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In the days after the Sept. 11, 2001, terrorist attacks, New York City became a focal point for researchers interested in studying everything from post-traumatic stress disorder to physical complications among workers at the Ground Zero site.
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A group of mental health professionals, trauma researchers, ethicists and IRB representatives have published a set of ethical guidelines for research with victims of disasters.
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Community-based research requires a special type of review, and so should have its own type of review board, one that balances the responsibilities that IRBs have to individuals with an appreciation for the needs of the community in which research is conducted.
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As IRBs seek to improve efficiency in their own operations, they often suffer from a lack of the most basic data about the costs of reviewing protocols.
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IRBs sometimes reject an investigator's request to use the short informed consent form, even when it would meet regulatory and ethical standards.
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A small but notable percentage of veterans in a long-term drug study were unable to retain some of the simplest information about it including the purpose of the study, the name of the drug and its main side effect for the entire course of the trial.
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The rapid growth in international research is providing challenges for human subjects protection in other countries, many of which lack the resources that American IRBs have.
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The IRB office at Memorial Medical Center in Johnstown, PA, began as many small IRB offices do, with one part-time employee. As the workload increased to about 80 protocols per year, the office turned the part-time position into a full-time administrator position, and organizational procedures were put in place.
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As the story developed in headlines from around the world it grew from questions about ethical lapses on the part of a South Korean stem cell researcher to his admission of fake data.
