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1 1 (March 24, 2016)

handle is hein.crs/govcdwx0001 and id is 1 raw text is: '. ~**\**\ &~ ~ riE SE .$rCh &~ ~ ~ March 24, 2016 Updating the Common Rule in an Era of Big Health Data Last fall the Department of Health and Human Services (HHS) and 15 other federal departments and agencies jointly released a proposed rule to amend the uniform set of regulations-informally known as the Common Rule-that govern the ethical conduct of research involving humans (80 Federal Register 53931, September 8, 2015). Federal regulations to protect human research subjects were first published by HHS in 1974 and revised in 1981 to implement the Belmont Report. That landmark report laid out an ethical framework for conducting human subject research based on the principles of (1) respect for persons (i.e., individuals are autonomous agents and should be given the opportunity to make informed choices based on their own judgment and opinions); (2) beneficence (i.e., the potential benefits of research should be maximized while minimizing the potential risks to research participants); and (3) justice (i.e., the benefits and the risks of research should be distributed fairly and not fall on one particular group). A modified version of the Common Rule was adopted by HHS and multiple other departments and agencies in 1991. While it has remained virtually unchanged since that time, the research landscape has undergone enormous change. One key area is the rapid growth of research involving the collection and use of biospecimens (i.e., human blood, tissue, and other biological samples). Biospecimens increasingly are used for genome sequencing and other genetic analysis. Repositories are being created to store biospecimens for use in secondary research, which may be unrelated to any primary research using the material at the time it was collected. The President's Precision Medicine Initiative to accelerate research on personalized treatments tailored to a patient's genetic characteristics seeks to establish a national research cohort of at least 1 million Americans who will contribute biospecimens for genomic sequencing (see CRS Insight IN10227, The Precision Medicine Initiative). The focus of the Common Rule traditionally has been to protect the safety of individuals who participate in clinical trials and other interventional research. But with the enormous growth in health data analytics-using large databases of clinical, genomic, and other types of data- much of today's health research involves the analysis of information rather than direct interactions with research subjects. Consequently, the primary risk for many research participants is no longer physical harm but loss of privacy. The stated purpose of the proposal is to modernize, simplify, and strengthen the current system of Common Rule oversight of research involving human subjects. The proposed changes seek to enhance the protections for research subjects while facilitating important new research. ~OT ~Rku4, MB as8d~~n d Cor..nnet Under the Common Rule, research protocols must be approved by an Institutional Review Board (IRB) to ensure that the rights and welfare of the research subjects are protected. The regulations list several criteria for IRB approval, including the requirement that researchers obtain the informed consent of their research subjects. The informed consent process includes an explanation of the purpose of the research, a description of the research procedures, and a description of the risks and benefits of the research, among other things. An IRB may decide to waive the informed consent requirement if it determines that the research poses no more than minimal risk to the subjects, the waiver will not adversely affect their rights and welfare, and the research is not practicable without a waiver. The Common Rule defines human subject research to include not only studies that obtain data through direct intervention or interaction with an individual, but also studies that acquire identifiable private information about an individual. Thus, the rule applies to non-interventional research on donated biospecimens and stored data provided the specimens and data are identifiable. The Common Rule states that information is identifiable if the researcher can readily ascertain the identity of the subject. A biospecimen or genome sequence that has been stripped of any accompanying identifiers-such as name, address, social security number, or any other identifying number, image, or code-is not considered readily identifiable and is not subject to the Common Rule. The Common Rule permits the informed consent process to include corollary and secondary research. For example, researchers may wish to store information and specimens obtained during the primary research study for use in future studies. In such instances, an IRB may approve an informed consent document that asks research participants to allow future research on their identifiable information or specimens. However, the document must contain sufficient detail about the future research to allow for truly informed consent. HHS and other departments and agencies have proposed a series of important changes to the Common Rule. Those include making the informed consent process more transparent and imposing strict new requirements on the information that must be given to prospective research subjects. The proposal also would exclude certain categories of research from the Common Rule that are deemed not to be research, or that are inherently low-risk and already subject to independent controls. -{a.. . :,?,?.- x, ¢- ,-O 'T ?. -- x-\ p\w gnom ggmm mppm qq\ a , q 's I 11LIANJILiN,

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