Broad Consent—Are We Asking Enough?

Abstract

Health data repository and biobank research ("repository research") relies on participants providing identifiable health information and biospecimens that may be used in perpetuity by innumerable researchers for unnamed research topics. With all the unknowns, the challenge of meaningfully obtaining informed consent from the repository research participant lacks easy solutions. Codified in revisions to the United States Common Rule 1 (which applies to federally supported research), "broad consent" is now the government-sanctioned solution for obtaining consent in the context of federally funded repository research. Broad consent has been described as "consent for an unspecified range of future research" that is subject to only "a few content and/or process restrictions. " 2 Among the benefits that health data repositories and biobanks provide to researchers is the opportunity to identify and study specific genes associated with particular illnesses or conditions. This information may facilitate early diagnosis and intervention for those carrying the affected genes, and perhaps aid in staving off disease onset or burdens. Berkman and colleagues recently illuminated the great value to public health, especially in pandemic settings, of researchers having access to readily available biospecimens and health data for expeditious research on infectious disease. 3 The authors described how the absence of broad consent in one ongoing clinical research study served to obstruct the legal transfer of biospecimens obtained during that standalone study, despite the utility of repurposing them for the unexpected and imminently needed research on the emergent Covid-19 pandemic.The inherent unknowns associated with repository research are the very reason that broad consent is so appealing. We do not know what hypotheses may spark in the minds of brilliant research doctors who are yet to be born or what types of pandemics or plagues may befall our society . . . and when. Still, while the new broad con-ABSTRACT Biobanks and health data repositories provide rich reservoirs of information for use in biomedical research. These repositories depend on participants donating identifiable health data and biospecimens that may be used in perpetuity by unlimited numbers of researchers for unnamed research topics. Since 1991, U.S. federal regulatory provisions, collectively known as the Common Rule, have required informed consent of participants in federally funded human subjects research, but recent changes to the Common Rule now sanction "broad consent" in the repository research context. Broad consent is not defined in the revised Common Rule; thus, researchers and their institutions are left to determine ad hoc what broad consent means and requires. Without leadership and guidance from the U.S. Department of Health and Human Services, stakeholders with potential conflicts of interest will reach their own conclusions and craft new and varied standards for consent. The result will be uneven protections for participants. KEYWORDS revised Comm...

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk‐based Mammascreening study

“…12 Thus, EU member states have adopted varied safeguards for the use of data, 13 butoftentimes in the absence of clear national guidelines, local researchers and their institutions are left to define policies and requirements. 14 …”

“…Although this wide‐encompassing legislation has had profound effects on the sharing and use of data in medical research, it did not fully resolve the issue regarding the interpretation of broad consent 12 . Thus, EU member states have adopted varied safeguards for the use of data, 13 butoftentimes in the absence of clear national guidelines, local researchers and their institutions are left to define policies and requirements 14 …”

“…12 Thus, EU member states have adopted varied safeguards for the use of data, 13 butoftentimes in the absence of clear national guidelines, local researchers and their institutions are left to define policies and requirements. 14 Undoubtedly research participants should serve an integral role in this discussion, underscoring the need for qualitative research to guide the review and adaptation of broad consent templates and policies. Their concerns and information needs are key elements in accepting broad consent and data sharing in research.…”