11/18/2023 0 Comments Clarify definition literatureIn this guidance, the term "pre-2018 Requirements" refers to the Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on Jand subsequently amended on June 23, 2005). IRB administrators, IRB chairpersons, relevant institutional officials, and investigators who may be concerned about whether scholarly or journalistic activities need to satisfy the 2018 Requirements of the regulations. This document explains how certain scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected are deemed not to be research under Department of Health and Human Services (HHS) 2018 Requirements of the regulations for the protection of human subjects (45 CFR Part 46), and consequently do not have to satisfy the requirements of those regulations. OHRP is available to discuss alternative approaches by telephone at 24 or 86, or by email at JScope: An institution may use an alternative approach if the approach satisfies the requirements of 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. The use of the word "must" in OHRP guidance means that something is required under the Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP guidance should be viewed as recommendations unless specific regulatory requirements are cited. This guidance does not create or confer any rights for or on any person and does not operate to bind OHRP or the public. This guidance, when finalized, will represent the Office for Human Research Protections’s (OHRP’s) current thinking on this topic. NOTE : This guidance is consistent with the 2018 Requirements (the revised Common Rule) effective July 19, 2018.
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