PREMIER Legal Requirements and Guidelines

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Objectives

Working in the laboratory requires compliance with applicable guidelines and legal regulations at any time. Every organization / laboratory / scientist must clarify in advance which legal regulations are valid for the respective work and ensure compliance with them accordingly.

Background

According to the International Science council, academic freedom and scientific autonomy are vital for science to progress and best serve to society, as confirmed by numerous legislative texts.

At the individual level, the independence granted to scientists obligates them to behavior that is ethical, honest, open-minded and objective. Such integrity in the conduct and communication of research is a critical component ensuring the individual right to academic freedom. While scientists should be free in their research and teaching activities, it is their responsibility to take into account the legal and regulatory framework in which they work.

See: ICSU The Principle of Universality of Science and Academic Freedom

== Tasks / Actions In order to create a lab specific action plan, the first step is an assessment, which will be carried out by the PREMIER team. The assessment will determine the status quo of the laboratory in regard to existing quality tools. Here you find the general tasks / actions that are necessary to implement the module.

Legal, Normative Conditions and Internal Requirements

Depending on the location where the research institution or laboratory operates, multiple laws, norms and guidelines may apply. For instance, in Europe, the European Code of Conduct for Research Integrity of the European Science Foundation published by ALLEA is to be considered. Other common guidance is the ICMJE recommendations developed to review best practice and ethical standards in the conduct and reporting of research and other material published in medical journals. It also help authors, editors, and others involved in peer review and biomedical publishing create and distribute medical journal articles.

Each researcher together with other instances at the organization is responsible for the compliance of applicable legal regulations. The researcher has to ensure that the regulations that apply at the personal level and to the research area are observed. As a rule, lack of knowledge of the applicable law and regulations does not excuse from responsibility.

The heads of the working groups are responsible for ensuring that the principles and requirements of Good Scientific Practice (GSP) are observed by all staff including themselves and that legal requirements are met. A synonym for GSP frequently used outside Germany is “Responsible Conduct of Research”.

International, national or regional regulations or requirements also apply to specific topics related to the particular scientific activity. Moreover, for entities handling human materials for research purposes many clinical standards applied. The applicable laws and regulations, e.g. Animal Welfare Protection Laws and the organization's internal statutes must be observed without exceptions. Failing to do so may result in illegal conduct.

The verification of the compatibility of the research with legal regulations, self-regulatory measures and ethical principles is initially the responsibility of the project leaders. Particularly within the framework of the legally required supervisory duty and in the sense of the GSP - the scientist's supervisors, i.e. the heads of the working group, are responsible for the scientific integrity and legal conformity of the research work of their working group.

Animal Welfare Law

People who work with animals in the laboratory are strictly obliged to observe the Animal Protection Law. It is therefore highly recommended to provide evidence of appropriate training in the handling of animals. Depending on national and international regulations, the government regularly checks compliance with the Animal Welfare Law on site.

Arrive Guidelines

Researchers working with animals in the laboratory should familiarize themselves with the Arrive Guidelines. The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of recommendations to improve the reporting of research involving animals – maximizing the quality and reliability of published research, and enabling others to better scrutinize, evaluate and reproduce it.

See: Arrive Guidelines

Good Scientific Practice (GSP)

All universities and non-university research institutions are obliged to implement Good Scientific Practice (GSP) in a legally binding manner. Good scientific practice is a guideline for researchers to implement reliable research.

Most universities have their own rules for implementing GSP. They are based on the guidelines of the Code of Good Scientific Practice of the German Research Foundation (DFG).

The aim of the Code is to enable the addressees - the scientists and academics and the management of universities and non-university research institutions - to align their internal structures, processes and actions with the guidelines for good scientific practice. A culture of scientific integrity is to be established in the scientific institutions, which is not so much based on violations of good scientific practice as on the professional ethics of scientists and academics.

Deutsche Forschungsgemeinschaft (DFG): Good Scientific Practice

Declaration of Independence and Confidentiality

Every academic research institution should provide a declaration of independence and confidentiality in order to define what science is commited to its purposes. This should, for example, include a binding declaration of scientific freedom and the right to strive for knowledge independently and without external influences.

Or also that behavior which systematically fails to meet the claim to scientific integrity, deliberately falls behind or violates applicable law, cannot claim to be protected by the constitutionally protected freedom of science.

References

• Deutsche Forschungsgemeinschaft (DFG): Good Scientific Practice
• ICMJE (Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals; Author Responsibilities - Conflicts of Interest)
• Datenschutzgrundverordnung
• Arrive Guidelines