IRB Jurisdiction and Limits on IRB Actions

Hershey, Nathan

doi:10.2307/3564145

Cited by 10 publications

(5 citation statements)

References 4 publications

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“…Central to such case studies would be an explicit enjoinder that IRBs take into consideration not only the costs of doing the proposed research but also the costs of not doing it. In general, we believe that a mirror must also be held up to the review process, so that its existence, fairness, and effectiveness can be examined and justified (see Cowan & Adams, 1979;Hershey, 1985).…”

Section: Resultsmentioning

confidence: 99%

The Institutional Review Board as a mirror of scientific and ethical standards.

Rosnow

Ceci

Blanck³

et al. 1993

American Psychologist

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Section: Resultsmentioning

confidence: 99%

The Institutional Review Board as a mirror of scientific and ethical standards.

Rosnow

Ceci

Blanck³

et al. 1993

American Psychologist

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“…The study designs, such as randomized controlled trials and cohort studies, are carefully reviewed by institutional review boards (IRBs)—also known as ethical review committees ( ERCs ) in some countries. IRBs are committed to protecting the rights and welfare of human subjects recruited to participate in biomedical or behavioral research (including social science research) 1 . This approach has long been the standard for biomedical research.…”

mentioning

confidence: 99%

Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs

Ferretti

Ienca

Hurst

et al. 2020

Ethics & Human Research

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T raditionally, human subjects research in the biomedical field engages healthy and sick people as research participants in order to test certain hypotheses about health and disease according to a well-defined study design. The study designs, such as randomized controlled trials and cohort studies, are carefully reviewed by institutional review boards (IRBs)-also known as ethical review committees (ERCs) in some countries. IRBs are committed to protecting the rights and welfare of human subjects recruited to participate in biomedical or behavioral research (including social science research). 1 This approach has long been the standard for biomedical research. Recently, however, biomedical research has begun to pursue opportunities afforded by big data. Big data research relies on large-scale databases, multiplication of data sources, advanced storage capacity, and novel computational tools that allow for high-velocity data analytics. 2 In the biomedical domain, big data trends are enabled by and allow for advances in areas such as whole genome sequencing, brain imaging, mobile health, and digital phenotyping. 3 Today, a large portion of health-related research relies on big data. Big data also enables researchers to draw health insights from data sources that are not strictly medical-data from wearable trackers, social media, and Internet searches, for example. 4 Big data research opens new prospects to accelerate health-related research and potentially elicit breakthroughs that will benefit patients. 5 Big data has been observed to shift the way biomedical researchers design and carry out their studies. 6 This research departs from the traditional research model because it is largely exploratory rather than hypothesis driven. Health-related big data research is based on the acquisition of large amounts of data from multiple and often heterogeneous sources, which are subsequently combined and mined using powerful data analytics tools. This reverse-engineered approach to health-related research allows researchers to extract features and valuable insights from large datasets, without being able to anticipate exactly what the data analysis will find.

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“…Another explanation to why RECs have difficulty evaluating CBPR projects is that several reasons make existing regulations difficult to apply to the CBPR research model. First, federal-wide assurances are given to institutions to conduct research within their confines, and therefore community engagement is out of their jurisdiction (Hershey, Cann, & Rothman, 1985). Second, the research team is required to complete cumbersome trainings not designed for the non-scientist (Flicker, Travers, Guta, McDonald, & Meagher, 2007; Pearson, Parker, Fisher, & Moreno, 2014).…”

Section: Discussionmentioning

confidence: 99%

Are Research Ethics Committees Prepared for Community-Based Participatory Research?

Tamariz

Medina

Taylor

et al. 2015

Journal of Empirical Research on Human Research Ethics

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Community-based participatory research (CBPR) is challenging to research ethics committees (RECs). We reviewed the REC preparedness when reviewing CBPR projects. We searched the MEDLINE database and included qualitative studies of CBPR researchers or REC members about their experiences with RECs. The search yielded 107 studies, of which 10 met our criteria. Barriers were that the community is not prepared to conduct research, the reluctance of RECs to work outside the university, the difficulty RECs have understanding CBPR, and that REC forms evaluate individual rather than community risk. Facilitators were having a CBPR expert as an REC member and educating RECs. Therefore, RECs are not prepared to evaluate CBPR projects leading to unnecessary delays in the approval process.

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IRB Jurisdiction and Limits on IRB Actions

Cited by 10 publications

References 4 publications

The Institutional Review Board as a mirror of scientific and ethical standards.

The Institutional Review Board as a mirror of scientific and ethical standards.

Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs

Are Research Ethics Committees Prepared for Community-Based Participatory Research?

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