Ethical Principles and Values of in.vent

in.vent is committed to the highest international ethical and legal standards. This statement underlines our firm commitment to ethical correct behaviour of all our doing.

1. The Declaration of Helsinki[1] & Declaration of Taipei[2] as developed by the World Medical Association state the ethical principles that provide guidance to physicians and other participants in medical research involving human subjects research on Health Databases, Big Data and Biobanks is basis of our guidelines.

2. in.vent only cooperates with networks, physicians, clinics and other organisations that comply with these standards.

3. Further standards are based on the statements of IVDR 2017/746.[3]

4. The notes of the German Central Ethical Committee[4] and the German Ethicsboard regarding biobanks for research purposes are taken into consideration as well as far as they are applicable.

5. Furthermore ICH-GCP guidelines[5] (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice) are taken into account whenever applicable.

-          Human Bio-Materials are valuable biomaterials needed but not restricted to medical research, development and production of IVDs, companion diagnostics, pharmaceutical and clinical trials

-          Human Bio-Materials can be leftovers, tissues and body fluids from operations or from laboratory diagnostics as well as donations procured for medical or scientific reason

-          all donations are preceded by statements according the ethical correctness of the projects of an International Review Board (IRB)[6] resp. ethical boards and committees, whenever applicable

-          the use of Human Bio-Materials is part of the personal rights of each single donor, therefore we commit to obtain informed donor consents in writing whenever it is of relevance donors may have limited knowledge in medical and pharmaceutical topics, therefore all signing of informed donor consents is preceded by detailed explanations to the donor. These explanations include all purposes, ways and lengths of use and all detailed information regarding the use of the donated biomaterials

-          all use of donated materials was, is and will be restricted to the purposes respectively the application the donor agreed to

-          all personal data referring to donated Human Bio-Materials are pseudonymised resp. anonymised before being transferred to third parties

-          the use of all personal data is restricted and confidential according all applicable laws and regulations and is closely monitored

-          collection, storage and the use of data is subject of the Declaration of Taipei. Individuals have the right to request and be provided with information about their data at any time.[7]

-          in.vent maintains a Quality Control System (ISO 9001)[8] and is as well as certified according to ISO 13485[9]

-          the compliance with the above mentioned guidelines is kept under strict surveillance

-          in.vent trains and informs its employees to ensure compliance with these guidelines on a regularly basis







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