Compliance and risk management in science

Compliance in the research sphere is of increasing importance. However, many different definitions and interpretations exist. Furthermore, questions arise: What does compliance want to accomplish? How can it be accomplished? And what challenges could come in the way?

 What is compliance in the context of safeguarding science?

The term “compliance” can be defined, in the context of safeguarding science, as follows: Compliance is the obligation to adhere to previously defined, both internal and external, regulations or basic ethical requirements. In various institutions, compliance is attempted to be guaranteed through a systematic approach. In this context, the term “compliance management” is often used. Usually, rule-compliant behaviour in an institution is ensured through active management and a predefined approach. Compliance in the research sphere includes topics like export control/dual use, secrecy protection, IT-security, anti-corruption or travel safety.

What are the goals of compliance management and how can they be achieved?

The goal of compliance management is not only to fulfil and monitor mandatory laws and regulations, but also to raise awareness for other principles and ethical issues. A vital challenge is the protection of knowledge. Active risk management and transparent action frameworks can form a stable foundation for knowledge protection and contribute to the prevention of knowledge loss. Another goal of compliance management is to protect employees as well as management from possible damage or legal consequences of any kind. Last but not least, a responsible approach to research freedom is also of high importance. To achieve these goals, a systematic approach, known as Compliance Management System, is a recommended first step. It should involve the entire organization including a change of culture and helps to fulfil elementary obligations. By linking with existing or new internal control systems and risk management tools, synergies can be created that can take knowledge protection to a new level.

Which challenges exist for scientists?

A fundamental challenge is the balance between compliance management and the autonomy of each individual scientist. Scientific freedom must be guaranteed. Scientific integrity and ethics are also two important points that must not be influenced by compliance measures. In addition to these internal challenges, there are further external challenges. All measures must be secured within the legal framework. In addition, funding agencies, auditing and supervisory authorities should also be involved. Contracts or agreements with cooperation partners must be adhered to. Finally, public pressure can also play a role in exerting influence. 

The graphic displays different levels which a compliance-system has to consider, ranging from institutional to international. The horizontal formation indicates that each level is as important as the next one.

Compliance graphic

© Safeguarding-Science.eu

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“Leitplancken” by Max-Planck-Gesellschaft – Guidelines for responsible conduct

The “Leitplanken” are outlying guidelines for a responsible conduct (72 Pages) and were published by the Max-Planck-Gesellschaft in September 2022. Within the document the English translation can be found.
Value: Serves as an example of how a renowned German institute operates in regard to compliance and conscientious conduct

Shortened abstract

For the Max Planck Society responsible and compliant behavior is a key basic requirement. It is essential for all employees – both in science and in the science support area – to observe the laws and internal regulations. Responsible behaviour must be based on the structures of our organization, a balanced system which links governance oriented towards academic freedom with an administration structure focused on compliance with the rules. It is up to each and every one of us to comply with the rules and act in line with our values – in short, to do the right thing. (…) In order to make sure that this remains the case, the information here should serve as a guide. (…)

EU compliance guidance for research involving dual-use items

The „EU compliance guidance for research involving dual-use items” is a helpful guide (49 Pages + Appendices) for European compliance rules regarding dual-use items.
Value: Acts as a tool for academics and research organizations to comply with the relevant national and EU rules and regulations as well as to identify, manage, and reduce risks connected with dual-use export controls

Shortened abstract

Research organizations have strong incentives to innovate and collaborate internationally as a basis to advancing research. (…) It is known that amidst many genuine and transparent collaborations to develop meaningful scientific and technological advancement, there are offers of collaboration, invitations and informal exchanges with covert motives, i.e. seeking access to research involving dual-use items for other purposes than those stated. Researchers and research organizations may then inadvertently violate export regulations. Dual-use export controls exist to govern activities involving items which can be used for both civil and military purposes (…). Raising awareness about these controls is an important aspect of preventing and mitigating risks related to non-compliance. In the EU, the level of experience in implementing and managing such compliance measures within research organizations varies significantly. Competent authorities in the EU are committed to provide guidance for research organizations on how to strengthen internal compliance measures