In accordance with GBR-113, the United Kingdom also allows a sponsor to delegate some or all of its testing-related functions to a contract research organisation (CRO) and/or institutional site. However, the ultimate responsibility for the quality and integrity of the study data remains with the sponsor. All audit responsibilities assigned to a policy management officer should be set out in a written agreement. The CRO should perform quality assurance and control. According to G-CTApp and GBR-103, a clinical trial sponsor in the UK or a country must be on a list of approved countries, which initially includes European Union (EU)/European Economic Area (EEA) countries. If this is not the case, the promoter must have a legal representative who is thus established. RGG-103 specifies that information relating to legal representatives must be entered into the « legal representative » section of the Integrated Search Request System (IARS) (GBR-78). Legal representative: In accordance with the UK GDPR, UK DPAct, GDPR and GBR-89, participants have the right to be informed about the collection and use of their personal data. This is a central transparency requirement under data protection laws. The UK GDPR defines the data that individuals have the right to be informed about (i.e. privacy information). In addition, as described in the UK-GDPR, UK-DPACT, G-G-GDPR and GBR-89, the participant has certain rights over the data, which are limited by a number of exceptions.
These exceptions must be weighed against what is fair to participants. As stated in the GDPR-G, exceptions to the rights of data subjects are not automatic, but must be considered from study to study. It is therefore important to consider the relevance of data rights for a particular study in the Participant Information Sheet (SIP) when offering or limiting the rights available to research participants. If data rights have already been offered or limited to participants that are not appropriate under the UK GDPR, the PIS may need to be revised as a non-essential change. For more information on the Sponsor`s data protection requirements (referred to as « controller » in the UK GDPR), see Sponsoring, Subtopic Quality, Data and Records Management. As stated in MHCTR, MHCTR2006 and GAfREC, applications for CTIMP require the positive opinion of a European Commission recognised by UKECA and approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) before the sponsor or his/her designated legal representative starts the study. The G-CTApp allows the MHRA review process to be conducted in parallel with the EC review, specifying that an opinion from the European Commission can be obtained before, during or after the electronic submission of the MHRA application to the Integrated Search Request System (IRAS) (GBR-78). Therefore, an IRAS account must be created to prepare an EC application.
According to GBR-78, SARI does not change the verification requirements, including approvals or signatures, of a regulatory body or national health authority (NHS). Therefore, different approvals are required depending on the type of study and the expert groups responsible. The legal basis for all types of requests is defined in the legal instruments: if you believe that your application has been wrongly rejected, you must send an e-mail IPUenquiries@mhra.gov.uk. Our legal basis for processing your personal data is Article 6(1)(e) of the UK GDPR, which allows us to process personal data where this is necessary for the performance of our public functions as a regulator. If you have any questions or concerns about how the MHRA protects and uses your personal information, please contact us first at dataprotection@mhra.gov.uk. You can also contact the DHSC Data Protection Officer, data_protection@dh.gov.uk. If you have any questions about the submission portal, please send submissions@mhra.gov.uk an email. The submission of a new FSMA and any updates to an FSMA must be made by the FMSA holder using the MHRA submissions. If you have any questions about MHRA submissions, you should send submissions@mhra.gov.uk an email. As set out in UK-HTA, GBR-9 and GBR-37, UK-HTA considers it a UK-wide offence to possess relevant human material or tissue with the intent to perform DNA analysis or to use the results of such analysis without the « qualified consent » of a participant and/or his/her legal representative, unless the information is used for an `exempted purpose`. The UK-HTA states that « permissible consent » is the consent required with respect to the analysis of DNA produced by the human body.
An « excluded purpose » is defined as follows: We will not disclose your identity to anyone outside the MHRA without your express consent, unless we are required or permitted to do so by law. For example, if we receive a court order or if you are a healthcare professional reporting an adverse medical device incident, see below for more details. Exceptionally, we may share it if we have established a legal basis for sharing personal data and can demonstrate that this is both necessary and proportionate. The appropriate legal basis depends on the type of application you are making. The legal bases are as follows: Office of Clinical Research: Email: clintrialhelpline@mhra.gov.uk Phone: +44 020-3080-6456 GBR-103 provides that if a sponsor is not established in the UK or on an approved list of countries (which originally includes European Union (EU)/European Economic Area (EEA) countries), it is required by law to have a legal representative based in the UK or in a country on the list of approved countries for the purposes of of the study. According to G-CTApprovedCountries, MHCTR-EUExit will refer to a list of countries where a clinical trial sponsor or legal representative may be established; these countries are initially EU and EEA countries. The MDCN and RGS-113 stipulate that contact information for the sponsor and investigator(s) must be provided to the research participant and/or his/her legal representative or guardian(s) in order to respond to trial-related requests. The MHCTR and G-ConsentPIS indicate that the researcher(s) must provide detailed information about the research study to the participant and/or his/her legal guardian(s). The MHCTR and G-ConsentPIS also state that oral and written information about the study, including ICF, must be easily understandable and submitted without coercion or undue influence to a potential subject to participate in the clinical trial. The participant and his or her legal representative or guardian should also be given sufficient time to consider whether or not to participate. Via G-ConsentPIS, the Participant Information Sheet (PIS) supports the consent process to ensure that participants have been properly informed. In addition, the PIS is part of the transparency information that must be provided to participants under data protection laws for the use and processing of personal data.
According to the UK GPR, UK DPCA, and GDPR, consent to participate in research is not the same as consent as a legal basis for processing personal data under data protection laws.
