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Times have changed, and the “Common Rule”—regulations that protect people who participate in research—is being revised.
Related: Using Quality Indicators to Assess and Improve Human Research Protection Programs at the VA
The regulations, in place since 1991, are followed by 18 federal agencies. The regulations were developed at a time when research was conducted mostly at single sites, usually at universities and medical institutions. Now, however, an increase in multisite studies and advances in technology have “highlighted the need to update the regulatory framework,” according to HHS.
Related: Improving Veteran Access to Clinical Trials
The Notice of Proposed Rulemaking (NPRM) is an effort to reinforce and modernize the regulations. For example, the NPRM advocates strengthening informed consent provisions to make sure individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study. The proposal also covers changes in review, such as requiring a single institutional review board, in most cases, for multisite research studies.
HHS is taking public comments on the NPRM through December 7, 2015.
Times have changed, and the “Common Rule”—regulations that protect people who participate in research—is being revised.
Related: Using Quality Indicators to Assess and Improve Human Research Protection Programs at the VA
The regulations, in place since 1991, are followed by 18 federal agencies. The regulations were developed at a time when research was conducted mostly at single sites, usually at universities and medical institutions. Now, however, an increase in multisite studies and advances in technology have “highlighted the need to update the regulatory framework,” according to HHS.
Related: Improving Veteran Access to Clinical Trials
The Notice of Proposed Rulemaking (NPRM) is an effort to reinforce and modernize the regulations. For example, the NPRM advocates strengthening informed consent provisions to make sure individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study. The proposal also covers changes in review, such as requiring a single institutional review board, in most cases, for multisite research studies.
HHS is taking public comments on the NPRM through December 7, 2015.
Times have changed, and the “Common Rule”—regulations that protect people who participate in research—is being revised.
Related: Using Quality Indicators to Assess and Improve Human Research Protection Programs at the VA
The regulations, in place since 1991, are followed by 18 federal agencies. The regulations were developed at a time when research was conducted mostly at single sites, usually at universities and medical institutions. Now, however, an increase in multisite studies and advances in technology have “highlighted the need to update the regulatory framework,” according to HHS.
Related: Improving Veteran Access to Clinical Trials
The Notice of Proposed Rulemaking (NPRM) is an effort to reinforce and modernize the regulations. For example, the NPRM advocates strengthening informed consent provisions to make sure individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study. The proposal also covers changes in review, such as requiring a single institutional review board, in most cases, for multisite research studies.
HHS is taking public comments on the NPRM through December 7, 2015.