Single IRB Review and Local Context Considerations: A Scoping Review.

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.

Hormonal Contraceptive Side Effects and Nonhormonal Alternatives on TikTok: A Content Analysis.

The use of hormonal contraceptives is decreasing in the United States alongside a growing interest in nonhormonal contraceptive options. Social media messaging may be contributing to this trend. TikTok thus offers a novel opportunity to understand how people share information about risks and alternatives for pregnancy prevention. To describe the availability and content of information about hormonal contraceptive side effects and nonhormonal contraceptive options on TikTok, we conducted a content analysis of 100 videos using the hashtags #birthcontrolsideeffects and #nonhormonalcontraception. We found that these videos were popular and often framed hormonal contraceptives and patient-provider interactions negatively, with users frequently discussing discontinuation of hormonal contraception and no plans for uptake of another contraceptive. When uptake of a new contraceptive method is mentioned, creators typically mention a fertility awareness-based method, which requires specialized knowledge to use safely and effectively. The risks and side effects of hormonal options were often overemphasized compared with the possible risks and side effects of nonhormonal options. This framing may suggest opportunities for providers and health educators to reassess how they counsel about contraceptive options. We conclude with recommendations for future research on TikTok and consider the policy implications of these findings.