Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies

Abstract

The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.

Market Considerations for Nanomedicines and Theranostic Nanomedicines

“…Clinical trials are expensive and their costs will likely increase in the future [88]. The oversight for nanomedicine may increase since it is an emerging technology with potential risks to be determined [89].…”

Blood-to-Brain Drug Delivery Using Nanocarriers

“…However, governmental regulations are hindered by a lack of toxicology data for nanocarriers (Fernandes et al 2010 ;Farrell et al 2011 ). In addition, Wolf and Jones ( 2011 ) have recommended extra oversight for clinical research due to the uncertain but possibly signifi cant risks of new science and technology associated with nanomedicine (including drug nanocarriers).…”

“…Providing preclinical proof that the investigational product is safe is one consideration, while regulatory aspects make up another. Wolf and Jones ( 2011 ) have recently reviewed whether or not it is necessary to have extra oversight, i.e., additional approval processes beyond the current institutional review boards (IRB) for emerging technologies such as nanocarriers. They claim that there is a heightened uncertainty regarding the risks in fast-evolving science, yielding complex and increasingly active materials.…”

Preventing Societal Health Risks Emerging in the Development Of Nanomedicine - What Should Prevail?

“…Heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant are identified as relevant confluent factors in support of the need for an exceptional oversight beyond the existing Common Rules 6 supervised by either local or federal institutions such as the US Department of Health and Human Services, the Federal Drug Administration (FDA), notably its Centres in charge of overseeing drug, biologics, and device approval, the National Institutes of Health or the National Cancer Institute (Wolf and Jones, 2011). Concern regarding potential risks does not involve only the volunteers and candidates recruited to participate to clinical trials, but also workers employed in the manufacturing industries, as well as, during the fundamental research stage, scientists conducting experiments in public or private laboratories.…”

“…Thus, beyond the individual approach, the core of this work also concentrates on workers' safety, and to a certain extent, exposure of close contacts and community effects. Indeed, since laboratory practices, waste, as well as human subject excretion of nanomaterials can raise environmental concern, analysis of environmental effects should also be examined (Wolf and Jones, 2011).…”