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 research 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. Sometimes it may also be sufficient to make an “ändringsansökan” (amendment application) to the existing approved ethics application. An ändringsansökan is also done in Ethix. There could be exceptions for certain clinical trials testing new investigational medicinal products.
More information can be found on our webpage about Human ethics application.
Determine the research principal (forskningshuvudman) 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 forskningshuvudmän. 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 "ansvarig forskningshuvudman".
In research projects where a clinical study is carried out, the study should be registered in a clinical trial registry, for example ClinicalTrials.gov. If there is more than one forskningshuvudman 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 “ansvarig forskningshuvudman” in the ethics application. However, if another “medverkande huvudman” 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 medverkande huvudmän is the "responsible registrant" (so-called sponsor for registration and reporting of results).
At Medarbetarportalen there is more information on how to proceed if you want to register a clinical trial or a clinical study.
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. . KI has drafted a “Guide to the application for ethics review” which is intended to be a support for researchers when they are going to fill in their ethics application.
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.