Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Gulf grows between research practice and participant preferences in genetic studies

21.01.2011
Realignment with participants' interest important for future of genomic research

Obtaining consent for genetic studies can be an opportunity for researchers to foster respectful engagement with participants, not merely to mitigate legal risk. This shift is proposed in a policy forum appearing tomorrow, Jan. 21, in Science, the journal of the American Academy for the Advancement of Science.

The authors of the article, "Research Practices and Participant Preferences: The Growing Gulf" recommend new approaches that treat participants as true stakeholders in research, who willingly take on risks because they believe the potential benefits to society outweigh potential harms. Current practices presume that study participants don't want to hear from researchers, or that participants find general, one-time consent acceptable. However, these practices may be contrary to participants' preferences, according to their report.

The commentators are ethicists and medical researchers from the University of Washington (UW) and Group Health Research Institute in Seattle. They are: Susan Brown Trinidad and Stephanie M. Fullerton from the UW Department of Bioethics and Humanities, Evette J. Ludman and Eric B. Larson from Group Health Research Institute, Gail Jarvik, division head, UW Medical Genetics, and Wylie Burke, department chair, UW Bioethics and Humanities.

The authors point to recent national events that have increased attention on the use of biological samples in research: The Immortal Life of Henrietta Lacks, a best-selling book on the origins of the HeLa cell line; a lawsuit over the Texas Department of Health Services supplying newborn screening blood samples for research; and the settlement of the Havasupai tribe's lawsuit against the Arizona Board of Regents for unauthorized use of biospecimens. Claims of harm in these and other cases have included breach of privacy, stigmatization, and attacks against cultural beliefs.

Settlements have included financial payments, research restrictions, and sample destruction. In some cases, plaintiffs simply wanted to be asked permission.

Increased scrutiny of research practices is coming at a time when advances in genomic science depend on collecting massive amounts of data for analysis, the authors observed. To obtain large numbers of samples, improve the reliability of findings, and achieve greater efficiency, genome scientists around the world have begun pooling biospecimens and data from previous studies. The Science commentary notes that current U.S. federal policies or laws regarding human subjects' protection or privacy of health information do not apply to studies using only coded samples and data. At the same time, other federal policies mandate data sharing and strongly encourage researchers to deposit their study data in public repositories such as the database of Genotypes and Phenotypes (dbGaP), a public access resource maintained by the National Institutes of Health.

The authors added that many disease-specific and general-purpose biorepositories have attracted many participants who have signed blanket informed consents for a broad range of potential purposes. Although a U.S. survey showed that more than 90 percent of respondents would be willing to have their samples and health data placed in a research biobank, their views on blanket consents were divided: 48 percent preferred one-time blanket consent, and 42 percent wanted the chance to re-consent for each new use of their data. Policy disagreement continues, the authors said. Some policy advisors want stronger regulations, but other s believe an opt-out model is better. In an opt-out, consent for research use of clinical samples (with personal identifiers removed) is presumed unless denied.

What's missing from research policy and practice, in many cases, is knowledge and consideration of participants' viewpoints and values, and participants' desire to be notified and to give permission for sharing of their data for other studies. Recent research at Group Health Cooperative, a non-profit Seattle health system, has offered insight into study participant views. Group Health patients enrolled in the Adult Changes in Thought (ACT) study, a long running joint UW and Group Health project on brain aging, were asked if their ACT data could be submitted to the database of Genotypes and Phenotypes (dbGaP). Telephone interviews with a sample of those who granted such permission showed that while they were willing to have their information used in this way, this didn't mean that they had no interest in learning how and by whom the data might be used.

"What was really important to participants in the cases we mention," said Susan Brown Trinidad, research scientist in the UW Department of Bioethics and Humanities, "wasn't solely driven by the desire for control, or the chance to say no to certain kinds of studies. Rather, participants viewed being asked as an important demonstration of the researchers' respect and appreciation."

When contact with research volunteers is feasible and practical, then the extra work to re-engage them for re-use of data can be a valuable investment in science.

"Our experience with the ACT study," said Dr. Eric B. Larson, executive director of Group Health Research Institute, "showed informing subjects and seeking additional consent was worthwhile. Every time we share information and involve research subjects, we build on the trusting relationship that ultimately improves our research — and the value our research has for participants, the scientific community, and the public. Through trusting relationships, research can inform patient care, while patient participation keeps informing research."

UW bioethicist, physician, and genetic researcher Wylie Burke has served for many years as a national advisor on the legal, ethical and social implications of genomic research.

"The good news here," she said, "is that participants are interested in research and feel themselves to have an investment in the studies in which they are involved. It's up to the research establishment – scientists, policy makers and institutional review boards – to respond appropriately."

About UW Medicine

UW Medicine trains health professionals and medical scientists, conducts research to improve health and prevent disease, and provides primary and specialty care to patients throughout Seattle/King County and the WWAMI (Washington, Wyoming, Alaska, Montana and Idaho) region. UW Medicine includes Harborview Medical Center, UW Medical Center, Northwest Hospital & Medical Center, UW Neighborhood Clinics, UW School of Medicine, UW Physicians, and Airlift Northwest. UW Medicine also shares in the ownership and governance of the Seattle Cancer Care Alliance with Seattle Children's Hospital and Fred Hutchinson Cancer Research Center and shares in ownership of Children's University Medical Group with Seattle Children's Hospital.

UW Medicine has major academic and service affiliations with Seattle Children's Hospital, Fred Hutchinson Cancer Research Center, the Veteran's Affairs Puget Sound Health Care System in Seattle, and the VA Hospital in Boise. The UW School of Medicine has been ranked No. 1 in the nation in primary-care training for the past 17 years by US News & World Report and is the top public institution for receipt of biomedical research funding from the National Institutes of Health and second among all institutions for NIH funding, public and private. UW Medicine's 2,000 faculty physicians and nearly 5,000 volunteer and part-time faculty include four Nobel Laureates, 32 members of the National Academy of Sciences, and 33 members of the Institute of Medicine. For more information about UW Medicine, visit http://www.uwmedicine.org/.

About Group Health Research Institute

Founded in 1947, Group Health Cooperative is a Seattle-based, consumer-governed, non-profit health care system. Group Health Research Institute (www.grouphealthresearch.org) changed its name from Group Health Center for Health Studies in 2009. Since 1983, the Institute has conducted nonproprietary public-interest research on preventing, diagnosis, and treating major health problems. Government and private research grants provide its main funding.

Leila Gray | EurekAlert!
Further information:
http://www.washington.edu

More articles from Life Sciences:

nachricht Multi-institutional collaboration uncovers how molecular machines assemble
02.12.2016 | Salk Institute

nachricht Fertilized egg cells trigger and monitor loss of sperm’s epigenetic memory
02.12.2016 | IMBA - Institut für Molekulare Biotechnologie der Österreichischen Akademie der Wissenschaften GmbH

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Novel silicon etching technique crafts 3-D gradient refractive index micro-optics

A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.

Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...

Im Focus: Quantum Particles Form Droplets

In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.

“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...

Im Focus: MADMAX: Max Planck Institute for Physics takes up axion research

The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.

The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...

Im Focus: Molecules change shape when wet

Broadband rotational spectroscopy unravels structural reshaping of isolated molecules in the gas phase to accommodate water

In two recent publications in the Journal of Chemical Physics and in the Journal of Physical Chemistry Letters, researchers around Melanie Schnell from the Max...

Im Focus: Fraunhofer ISE Develops Highly Compact, High Frequency DC/DC Converter for Aviation

The efficiency of power electronic systems is not solely dependent on electrical efficiency but also on weight, for example, in mobile systems. When the weight of relevant components and devices in airplanes, for instance, is reduced, fuel savings can be achieved and correspondingly greenhouse gas emissions decreased. New materials and components based on gallium nitride (GaN) can help to reduce weight and increase the efficiency. With these new materials, power electronic switches can be operated at higher switching frequency, resulting in higher power density and lower material costs.

Researchers at the Fraunhofer Institute for Solar Energy Systems ISE together with partners have investigated how these materials can be used to make power...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ICTM Conference 2017: Production technology for turbomachine manufacturing of the future

16.11.2016 | Event News

Innovation Day Laser Technology – Laser Additive Manufacturing

01.11.2016 | Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

 
Latest News

UTSA study describes new minimally invasive device to treat cancer and other illnesses

02.12.2016 | Medical Engineering

Plasma-zapping process could yield trans fat-free soybean oil product

02.12.2016 | Agricultural and Forestry Science

What do Netflix, Google and planetary systems have in common?

02.12.2016 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>