Manual Clinical Research and the Law

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Trials must undergo independent scientific and ethical review and approval, and are subject to random audits by authorities during or after their execution. For every clinical trial we sponsor, Novo Nordisk establishes safety committees that report any adverse events on a global level to health authorities, and who take appropriate action when required.

In addition, Bioethics Expert Groups keep track of emerging issues, re-evaluate risks and act upon any findings.

EU law and the regulation on clinical trials

Current topics under review include: global adherence to ethical guidelines, focus on vulnerable populations in informed consent especially children , transparency in investigator-sponsored studies, use of social media and collection of clinical data in real world evidence studies. All Novo Nordisk clinical trials and clinical research activities are governed by national laws and international conventions.

Novo Nordisk has a governance structure in place which ensures that current and new regulations, directives and external guidelines are adhered to and that all clinical research activities are approved both by medically qualified staff and senior management.

Our Chief Medical Officer is accountable for ensuring that Novo Nordisk respects the rights, integrity and dignity of people participating in clinical trials. The Chair of the Bioethics Council coordinates ethical standards, including respect for human rights. More information about our bioethics governance. Our global management systems ensure respect for the dignity and rights of all clinical trial participants. These systems are continuously evaluated and updated to reflect changing ethical standards and emerging risks.

Clinical Research Law Blog |

We track our performance on ethics and human rights in clinical trials. Our initiatives within the focus areas are overall on track and we are making continuous improvements. In , we produced a paediatric patient information assent form. We ensure children participating in trials are able to express their own views freely in all matters affecting them. Their views are given due weight corresponding to their age and maturity, in accordance with the Convention on the Rights of the Child. We provide lay person language informed consent forms to improve the readability of the material.

Tests showed that readers better understood the key concepts and decisions when participating in clinical research, eg voluntarism, randomisation and placebo control. We have also improved the information regarding concerns or complaints for participants. These revisions have been completed with the help of health literacy experts and patient organisations. We ensure clinical trial participants can easily access information about their rights and the grievance process.

In the case of any concerns or complaints, this is provided through the national health authorities and patient ombudsman or ethics committees. We ensure that participants are compensated for any clinical research-related injury according to domestic law. We have regular consultations with healthcare professionals on clinical research design and protocols. To ensure that the rights and well-being of trial participants are given priority, all investigators working on our clinical trials are trained in Good Clinical Practice. When necessary, we offer such training for doctors, nurses and pharmacists at clinical research sites.

Through these associations, we work with regulatory authorities to improve the requirements for clinical trials conduct, such as the revision of the Declaration of Helsinki. Human biosample ethics. Gene technology ethics. Back Clinical trial ethics. Clinical trials. Assessing risks.

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See how we share our clinical trial results Global standards for clinical trial activities are never compromised and our research activities only take place in countries where the environment, infrastructure, medical standards, Independent Ethics Committees IEC or Institutional Review Boards IRB are all adequate and regulated.

Our position on clinical trials. Novo Nordisk will: Ensure that the above standards are applied globally for the safety, rights, integrity, confidentiality and well-being of participants in Novo Nordisk sponsored clinical research, and that these always prevail over interests of science, society and commerce. Ensure that the above standards are applied globally for the safety, rights, integrity, confidentiality and well-being of participants in Novo Nordisk sponsored clinical research, and that these always prevail over interests of science, society and commerce.

Ensure that each clinical research activity has a clear and detailed protocol based on sound medical and scientific methodology and ethical considerations outlined in these principles.

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Approval by regulatory authorities is also required as applicable by local law. Ensure that trial information for all Novo Nordisk sponsored clinical research is registered in publicly accessible databases according to current requirements. Ensure that signed informed consent is obtained for all participants in Novo Nordisk sponsored clinical research, before any clinical activity is initiated. The assigned ethic committee either the CEIC or a CES is also provided with the authority to, in non-interventional studies and exceptional situations, remove the need for explaining to the participant what the trial is about and attaining informed consent.

Specific provisions are established for clinical trial participants, including the minimum requirements for the protection of participants, specific provisions regarding the participation of minors and disabled individuals in clinical trials, as well as provisions related to obtaining informed consent Articles 6 to 8. The procedure for attaining consent on minors too has been more detailed. Alongside the other requirements, a clinical trial can only be performed on minors when it has been obtained the informed consent of a minor aged above 16 years and his legal representative.

If the minor has less than 16 years, the representative is the sole responsible for grating informed consent, although it must reflect the presumed will of the minor. The assigned ethic committee again is given the right, under exceptional circumstances, to waive the requirements of informed consent and informing the minor patients in clinical studies without intervention. The assigned ethic committee is given the same right for participants of age unable to provide informed consent.

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