The efforts to "modernize and revise" current regulations for the protection of human subjects are both necessary and timely. The Department of Health and Human Services’ proposal reflects knowledge and experience gained through an explosion of research in the past 20 years. There is awareness that the founding principles that guide medical research can still be realized while creating a system that is more efficient, clear, and calibrated.
People often like to state we are entering the era of "individualized medicine." This is a way for the research to be more "individualized," too: for human subjects, medical researchers, and members of institutional review boards (IRBs). A more fluid and responsive system would be a worthy achievement.
I believe the proposed changes can propel research forward, reducing frustration among researchers, removing unnecessary bureaucratic hurdles, and stimulating new ways to address important research questions. At best, it will encourage more physicians and trainees to become investigators and allow members of IRBs to more appropriately allocate their time to higher risk studies. For human subjects, one example of progress is that consent forms could be targeted to provide valuable information rather than appear as long and legalistic documents that are both confusing and unhelpful.
My experience has been that many people with neurological conditions, likely the majority, want to participate in research and see it as valuable. It is our job as researchers and institutions to not overwhelm human subjects by an unnecessary array of forms and documents while honestly conveying risk. It is our job to make sure that our subjects are actually informed and protected and that we are not merely going through the motions of documentation to fulfill requirements. It is also the role of government to make sure that it is creating rules that can effectively drive research forward and allow researchers to do the work that is needed.
These proposed changes hold promise for fueling multicenter research studies for rare or "orphan" neurological conditions by allowing a single IRB to be responsible for oversight of a domestic multicenter study. It is likely that more centers will become involved and more studies will be feasible if that change happens. Reducing barriers that have provided no added protection to participants can free up researchers’ time and allow more time for participants to interact with researchers in a meaningful way.
This proposal also recognizes the growth of work in social and behavioral sciences, stating that this research may be "overregulated" in some cases. Neurological disease overlaps significantly with the behavioral sciences, in realms of child development, cognitive outcomes research, dementia, disability, and quality of life. Many surveys that have been regulated by IRBs have posed no physical risk and IRBs may not be the best place to adjudicate all aspects of informational risk.
Minimal-risk studies could start soon after application in this new proposal. This will be especially helpful for trainees in neurology who often participate in minimal-risk studies during residency and fellowship but currently experience delays of months to start their projects.
Clarification of biospecimen rules also will allow people with neurological conditions to give their consent for their specimen to be used for future relevant studies if they so choose. As advances are made in diagnosis and detection, such as cerebrospinal fluid biomarkers in neurodegenerative and neurocritical conditions, these changes may allow for continued contributions by people with neurological conditions that can benefit patients for many years to come.
In short, this process is about refining existing rules to help researchers and protect human subjects while also being cognizant of where the risks to human subjects actually exist. Neurologists stand to benefit. As both a clinical researcher and a participant in human subjects’ research, I feel I have the chance to benefit twice.
Dr. Farrah Mateen is a fellow in neuroimmunology and neurological infectious diseases and is a doctoral candidate in international health at Johns Hopkins University, Baltimore. She is the chair of the American Academy of Neurology Ethics Section. The views expressed here are her own.