Nicolle Strand and Elizabeth Fenton of the Bioethics Commission

During this podcast, we talked to Nicolle Strand and Elizabeth Fenton of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), which is an incredible but surprisingly underutilized resource when it comes to reviewing human subjects research. We are going to specifically discuss the Bioethics Commission's report Gray Matters: Integrative Approaches for Neuroscience, Ethics and Society, which looks at the ethical issues associated with neurological research. Play the podcast in the player below or download it to your computer, smart phone, or tablet. Or, subscribe to the podcast on iTunes or Stitcher, listen on Google Play Music, or sign up to be notified when a new podcast is available.

Key Ethical Issues in Neuroscience Research

The Gray Matters report came out in response to President Obama’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) initiative and was tasked with looking at the following three key ethical issues:

Cognitive enhancement: How the use of drugs in neurological research can lead to unfair advantages on the part of its subjects.

Neuroscience and the legal system: How to be aware of how research findings can be misunderstood and misused in this context.

Consent capacity: How to enroll research participants whose conditions could lead to impaired consent capacity.

How to effectively and practically address the issue of consent capacity

The third issue of consent capacity was of particular interest to the Bioethics Commission, and the authors of the Gray Matters report make four important recommendations regarding this subject:

  1. We would like to responsibly include participants with impaired consent capacity in neuroscience research, but this can be a contentious topic, causing advisory bodies to swing back and forth in recommendations between over- and under- protection. The Bioethics Commission stresses that we must find a way to continue to advance research in the field without being exploitative.
  2. We must support research on consent capacity and ethical protection in order to capture a broad swath of conceptual and empirical research, which means we have to develop better, more careful and individualized assessment procedures in order to determine what it means to be able to consent.
  3. IRB deliberations should collaborate with members of stakeholder communities in reviewing ethical issues and stigmas associated with impaired consent capacity. There is a perception in the field that a person who lacks consent capacity is vulnerable, but we still need to include these participants. Therefore, we need to include the perspectives of the subjects’ advocacy committees on review boards. 
  4. We need to establish requirements for identifying legally authorized representatives (LARs). There are not many laws regarding assigning an LAR for research as opposed to clinical care, making this a complicated and confusing realm regarding legal liability. In order to establish clear guidelines for IRBs, we can look to local community practices as a guide instead of relying on state laws.

Keeping in mind the greater good that comes from research

In summary, the Bioethics Commission emphasizes that it is crucial that IRBs remember to think in the context of the public benefit that comes from research, as opposed to focusing exclusively on harm and risk. Misunderstanding can lead to overprotection, which can hamper research or stop it altogether, so we need to add a more measured and thoughtful take in order to distinguish between hype and reality.

The Bioethics Commission's reports are all available to the public and can be downloaded as PDFs at Bioethics.gov. The Bioethics Commission has also developed a whole suite of educational materials pulling out the most practical applications of their research for various audiences.