPI are complied with at the University of Valladolid, and will also ensure that researchers do not suffer harassment at work by monitoring compliance with the criteria established in the Protocol for the Prevention and Inhibition of Harassment in the Workplace, which, as established in point II.1, covers, in addition to the PDI and PAS, the group of scholarship holders, personnel in training and personnel contracted for research projects.
It will act as an arbitration body in conflicts that may arise in relation to the integrity of research. The decisions of the IRB will be binding for those conflicts that are submitted to its arbitration.
The IRB shall remain alert to new issues that may arise in relation to research integrity and shall accordingly propose to update, if necessary, the CBPI.
The REC will at all times guarantee diligence in its management, independence in its actions, anonymity and confidentiality in the treatment of personal data, the solvency of the information generated, impartiality in its deliberations, the fairness of its decisions and the possibility of appealing them.

Composition of the IRB

The composition of the IRB shall be established by the Governing Council upon proposal of the Research Committee.

Allegations, claims or complaints for non-compliance with the Code of Good Practices in Research may be submitted to any of the registries of the University of Valladolid, including the registry of the University Community Ombudsman, addressed to the Vice Rector responsible for research or to the Community Ombudsman, who will process them in a timely manner.

Laws, regulations and documentation:
1)    Law 14/2007, of July 3, 2007, on biomedical research.
2)    On this page of the Spanish Bioethics Committee you will find many links to legislation related to this topic.
3)    Recommendations of the Spanish Bioethics Committee on the implementation of good scientific practices in Spain.
4)   Network of Ethics Committees of Universities and Public Research Bodies
5)   ROYAL DECREE 1201/2005 of October 10, 2005, on the protection of animals used for experimental and other scientific purposes.
6)   ROYAL DECREE 223/2004, of February 6, 2004, regulating clinical trials with drugs.