Proposed Revisions to the Common Rule

2013 ◽  
Keyword(s):  
Common Rule ◽  
The Common

The Reasonable Person Standard for Research Disclosure: A Reasonable Addition to the Common Rule

2019 ◽  
Vol 47 (2) ◽  
pp. 194-202 ◽  
Author(s):  
Rebecca Dresser
Keyword(s):  
Personal Experience ◽  
National Commission ◽  
Reasonable Person ◽  
Common Rule ◽  
Reasonable Person Standard ◽  
Research Oversight ◽  
The Common ◽  
Oversight System ◽  
Study Participants ◽  
Injured Patients

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.

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

2019 ◽  
Vol 47 (2) ◽  
pp. 203-212 ◽  
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.

scholarly journals Redressing Past Wrongs: Changing the Common Rule to Increase Minority Voices in Research

2013 ◽  
Vol 103 (12) ◽  
pp. 2136-2140 ◽  
Author(s):  
William C. Rencher ◽  
Leslie E. Wolf
Keyword(s):  
Common Rule ◽  
The Common ◽  
Past Wrongs

scholarly journals Revisions to the Common Rule: A proposal in search of evidence

2017 ◽  
Vol 13 (2) ◽  
pp. 92-96 ◽  
Author(s):  
Stuart G Nicholls
Keyword(s):  
Implementation Science ◽  
Present Article ◽  
Health Research ◽  
Scientific Community ◽  
Evidence Based Practice ◽  
Evidence Based ◽  
Common Rule ◽  
The Public ◽  
Regulatory Changes ◽  
The Common

Proposed changes to the Common Rule are proffered to save almost 7,000 reviews annually and consequently vast amounts of investigator and IRB-member time. However, the proposed changes have been subject to criticism. While some have lauded the changes as being imperfect, but nevertheless as improvements, others have contended that ‘neither the scientific community nor the public can be confident that improved practices will emerge from the regulatory changes mandated by the NPRM.’ In the present article, I discuss an important aspect that has been overlooked: the question of whether benefits will emerge is demonstrably empirical, yet data upon which to draw conclusions are conspicuous by their absence. This is thrown into sharp relief when we consider the current environment in which health research is increasingly focused on providing evidence of need or benefit, where there is greater emphasis on evidence-based practice, and when we have the nascent field of implementation science.

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