Students research informed consent laws

August 14, 2013

In 1951 scientists took some of Henrietta Lacks' cells, nicknaming them HeLa. She didn't know. They didn't ask.

Yet, those cells transformed medicine and led to many medical breakthroughs that have saved countless lives. Therein lays an ethical conundrum at the heart of a summer research project by two Indiana State University students. The students investigated how the laws have changed regarding informed consent as part of the Summer Undergraduate Research Experience and The Center for Genomic Advocacy.

The project began, in part, with Indiana State's selection for the fall read of "The Immortal Life of Henrietta Lacks," which traces the cells and their continued life after they were taken from the poor black tobacco farmer during a medical procedure.

"Genetic information was taken without her consent and used in research," said Bobby Webb, a senior political science and legal studies major from LaPorte, Ind. "There's been a lot of money made from research on those cells. It brings an ethical dilemma to policy."

Webb along with senior education major Dianne Reeves worked with Nathan Myers, assistant professor of political science, and Chia-An Chao, associate professor of business education, information and technology, to investigate the types of consent laws passed by the states.

"All of us interact at some time with the medical system," Myers said. "We need to know how a sample collected for research is going to be used. Henrietta Lacks had no reason to think her cells were different or special. It's important when giving information to doctors or scientists that we're protected so we know how that information is used."

Chao called the issue complex and evolving, stating that when doctors and researchers discuss consent and risks of genetic testing and research participation, those risks are based on current research and capabilities of genomic and information technologies. The risks include the interpretation and communication of test results, as well as access and use of that information.

"The risks you sign off may be valid at that time, but down the road, that understanding can change," she said. "The informed consent process is critical - it is the first step in helping patients and research participants make informed decision before consenting to the collection, storage and use of their genetic material and information."

The federal government passed the Genetic Information Nondiscrimination Act of 2008, which doesn't allow employers and health insurance companies to make hiring and insuring decisions based on a person's genetic information. There are also federal regulations governing informed consent for research subjects. However, for decades state governments have been enacting legislation affecting the use of genetic samples as well. Recently the federal government has revisited its regulations, partially in response to different state policies.

"Almost every state has some sort of genetic testing legislation," Webb said. "Most of it is about insurance."

"Informed consent protects the rights of the subjects and the patients," Reeves said.

Research subjects must give consent for samples to be taken and tests to be run. Broad or narrow consent determines what then can be done with those samples. Myers explained that under narrow consent samples taken in a cancer research study may only be used in that study. However, under broad consent that sample may be used in other research.

In surveying the states, Webb and Reeves examined the political make up of each state and political divides between the houses and the governor. They also looked at the poverty and graduation rates.

"Poverty didn't have an effect for broad or narrow (consent)," Reeves said. Higher poverty rates were found in states with legislation that was not easily assigned to either category.

However they found divided governments passed more informed consent legislation. They found 12 laws with broad consent, with nine of those laws coming from a politically divided government. They found 28 pieces of legislation with narrow consent with 18 coming during a divided government.

They also found a small variation regarding graduation rates. States that average more graduates tend to have broader legislation. States with broad consent laws have an average graduation rate of 76.4 percent while states with narrow consent have an average of 75.7 percent graduation rate. States without consent laws have an average of 73 percent.

"The hypothesis is they might be more favorable toward science research and want scientists to be able to do research with fewer constraints," Myers said about the graduation rates in states with the broader laws.

"Right now, it's a first cut analysis to see if there is any difference in the raw numbers," Chao said. "The next step will be statistical analysis."

And then they will form new questions and hope to further their research.

"We learned a lot from what Bobby and Dianne found," Myers said. "They dug in and found the nuances in legislation and gave us lines of future research."

For the students, they learned about conducting research as well as policy and genomic advocacy.

"I thought it was a good opportunity to dabble in something I didn't know about," Webb said. "I hadn't done research like this before."

Reeves, who had her interest in genetic testing stirred during her education classes, found herself fascinated by the research.

"It kept drawing me in further and further. I just couldn't stop," Reeves said. "I'd do this work and then in my spare time I'd do other research. It fueled my curiosity. I want to know what's out there, what are we signing and what's the law."

Photos: http://isuphoto.smugmug.com/Other/Media-Services/Public-Policy-on-Genomics/i-7sX798c/0/L/July%2030%2C%202013-Public%20Policy%20on%20Genomics%206889-L.jpg Dianne Reeves and Bobby Webb ISU Photo/Rachel Keyes

http://isuphoto.smugmug.com/Other/Media-Services/Public-Policy-on-Genomics/i-zXDCRbP/0/L/July%2030%2C%202013-Public%20Policy%20on%20Genomics%206907-L.jpgDianne Reeves and Bobby Webb explain their findings on genomic policy. ISU Photo/Rachel Keyes

http://isuphoto.smugmug.com/Other/Media-Services/Public-Policy-on-Genomics/i-9qVVZWP/0/L/July%2030%2C%202013-Public%20Policy%20on%20Genomics%206875-L.jpg-An Chao, Dianne Reeves, Nathan Myers, Bobby Webb ISU Photo/Rachel Keyes

Contact: Nathan Myers, Indiana State University, assistant professor of political science, at nathan.myers@indstate.edu, 812-237-2503 Chia-An Chao, Indiana State University, associate professor of business education, at chia-an.chao@indstate.edu, 812-237-2075

Writer: Jennifer Sicking, Indiana State University, associate director of media relations, at jennifer.sicking@indstate.edu, 812-237-7972