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SACHRP Approves Participant Payment Guidelines
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently approved guidelines on paying research participants, addressing a range of issues from “token” payments to frank coercion. After considerable discussion into the ethical implications of paying subjects too much or too little, SACHRP approved the guidelines, entitled “Addressing Ethical Concerns Regarding Offers of Payment to Research Participants.”
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Indigenous People Grill NIH on All of Us Protections
Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians. A key part of the dialogue is letting American Indian/Alaska Native Tribal Nations ask questions and express concerns about the project.
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Identifiable Data Are Not What They Used to Be
IRBs and researchers should change their old habits when it comes to assessing studies for privacy and confidentiality. Researchers recently showed that de-identified data could be used to find a specific person. Using a mathematical model in databases of more than 200 populations, researchers found they could correctly re-identify 99.98% of Americans, using 15 demographic attributes.
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Tips for IRBs Reviewing Pragmatic Trials
Flexibility is needed when reviewing pragmatic clinical trials, which typically enroll a broader population of patients and might need more adaptable informed consent than traditional clinical trials. Researchers have raised questions about how pragmatic trials should be regulated and what IRBs should do to protect participants, but not discourage this type of research.
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Pragmatic Trials on the Rise as Data Collection Pushes Trend
Several recent changes are driving the pragmatic trial trend nationally, including acceptance from regulators and the growth of big data. Pragmatic clinical trials measure effectiveness of a study drug, device, or intervention on a wider range of people. Unlike clinical trials that exclude people based on health conditions and other criteria, pragmatic trials study a treatment’s effect on a group of people who are more representative of patients in clinical practice and the real world.
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Calls for IRB Transparency in a Closed-Door System
It is a common critical observation in human research that IRBs operate in a sort of “black box,” making decisions that could greatly affect a general public that remains largely oblivious of their role and function. This default ought to change toward transparency, both for the good of the research community and to be in line with the increasing calls for publishing research results, reporting all clinical trial data, and sharing consent forms, experts say.
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Social Media Research Presents Many Unresolved Ethical Issues
Direct-to-consumer wellness products, location-tracking apps, and access to personal data on social networks present both exciting opportunities and significant ethical worries for researchers. The authors of a recent paper proposed steps the scientific community can take to ensure social media data are used ethically. The paper was prompted in part by the recent Cambridge Analytica scandal, involving allegations that the firm used data improperly obtained from Facebook to build voter profiles.
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Testing an Intervention to Reinforce Ethical Research Practices
Historically, the value of scientific research has been undermined to some degree by lack of reproducible results, unpublished data, and studies that achieve statistical significance but are false positives. Some of these trends are fueled by researchers’ acceptance of “questionable research practices (QRPs),” researchers noted in a recent study.
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Ensure Study Participants Understand That Biobanking Is Research
In a recent study, parents in a pediatric ICU were approached to give consent to storage of their children’s specimens in a biobank for future research. In surveying parents afterward, the researchers found that almost half of those asked about the biobank did not seem to understand that storage of clinical specimens was a research pursuit.
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