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Informed consent and biorepositories
Most are okay with controversial aspects
Research participants are more open to sharing their medical tissue for research than is commonly thought, but they also do expect to hear about the results of any health findings, a researcher says.
A study of 40 people in the Durham, NC, area found that most people were comfortable with some of the more controversial elements of an informed consent document relating to tissue collected for a biorepository, says Laura Beskow, MPH, PhD, an assistant research professor at the Duke Institute for Genome Sciences & Policy in Durham, NC.
"We developed a biorepository consent form and recruited 40 people to have them read the form," Beskow says. "Then we interviewed them about what they thought of the form and recorded their opinions."
Participants mostly were okay with some of the issues that sometimes are debated in research ethics forums. For instance, most of the subjects were fine with informed consent language that discusses using the tissue for unspecified future research, indefinite storage time-frame for the tissue, and even for the potential of their tissue being used for commercial purposes, Beskow says.
More than half of the interviewees also were comfortable with being contacted periodically to update their personal information and to be informed of additional research opportunities.1
A majority of those who read the IC document also were willing to provide continuous access to their medical records, and most said they would not expect profits from any commercial use of the specimens to be shared with them.1
Although most people approved access to their medical records, this was one item that caused major concern among other members of the group, Beskow says.
The other thing that people expressed concern about was whether they would have access to their individual results, she says.
In the informed consent template, there is a bold-faced question of "Will I find out the results of the research?"1
The answer given in the IC template is as follows: "You should not expect to get individual results from research done with your blood. Researchers must study samples from many people over many years before they can know if the results have meaning. The results will not affect your care right now. They will be given to your doctor and will not be put in your medical record. You can get general news about studies being done through the Biorepository at this [Web site….]"1
"Most people understood and were comfortable with this language in the informed consent," Beskow says. "But when we asked, 'If researchers did happen to find something serious about your health, would you expect them to tell you about it?' more than three-quarters of the people said, 'Yes.'"
They wanted researchers to tell them about it as a matter of routine, Beskow says.
"I can't think of a more hotly debated topic in the research policy and ethics world," she adds. "The people we were interviewing were saying, 'I'm helping you out with this research by giving you my sample, so you should help me out if there's something you find about my health.'"
For other participants, this was considered a common courtesy, Beskow says.
"Arguments on the other side of this debate are that if we're talking about genetic results, then even if it looks like someone is at increased risk for their condition, often times there's not something you can tell them about what to do with this information," Beskow says.
"Also, people say that giving subjects' their individual medical information is not the purpose of the research, and expecting resources to be spent on giving people advice is not the way research resources should be spent," Beskow adds.
"We also asked people in our interview if the researchers did find something serious, would they prefer the investigators contact them directly or whether they preferred to have the investigator go to their doctor with the results," Beskow says. "And I believe their preferences were pretty evenly split: some say they'd rather hear the information from their physician, and other people said, 'Oh, doctors offices are so busy they'll lose the message and forget to tell me.'"
This debate likely will continue, she notes.
On the positive side, the study's findings were good news for investigators who worry about people wanting to share in the profits of their tissue's use for commercial purposes, Beskow says.
"There's been a lot of discussion in ethics literature about this idea that commercial products could be developed," Beskow says. "And the discussion about that generally suggests that participants would be unhappy about that and wouldn't want their biologic specimen to be used to develop a commercial product that someone will derive a profit from."
This isn't as big a controversy with subjects as ethicists might expect, however.
"Not only were people comfortable with the commercial use, but some were very positive about that," Beskow says. "They said, 'That's why you do this; you do it to help people and to develop drugs and tests.'"
Beskow continues to study informed consent and biorepositories with her next study focusing on how to simplify biorepository consent documents.
"We're doing a three-part study where the first part is to ask research participants what information in the consent form is the most important in helping them make a decision about whether to take part in a biorepository study," Beskow says. "We're essentially asking people to read the consent form and highlight the sentences that are important to them if they're making a decision."
The second part is to ask IRB members and researchers to do the same thing, highlighting the IC language they think is most important for making a decision, she adds.
"We think it will be interesting to see the difference between what they say and what the participants say," Beskow says.
"And the third part of the study is to evaluate the simplified consent form as compared with a traditional consent form and having people read one version or another to test their comprehension of what they're reading," Beskow adds.