IEEE Technology and Society Magazine - December 2021 - 59

norms established by professional bodies. Many of
these professional bodies are soft-law mechanisms,
not regulatory enforcement authorities. To elaborate,
research ethics emerged strongly through soft
law mechanisms, such as the normative statements
of the World Medical Association in the Declaration
of Helsinki [30]. Soft law motivation in the research
profession has continued throughout the twentieth
and into the twenty-first century as the Singapore
Statement on Research Integrity [31]. In some cases,
these soft law norms have been translated into " hard
law " practices via regulatory requirements for review
of projects that are enforced through state agencies.
However, other forms of review boards make up this
landscape-professional conduct review boards oversee
and pass judgment on cases when a professionals'
conduct is called into question by members of the
public or their peers [32]. One example is the National
Society of Professional Engineers (NSPE) Board of Ethical
Review (BER) [33]. Likewise, consumer product
safety and data safety and monitoring boards (DSMBs)
review evidence of harm to determine appropriate
strategies to mitigate harms, such as stopping a clinical
trial or requesting a product recall [34].
Soft law
Soft law is often understood as a set of normatively,
but not legally, binding commitments straddling
the spaces between law in the books, law in
action, and moral and political norms not yet codified
in either [35]. Soft law helps to bind actors
together through a set of negotiated commitments so
that noncompliance results in credible schemes of
punishment and reward, such as reputational costs
[36]. Soft law is described as an instrument appropriate
to the international arena, where state-to-state
relations are governed through legal instruments,
and organizational arrangements are distinct from
how domestic actors are governed through hard law.
Soft law is part voluntarism, consensus-building, and
applied ethics, where none have the force of law. As
Campbell and Glass describe,
" ethics rests primarily on the voluntary actions
of individuals, guided by their own consciences,
whereas law is a collectively articulated set of rules
backed by the state's power to coerce and sanction.
In the areas of clinical practice and research,
the law provides only the most general kinds of
instruction or prohibition and is only infrequently
brought to bear on correct behavior. The role of ethics
policies, codes, and guidelines in legal culture is
ambiguous. When they overlap with existing law or
are adopted by legislators in statutes or regulations,
it is clear that they represent " legal standards " or
" legal norms " and are binding in judicial decision
making. Standards that are not enacted in law or
regulation, however, do not have a definitive legal
status, even though they may affect the behavior
of health care professionals. This body of policies,
codes, and guidelines has been referred to as " soft
law " because of its uncertain legal status " [37].
With particular respect to the formation of obligation
relationships, scholars such as Kenneth Abbott
and Duncan Snidal describe schemes of international
law as a set of relationships which vary on three critical
dimensions: 1) the precision of rules; 2) [the scheme
of] obligation; and 3) delegation to third-party decision-maker-which
taken together can give laws a
" harder " or " softer " legal character [38]. Each dimension
is a critical factor for establishing new regimes of
soft law, such as those that would be necessary for AI
review boards at the research and production level.
With respect to AI research, the precision of the rules
and obligations will be a significant consideration in
the credibility of soft law mechanisms. For the context
of production-level AI, where the economic stakes of
failure and success are sufficiently high to induce
firms to " cheat, " the articulation of roles and the delegation
of tasks for a neutral third-party decision-maker
will be an important problem to solve.
Soft law governance and the role of
review boards
The World Medical Associations' (WMA) Declaration
of Helsinki is considered a major starting
point for the development of global research ethics
norms. It crystalized the ethics of medical research,
including establishing the requirement that research
be reviewed by a body of peers for conformity to
ethical standards (WMA article 23) [30]. What the
Declaration did not do is harden the norms or institutions
of research ethics into international " hard "
law, leaving ethics and review board governance to
highly distributed systems in individual nations and
in the realm of soft law [39].
From the Declaration to the Common Rule, many
of the normative terms within the field of research
ethics have an uncertain foundation in law. Although
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