Dr. Robbee Wedow of Purdue University discusses the challenges of ensuring informed consent among research participants when it is becoming standard practice to collect data in gene repositories to be available for future research.
Imagine you’ve agreed to be part of an exciting new long-term research study to better understand human health and behavior. In recent years you have visited a gathering place where you fill out some questionnaires about your health and daily activities. Research assistants take your height, weight and some other physical characteristics about you. Since you agreed to contribute your genetic data to the study, you also provided a saliva sample during your first visit.
Next, you see a news article reporting that researchers analyzing data from the study you’re participating in have found genetic variants that predict the likelihood of someone completing college.
You remember reading a long form when you agreed to provide your details, but you can’t remember all the details well. You know the study was about health, but how do these findings about genes and education have anything to do with health? Did they analyze your data specifically? What did they find?
What are biobanks?
Many scientific research studies collect data intended to answer a specific research question. For example, to study the genetics of diabetes, researchers could collect data on blood pressure and lipid levels in addition to genetic data.
But increasingly, scientists are collecting large amounts of data to be stored in biobanks, archives that store genetic data and other biological samples such as blood, urine or tumor tissue for use in a large number of future studies.
Some biobanks, such as the UK Biobank, link data on biological samples to other data collected, such as sexual behaviour, medical history, weight, diet and lifestyle. Even private companies like 23andMe get consent from their customers for their data to be used in research activities.
As a researcher interested in the intersection of social behaviors and genetics, I frequently have conversations with people who were unaware of how their genetic data is being used. They are often surprised that genetic data that they have consented to be used for research at a private company using a DNA test kit or at a biobank while visiting their local clinic can be used to study the genetics of behavior or behavior same-sex sexual risk -taking.
In our newly published research, my colleagues and I found that even choosing not to answer survey questions can reveal information about the population (we found that not answering survey questions correlated with levels of education, health, and income of a person) if genetic data is available.
Genetic data and informed consent
The research that can be done with biobank data might sound scary, but it doesn’t have to be. Genetic data, such as the data used in our study, is de-identified. This means that it cannot be traced back to individual research participants, who remain anonymous.
Additionally, the genetic data for these types of genetic studies is used in the aggregate, which means that it is not used to predict or evaluate any particular individual’s responses or behaviors.
Researchers do not use genetic data to target individuals with certain genetic profiles. Nearly all genetic research is used to better understand how health behaviors and other factors affect health and to figure out how to improve outcomes. This goal is why most research participants agree to contribute their data to research in the first place: helping the world through science.
The question is whether research participants really understand how their data can be used. Many of the original ideas about developing informed consent process and institutional review boards, or IRBs, intended to protect research participants from direct harm or privacy violations were based on the expectation that research studies would address particular issues on a single topic, such as cardiovascular disease or lung cancer. This goal was to not repeat unethical research atrocities like the infamous Tuskegee Syphilis Study, in which researchers failed to tell participants, who were all black men, that they had syphilis and refused treatment that was already widely available. and known to be highly effective.
But because genetic data is de-identified, it is often considered exempt from the IRB’s comprehensive review, which is a US protocol for ensuring that studies meet ethical standards and institutional policies. And the large number of research questions that can be explored with biobanks, coupled with the amount and types of data collected, have rendered these original protections insufficient to ensure truly informed consent.
Improve informed consent
To be clear, biobanks are of enormous importance to public health research. They allow researchers to link many different outcomes and variables together to paint a critical big picture of human health and behavior. And in contrast to personally identifiable online or phone data that companies collect to show you targeted ads, biobanks collect anonymous data that is evaluated in the aggregate.
In the age of vast data collection, ensuring participants are aware of how their data can and cannot be used is necessary to ensure biobanks are a transparent tool for the global good.
Biobanks cannot predict how a participant’s data will be used in the future, so it can be difficult for researchers and ethicists to report the “informed” part of “informed consent.” Even so, more needs to be done to earn the trust of valuable research participants who contribute data to improve science and society.
By Dr. Robbee Wedow
Dr. Robbee Wedow is an assistant professor of sociology and data science at Purdue University. His primary research interest is sociogenomics, which lies at the intersection of sociology, demography, and statistical and computational genetics.
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