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Hello. I’m Yvonne Lau from the HHS Office for Human Research Protections, and I’m going to talk about Broad Consent in the Revised Common Rule that was published on January 19, 2017. Under the revised Common Rule, there is now a new term and a new option called Broad Consent. This option provides another way to facilitate the conduct of minimal risk research. The rationale behind creating this category is that it would allow subjects a means to exercise their autonomy to allow secondary research use of their identifiable materials for future unspecified research. I said that Broad Consent is a new option provided under the revised Common Rule. In the Pre-2018 Common Rule, the term “Broad Consent” does not actually exist. This may be strange to some of you since, in the research community, we understand that a number of you have been referring to the type of standard informed consent where you provide information that describes a broader future secondary research use. So the question i...
