Laws and regulations
When a clinical study is conducted, a number of legal requirements must be complied with in order for the research to be legal. The legislation aims primarily to protect the persons participating in a clinical study, and to quality assure the clinical study. Ethical aspects are also topical, among them the requirement for ethical vetting.
Ethical principles and regulations
The ethical rules that apply to research are based on international conventions, which lay down the principles for research ethics. These conventions have formed the basis for the legislation that has been worked out, both internationally and nationally. Swedish research is covered both by international conventions and by international and national legislation. The rules are there to ensure individuals are not harmed or subjected to unnecessary risk when persons or personal data are used in research.
The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association (WMA) in 1964. The Declaration contains ethical principles for doctors and other participants in medical research. The Declaration of Helsinki is not legally binding, but has had major impact on national legislation.
Research on living or deceased persons, on biological material from humans, or research that involves handling sensitive personal data or data on breaches of the law must be reviewed and approved by Ethical Review Authority. Ethical review is regulated in the Act (2003:460) concerning the Ethical Review of Research Involving Humans and is concerned primarily with striking a balance between societal benefit and the study participants’ health, safety and right to personal integrity. The requirement for an ethical review applies even if the study participant has given express consent to the use and handling of the data.
Personal data handling
The General Data Protection Regulation regulates if and how researchers may handle personal data in their research. An important part of integrity protection in conjunction with research is that the persons on whom the research is carried out are entitled to get information that and how their personal is used, for example who is responsible for the handling of personal data, for what purpose the data is handled, and for how long the data will be saved.
In the General Data Protection Regulation (GDPR), there are additional provisions for specific categories of personal data (in national legislation still called sensitive data). Specific categories of personal data are data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or membership of the trade union, processing of genetic data, biometric data to uniquely identify a natural person, health data or data on a sexually active person or sexual orientation.
The main rule is that processing of sensitive personal data is prohibited. However, there are provisions on exceptions to the prohibition, including for the treatment of sensitive personal data in research. A condition for research containing sensitive personal data is a valid approval from a regional ethics committee. The same applies to the processing of personal data about criminal offenses.
Public access to information and secrecy
Transparency in public administration is maintained through the principle of public access to information. This means that everybody has the right to partake of data from public agencies and other public actors (“public documents”). Public access to information is the main rule, and if data used in the activities of a public agency need to be protected, this must be regulated in law, which is done in the form of specific secrecy provisions in the Public Access to Information and Secrecy Act (SFS 2009:400).
Within health and medical care, the main rule is that secrecy applies to data about a person’s state of health and other personal circumstances, unless it is clear that the data may be disclosed without harm to the individual or anyone related to the individual. It is thus the provisions of the Public Access to Information and Secrecy Act that determine whether patient data may be disclosed by a public care provider. Each care provider must decide independently whether data requested may be disclosed.
The professional duty of confidentiality of employees of private care providers is regulated in the Patient Safety Act (SFS 2010:659). The regulation of the professional duty of confidentiality means that employees of a private care provider may not disclose without authorisation what he or she have learnt in a professional capacity about a person’s state of health or any other personal circumstances. The duty to report that follows from a law or ordinance is not regarded as unauthorised disclosure. There are also exceptions that make it possible to disclose certain information to the police or public prosecutor, for example.
However, the main rule is that a patient will dispose himself or herself over his or her own data. When a patient wishes to take part in a clinical study, he or she may waive the confidentiality that covers the patient records with a care provider. Such a waiver makes it possible for the care provider to issue data to the person conducting a clinical study. A waiver of confidentiality is usually given in conjunction with the patient consenting to take part in a study.
Research projects in which study participants are exposed to ionizing radiation
There are special regulations for medical exposure to ionizing radiation, such as X-ray examinations. These become applicable in clinical studies where participants are exposed to ionizing radiation. The Swedish regulations are based on EU-legislation that has been implemented in Swedish law, among other things through the Radiation Protection Act (2018: 396) and the Radiation Protection Ordinance (2018: 506).
Medical exposure requires a permit from the Swedish Radiation Safety Authority and is issued to care providers. All regions and some healthcare companies have such permits. The condition usually also includes exposure of researchers. The activities of these care providers are covered by regulations, for example the Swedish Radiation Safety Authority's regulations (SSMFS 2018: 5) on medical exposures. It follows from the regulations that the licensee must ensure that the radiation protection is optimized and the exposure is justified.
The research principal should therefore cooperate with the care provider (permit holder) in the planning of projects where study participants are exposed to ionizing radiation so that the requirements for radiation protection for the study participant can be met.
The Swedish Ethics Review Authority, and in some cases the Swedish Medical Products Agency, shall in cases where the study participants do not receive any direct medical benefit from the exposure establish a dose restriction. This is stated in the Radiation Protection Ordinance (2018: 506). For all irradiation for research purposes, the same principles shall apply to optimization as for medical treatment or examination.
Specific rules for medicinal products or medical devices
There are specific rules to attend to for clinical studies of medicinal products and clinical investigations of medical products .
Specific rules for medicinal products
Approval from the Medical Products Agency
Clinical medicine studies must be approved by the Medical Products Agency. Information about how to apply is available on the Medical Products Agency’s website. There are special regulations that govern how this type of studies shall be conducted. The Medical Products Agency has made a summary of the regulations that apply for clinical medicine studies.
Specific rules for medical devices
Medical devices are in the EU regulated by two categories that follow different regulations:
- For medical devices, the EU Regulation on Medical Devices (MDR) applies. New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
- For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New rules apply within the EU from 26 May 2022.
Coordinated review from the Swedish Medical Products Agency and the Swedish Ethical Review Authority
From 15 July 2021, most of clinical investigations of medical devices must be submitted to the Swedish Medical Products Agency. The Swedish Medical Products Agency and the Swedish Ethical Review Authority coordinate their review and thus the application for ethical review must be sent to the Swedish Medical Products Agency. Also note that clinical investigations of medical devices on CE-marked products that previously only needed to be sent to the Swedish Ethical Review Authority must be notified to the Swedish Medical Products Agency from 15 July 2021. Information about the notification procedure is available on the websites of the Swedish Medical Products Agency and the Swedish Ethical Review Authority
Medical devices - current EU regulation and national legislation
From 26 May 2021, EU Regulation 2017/745 on medical devices are applied within the EU. As of 15 July 2021, two new Swedish laws also apply:
- Law with supplementary provisions to the EU regulation on medical devices (SFS 2021: 600) (in Swedish) External link.
- Law with supplementary provisions on ethical review of the EU regulation on medical devices (SFS 2021: 603) (in Swedish) External link.
Clinical investigations of medical devices must comply with the rules for notification and permit requirements that applied at the time when the trial received the applicable permits.
Clinical investigations of medical devices that did not need to be sent to the Swedish Medical Products Agency before 26 May 2021 and that received permission from the Swedish Ethical Review Authority before 26 May 2021 do not need to be reported to the Swedish Medical Products Agency afterwards.
Medical devices for in vitro diagnostics - new EU regulation
New rules apply within the EU from 26 May 2022 when the EU Regulation 2017/746 on medical devices for in vitro diagnostics (IVDR) will be applied.
IVDR defines a performance study as a study conducted to determine or confirm the analytical or clinical performance of a product.
The purpose of clinical performance studies is to establish or confirm aspects of product performance that cannot be determined through analytical performance studies, literature studies, and / or previous experience from routine diagnostic testing.
Performance studies that are started before IVDR has started to be applied may continue to be carried out in accordance with the previous regulations (LVFS 2001: 7 based on IVDD) f even after the application date for IVDR. Sponsor does not need to submit any application or application to the Swedish Medical Products Agency for ongoing performance studies.