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1 1 (May 16, 2017)

handle is hein.crs/govcfwv0001 and id is 1 raw text is: FF. ' -iE S .r , i , May 16, 2017 Updated Common Rule: Research Using Stored Biospecimens On January 19, 2017, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies jointly published a final rule to amend the uniform set of regulations known as the Common Rule-that govern the ethical conduct of research supported by these agencies involving humans (82 Federal Register 7149). The Common Rule has remained virtually unchanged since it was adopted in 1991, while the research landscape has undergone enormous transformation. One key area of change is the rapid growth of research involving biospecimens (e.g., human blood, tissue, and other biological specimens), which increasingly are collected and used for whole genome sequencing and other genetic analysis. Repositories store biospecimens for possible use in future (i.e., secondary) research that may be unrelated to the clinical or research use of the material at the time it was collected. The All of Us research program part of the Precision Medicine Initiative to accelerate research on personalized treatments tailored to a patient's genetic and other characteristics seeks to establish a national research cohort of at least 1 million Americans who will contribute biospecimens for genome sequencing and other analyses (see CRS Insight IN10227, The Precision Medicine Initiative). Traditionally, the Common Rule has protected the rights and welfare of individuals participating 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 health information rather than direct interactions with research subjects. Consequently, the primary risk for these research participants is no longer physical harm but loss of privacy. According to HHS, the purpose of the final rule is to modernize, simplify, and strengthen the Common Rule to better protect human research subjects, while facilitating new research and reducing burden and ambiguity for investigators. The final rule makes a series of important changes to the Common Rule, almost all of which take effect on January 19, 2018. They include making the informed consent process more transparent and imposing strict new requirements on the information given to prospective research subjects. But it is the treatment of biospecimens that has attracted by far the most public comment. Cm,,-,;n Ruk-, IR Revkew, ,-,d Under the Common Rule, research protocols must be reviewed and 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 and appropriately document 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 intervention or interaction with an individual but also studies that obtain identifiable private information. Thus, it applies to non-interventional research using biospecimens and stored data provided the specimens and data are identifiable. The final rule modifies the definition of human subject research to clarify the current interpretation of the regulations by explicitly stating that it includes obtaining and analyzing information and biospecimens through intervention, as well as research that obtains, uses, analyzes, or generates identifiable private information or identifiable biospecimens. Nonidentifiable private information and nonidentifiable biospecimens remain outside the scope of the Common Rule. The Common Rule states that information is identifiable if the subject's identity may readily be ascertained by the researcher. A biospecimen or genome sequence stripped of any accompanying identifiers (e.g., name, address, social security number) is not considered readily identifiable. During the informed consent process, researchers may seek consent to store identifiable information and biospecimens obtained during the primary research study for use in secondary research. But providing an adequate description of the secondary research is a challenge. Currently, if an IRB reviewing a secondary research project concludes that the original informed consent document does not adequately describe the secondary research, then the researchers must either find the research subjects and obtain their informed consent (unless waived by the IRB) to conduct the new research or strip the identifiers from the research material. Under the final rule, researchers will now have the option of obtaining subject to limited IRB review broad consent for the storage, maintenance, and yet-to-be specified secondary research use of identifiable private information or biospecimens, rather than having to undergo full IRB review and obtain study-specific informed consent (unless waived by the IRB); see Figure 1. gogn, q \pp\\m -,\\mw-m ggmm g , q aS ' X 11LULANJILiN,

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