9. Subject considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them? 

Yes, subject to approval by the Ethics Research Authority.

If advertising material is to be used in the recruitment of research participants, it must be submitted under Part II of the clinical trial application form (please see Section 3.1 of this guidebook for more information).

9.2 Vulnerable Subjects

The MPA website, under the “Subjects and informed consent section”, indicates the following:

Pregnant or breastfeeding women

A clinical trial on pregnant or breastfeeding women may be conducted only where all the conditions set out in Articles 28 and 33 of the CTR 536/2014 are met.

Emergency situations

In a clinical trial in an emergency situation, a subject may be included, and at the same time a first intervention according to the protocol may be carried out, prior to informed consent being obtained. The trial protocol should describe the information and consent process in relation to the inclusion of the subject.

The condition is that all the circumstances set out in Article 35 of the CTR apply:

• Due to a sudden life-threatening or other sudden serious medical condition, the subject is unable to give prior informed consent and to receive information about the clinical trial in advance.
• There are scientific grounds to expect that the subject’s participation in the clinical trial will have the potential to produce a direct clinically relevant benefit for the subject, resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject or the diagnosis of their condition.
• It is not possible within the therapeutic window to provide all prior information to and obtain consent from the subject’s legally designated representative.
• The clinical trial relates directly to the subject’s medical condition and the trial is of such a nature that it may be conducted exclusively in emergency situations.
• The clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject’s condition.

After the first intervention, the investigator shall obtain informed consent for the subject to continue participation in the trial. In the case of incapacitated subjects and minors, the investigator shall inform the subject and the legally designated representative (guardian or custodian) as soon as possible and obtain the informed consent of the representative.

In the case of other subjects, the investigator shall, as soon as possible, inform the subject or the representative, whichever is sooner. Informed consent shall be obtained from the subject or the representative, whichever is sooner. If the representative is the person giving consent, consent shall be obtained from the subject as soon as he or she is capable to be able to continue participation in the trial.

If the subject or, where applicable, their representative does not give consent, he or she shall be informed of their right to object to the use of the data obtained.

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

The MPA specifies special conditions to be met for clinical trials involving minors.

A clinical trial on minors may be conducted only where all the conditions set out in Articles 28 and 32 of the CTR are met. Among other things, minor subjects shall be informed about the trial by the investigator or another member of the investigational team who has experience working with children. The information should be adapted to the child’s age and mental maturity. The information shall be both oral and written.

There are also national rules to consider:

In Sweden, a minor is a person younger than 18 years of age.

According to the Swedish Medicinal Products Act (2015:315), guardians are legally designated representatives who may give informed consent to a clinical trial on a medicinal product on behalf of a minor subject. Note that, if there are two guardians, both must sign and date the consent form before any study-related measures are taken. However, the signing need not take place at the same time. If a guardian is located elsewhere, the consent may in urgent cases be sent by digital means (for example by e-mail), and later confirmed by original documents.

According to the Medicinal Products Act, a minor subject who has reached the age of 15 shall also give their own informed consent to participate in the clinical trial on a medicinal product, provided that the subject understands the implications of the trial for him or her.

According to the Medicinal Products Act, if a minor subject reaches the age of 15 during the course of a clinical trial, the subject’s explicit informed consent shall be obtained before that subject can continue to participate in the clinical trial.

A subject who has reached the age of 15 and has given their consent as described above does not have to give a new consent if they reach the age of 18 during the course of the trial.

9.4 Financial Disclosures

It is a requirement for Swedish investigators to submit a signed Declaration of conflicts of interest under Part II of the clinical trial application.

Any circumstances that may affect the impartiality of the investigators, such as financial interests and institutional affiliation, shall be disclosed. 

See the Swedish template "Declaration of conflicts of interest" which can be used under the tab "Suitability of the investigator" in CTIS.

9.5 ICF translations – Are Certificates Required?

The national law is silent on whether or not a translation certification is required. Under normal practice, Certificates of Translations (CoTs) are not required to be submitted. However, relevant CoTs should be filed within the Trial Master File.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study, and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

According to the Patient Injury Act (1996:799), healthcare providers are obliged to have insurance that covers damages in healthcare. The regions have their insurance, Patient Insurance, with the Regions Mutual Insurance Company (LÖF). This insurance also covers damages that may occur in connection with research on people who are patients in health care.

Läkemedelsförsäkringen AB provides compensation for damages that occur as a result of the use of drugs or placebos. The insurance applies to medicines from companies and organizations that have taken out insurance with Läkemedelsförsäkringen. It also covers damages that have occurred in connection with research.

The Swedish Clinical Studies Sweden (Kliniska Studier Sverige) provides useful templates for clinical trials according to the EU Regulation 536/2014, and one of them is a template for the certificate of insurance coverage.