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TitleGray Matters
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Table of Contents
                            Gray Matters: Topics at the Intersection of Neuroscience, Ethics and Society (front cover)
Report title page
Tribute to Dr. John D. Arras
About the Presidential Commission for the Study of Bioethical Issues
Table of Contents
Letter of Transmittal to the President
Letter from the President to the Bioethics Commission
Members of the Bioethics Commission
Bioethics Commission Staff and Consultants
Acknowledgements
EXECUTIVE SUMMARY
CHAPTER 1: Introduction
	Background and the Promise of Neuroscience
	About this Report
CHAPTER 2: Cognitive Enhancement and Beyond
	Goals and Purposes of Neural Modification
	Ethical Analysis
	Recommendations
CHAPTER 3: Capacity and the Consent Process
	Ethical Analysis
	History of U.S. Policy Proposals and Recommendations
	Current Regulatory Framework
	Additional Ethical Safeguards
	Gaps in Our Understanding of Consent Capacity and Additional Protections
	Recommendations
CHAPTER 4: Neuroscience and the Legal System
	Ethical Analysis
	Current Use of Neuroscience within the Legal System
	The Value of Neuroscience to the Legal System
	Challenges of Applying Neuroscience to the Legal System
	Recommendations
CONCLUSION
	Recommendation
ENDNOTES
APPENDICES
	Appendix I: History of Major U.S. Policy Proposals and Recommendations on Consent Capacity in Research
	Appendix II: Guest Presenters to the Bioethics Commission Regarding Ethics and Neuroscience
                        
Document Text Contents
Page 1

VOLUME 2

GRAY MATTERS
Topics at the Intersection of
Neuroscience, Ethics, and Society

March 2015

Page 2

On the cover: Illustrated representation of
the surface of the brain and spinal cord.

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70

GR AY MATTERS Topics at the Intersection of Neuroscience, Ethics, and Society

can help protect participants from exploitation, by seeking to avoid the most
obvious forms of exploitation in which social benefits that result from research
are gained regardless of the expense to participants. Limits on risk help prevent
some individuals from unknowingly bearing egregious risks of harm for the
benefit of others.

The diversity of valuable research involving individuals with potentially
impaired consent capacity poses a challenge to uniform recommendations
for protecting these participants by limiting risk; research protocols can
vary widely in the nature and degree of risk participants might confront.
Several advisory bodies have recommended limitations on the level of risk to
which adults with impaired consent capacity can be exposed in a particular
protocol.257 Some experts have proposed limiting participation to protocols
with the potential for direct therapeutic benefit.258 Such safeguards are similar
to protections in place for research involving other vulnerable groups (such as
children) who cannot protect their own interests through informed consent.
In the case of research involving children, regulations generally only allow
research to proceed if it poses no more than minimal risk or offers a possibility
of direct benefit to participants; otherwise, regulations require more stringent
safeguards.259

Some advisory groups recommend that participants with impaired consent
capacity not be included in research without the prospect of direct benefit,
unless that research is of “vital importance.”260 Other groups propose that
researchers only recruit participants with impaired consent capacity if
the research is relevant to their disorder.261 Still other advisory bodies have
supported the inclusion of participants with impaired consent capacity in
minimal risk research, recognizing exclusion as disrespectful and possibly
unjust.262 Less agreement exists regarding the conditions under which it might
be acceptable to enroll individuals with impaired consent capacity in research
that poses greater than minimal risk and does not offer a prospect of direct
benefit. This determination remains at the discretion of individual IRBs.

Legally Authorized Representatives

Participants with impaired consent capacity can be enrolled in certain kinds
of research by an LAR. LARs, sometimes referred to as surrogate or proxy

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71

Capacity and the Consent Process III

decision makers, are individuals with the legal power to make decisions on
behalf of others. State laws dictate who can serve as an LAR, how much
decision-making power an LAR has, what kinds of decisions the LAR can
make, and what processes and procedures are required to establish an LAR.
Using an LAR is one important way to facilitate inclusion of participants with
impaired consent capacity in research, ensuring the just distribution of the
benefits that might accrue to people who share the disorder under study. Using
an LAR also is a reasonable way to help protect participants from exploitation,
because loved ones or caregivers who have been designated as LARs (as
discussed below) are often the best proxy for representing participant interests.

State laws vary regarding who can serve as an LAR. In most states, health
care proxies, or those holding a durable power of attorney for health care
previously appointed by individuals when they were capable, are deemed the
most appropriate LARs. State laws usually include a list of possible LARs in
a hierarchy, including those with health care power of attorney followed by
the individual’s next of kin (e.g., spouse, adult children, parents, and siblings).
Most state laws describe LARs as having authority for medical decision
making, but do not indicate whether the LAR’s decision-making power applies
to research participation. Although OHRP guidance indicates that LARs
appointed for medical care can make certain research enrollment decisions
under applicable state law, uncertainty remains about whether laws specific to
medical decisions can or should extend to research decisions. Medical decisions
are presumed in most cases to be compatible with the best medical interests of
the individual, whereas research enrollment entails procedures or interventions
done for reasons other than the individual’s medical interests.

LAR decision making is complex. LARs are often confronted with questions
about how to make decisions on behalf of their loved ones. For example, how
should they best honor the potential participant’s prior wishes and enduring
interests? Should they do what the potential participant would have wanted
before their impairment? Or should they attempt to determine what they
would want in the present (and how can this be ascertained)? The dilemma is
deep: How does even someone as close as a loving spouse or parent ascertain,
and act in accordance with, the values, authenticity, and sense of self of their
loved ones who no longer have the capacity to consent for themselves?

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Presidential Commission for the Study of Bioethical Issues
1425 New York Avenue NW, Suite C-100
Washington, D.C. 20005
(202) 233-3960
http://www.bioethics.gov

http://www.bioethics.gov

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