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1 1 (December 10, 2018)

handle is hein.crs/govyci0001 and id is 1 raw text is: Congressional Research Service Informing the legislative debate since 1914 December 10, 2018 Updated Common Rule: Key Changes for 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). 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 Common Rule had remained virtually unchanged since it was adopted in 1991, while the research landscape has undergone significant transformation. Traditionally, the Common Rule has protected the rights and welfare of individuals participating in clinical trials and other interventional research. However, much of today's health research involves the analysis of health information rather than direct interactions with research subjects due to the growth in health data analytics, that is, using large databases of clinical, genomic, and other types of data in health research. Consequently, the primary risk for these research participants is no longer physical harm, but rather loss of privacy and loss of control over the use of their information. The rapid growth of research involving biospecimens, which increasingly are collected and used for whole genome sequencing and other genetic analysis, in particular has resulted in new challenges in the protection of human research subjects. Repositories store biospecimens for possible use in future (i.e., secondary) research that may be unrelated to the primary clinical or research use of the material. For example, the All of Us research program-part of the Precision Medicine Initiative (PMI) to accelerate research on personalized treatments tailored to a patient's characteristics-seeks to establish a national cohort of at least 1 million Americans who will contribute biospecimens for genome sequencing and other unspecified analyses. The final rule made a series of changes to the Common Rule, including, among others, making the informed consent process more transparent and imposing strict new requirements on the information given to prospective research subjects; changes to existing and creation of new exemptions to the requirements; and definitional changes, among other things. Many of these changes together create a new approach to regulating research with identifiable private information and biospecimens, and it is these changes that have generally received the most attention. The general compliance date of the revised common rule (referred to as the 2018 Rule or the 2018 Requirements) was delayed initially to July 19, 2018 (83 https://crsreport Federal Register 2885), and again to January 21, 2019 (83 Federal Register 28497), from the original compliance date of January 19, 2018. Definition of Human Subject Research 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 noninterventional research using biospecimens and stored data provided the specimens and data are identifiable. 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 to be readily 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. Research using nonidentifiable private information and nonidentifiable biospecimens remains outside the scope of the Common Rule. IRB Review and Informed Consent 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 regulation lists 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 final rule adds new informed consent requirements relating to any research involving the collection of identifiable biospecimens or private information. Specifically, it requires that the informed consent include either a statement that de-identified biospecimens may be used in future research without additional consent or that the subject's biospecimens or private information will never .congress.gov 0

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