For the first time since it was issued in 1991, the Common Rule – the set of federal regulations for ethical conduct of human-subjects research – has been updated. The Common Rule was amended not only by department initiative but also by more than 2100 public proposals that US Health Department started to accepts back in 2015. An article written by Health Department officials that gives reflection to new amendments was recently published in the New England Journal of Medicine.
Authors note that proposal to improve informed consent so that it would be easier to understand received substantial public support as informed consent forms are growing longer under new regulatory rules. New rule will order to give the information that a “reasonable person” would want to have to make a decision. Patient information leaflet should also be posted online.
Oversight will become more flexible. Research participants could be better protected if less time and effort were devoted to the oversight of low-risk studies. New rule facilitates a possibility for institutional review boards (IRB’s) administrators, and researchers to focus on ensuring appropriate protection in higher-risk studies.
Moreover, researchers will be given a permission to seek consent which allows participants to agree to researchers’ using their identifiable private information or identifiable biospecimens, originally obtained for other purposes in future studies that are not developed yet.
The new rule also adopts the proposal to generally require a single IRB review only for multi-institutional studies conducted in the United States.
Health Department paid attention not only to suggestions to implicate some of useful procedures into practice but also to comments that opposed original department’s proposals. For example, the new rule does not adopt the proposal to cover researchers’ use of unidentified biospecimens (such as leftover portions of blood samples) and to require informed consent for such research. Commenters’ complaints about the complexity of some proposals also shaped the final rule, including the federal agencies’ decision not to adopt the proposal to extend the Common Rule to clinical trials that are not federally funded.
Many of these amendments will come into force in 2018. Government-funded research in the US defines general scientific research direction all over the world, thus showing pharmaceutical industry a way to further business development. Focus on protection of research participants will result in greater trust of community in the research enterprise.