On 1st July 2021 , Health Sciences Authority (HSA) Singapore issued new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue, which will applies to new clinical trial applications submitted to HSA from 1 August 2021.
The purpose of this guidance document is to provide guidance to sponsors and investigators on the information to be provided to trial participants as part of the informed consent process, prior to collecting human tissue in clinical trials regulated under the Health Products Act and the Medicines Act.
This guidance applies to clinical trials regulated by HSA:
(i) Clinical trials of Therapeutic Products or Class 2 Cell, Tissue and Gene Therapy Products (CTGTPs) that are subject to the requirements of a Clinical Trial Authorisation (CTA) or a Clinical Trial Notification (CTN);
(ii) Clinical trials of Medicinal Products that are subject to the requirements of a Clinical Trial Certificate (CTC).
For the purposes of Regulation 19(1)(u) of the Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations, the following information should be provided to potential trial participants or their legal representatives for clinical trials involving the collection of human tissue, in addition to the Specific Consent Elements:
- (a) the provision of the tissue is voluntary and the renunciation of the trial participant’s rights to the tissue and any intellectual property rights that may be derived from the use of the tissue;
- (b) whether the tissue taken from the trial participant will be destroyed, discarded or stored and used for future research;
- (c) where applicable, whether the trial participant’s individually-identifiable information will be used for future research4;
- (d) whether the trial participant would wish to be re-identified in the case of an incidental finding relating to the collected tissue if the research expressly provides for such re-identification;
- (e) whether the tissue will be exported or removed from Singapore to a place outside Singapore.
More details can be found in the CLINICAL TRIALS GUIDANCE – CONSENT REQUIREMENTS FOR CLINICAL TRIALS INVOLVING COLLECTION AND USE OF HUMAN TISSUE GN-IOCTB-15 Rev. No. 001: https://www.hsa.gov.sg/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-15_consent_human_tissue_1jul2021.pdf