Ethics and Compliance

Ethical review and approval of research involving humans is required by Swedish law. Clinical studies and clinical trials conducted at KI must comply with these ethical requirements, and trials must adhere to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) principles and Good Clinical Practice (GCP) guidelines to protect human subject rights, integrity, and confidentiality.

Ethics Research
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Ethical requirements 

If research is conducted on living or deceased humans, on biological material from humans, or involves the handling of sensitive personal data, then ethical review and approval is required by the Swedish Ethical Review Authority.

Ethical approval must be in place before any work or research begins. This applies to all types of approval that may be required for a clinical study and/or clinical trial.

In many cases, if the new project does not deviate from the research described in the ethical application, and the consent given by the patients/subjects, an existing approval can often be used in several different externally funded projects. There could be exceptions for certain clinical trials testing new investigational medicinal products.

Researchers can also read more about medical research ethics in the Declaration of Helsinki.

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Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international guideline to ensure that clinical trials are designed, conducted, implemented, monitored, audited, recorded, analyzed, and reported scientifically and ethically. It also aims to protect human subject rights, integrity, and confidentiality. GCP follows the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and enforces tight guidelines on ethical aspects of clinical research. There are six principles of the ICH-GCP and more information on these principles and guidelines are available on the ICH homepage. Researchers must comply with ICH-GCP guidelines in accordance with Karolinska Institutet requirements and EU legal regulations. Researchers at KI involved with clinical trial research may also be required to take a GCP course to obtain a GCP certification.

Regulations for sensitive personal data

The General Data Protection Regulation (GDPR) regulates the handling of personal data in research. There are provisions for specific categories of personal data that are classified as sensitive. Sensitive personal data are data that reveal racial or ethnic origin, sexual activity or sexual orientation, biometric data to uniquely identify a natural person, political beliefs, religious or philosophical beliefs, membership of the trade union, health data, or processing of genetic data. 

Clinical research involving sensitive personal data is required by law to have the research ethically reviewed and approved by the Swedish Ethical Review Authority.

 

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Research principal on ethics application

It is important to ascertain the research principal of a research project before registering a clinical study. The Swedish law (2003:460) concerning the “Ethical Review of Research Involving Humans” defines a research principal as a “state authority or a person or legal person in which research activities are carried out.” If there is more than one research principal for the same research project, it is recommended that the clinical study is registered under the name of the institution stipulated in the ethical application as the “responsible research principal (ansvarig forskningshuvudman) for submitting the ethical application.” In cases where KI is not the research principal that is submitting the ethical application, then the parties involved must agree upon who will be the responsible ‘Sponsor’ for registration and reporting (responsible registrant). It is important to discuss these issues with the research principal and collaborating institutions regarding the share of responsibilities. These include, for example, where data will be stored and analyzed, managing agreements, registering and reporting results, etc. Researchers can also access more information and apply for ethical approval using the new system “Ethix” at the Swedish Ethical Review Authority. KI, together with Region Stockholm, has drafted a joint document called “Guidance – appointing a responsible research principal for the ethical application for research where Karolinska institutet collaborates with health care providers in Region Stockholm”. The aim of the document is to provide guidance and basis for discussion when appointing the “responsible” research principal.

Verify research principal/sponsor 

Clinical studies

Prior to registering a clinical study in clinicaltrials.gov, researchers should contact the Compliance & Data Office (CDO) with a copy of their ethical application/approval to verify the research principal/responsible registrant (more information available on the Regulations and Requirements webpage). This is done in order to ensure the clinical study is registered in the correct Sponsor organization account in clinicaltrials.gov. Once Karolinska Institutet (KI) is confirmed as the research principal or "responsible registrant", the clinical study can be registered with KI as the Sponsor in the KI organization account in clinicaltrials.gov.

Clinical trials

The sponsor for the clinical trial is decided prior to the clinical trial application is registered in CTIS. There, the application is examined in parallel by the Medical Products Agency and Swedish Ethical Review Authority. In CTIS, KI has an “Organisation-centric approach” and all clinical trials with KI as sponsor/research principal shall be registered under KI:s High-level Administrator account. If Karolinska Institutet is the Sponsor or research principal of a clinical trial, researchers should contact the Compliance & Data Office (CDO) for support and guidance.