Biomedical research ethics updating international guidelines
And the review system is inefficient, with numerous [institutional review board (IRB)] reviews for multicenter studies delaying initiation of research for months or years, despite little evidence that multiple reviews enhance protections.
Many, therefore, feel that changes are needed to enhance protections for research participants, improve efficiency, and reflect the changing nature of research.
Proposed revisions to both the Common Rule and the CIOMS Guidelines emerged from this rich context of substantive change and normative debate.
Although the Common Rule and the CIOMS Guidelines both pertain to the conduct of human subjects research, they are qualitatively different.
Coming in at 131 Federal Register pages, the NPRM proposes several significant changes to the Common Rule aimed at: improving the informed consent process; strengthening consent requirements for use of stored biospecimens in research; limiting use of waivers and alteration of consent for research involving biospecimens; excluding certain kinds of activities from coverage under the Common Rule; adding additional categories of exempt research; mandating that US institutions engaged in cooperative research rely on a single IRB; eliminating continuing review for studies that undergo expedited review and for studies that have completed study interventions; and extending the scope of the policy to cover all clinical trials conducted at US institutions that receive federal funding for human subjects research.
The NPRM was highly anticipated and, therefore, subject to great scrutiny upon publication.
This can help with recruitment of a larger number of research participants and more diverse study populations.
Over the last several decades, the volume and nature of human subjects research have changed considerably.[a]n expansion in the number and type of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques for use with human biospecimens; and the growing use of electronic health data and other digital records to enable very large data sets to be analyzed and combined in novel ways.