Human biosamples

“Patients and other volunteers who want to donate biosamples need to be confident that samples will be collected, stored and used ethically, and that their donation will be used for the good of research.”

Brian J. Clark,
Senior Director, Human Biosample Governance
LinkedIn profile

 

Brian J. Clark

Human biosamples are biological samples from humans, such as tissue and blood. Biosamples donated by patients and other volunteers play vital parts in research to find new means of preventing, diagnosing or treating diseases.

Human biosamples can provide a bridge between laboratory research and clinical information about actual patients. It does this by enabling researchers to study a disease directly in the laboratory, and to link the results with what is known about the clinical behaviour of the disease.

Novo Nordisk aims to give donors the confidence that their donation will make a difference and that they will be making a personal contribution to the fight against diseases such as diabetes, obesity and haemophilia.


Novo Nordisk's position on human biosamples

1 Respect of legal and ethical rights 
Novo Nordisk recognises its responsibility to respect the legal and ethical rights of the people who donate human biosamples.

2 Compliance of laws and regulations 
Novo Nordisk’s research using human biosamples complies with all relevant national and international laws and regulations and takes note of external guidelines on bioethics and best practice, insofar as they apply. Novo Nordisk’s internal governance processes assure the legality and ethics of its uses of biosamples.

3 Consent of donation 
Biosamples must be donated with appropriate consent, or with legally and societally acceptable alternatives to individual donor consent where necessary. Consent to donate human biosamples should not be influenced by coercion, financial inducements or give rise to financial gain for the donor or next of kin. All uses of biosamples and data must always be within the scope of consent.

4 Right to withdraw consent 
The right of donors to withdraw consent for future uses of their biosamples must be respected, where practicable, without question and without detriment to their clinical care.

Financial transactions 
Novo Nordisk has strict standards for financial transactions relating to the acquisition of human biosamples for research uses. These are aligned with Article 21 of the Convention on Human Rights and Biomedicine of the Council of Europe, which states that the human body and its parts must not directly give rise to financial gain.

6 Approval by ethics committee 
Public trust and confidence are protected by ensuring that research activities using human biosamples and data are approved by an ethics committee (EC) / Institutional Review Board (IRB) or equivalent, where applicable.

Privacy protection
Novo Nordisk protects the privacy of people who donate human biosamples by safeguarding the use of biosamples and sensitive personal data with appropriate security measures.

8 Clinical trials
Novo Nordisk’s position on Clinical trials covers additional aspects of the use of human biosamples and data obtained from people enrolled in our clinical trials.

9 Stem cells
Novo Nordisk’s position on Stem cells covers additional aspects of the use of stem cells in research and the development of cellular therapeutics.


How we use human biosamples at Novo Nordisk


Human Biosamples Brochure

Human biosamples in pharmaceutical research

Download our brochure about human biosamples in pharmaceutical research

 


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