Changes to the clinical trial regulations

The new Human Biomedical Research Act (HBRA) has introduced significant changes into how human subjects research is to be regulated in Singapore. To help practitioners adapt to these changes, CENTRES will be hosting a workshop in February on the HBRA, and we plan further events in 2016. But the HBRA is not the only recent change to research ethics governance in Singapore. The Health Sciences Authority released for public consultation planned changes to the regulations of clinical trials  (the consultation period has now closed). This post will briefly discuss some of the changes that are coming.

Streamlining

One main purpose of the changes is to consolidate regulations of therapeutic products previously found under multiple Acts – the Health Products Act, Medicines Act and the Poisons Act. Going forward, the relevant regulations for therapeutic products will be found in the Health Products Act alone, to avoid the need of stakeholders to refer to multiple pieces of legislation. This includes the regulations governing clinical trials of therapeutic products. But the HBRA will still be a separate piece of legislation with somewhat different governance structure (more on that below).

Two-track system

Under the current regime, investigators in clinical trials need a clinical trial certificate issued by HSA to begin a trial. The new system relaxes these requirements by creating two tracks for clinical research. The first track operates in a similar fashion as the old CTC system, requiring HSA approval for each new protocol. But the second track only requires HSA notification of a trial. A trial falls under the second track if it tests an already-approved product for its approved indication. In addition, purely observational trials (where no additional interventions are applied beyond care that would already be given) are completely excluded from the clinical trials regulations – though that likely means they will fall under the HBRA instead.

Intersection with the HBRA

The HBRA specifically excluded from its main scope research that fell under the Medicines Act (Clinical Trials) and the Health Products Act. There is, to be sure, at least one important new point of intersection with the revisions to the clinical trial regulations – clinical trials are required to be approved by IRBs appointed under the requirements of the HBRA (Part 4).   But other points of difference remain. Under the HBRA (§23(3)), for instance, all deviations of the HBRA must be reported to the Director of Medical Sciences, while only serious deviations from the Clinical Trials regulations (§11(1)) are required to be reported to the Health Sciences Authority. Deception is permitted under some specific circumstances under the HBRA (§26(2)) but not under the Clinical Trials regulations (§20). And for minors who lack capacity to consent: under the HBRA (§8(1)), they can participate in research if their guardian consents and the research needs such minors to be effectively carried out; but under the Clinical Trials regulations (§16(7)(b)), there are further requirements that the subject benefits from the research (or, if there are no prospects of direct benefits, that the trial benefits the ‘group of subjects’ involved in the trial and the risks are low).

Subtle differences between the HBRA and the Clinical Trials regulations thus persist. Generally speaking, clinical trials regulations are tighter, owing to the risks and invasiveness involved in trials of therapeutic products. IRBs that oversee both clinical trials as well as non-clinical human biomedical research will thus need to become familiar with both legal regimes in order to adequately oversee research.

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