Inviting researchers to attend institutional review board sessions designed to approve these same investigators’ requests to conduct research involving human subjects doesn’t seem to affect the efficiency of the process one way or the other, a new study led by Johns Hopkins bioethicists suggests.
The findings are the result of one of the few studies to date that have sought to verify or challenge a fairly wide perception that inviting participation by so-called principal investigators, or PIs, could introduce more inefficiencies in what already is a lengthy and detailed process beset by scheduling problems, poor investigator-IRB relationships and administrative delays. Some researchers have suggested an opposing view: that inviting PIs can improve efficiency.
“The limited data on IRBs indicate they do not routinely invite PIs to attend convened meetings,” says Holly Taylor, assistant professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and assistant director of empirical research at the Johns Hopkins Berman Institute of Bioethics. She and her coauthors on the review of IRB practices at The Johns Hopkins University say one national estimate found that fewer than 9 percent of IRBs require PIs to attend the meetings.
Under federal law and regulations, and to assure the safety and welfare of research volunteers, all institutions that receive federal funds to conduct human subject research require review and approval by an IRB, a group generally composed of senior scientists not involved in the research under review along with individuals who represent the lay community. Bioethicists and others familiar with human research protocols also may be involved.
Among other things, IRBs carefully consider questions such as whether the study’s science is valid and generalizable, whether its benefits outweigh risks that volunteers might encounter, and whether volunteers will be adequately informed about the study to consent to participate.
While serving as members of four IRBs at the Johns Hopkins University School of Medicine, Holly A. Taylor, Nancy E. Kass and other bioethicists at theBerman Institute of Bioethics noticed that some IRBs regularly invite PIs when their research plans are discussed while other IRBs do not.
Wondering whether there was any difference in inefficiency between IRBs that did or did not invite PIs, Taylor and Kass, along with former Johns Hopkins master’s degree student Peter Currie, now a law student at Georgetown University, looked back at 125 IRB reviews conducted by four Johns Hopkins School of Medicine IRBs between March 2002 and June 2005. Two of the IRBs did not regularly invite PIs to their meetings, one did, and a fourth switched midway through the examination period from not inviting PIs to inviting them.
The team wondered, for example, whether PIs in attendance could more efficiently answer any questions that arise quickly and directly, rather than by replying to multiple calls and e-mails from different board members after a meeting takes place. So they checked the total time it took to approve the research plans, how many pieces of correspondence passed between the IRB and the PI, and how many meetings took place where a particular study was discussed.
Their analysis, published in the January-February Issue of IRB: Ethics & Human Research, showed few differences between IRBs that invited PIs to attend meetings and those that didn’t. All took an average of 65 days to approve each study’s plans, had about five pieces of correspondence pass between the IRB and the PI, and reviewed a study at an average of 1.6 meetings.
Taylor noted that in the IRB that switched from not inviting PIs to inviting them, time to approval went down from an average of 114 days when PIs weren’t present at meetings to 70 days when PIs attended. Additionally, the number of meetings where each study was discussed changed from an average of 2.4 to 1.7. The researchers aren’t sure whether the presence of the investigator was a factor in this improved efficiency, but they suggest that it could be one of many factors that led to the change.
“PIs are really busy, and some IRB members might worry that requiring PI attendance could delay scheduling. We didn’t find that was the case,” she says.
She and her colleagues plan to eventually test PI attendance at multiple research institutions prospectively by randomly assigning PIs to be present or absent at meetings. Taylor notes that finding ways to improve the efficiency of IRB approval can help researchers begin their research faster.
The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft
Europe’s Demographic Future. Where the Regions Are Heading after a Decade of Crises
10.08.2017 | Berlin-Institut für Bevölkerung und Entwicklung
Plants and algae use the enzyme Rubisco to fix carbon dioxide, removing it from the atmosphere and converting it into biomass. Algae have figured out a way to increase the efficiency of carbon fixation. They gather most of their Rubisco into a ball-shaped microcompartment called the pyrenoid, which they flood with a high local concentration of carbon dioxide. A team of scientists at Princeton University, the Carnegie Institution for Science, Stanford University and the Max Plank Institute of Biochemistry have unravelled the mysteries of how the pyrenoid is assembled. These insights can help to engineer crops that remove more carbon dioxide from the atmosphere while producing more food.
A warming planet
Our brains house extremely complex neuronal circuits, whose detailed structures are still largely unknown. This is especially true for the so-called cerebral cortex of mammals, where among other things vision, thoughts or spatial orientation are being computed. Here the rules by which nerve cells are connected to each other are only partly understood. A team of scientists around Moritz Helmstaedter at the Frankfiurt Max Planck Institute for Brain Research and Helene Schmidt (Humboldt University in Berlin) have now discovered a surprisingly precise nerve cell connectivity pattern in the part of the cerebral cortex that is responsible for orienting the individual animal or human in space.
The researchers report online in Nature (Schmidt et al., 2017. Axonal synapse sorting in medial entorhinal cortex, DOI: 10.1038/nature24005) that synapses in...
Whispering gallery mode (WGM) resonators are used to make tiny micro-lasers, sensors, switches, routers and other devices. These tiny structures rely on a...
Using ultrafast flashes of laser and x-ray radiation, scientists at the Max Planck Institute of Quantum Optics (Garching, Germany) took snapshots of the briefest electron motion inside a solid material to date. The electron motion lasted only 750 billionths of the billionth of a second before it fainted, setting a new record of human capability to capture ultrafast processes inside solids!
When x-rays shine onto solid materials or large molecules, an electron is pushed away from its original place near the nucleus of the atom, leaving a hole...
For the first time, physicists have successfully imaged spiral magnetic ordering in a multiferroic material. These materials are considered highly promising candidates for future data storage media. The researchers were able to prove their findings using unique quantum sensors that were developed at Basel University and that can analyze electromagnetic fields on the nanometer scale. The results – obtained by scientists from the University of Basel’s Department of Physics, the Swiss Nanoscience Institute, the University of Montpellier and several laboratories from University Paris-Saclay – were recently published in the journal Nature.
Multiferroics are materials that simultaneously react to electric and magnetic fields. These two properties are rarely found together, and their combined...
19.09.2017 | Event News
12.09.2017 | Event News
06.09.2017 | Event News
22.09.2017 | Life Sciences
22.09.2017 | Medical Engineering
22.09.2017 | Physics and Astronomy