Ethics and Compliance: Clinical studies
Ethical review and approval of research involving humans is required by Swedish law. Clinical studies/trials conducted at KI must comply with these ethical requirements, and trials must adhere to the ICH-principles and Good Clinical Practice (GCP) guidelines to protect human subjects. These principles and guidelines are explained below, as well as how to reason when appointing the responsible research principal prior to writing the ethics application and registering a clinical study.
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 part of the research begins. This applies to all types of approval that may be required for a clinical study and/or clinical trial. More information and the possibility to apply for ethical approval can be found in the Swedish Ethical review Authority’s portal Ethix.
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.
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.
Determine the research principal and ethics application
It is important to ascertain the responsible research principal (ansvarig forskningshuvudman), and any participating research principals (medverkande huvudmän), of a research project before you send in the ethical application. According to the act (2003:460) concerning the “Ethical Review of Research Involving Humans” a research principal is defined as a “state authority or a person or legal person in which research activities are carried out.”
Discussing the division of responsibilities within the research project is important, especially if there are several research principals. That include, for example, where data will be stored and analyzed, management of agreements, registering and reporting of results, etc. KI, together with Region Stockholm, has drafted a joint “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 is to provide guidance when appointing the responsible research principal.
In research projects where a clinical trial is carried out, the clinical study should be registered in a clinical trial register, for example ClinicalTrials.gov. If there is more than one research principal for the same research project, it is recommended that the clinical study is registered under the organization account that belongs to the institution/hospital that is appointed the responsible research principal in the research application. However, if another participating research principal is better suited to be responsible for the clinical trial registration and reporting of results, it must be described and made clear in the ethics application which of the participating research principals is the "responsible registrant" (so-called sponsor for registration and reporting of results).
Verify research principal/responsible registrant prior to registration
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 under the correct organization account in clinicaltrials.gov. Once Karolinska Institutet (KI) is confirmed as the responsible research principal or responsible registrant, the clinical study can be registered under the KI organization account in clinicaltrials.gov.
Responsible research principal/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 the 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 KIs High-level Administrator account. If Karolinska Institutet is the Sponsor or responsible research principal of a clinical trial, researchers should contact the Compliance & Data Office (CDO) for support and guidance.