Common Rule revisions: Comparing changes in US and Singaporean research regulations

Medical Law.jpgWhile Singapore will see a new regulatory regime for research as the Human Biomedical Research Act (HBRA) comes into force, the US has undergone one of the most major revisions to its own ‘Common Rule’ regulating research in decades. Interestingly, the new Common Rule overall relaxes restrictions on various aspects of research in the US. In this post I’ll briefly summarise some of the big takeaways, and draw some comparisons to the HBRA.

Softening in the face of Public Comment

The previous draft of the revised Common Rule had several provisions that did not make it into the final draft due to strong public backlash during the comment period. Most prominently: the draft would have required broad consent for research on de-identified biological samples. Researchers reacted very negatively, stating that this would significantly interfere with important biomedical research without providing significant additional protection to participants (as the main risks are informational). Patient groups were in agreement, concerned that innovative treatments would be delayed due to excessive bureaucratic regulation. The requirement was scrapped, and broad consent is now only required for research on identifiable samples.

The previous draft also would have significantly expanded the reach of the Common Rule. Currently, the Common Rule only applies to federally-funded research, with almost identical requirements for research on products that are to be marketed and regulated by the Food and Drug Agency. This leaves a significant gap – clinical trials involving, say, experimental surgical techniques, or non-pharmaceutical research funded by private grants are not directly regulated. The revisions would have expanded the scope of the Common Rule to involve all research at institutions that receive a single dollar of federal funding for any of its research activities. Reaction to the expansion was more mixed than the broad consent proposal. However, legal and practical concerns convinced the Department of Health and Human Services to remove the expanded scope from the final version of the new Common Rule.

In contrast, the HBRA is more strict on both these fronts. The HBRA does allow for a waiver of consent requirements for research on ‘legacy tissue’ (Section 64) that has been anonymized before the enforcement of the tissue framework (later this year). However, it appears that consent *will* be required for research use of even anonymized tissue, if the anonymization happens after the appointed date, as would be the case for all newly-gathered tissue. (This is the case, even though research on anonymized tissue would not qualify under the definition of “human biomedical research”; Section 37(6) requires consent for research on all tissue without reference to anonymization or “human biomedical research”)

The HBRA, like most other countries’ legal regimes, also applies to all research that fits the relevant definitions, regardless of funding source or marketing intent. The US remains an international outlier in its limited scope of regulation.

Easing the regulatory process

The two changes above would have amounted to significant new restrictions on research. Without them, the remaining Common Rule revisions generally contain provisions to make research easier and more efficient. One common complaint is the inclusion of too many minimal risk social science studies in the regulatory regime. Several new risk-based exemption categories are meant to ease the burden of the regulations in those areas that pose little danger to participants.

‘Broad consent’ is now in the Common Rule an officially recognized category of consent for future research that IRBs may use in lieu of the Common Rule’s standard consent requirements. This primarily applies to identifiable data and tissue research: instead of having to obtain consent for each new study on previously-gathered data and tissue, researchers may use a short summary of the sorts of research that may be conducted and oversight to be provided. A broad consent template has not yet been produced by US officials, and may be published for further comment at a later date.

Other provisions include encouraging shorter consent forms; reducing the need for continuing review in certain studies; centralizing IRB oversight for multi-centre studies; instructing researchers to provide a detailed plan on whether and how to return individual research results to participants; and explicitly requiring notification of any genetic testing that is to be done on gathered samples.

Unlike the Common Rule, the HBRA is a new Act covering a previously unregulated space (biomedical research outside clinical trials) and thus by nature is expanding regulatory oversight. Still, the HBRA contains its own provisions aimed at minimising intrusiveness. In particular, it has its own exemptions for certain low-risk social, behavioural and educational research not studying a particular disease. ‘Broad consent’ is not a recognised category in the law, though at 12(1)(i-j) it requires participants to be informed of whether tissue or identifiable data will be used in future research. It remains to be clarified whether this future research would need to fulfil all the consent requirements of Section 12, or whether that blanket statement is sufficient consent for any future research.

Many of the Common Rule revisions concern tissue research. The HBRA’s own framework spends considerable time on tissue banking and research. Later this year, MOH is expected to publish regulations governing such tissue banking activities; CENTRES plans to host case-based workshops (along the lines of our previous HBRA workshops) once these regulations have been promulgated.

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