Give the DNA to the scientist, do you want to know the result? Data feedback
July 26, 2018 Source: China Science News Author: Lu also
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As more and more people share their tissue samples and DNA with researchers, the need to give back the hidden information in these samples to providers is more urgent than ever.
The National Institute of Science, Engineering and Medicine (NASEM) recently released a 335-page report urging researchers and regulators to return more biological data to those providers. Feeding data back to individuals is part of a broader effort to give participants a voice in research, especially in their body organization, but how to better serve the recipients and researchers. It is still unclear.
In fact, this issue has been receiving much attention for many years. Because DNA sequencing of participants' samples is unexpected, and these samples are not always relevant to the original study, such as in a heart disease study, participants may find genes that are prone to breast cancer. In addition, scientists often find mutations or other information that is medically meaningful to an individual.
For participants, if their DNA is worth publishing and helps promote science, why not share it with them?
Taking into account these issues and regulatory inconsistencies, the US Food and Drug Administration, Medicare and Medicaid Services Center (CMS) and the National Institutes of Health (NIH) began to seek help from NASEM.
Jeffrey Botkin, chairman of the committee and a pediatrician and bioethicist at the University of Utah School of Medicine in Salt Lake City, said that after about a year of work, the committee concluded that "the feedback to carefully expand the results is correct."
Researchers have traditionally valued feedback for medically meaningful results that have a large impact on disease risk and are medically "operable," meaning that some measures can be taken to prevent the disease. In 2013, the Maryland School of Medical Genetics and Genomics published a list of genetic mutations, and the college said that results will only be returned when asked.
However, the NASEM report did not consider which genetic mutations or other data should be fed back—for example, the controversial Alzheimer's disease susceptible mutation APOE4. Instead, the authors weighed a broader set of considerations, considering whether to expand the type of results and shared information, such as from DNA to biomarkers to potential toxins in body fluids.
Botkin said that it can be based on research that asks participants what they want. These results are "obviously valuable to many participants - sometimes for medical decisions, and in many cases for curiosity."
“I am surprised and pleased with this report, which is a new era of recognition of the partnerships of research participants.†Kathy Hudson, CEO of the People-Centered Research Foundation, said, “It’s refreshing to say goodbye to the parental style.â€
However, a huge obstacle is that research institutions have not established a feedback mechanism for results. Moreover, doing so is a burden for the research team, whether it is logistics or cost. Relevant feedback management regulations are also confusing and confusing.
However, the NASEM report addresses these issues in 12 recommendations and urges systematic changes.
Currently, human tissue research is conducted in a range of different laboratories, using different quality control measures, and there is no uniform certification process for all laboratories.
In response, the NASEM report requires NIH to establish a certification system for laboratories that process human samples, which helps manage how they are analyzed and reported; certified laboratories can return certain DNA discoveries and other information to needed Participants.
An authentication process like this can help researchers deal with the conflicts they face. On the one hand, CMS prohibits laboratory feedback without “clinical†certification. On the other hand, the Health Insurance Portability and Accountability Act (1996), which aims to protect health and privacy, supports participants in requesting results. In this case, what should the research team do?
"We know that researchers and institutions feel a dilemma," Botkin said.
A new certification system can help solve this problem. The relevant agencies recommend that the CMS revise its rules prohibiting the return of results from non-clinical certification laboratories, and allow those laboratories that are certified according to the potential new rules to return the results to the participants.
It may also reduce some of the problems that plague consumers' genetic testing: some companies claim that because they do not use clinically certified laboratories for raw data analysis, the results of their feedback may be wrong.
The NASEM report also suggests other ways to ensure accuracy and transparency. It urges researchers to carefully consider what will be returned before the study begins and seek funding accordingly. In addition, Botkin said that it is vital to keep participants happy, which can help researchers recruit enough suitable participants.
Although these goals sound admirable, Ellen Wright Clayton, a law and genetics expert at Vanderbilt University in Nashville, said: “The devil is hidden in the details, considering the needs of the participants.†She has been looking for ways to do it for a long time. The research results are returned to patients, doctors and funders.
Clayton added: “Ethically, rewarding these results will be a real challenge. Part of the reason is that there are not enough genetic counselors to help those who receive unpredictable results,†she said. “Although some people will definitely Get help, but this will be a destructive change." (Lu also compiled)
Chinese Journal of Science (2018-07-26 3rd Edition International)
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