5. The common rule and social research

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort.

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Key Information in the New Common Rule: Can It Save Research Consent?

The Journal of Law Medicine & Ethics ◽

10.1177/1073110519857276 ◽

2019 ◽

Vol 47 (2) ◽

pp. 203-212 ◽

Cited By ~ 2

Author(s):

Nancy M. P. King

Keyword(s):

Information Disclosure ◽

Research Participation ◽

Recent Attempt ◽

Regulatory Regime ◽

Decision Making Process ◽

Common Rule ◽

Consent Forms ◽

Information Requirement ◽

Mutual Learning ◽

The Common

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

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