But that strategy poses ethical challenges to informed consent, as well as potential risks to the people recruited, and it is unlikely that there is a "one-size-fits-all" solution, concludes an article in IRB: Ethics & Human Research.
The advantage of "recruitment by genotype" is that it eliminates the time-consuming, expensive process of screening new populations to find subjects who have the genetic variant of interest. The ethical challenge is that it requires the disclosure to individuals of genetic information discovered about them in prior research – for example, research on tissue samples that they donated for scientific study. Such information can carry risks and harms because it is often preliminary and easily misinterpreted, and it may be unwanted by some individuals. But without this information, potential participants would be uninformed about why they are being recruited for the new study.
As the first step toward developing ethical guidelines on genotype-driven recruitment, the authors conducted an online survey of 201 chairs of institutional review boards (IRBs). The survey asked a series of questions about 1) the conditions that should be met before recontacting individuals for genetic research recruitment, and 2) whether individuals' genetic research results from the first study should be disclosed as part of the recruitment process for the second study.
The responses were diverse and in some cases contradictory. Only 37 percent of IRB chairs agreed with the general statement, "Researchers should be allowed to contact participants in one genetic research study in order to invite their participation in another genetic research study." But more detailed questions revealed greater willingness of permit contacting of participants if certain conditions were met. For example, 91 percent said that it would be important that the possibility of such contact was disclosed during the consent process for the first study.
However, when the researchers presented the respondents with a hypothetical scenario in which the original consent form did not mention the possibility of contact about future research, 51 percent of the IRB chairs said they definitely or probably would allow the researcher to contact eligible participants anyway. The findings suggest that while consent disclosures are important and highly preferable, "not all chairs necessarily view them as imperative," the authors concluded.
There was a similar variation in response to questions about offering people information about their genetic results from previous studies. Only 42 percent of IRB chairs agreed with the general statement, "Each participant should be offered his/her individual genetic results from the first study when contacted about taking part in the second study." But most said that specific conditions would be important in determining whether it was ethically acceptable to reveal that information: 87 percent of respondents said that statements in the consent form for the first study concerning disclosure of individual genetic research results would be important, 86 percent cited the level of clinical validity (defined as "the accuracy with which the presence of a gene variant predicts the presence of a clinical condition or predisposition"), and 76 percent cited the level of clinical utility (defined as "the availability and effectiveness of interventions aimed at avoiding the adverse clinical consequences of a gene variant").
The survey concluded with questions about specific ethical dilemmas involved in genotype-driven research recruitment. For example, asked to weigh the value of avoiding disclosure of genetic information with uncertain clinical utility against the value of promoting participants' autonomy in determining the utility of the information, 46 percent chose disclosure and 39 percent chose autonomy.
"A major consequence of these findings is that it is unlikely that there will be a "one-size-fits-all solution, but rather several approaches to genotype-driven recruitment that may be ethically acceptable depending on a variety of context-dependent factors," the authors concluded. The two strongest context-dependent factors identified in the survey were 1) disclosure made during informed consent for the original study, and 2) the clinical validity (and, to a slightly lesser degree, the clinical utility) of the information.
The authors are Laura M. Beskow, MPH, PhD, assistant research professor of the Duke Institute for Genome Sciences and Policy at Duke University; Emily E. Namey, MA, clinical research coordinator, Duke Institute for Genome Sciences and Policy; Patrick R. Miller, PhD, postdoctoral fellow in the Social Science Research Institute at Duke University; Daniel K. Nelson, MS, CIP, director of the Office of Human Research Ethics and professor at the University of North Carolina, Chapel Hill; and Alexandra Cooper, PhD, associate director for education and training at the Social Science Research Institute at Duke University.
Michael Turton | EurekAlert!
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
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...
MBM ScienceBridge GmbH successfully negotiated a license agreement between University Medical Center Göttingen (UMG) and the biotech company Tissue Systems Holding GmbH about commercial use of a multi-well tissue plate for automated and reliable tissue engineering & drug testing.
MBM ScienceBridge GmbH successfully negotiated a license agreement between University Medical Center Göttingen (UMG) and the biotech company Tissue Systems...
Pathogenic bacteria are becoming resistant to common antibiotics to an ever increasing degree. One of the most difficult germs is Pseudomonas aeruginosa, a...
19.09.2017 | Event News
12.09.2017 | Event News
06.09.2017 | Event News
20.09.2017 | Life Sciences
20.09.2017 | Power and Electrical Engineering
20.09.2017 | Physics and Astronomy