Public prefers limited informed consent process for biobanks

June 29, 2011

Biobanks are repositories for tissue samples, usually in the form of blood or saliva or leftover tissue from surgical procedures. These samples are collected and used for future research, including genetic research. They may be linked to personal health information regarding the sample donor. People who are eligible to donate these samples and researchers who want to use them face important questions with respect to whether and how informed consent should be obtained for sample and health information collection and use.

A team of University of Iowa researchers led by Christian Simon, Ph.D., associate professor of and humanities in the Department of at the UI Roy J. and Lucille A. Carver College of Medicine, conducted a study to determine people's preferences with respect to for biobanking. The study, "Active choice but not too active: Public perspectives on biobank consent models," was published ahead of print in last month's online edition of the journal, Genetics in Medicine. The study involved 751 telephone surveys and seven focus groups with English-speaking members of the public who were randomly sampled from counties across Iowa. Over half the study participants were female.

Most study participants had not heard of a "biobank" before, but when it was explained to them what biobanks were and that they could help advance research on genetic and nongenetic aspects of disease, most study participants were enthusiastic.

The majority (95 percent) of survey participants rejected the idea of deriving and banking samples without first informing and asking patients for their permission—obtaining their informed consent.

"This speaks to the premium many people place on being informed and having a choice about participating in research," Simon said.

Participants were also asked whether they would prefer to opt in or out of biobank participation.

"This distinction is important because opt-in consent typically involves more detail, more time and a more active decision on research participation when compared to an opt-out process," Simon explained.

Sixty-seven percent of those surveyed and 63 percent of those who participated in the focus groups said they would prefer an opt-in consent process.

"Nonetheless," Simon said, "a substantial minority -- 18 percent in the surveys and 25 percent in the focus groups -- said they would prefer an opt-out process, primarily because they felt it provided at least some level of choice, involved less time for potential donors and fewer resources for the biobank, and would help with accrual and therefore also medical research and progress."

were then asked to consider whether they would prefer a broad description of how their samples and might be used in future research, whether they wanted to control what research their samples and health information are used in via "menu-type" consent forms, or whether they wanted to be contacted for their permission every time their samples and health information became eligible for research.

"Broad consent was preferred by more people when compared to either the menu or study-specific types of consent," Simon said. "However, if you were to lump together the people who said they preferred the menu and study-specific types of consent on the grounds that both these approaches promote more control over sample use than broad consent, the margin is not so impressive."

Forty-one percent of people surveyed – and 54 percent of those in focus groups – were in favor of the broad approach to providing consent.

Simon noted that some experts have suggested that more than one consent approach should be offered to people to allow for a diversity of consent preferences.

"Of course, there may be significant cost and logistic implications to creating such multiple options," Simon said.

He said the study findings will provide a starting point for discussions about consenting patients to a new comprehensive tissue biobank at UI Hospitals and Clinics, which will house thousands of for future research purposes. The tissue will be accessed for DNA as well as RNA, Simon said.

"Biobanks are going to be – already are – dependent on public support and participation," Simon said. "Putting into place an informed consent process that meets formal requirements and standards and that works for people by taking their values and preferences into account is one way that we can reach out and build public support and trust for biobanks."

Explore further: New legal model proposed to counter red tape, boost participation in DNA sample research

Related Stories

New legal model proposed to counter red tape, boost participation in DNA sample research

April 18, 2011
Healthy people who contribute DNA samples for medical research see their relationship with researchers as sharing a trade secret, rather than participation in traditional medical research, according to a new study.

New approach to IVF embryo donations lets people weigh decision

April 7, 2011
People who use in vitro fertilization to conceive children often have leftover embryos and must decide whether to store them, dispose of them or possibly donate them for research. A new process developed by researchers at ...

Recommended for you

Genome analysis with near-complete privacy possible, say researchers

August 17, 2017
It is now possible to scour complete human genomes for the presence of disease-associated genes without revealing any genetic information not directly associated with the inquiry, say Stanford University researchers.

Science Says: DNA test results may not change health habits

August 17, 2017
If you learned your DNA made you more susceptible to getting a disease, wouldn't you work to stay healthy?

Genetic variants found to play key role in human immune system

August 16, 2017
It is widely recognized that people respond differently to infections. This can partially be explained by genetics, shows a new study published today in Nature Communications by an international collaboration of researchers ...

Phenotype varies for presumed pathogenic variants in KCNB1

August 16, 2017
(HealthDay)—De novo KCNB1 missense and loss-of-function variants are associated with neurodevelopmental disorders, with or without seizures, according to a study published online Aug. 14 in JAMA Neurology.

Active non-coding DNA might help pinpoint genetic risk for psychiatric disorders

August 16, 2017
Northwestern Medicine scientists have demonstrated a new method of analyzing non-coding regions of DNA in neurons, which may help to pinpoint which genetic variants are most important to the development of schizophrenia and ...

Evolved masculine and feminine behaviors can be inherited from social environment

August 15, 2017
The different ways men and women behave, passed down from generation to generation, can be inherited from our social environment - not just from genes, experts have suggested.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.