The role of state law in protecting human subjects of public health research and practice.

Temple University Beasley School of Law, USA.
The Journal of Law Medicine &amp Ethics (Impact Factor: 1.17). 02/2003; 31(4):654-62. DOI: 10.1111/j.1748-720X.2003.tb00132.x
Source: PubMed

ABSTRACT Public health activities present important ethical issues and risks to human subjects, whether these activities are considered research or practice. The federal regulations designed to protect human subjects during research studies, known as the Common Rule, may apply to a number of public health activities, such as disease reporting, surveys, or review of medical records. The extent that the Common Rule should apply to public health practice is still debated, but the National Bioethics Advisory Commission (NBAC) suggests that state law could offer meaningful guarantees that public health activities will protect the rights and welfare of individuals. This study sought to evaluate whether state public health law provides protection for people comparable to the Common Rule. State statutes that set the powers and duties of health agencies were reviewed to identify provisions that provided protections analogous to those provided by the Common Rule. The Common Rule contains six key protections: 1) consent for data collection; 2) protection of private information in collected data; 3) use of a bona fide, safe, and effective research design; 4) equitable selection of subjects; 5) appropriate data safety monitoring; and 6) protection of vulnerable populations. Our analysis showed that the protection provided to the subjects of public health practice by state law is comparable to the protection provided to research subjects under the Common Rule, but clearly not identical. The Common Rule requires individual informed consent prior to information collection. By contrast, there is no state law requirement for individualized consent for many kinds of data collection; consent may not be revoked; and notice for most people will be formal rather than actual. Privacy protections and data security requirements, which are explicitly outlined in the Common Rule, vary greatly under state public health laws. Data collection plans are not required under state law to be formally reviewed for either scientific or ethical quality. Ethical performance, including protection or inclusion of vulnerable populations, is not an explicit performance measure in the accountability/ management framework of public health. The Common Rule achieves accountability through the Institutional Review Board system; state law obtains accountability more indirectly through courts, elections, and the media. Ultimately, state public health law is an important regulatory resource to protect human subjects, complementing not only the Common Rule, but other ethical standards. The importance of effective public health practice justifies the development and understanding of regulatory approaches that promote excellent public health practice, including respect for human subjects.

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May 31, 2014