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Guideline and Regulations

... to ensure good scientific practice

Preface

The following guidelines are based on the guidelines of the German Rheumatism Research Centre Berlin, a Leibniz Institute (hereinafter DRFZ) Berlin of 2010 and have been updated in 2018. They are in accordance with the recommendations of the Leibniz Association for ensuring good scientific practice and dealing with allegations of scientific misconduct of 29.11.2018

The guidelines apply to all persons working in the premises of the DRFZ, i.e. for employees as well as for “Hospitierende” (see below for explanation of this term).

“Hospitierende”/ “Hospitant” is a term used to define those who are not employed by the DRFZ, but who work in the laboratories there, such as liaison group members, master’s students and guest scientists.

The guidelines at the DRFZ:

Good Scientific Practice Rules

General information
All scientists are obliged to comply with the rules of good scientific practice. These rules are an integral part of the training of young scientists, and are the responsibility of the group leader in charge of the research project. They must ensure that all tasks such as leadership, supervision, conflict resolution and quality assurance are clearly assigned and that they are actually carried out.

  1. Good scientific practice rules include:
    a) To work lege artis.
    b) To fully document all steps and results of an experiment or study, as well as to keep records and primary data safe. Experimental protocols shall record the aim of the experiment, the experimental conditions, the conduct of the experiment and the result of the experiment in a comprehensible manner and in a form that cannot be changed afterwards.
    c) Critically and consistently review the validity and reproducibility of all results from experiments and other research designs.
    d) Honesty in the delimitation of the contributions of all participants and transparency in the disclosure of third-party funding sources.
    e)  To respect the intellectual authorship of others in all publications and to duly identify all citations and quotations.
    f) To pay particular attention to the training and promotion of young researchers, to ensure adequate supervision of researchers in the preparation and academic evaluation of academic theses to hold regular meetings and to monitor progress of work.
    g) Ensure responsible co-operation and responsible leadership in working groups, including adequate supervision of their members.
    h) To ensure the responsibility of the authors of scientific publications for their content, including the presentation of the results and their discussion as a whole as well as the explicit identification and justification of cases in which the responsibility extends only to a part of the publication.
    i) To give priority to originality and quality as performance and evaluation criteria for examinations, awards, promotions, recruitments, appointments and allocations, always over the criterion of quantity.
  2. Scientific publications should describe scientific results and their occurrence completely and comprehensibly. Previously published results and texts can only be a part of later publications (double publication) if they are necessary for understanding the context of the publication and if reference is made to its first publication.
  3. Authors of original scientific publications may only be named as such if they contributed significantly to the conception of the studies or experiments, to the preparation, analysis and interpretation of the data and to the formulation of the manuscript itself and to have agreed to its publication, i.e. to take responsibility for them. Authors of a scientific publication share responsibility for their content. Exceptions should be indicated. All researchers who have made significant contributions to the idea, planning, implementation or analysis of research work should be mentioned as co-authors. People with small contributions are mentioned in the acknowledgements. A so-called honorary authorship is excluded. These arrangements should be the subject of a cooperation agreement, for example for large collaborative research projects.
  4. Group leaders must ensure that original data is retained as the basis for publications on durable and secure media for at least 10 years. Further storage obligations due to legal regulations as well as measures for the protection of personal data remain unaffected
Scientific misconduct

General information
In order to fulfil its responsibility in research and the tasks directly associated with it in the promotion of young researchers, the DRFZ must take legal measures to deal with cases of scientific misconduct so that it can meet its expectations and also so that tax and private benefits are not misappropriated.
Scientific misconduct is considered to be if, in scientific work, deliberate or grossly negligent misstatements are made, intellectual property of others is violated, or their research activities are sabotaged. In particular, misconduct is considered:

  1.  Misrepresentation (false information) – in particular:
    a) inventing data;
    b) falsifying of data, for example by selecting and rejecting unwanted results without disclosing it;
    c) by manipulating a figure or illustration;
    d) incorrect information in a letter of application, in publication lists or a request for funding (including misrepresentation of the publication source and publications in print);
    e) duplication of data or texts without disclosing them.
  2. Infringement of intellectual property – in particular
    a) In relation to a copyrighted work created by another or essential scientific knowledge, hypotheses, teachings or research approaches originating from another:
    – unauthorized use under presumption of authorship (plagiarism);
    – the exploitation of research approaches and ideas, in particular as a reviewer or member of an evaluation process (theft of ideas);
    – the presumption or unfounded acceptance of scientific authorship or co-authorship, as well as the refusal of such;
    – the corruption of the content;
    – the arbitrary delay in the publication of a scientific paper, in particular as a publisher or expert; or
    – unauthorized publication and disclosure to third parties, as long as the work, cognition, hypothesis, teaching or research approach has not yet been published.
    b) The use of (co-) authorship of persons without their consent.
  3. Sabotage of the research activities of others (including damaging, destroying or manipulating experimental setups, equipment, documentation, hardware, software, chemicals, cell and microorganism cultures or other items that others may need to conduct an experiment).
  4. The elimination of original data as a breach of legal or disciplinary principles of scientific work. This also applies to illegal non-removal (in particular personal) data.
  5. The gross neglect of scientific leadership responsibility and duty to supervise by group leaders or institute leaders in a manner conducive to violations of good scientific practice is scientific misconduct.
  6. Co-authoring by accepting the participation in a forgery-related publication is scientific misconduct.
  7. The deliberate pretense of the implementation or use of measures and procedures for quality assurance (such as peer review) is scientific misconduct.
Ombudsperson and guidelines to investigate allegations of scientific misconduct
  1. The scientific director of the DRFZ appoints an Ombudsperson as the contact person in case of disagreements, suspicions and disputes. The Ombudsperson must not have any personnel responsibility or employment relationship with the DRFZ. As a confidant, he or she advises those who informed them about a suspected scientific misconduct and checks the plausibility of the allegations. The term of office of the Ombudsperson is three years, with re-election being possible after this time. The Ombudsperson is obliged to report to the Scientific Board. They are not bound by instructions.
  2. If the ombudsperson receives evidence of scientific misconduct, they will examine the facts at their own discretion. If they come to the conclusion that there are sufficient grounds for suspecting scientific misconduct, the matter will be submitted without delay to a committee specially convened for this purpose.
  3. The commission for the investigation of allegations of scientific misconduct is formed from the members of the Board of Trustees, the Scientific Advisory Board and the researchers. Its members are: one member of the Board of Trustees, one member of the Scientific Advisory Board and one scientists of the DRFZ. The Scientific Director and the Ombudsperson are guests with an advisory role. The Commission also acts when evidence of scientific misconduct is addressed directly to it.
  4. The Commission shall clarify the situation in accordance with its possibilities and report to the Board of Trustees. The procedure shall be determined at its discretion. The legal hearing of those affected must be upheld. They can demand – as well as the informants with counter-statements – to be heard personally. The file inspection right of the parties is governed by the legal provisions
  5. If the Commission decides that a further examination of the allegations is necessary, the case shall be forwarded within 4 weeks to the central Ombudsperson of the Leibniz Association.
Guidelines for cooperation with industry and corruption prevention at the German Rheumatism Research Centre Berlin (DRFZ), a Leibniz Institute

They guidelines mainly relate to the following areas:
• ordering of laboratory materials and commissioning of third-party services,
• acceptance of gifts and promotional items,
• provision of advisory services by DRFZ employees / “Hospitierende”
• implementation of joint experimental and clinical research projects,
• attendance and travel to congresses at the invitation of third parties,
• lecturing.

“Hospitierende”/ “Hospitant” is a term used to define those who are not employed by the DRFZ, but who work in the laboratories there, such as liaison group members, master’s students and guest scientists.

As a uniform code of conduct recognized by medical universities, scientific societies, associations of health insurances and the research industry, the “Code of Medical Products is the basis of the DRFZ guidelines. It applies, unless otherwise stated below.

The basic principles are:

1. Separation principle
The separation principle requires a clear separation between benefits and any sales transactions. According to the separation principle, benefits may not be made to employees / temporary staff on the basis of sales transactions. In particular, they must not be granted in order to unduly influence procurement decisions. This principle is especially important for persons who make purchasing decisions or influence procurement decisions.
The principle of separation implements the criminal law postulate that benefits to employees / “Hospitierende”, directly or indirectly, to influence procurement decisions, are inadmissible. When procuring and placing orders, the price and quality principle applies. Companies in which employees / “Hospitierende” of the DRFZ are involved may not be preferred. Donations to the DRFZ must be unrelated to procurement measures and billing. Research collaborations must generally be viewed in terms of the charitable status of the institute and must be approved by the Board of Directors prior to commencement of cooperation.

2. Transparency / approval principle
The Transparency Principle requires the disclosure to the DRFZ of benefits that favour or may benefit DRFZ employees or “Hospitierende”.
2.1. Secondary activities
Secondary employment of full time employees / “Hospitierende” requires the written consent of at least one member of the board.
2.1.1. Secondary employment without relation to the DRFZ
If the employees / “Hospitierende” act outside of the DRFZ’s activity as regulated by the employment contract or by the internship contract, any form of cooperation and donation requires the approval of a member of the board.
2.1.2. Secondary employment with relation to the DRFZ.
If the employees / “Hospitierende” act in relation to their activities at the DRFZ, then there is a contractual relationship between the company and the DRFZ. Services and consideration of industrial cooperation must be in reasonable proportion to each other. This refers above all to the amount of remuneration for paid lectures, travel or consultations. Lecturing and consulting activities are subject to approval by the directors and a member of the executive board. The informal secondary employment application must state the time and financial extent of the secondary employment. Time compensation in favour of the DRFZ (vacation, overtime) is to be made for activities during the period of employment. The sum of the annual allowances may not exceed a maximum volume of 15% of the annual gross income of the employee / “Hospitierende”. Donations may under no circumstances serve any private interests.
Travel sponsorship and fees are to be displayed in the business travel applications.
Strict compliance with the approval principle ensures compliance with official regulations, on the one hand, and avoids criminal prosecution for taking advantage of benefits and granting benefits (§§ 331, 333 StGB) on the other. In addition, the actual and legal preliminary examination of a transaction by the authorizing body can considerably reduce the possible impression that an advantage is directed to a non-committal official act in the sense of bribery offenses (§§ 332, 334 StGB).

3. Documentation principle
The documentation principle requires that all paid or unpaid (starting from a value of 10 €) services of the industry to employees / “Hospitierende” of the DRFZ be reported to their superiors in writing so that the nature and extent of the cooperation can be understood at any time. Adherence to this principle makes it possible to understand cooperative relationships between DRFZ employees / “Hospitierende” based on a complete documentation of the underlying contractual relationships and the services provided. The documents must be kept in compliance with the civil and commercial law deadlines and with regard to the criminal limitation periods.

4. Equivalence principle
The acceptance of gifts and advertising material worth more than 10, – € is to be approved by the superiors.

All group leaders have the task to inform the members of their working groups.

Regulations for the preparation of a thesis at the German Rheumatism Research Centre Berlin (DRFZ), a Leibniz Institute

The training of students and the preparation of a thesis at the DRFZ is under the responsibility and official direction of persons who have a right to examine at the corresponding faculties of the universities of these students. In addition to the training guidelines of the DRFZ, the respective valid examination regulations of the universities and the guidelines of the graduate schools apply. In the case of scientific examination papers, the DRFZ must be provided with proof of enrolment at a university at the beginning of the examination work.

Registration of a doctoral or master thesis

§1 “Einstellungslaufzettel” or Docket
Students who want to carry out a master’s or doctoral thesis at the DRFZ will be introduced to Scientific Director’s Secretary by the person responsible for the project. After electronic registration, they will receive a docket called a “laufzettel” (see attachment 1), with which they can introduce themselves to the listed infrastructure managers of the DRFZ. The information about the regulations of the DRFZ is acknowledged by the responsible persons on this orientation exercise sheet.

§2 Training
Group leaders should ensure that students receive the instructions to familiarize themselves with the techniques needed for the project. A list of those responsible for the various technologies will be provided by the lab managers upon registration. When using devices, the instructions of the responsible person must be followed. For example cytometry: it is necessary to visit the cytometry course of the FCCF Central Laboratory. Here students receive a theoretical introduction to cytometry, followed by a practical introduction to the devices to be used from experienced personnel. The group leaders then confirm the practical instructions with their signature. Only then will a FACS user account be set up. This account expires annually, but can be extended. If the devices are handled improperly, the first course of action is a verbal warning. In case of repeated improper handling, the group leader and the student will be warned. In case of further violation, the user account will be blocked. Publications produced with the support of the FCCF Central Laboratory, or other research infrastructures, or within the Science Chronic Inflammation Science Campus must be acknowledged.
In order to give the employees of animal husbandry a good overview of the persons who perform experiments with mice, the students are introduced to animal husbandry.

§3 Scientific support
The students of the programme areas 1 and 3 are obligated to register with the responsible persons of the scientific clubs and to present their projects there repeatedly. Participation in the weekly literature seminar and at a scientific club, which is determined in consultation with the supervisors of the respective working groups, is compulsory, as is the participation in the weekly institute seminars. Doctoral students in the epidemiology program are required to attend the doctoral seminars and the weekly seminar of the programme area. In addition, graduate school students have to attend the events of these graduate schools.

§4 Help for international students
For international students, the DRFZ Welcome Center offers support in the handling of formalities and administrative procedures.

§5 Animal experiments
Before taking up animal experiments, approval must be granted by the competent authority (State Office for Health and Social Affairs). The application is the responsibility of the group leader. Doctoral candidates must provide evidence of expertise and abilities according to § 7 of the German Animal Welfare Act (TierSchG) and the German Animal Welfare Test Ordinance (TierSchVersV), Appendix 1, Section 3. If there is no proof, it is possible to acquire the expertise in the MPIIB / DRFZ Mouse Course, which takes place twice a year.

§6 “Hospitierende”
Students who are not employed at the DRFZ, e.g. Scholarship holders or employees of the Charité, have to conclude a guest student contract with the DRFZ and are called “Hospitierende”. The “Hospitierende”contract regulates the connection of students to a working group, accident insurance on the way to work and in the DRFZ building, access to resources of the DRFZ and access to the DRFZ itself. The magnetic card issued is personal and must not be disclosed to third parties. The card must be returned at the end of the project or employment relationship.

§7 Equal Opportunity Officer and Ombudsperson
The students are referred by the group leaders to the Equal Opportunity Officer and the Ombudsperson.

§8 Medical examination by the company doctors
Before handling human material, proof of a successful hepatitis vaccine must be provided. If necessary, it can be administered by the company doctors. Regular examinations are to be carried out at the prescribed intervals.

Implementation of a thesis

§9 Duration
The DRFZ aims to prepare a scientific or epidemiological doctoral thesis over a period of three years.

§10 Good scientific practice rules
Students as well as group leaders commit themselves to observing the rules of good scientific practice of the DRFZ (www.drfz.de) with their signature. In the case of violations, the management of the institute and / or the ombudsperson will immediately initiate the necessary measures.

§11 Safety instructions
Participation in the annual announced safety instructions (genetic engineering, occupational safety and, if necessary, radiation protection) is compulsory.

§12 Record keeping
Students commit to the proper protocol of record keeping. Paginate logbooks (laboratory books) are issued by the Scientific Director’s Secretary and are at the end of the employment or “Hospitant” contract to be returned there as they remain the property of the DRFZ. The experiments are dated and traceable. In the corresponding experiments, the provisions of the law to record all experiments (GenTAufz) and the statutory regulations for logging animal experiments are applied. Animals used in experiments are assigned to the respective permits.

§13 Pregnancy and parental leave
Female students should inform their supervisors and the HR department as soon as possible about a known pregnancy so that legal regulations can be taken into account. In the case of fixed-term employment contracts, the duration may be interrupted on application for pregnancy, maternity and parental leave, and the contracts will automatically be extended by these times. If necessary, the institute directors, group leader or the personnel office inform students about the possibilities for reconciling work and family life at the DRFZ.

§14 Conflict resolution and Ombudsperson
In the case of conflicts between students, or between students and their group leaders, a mediation meeting is first called for to try and resolve the conflict between the parties under the moderation of the directors. If this fails, or in the case of conflict between the institute’s directors and employees, an Ombudsperson will become involved to mediate the dispute.

Education during doctoral or master thesis work

§15 Internal seminars
For PhD students, participation in events taking place within the framework of the Chronic Inflammation Forum is compulsory. These are e.g. the weekly institute seminar, the literature seminars, or other cell- or technology-related clubs. Likewise, participation in the regular teachings on laboratory safety and the handling of hazardous substances are also compulsory.

§16 Animal experimental work
The participation in the animal experimental course of the MPIIB / DRFZ, which takes place twice a year, is compulsory if it is necessary for the experimental work. The course must be completed before the beginning of animal experiments. Alternatively, proof of expertise and ability in accordance with § 7 of the German Animal Welfare Act (TierSchG) and according to the German Animal Welfare Test Ordinance (TierSchVersV), Appendix 1, Section 3 may be submitted.

§17 Cytometry and microscopy
Participation in one of the in-house cytometry or microscopy courses is obligatory if it is necessary for the experimental work. The course must be completed before the start of the experiments and is a prerequisite for setting up an account on the device to be used.

§18 Statistics
A basic statistical knowledge should have been acquired during the bachelor’s degree and is assumed in the planning and recording of the experiments. If necessary, further courses, e.g. within the framework of the LeGCI Graduate School can be attended. Advice on the planning phase of experiments and with regard to statistical evaluation is provided by the group leaders. Data analyses must be carried out independently.

§19 External courses
Participation in external courses, especially the Autumn and Spring Schools of the German Society for Immunology, the Summer School of the ScienceCampus Chonic Inflammation, and in the courses of the Berlin Graduate Schools, is welcome and supported by the DRFZ, as is the active participation in scientific congresses through posters and / or lectures. Students are encouraged to apply for travel grants from the organizers or from scientific societies.

Completion of the doctoral or master’s thesis- Cessation of employment

§20 “Abschluss-Laufzettel” – End of contract docket
The end of contract docket “Abschluss-Laufzettel” (Annex 2) for completing an activity at the DRFZ must be completed. The laboratory logbook is the property of the DRFZ and is delivered to the secretary of the scientific director.

§21 Referencing where the thesis work was performed
In the written work, in lectures and in publications, it should be noted that the work was carried out at the “German Rheumatism Research Center Berlin, a Leibniz Institute”. Also any third-party funds which contributed to the work should be mentioned.

§22 Library
A copy of the thesis will be handed in the DRFZ library. For electronically submitted works, a corresponding electronic document must be submitted.

§23 Publication of results
The students undertake to process the question of the thesis swiftly within the given timeframe and not to hand over the data obtained to third parties without the consent of the supervisor. Publications should be made jointly by supervisors and students. Publications should be made public to the library as soon as they are printed, so that they can be included in the institute’s statistics.

§24 Handover
The documentation of the experiments within the thesis, laboratory materials, reagents, animal breeding and cell lines are to be handed over to the group leader. The workplace should be left in a tidy state.

What can I accept as an employee or guest student “Hospitierende” of the German Rheumatism Research Centre Berlin (DRFZ), a Leibniz Institute?

DRFZ new employees /“Hospitierende” have a fundamental ban on demanding, promising or accepting rewards, gifts and other benefits to themselves or others in relation to their duties. In principle, benefits may only be accepted if the consent of the responsible supervisor is given.
Consent has already been granted for

  1. The acceptance of generally considered low-grade gifts (for example mass-produced items such as ballpoint pens, calendars, notepads), provided that their total value does not exceed € 10 and the donation per calendar year is not repeated per sponsor.
  2. The acceptance of gifts from the work environment and from external partners – on the occasion of a birthday, service anniversary or farewell to an amount of 25 €.
  3. The acceptance of gifts from colleagues.
  4. The usual reasonable entertainment on the occasion of official activities, meetings, visits and the like, or if they have their reason in the rules of traffic and courtesy, to which the employees / interns cannot escape, without against social forms violated.
  5. Hospitality at general events where the employee (s) attend as part of their function on assignment, or in relation to the social obligations imposed by the function (e.g. social events serving the interests of the service, introduction or farewell of Officials, official receptions, anniversaries, laying of the foundation stone, topping-out ceremonies, inaugurations, openings, meetings of bodies of economic enterprises in which the public sector is involved). The representation of the DRFZ is restricted to the management or the persons assigned by it.
  6. Discounts granted on the basis of private-law agreements (e.g. membership of an association which offers discounts alone, or in addition to other purposes) for purely private transactions, if the appearance of influencing the administration is avoided (e.g. fuel bonus points for members of an automobile club – but not just for a particular profession of the public service – discounts on a hardware store, airline miles programs of various airlines). Airline miles may not be used for private travel, but must be used exclusively in the context of the service.