The updates to the Common Rule, effective January 19, 2018, make some significant changes of which those involved in government-funded clinical research involving human subjects should be aware. These changes include:
To get your organization started, here are some action items to help with Common Rule compliance:
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New definitions for “identifiable biospecimen,” “private information,” and “identifiable private information” (IPI)
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New exemption for “Secondary Use Research” using IPI or biospecimens already obtained from the subject for other purposes (different research, clinical purposes) and the use/storage of IPI and biospecimens
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New list of vulnerable populations: children, prisoners, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons
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Revised informed consent requirements. The informed consent must:
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Begin with key information most likely to assist the subject in understanding why/why not to participate
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Be posted on a “federal website”
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Have a statement about IPI and biospecimens, including:
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The types of research that may be conducted in the future
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If the IPI/biospecimens might be shared with other researchers
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A description of the period of time allowed for storage and maintenance of the biospecimens and when the IPI or biospecimens may be used for research
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Whether biospecimens may be used for commercial profit and whether the subject will share in such profits
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Whether clinically relevant research results from secondary research will be disclosed to subjects and, if so, under what conditions
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Whether research involving biospecimens might include whole genome sequencing
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Permit researchers to seek broad informed consent that covers the subject of the current research and future unspecified research using IPI/biospecimens
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New concept of “limited IRB review”
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For U.S. institutions involved in cooperative (multi-site) research, they must rely on a single IRB approval unless an exception applies (effective January 20, 2020)
To get your organization started, here are some action items to help with Common Rule compliance:
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Revise informed consent form templates.
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Establish a process for timely posting of informed consent forms to the federal website.
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Decide whether you will permit secondary use research and allow for broad informed consent.(If yes, institute a process for how to handle subjects who decline to give broad consent.)
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Begin working toward the use of single IRB approval for multi-site research studies, including development of an IRB Authorization Agreement (a.k.a., Reliance Agreement) to meet the January 2020 deadline.