Paper Title
Are Changes to the Common Rule Necessary to Address Evolving Areas of Research?
Keywords
- common rule
- human subjects research
- research ethics
- institutional review board (irb)
- u.s. department of health and human services
- advanced notice of proposed rulemaking (anprm)
- research regulation
- ethical guidelines
- clinical research
- collaborative research
- international research
- research oversight
- academic medical centers
- outpatient clinics
- community hospitals
- nontraditional research venues
- technological advances
- data privacy
- informed consent
- social media research
- mobile applications
- big data
- research methods
- data sharing
- data security
- biomedical research
- behavioral research
- ethical challenges
- federal regulations
- privacy protections
- research governance
- human research protections
- research policy
- ethical considerations
- research innovation
- emerging technologies
- research compliance
- public health research
- digital data ethics
- research participant protections
- research integrity
- ethical review
- multi-site studies
- global health research
- participant rights
- data ethics
- future of research
- regulatory updates
Article Type
Research Article
Research Impact Tools
Publication Info
Volume: 41 | Issue: 2 | Pages: 454-469
Published On
June, 2012
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Abstract
The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.
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