The following comment refers to this/these guideline(s)
Researchers are responsible for putting the fundamental values and norms of research into practice and advocating for them. Education in the principles of good research begins at the earliest possible stage in academic teaching and research training. Researchers at all career levels regularly update their knowledge about the standards of good research practice and the current state of the art.
Experienced and early career researchers support each other in a process of continuous mutual learning and ongoing training and maintain a regular dialogue.
Organisational responsibility of heads of research institutions
The heads of HEIs and non-HEI research institutions create the basic framework for research. They are responsible for ensuring adherence to and the promotion of good practice, and for appropriate career support for all researchers. The heads of research institutions guarantee the necessary conditions to enable researchers to comply with legal and ethical standards. The basic framework includes clear written policies and procedures for staff selection and development as well as for early career support and equal opportunity.
The head of each HEI and non-HEI research institution is responsible for ensuring that an appropriate organisational structure is in place at the institution. He or she makes certain that the tasks of leadership, supervision, quality assurance and conflict management are clearly allocated in accordance with the size of individual research work units and suitably communicated to members and employees.
With regard to staff selection and development, due consideration is given to gender equality and diversity. The relevant processes are transparent and avoid implicit bias as much as possible. Suitable supervisory structures and policies are established for early career researchers. Honest career advice, training opportunities and mentoring are offered to researchers and research support staff.
Legal and ethical frameworks, usage rights
Researchers adopt a responsible approach to the constitutionally guaranteed freedom of research. They comply with rights and obligations, particularly those arising from legal requirements and contracts with third parties, and where necessary seek approvals and ethics statements and present these when required. With regard to research projects, the potential consequences of the research should be evaluated in detail and the ethical aspects should be assessed. The legal framework of a research project includes documented agreements on usage rights relating to data and results generated by the project.
Researchers maintain a continual awareness of the risks associated with the misuse of research results. Their responsibility is not limited to compliance with legal requirements but also includes an obligation to use their knowledge, experience and skills such that risks can be recognised, assessed and evaluated. They pay particular attention to the aspects associated with security-relevant research (dual use). HEIs and non-HEI research institutions are responsible for ensuring that their members’ and employees’ actions comply with regulations and promote this through suitable organisational structures. They develop binding ethical guidance and policies and define procedures to assess ethical issues relating to research projects.
Where possible and practicable, researchers conclude documented agreements on usage rights at the earliest possible point in a research project. Documented agreements are especially useful when multiple academic and/or non-academic institutions are involved in a research project or when it is likely that a researcher will move to a different institution and continue using the data he or she generated for his or her own research purposes. In particular, the researcher who collected the data is entitled to use them. During a research project, those entitled to use the data decide whether third parties should have access to them (subject to data protection regulations).
Ethical requirements applicable to clinical research projects
Ethics committees are bodies established by universities, professional associations or countries to provide ethical and legal advice, control and oversight for researchers who are planning to carry out investigations involving living and deceased human subjects, identifiable human material or identifiable data. In the field of clinical research, it is standard practice to have reviews and approvals of such research projects carried out by the relevant local ethics committee. This ensures that the rights and safety of the subjects are protected in accordance with the Declaration of Helsinki.
Association of Medical Ethics Committees in Germany
“The Association standardises the work of the ethics committees, especially in decision-making and procedural matters. It offers continuing education on the work of medical ethics committees and promotes the exchange of ideas and experience both nationally and internationally. The Association also is involved in the concerns of medical ethics committees in public discourse.”
The comment belongs to the following categories:
GL2 (Life sciences) , GL3 (Life sciences) , GL10 (Life sciences)