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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.
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.
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.
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.
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.
The most important way to improve IRB meetings is through preparation. The IRB chair has to have a sense of what is on the agenda, and anticipate an important discussion points, an IRB chair says.
The Office for Human Research Protections is making implementation of the revised Common Rule a little easier for IRBs with two exceptions to the single IRB review requirement.
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Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.
