Let’s say you’ve had a blood test, a biopsy or surgery. Did you know that any cells or tissues you leave behind in the process are fair game for scientists to use in their research without asking you and without getting your permission first?
Are you okay with that?
That’s the question posed today in a New York Times editorial by Rebecca Skloot, who leads with an anecdote about Jeffrey Gray, Ph.D., a microbiologist and vice president for research at Des Moines University. Skloot notes that recently he instructed a room full of DMU medical students “to take out their phones. Unlock them, he said. They looked at him like, Are you nuts? They wanted to know, Why? What will they look at? How will they use that information?
“‘In other words, they wanted to be informed and they wanted to give consent,’ Dr. Gray said later,” Skloot continues. “Now imagine those phones are cells in your body containing all the genetic information that makes you you, he told the students. Do you want scientists to pass them around and use them in research without your consent? Because right now, they can.”
That’s been the case for years under the Federal Policy for Protection of Human Subjects, or the Common Rule, to which the U.S. government has proposed sweeping changes. When the Common Rule was established, Skloot notes, researchers could use collected biospecimens so long as the donor’s identity is removed, because that made them “anonymous.” In today’s environment of precision science, however, Skloot writes that “scientists have proven it’s possible to ‘re-identify’ anonymous samples using DNA and publicly available information. Nothing prohibits this.”
Skloot, who gave presentations on the DMU campus and in Des Moines in April 2015, is a highly creditable person to comment on this issue. She is the author of the bestseller The Immortal Life of Henrietta Lacks, a poor black tobacco farmer whose cancer cells, taken without her knowledge in 1951, contributed to vast amounts of research and are still being used in laboratories worldwide. All her genetic information – and potentially that of her descendants – was sequenced and posted online without her family’s knowledge, consent or retribution.
That situation could change under the proposed Common Rule changes, but Skloot points out they haven’t been widely publicized or laid out in a particularly clear way. According to a summary posted on the U.S. Department of Health and Human Services website, the rules relating to informed consent “would be significantly tightened to make sure that the process becomes more meaningful. Consent forms would no longer be able to be unduly long documents, with the most important information often buried and hard to find. They would need to give appropriate details about the research that is most relevant to a person’s decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information…In addition, informed consent would generally be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is.”
Skloot and Gray share a mission of encouraging everyone to contemplate this issue and read the proposed changes – and to do so quickly, as the opportunity to comment ends Jan. 6, 2016. Check out the links in this post to take action.
“The goal of Rebecca Skloot’s article is to get people to go to the federal website to make their own opinions known regarding the proposed changes to the laws governing the use of humans and tissues in medical research,” Gray says. “This is a really important issue impacting medicine in the future.”
