Internal Review Boards
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Study: Research Subjects Might Consent to Records Use, But Want to be Asked
Researchers and IRBs could learn a lot about what research participants want with informed consent and privacy if they ask. One way to find out what research subjects think is called democratic deliberation. Using this technique, researchers found that most patients want someone to ask them before deidentified medical records are used for research.
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Need Researchers to Pay Attention? Try Experimenting With Engaging Content
At one time or another, IRBs have ignored some part of the website content, simply adding new information rather than revamping educational pages and instructions. This can lead to redundancy and waste. A better long-term solution is to replace older educational information for researchers with more engaging content.
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Money Matters: Payment to Research Participants ‘Haphazard’
The authors of a new study on payment to research participants underscored concerns that “undue influence” of higher payments may be overemphasized in compensation to human subjects. They found wide variation of payment practices across studies in the same region and populations, suggesting a “haphazard” approach to compensation for research participation.
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Right to Try in Oncology: Gatekeepers or Mercenaries?
While the federal Right to Try law passed in 2018 has thus far resulted in little activity, bioethicists expect oncology will be on the frontlines of an anticipated increase in requests for investigational new drugs.
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Gene-Altered Twins Face Uncertain Future
Chinese twins born in 2018 face a future fraught with potential health complications after a rogue gene-editing experiment that “basically broke every single principle of ethical medical research,” an expert says. The experiment shocked many in the scientific community, who cited widespread agreement that there were too many unknowns to proceed with CRISPR in human research subjects.
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Bioengineered Organ Research on the Recently Deceased
The next frontier in transplant medicine includes bioengineered organs, which raise ethical issues but could help alleviate a critical shortage that leaves more than 100,000 people on organ wait lists annually in the United States.
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Bioemergency Research Might Weigh Risk-Benefit Ratio Differently
The risk-benefit ratio can be different when studies are proposed in response to a national bioemergency, such as Ebola outbreaks and epidemics. Researchers may need to tolerate greater risk to subjects, experts say. The bioemergency research tradeoff is that there might be a greater amount of benefit to society.
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SACHRP Recommendations on Pay-to-Participate Research
The Secretary’s Advisory Committee on Human Research Protections used a series of questions in crafting recommendations on the complex issue of requiring research subjects to pay to participate. While still subject to some wordsmithing, the unpublished, finalized draft discussed at the SACHRP meeting included five questions and committee answers.
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New SACHRP Guidelines on ‘Pay-to-Participate’ Research
The Secretary’s Advisory Committee on Human Research Protections has finalized recommendations to assist IRBs dealing with “pay-for-participation” studies, which raise numerous ethical issues but may produce meaningful data if properly vetted.
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Methods to Improve the IRB/PI Relationship
There are natural conflicts between IRBs and principal investigators, but IRBs can take several steps to improve this crucial relationship. For instance, IRBs should treat everything on a case-by-case basis, depending on the situation, the principal investigator, and the IRB’s policies.