Consent for Biobank Donations High in US Survey

Neil Osterweil

January 30, 2015

Biobanks are repositories of research gold, offering investigators virtually unlimited access to cells, blood samples, and other donated tissues for myriad research projects, including basic and clinical investigations and drug development.

But patients' willingness to donate tissue samples to research biobanks may hinge on how the information is presented to them, say medical ethicists.

Results of a survey of adults' attitudes toward tissue donation and informed consent show that when the question was framed broadly, using a "blanket consent" approach, more than two thirds of patients said they were willing to donate tissue samples to a biobank.

However, when confronted with specific, hypothetical examples of how their tissues might be used, such as research to make abortion techniques safer and more effective, fewer participants said they would be willing to give blanket consent, report Tom Tomlinson, PhD, from the Center for Ethics and Humanities in the Life Sciences, Michigan State University East Lansing, and colleagues.

One fourth of all participants in the survey said that the best option for consent would be a combination of blanket consent with an option to withdraw their approval if their tissues are being used in projects of which they disapprove, the authors report.

"As recruitment of donors becomes more widespread, such concerns may need to be addressed to moderate possible effects on donation rates," they write in a research letter published in the January 27 issue of JAMA.

Uninformed Consent

Rebecca Skloot, author of the best-selling book The Immortal Life of Henrietta Lacks, which deals with the consequences of human tissue research without donor knowledge or consent, tells Medscape Medical News that potential donors want to know where bits of themselves are going and how they might be used.

"What I hear from most people is that they want to know how their tissue is being used in research — some want to be able to find out more information about the study, some don't — and they want to be able to withdraw if they feel uncomfortable about it. And that is exactly in line with federal regulations regarding human subject research," she said.

The Immortal Life of Henrietta Lacks tells the remarkable story of how cervical cancer cells taken without consent or even knowledge from a poor tobacco farmer from Virginia became the HeLa cell line, the first immortalized cell line used in medical research. Henrietta Lacks died from cervical cancer in 1951, at age 31 years.

"Her cells were part of research into the genes that cause cancer and those that suppress it; they helped develop drugs for treating herpes, leukemia, influenza, hemophilia, and Parkinson's disease, and they've been used to study lactose digestion, sexually transmitted diseases, appendicitis, human longevity, mosquito mating, and the negative cellular effects of working in sewers," Skloot writes in the book.

But Henrietta Lacks' family was hurt and outraged when they learned from a Rolling Stone reporter in 1976 that HeLa cells (and other cell lines), in his words, "are swapped, traded, forwarded, begged, and borrowed among research institutions around the world."

In 1976, a small vial of HeLa cells could be purchased from a commercial laboratory for about $25. A casual search of the Internet shows that now, in 2015, commercial laboratory supplies peddle HeLa-based cell cultures from about $500 to more than $1000.

Biobank Consent Survey

In the current study, , Dr Tomlinson and colleagues surveyed participants in the GfK Knowledge Panel, a large-scale online panel based on a representative random sample of US adults aged 18 years and older, to gauge whether US adults would be willing to donate to a biobank and under what conditions.

The survey presented a description of a fictional biobank and asked participants to indicate on a 6-point scale their willingness to donate tissues under a blanket consent agreement and under seven potential research scenarios, including the aforementioned question about abortion, the use of tissues by for-profit firms to develop drugs, the use of animals as hosts for growing human organs for transplant, the creation of vaccines against biological weapons, or the use of the tissues themselves to create new biological weapons.

The authors received complete responses from 1599 (60.2%) of 2654 participants who received the survey.

Under the blanket consent condition, 68.0% of respondents said they were willing to donate tissues, but a significantly smaller proportion of respondents said they would agree under all but one of the hypothetical scenarios (range for 5 questions, 49.5% - 64.2%).

The single exception was a scenario in which donations could be used to "develop stem cells that have the donor's genetic code. These could be kept alive for many years. Scientists might use those stem cells to create many different kinds of tissues and organs for use in medical research." In all, 70.1% of respondents said they would be willing to donate under such a scenario.

When asked which of five informed-consent options they found most acceptable, 25.5% said blanket consent with option to withdraw was best, followed by plain blank consent (no donor control, 21.1%) and blanket combined with a caution that "[s]ome people may have moral, religious or cultural concerns about some kinds of research," giving them the option not to donate (19.7%).

Nearly half of all participants (45.0%) rated as the "worst" consent option real-time, specific consent for each use of the donated sample, in which the biobank contacts the donor to obtain consent whenever there is a research request for the tissues.

No Federal Rule

Skloot noted that in 1951, when physicians took Henrietta Lacks' cells without permission, and in 2009, when the first edition of her book went to press, there was no federal law requiring patient notification that harvested cells were being used in research. Still today, there is still no such law on the books; although a proposed regulation has been offered for public comment, it has languished without action for years.

"Where did those proposed regulations go? They were proposed years ago," Skloot said.

Although there is rigorous federal oversight of how intact human beings are treated in medical research, the rules applying to tissue research are far more lax. And what the consent scenarios described by Dr Tomlinson and colleagues fail to mention is that despite alleged privacy safeguards, research using donated tissues "could someday identify you and reveal personal information about you," Skloot added.

In 2013, researchers at the European Molecular Biology Laboratory in Heidelberg, Germany, sequenced and published the HeLa genome sequence, exposing the Lacks' family's genetic heritage to the world at large.

"This whole sequence could tell you whether she had the gene for early-onset Alzheimer's, which no one in the family wanted to know whether they had it or not," Skloot said. "The family didn't know that someone could use HeLa cells to do that, and really nobody did, because the technology didn't exist when they first took the cells."

In the 5 years since her book's publication, Skloot has toured and spoken on talk shows and at medical schools, research institutions, and countless other venues.

"What I hear across the board is that people want to donate, they understand why donating tissues is important for science. They want to be told, and they want to be asked how their tissues will be used," she said.

The study by was supported by a grant from the National Genome Research Institute. The investigators and Skloot have disclosed no relevant financial relationships.

JAMA. 2015:313:417-419. Extract


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