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? 

This area of regulation is evolving.

The outcome of the MHRA, HRA, and Northern Ireland Department of Health consultation to reform national clinical trial legislation (“the Consultation”) - “Government response to consultation on legislative proposals for clinical trials” - has been published (updated 21 March 2023). The need for participant diversity is stressed throughout the document, and the use of digital tools and platforms to enable this is an effective method of recruiting a diverse range of participants.

Prior to the Consultation, the Department of Health & Social Care published a paper entitled “The Future of UK Clinical Research Delivery: 2021 to 2022 Implementation Plan”. The Plan proposes to “deliver ambitious new initiatives that will set us on the path towards realizing our bold vision for the future of UK clinical research”, and to “support and enable the delivery and evaluation of innovative models of trial delivery, such as … decentralized models and remote participation”. The Paper further mentions the development of “a ‘Find, Recruit and Follow-up’ service – to make it easier than ever for researchers to connect with the digital tools and platforms that will expedite research recruitment, set-up, and monitoring”. One of the tools is the Speedy Patient Recruitment into Trials software (SPRINT).

Though there are no direct regulatory provisions in relation to the use of social media for recruitment, both the Government response to the Consultation and the Plan, indicate that the use of digital services to recruit participants, as approved by the MHRA, will be permitted.

9.2 Vulnerable Subjects

As per the MHCTR, The Medical Research Council guidance for assessing individuals’ capacity to consent to participation in research (MRC Guidance), and the International Council for Harmonization’s Guideline for Good Clinical Practice E6(R2), in all United Kingdom (UK) clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. 

The MRC Guidance characterizes vulnerable populations as those who are dependent on others and are unable to express their opinion freely or make their own decisions. These participants may include children, persons with mental or physical incapacities, persons with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, prisoners, detainees, refugees, members of a group with a hierarchical structure, such as students, subordinate hospital and laboratory personnel, pharmaceutical industry employees, members of the armed forces, and persons kept in detention.

The UK Research and Innovation has developed some guidance on “Research with potentially vulnerable people”. This guidance provides points that researchers should consider as well as their responsibilities when conducting research with participants who are considered vulnerable.

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

There are many ethical and legal issues to consider when involving children and young people in research. The requirements for consent, where participants are children and/or young people, depend on the type of study and where in the UK it is taking place. 

According to the MHCTR, a minor is an individual under 16 years of age. As set forth in the MHCTR, the MHCTR2006, the UK - Medical Research Council (MRC) - Consent and Participant Information Guidance, the MRC Guidance “Involving children in research”, and the International Council for Harmonization's Guideline for Good Clinical Practice E6(R2), when the research participant is a minor, informed consent should be obtained from his/her legal representative(s) and/or guardian(s).

Legally, the researcher needs only to obtain consent from one (1) person with parental responsibility; however, consent from all legal representative(s) and/or guardians is encouraged. Additionally, precautions against possible physical and mental harm should be exercised. All pediatric participants should be informed to the fullest extent possible about the study in language and terms that they are easily able to understand. The rights of the minors should also be respected for their voluntary decision to participate in a clinical study.

The MHCTR, the MHCTR2006, and the MRC Guidance “Involving children in research”, state that a study may only be conducted on minors if several conditions are fulfilled including:

1. An ethics committee (EC), following consultation with pediatric experts, has endorsed the protocol.
2. The legal representative(s) and/or guardian(s) have had an interview with the investigator(s) to understand the trial objectives and risks, have been provided with a point of contact for further information, and have been informed of the right to withdraw the minor from the trial at any time.

Below you will find specific guidance on consent by and on behalf of children and young people in England, Wales, and Northern Ireland. If your project is taking place in Scotland, please refer to HRA’s specific online guidance on the principles of consent by and on behalf of children and young people in Scotland. Their online guidance includes information on involving children and young people in the consent process including when to seek assent. To find out more, please visit this online consent and participant information sheet preparation guidance.

9.4 Financial Disclosures

Specifically for the UK, there is no guidance explicitly stating the financial disclosure requirement by the Chief Investigator or Investigator. 

9.5 ICF translations – Are Certificates Required?

The documents should be submitted in English. Translations are not applicable unless it is known that a non-English speaker participant may participate in the study.

When translation of ICFs is required, the Certificate of translation must be filed within the Trial Master File (TMF).

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?

These particular details are not specified within the existing legislation. However, the ABPI guidance on “Clinical Trial Compensation Guidelines” indicates the following:

“The amount of compensation paid should be appropriate to the nature, severity, and persistence of the injury and should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English Court in cases where legal liability is admitted.”