blog.bioethics.net

Racing For a Cure--And Taking Genetic Samples at the Same Time?

As a woman and a supporter of research of all kinds, I still have a hard time swallowing this request: "You are healthy. You feel great. Can you help us out by participating in a research study where we will biopsy your breast and take out healthy tissue for our cancer genetics database?"

To create a database out of tissues of women at risk for breast cancer is one thing, but to ask completely healthy women to give is another. But this is precisely what the Indiana University's Susan G. Komen for the Cure Tissue Bank at IU Simon Cancer Center is asking women to do, says the Indianapolis Star.

The database has collected tissue samples from over 450 women and blood samples from more than 4,500, says the Star, and is the world's only repository of healthy breast tissue.

What would motivate hundreds of healthy women to undergo breast biopsies for research from which they will derive no benefit whatsoever? How did the database get so many volunteers to donate breast tissue and blood so fast. Volunteers for the study, and even blood samples, were collected at the annual Komen Race for the Cure.

But do these women, clearly motivated by the desire to help those with breast cancer and/or genetics research, understand how their samples will be used? Are they paying attention to the informed consent process or are they more likely to be the kind of women who would do anything to advance breast cancer research and the search for a cure?

Of course, it is impossible to know what motivates any healthy volunteer to participate in research unless you ask them, but the potential for inadequate informed consent here is not small. Blood draws are innocuous enough--but collecting them at the race? Then asking people to volunteer to undergo a breast biopsy to collect tissue samples? Moreover, I would guess that a significant number of volunteers have a first-degree relative with breast cancer, motivating them to do whatever it takes to find a cure--particularly on a day like the Race for the Cure.

Even though the researchers seem to have taken the ethical considerations about informed consent for donating samples to a genetic database into account (according to the Star the PI of the study "consulted with experts at IU's Bioethics Center, where she got help crafting a paragraph for the consent form"), it would seem that her recruitment methods did not get the same scrutiny. The database would seem to have tremendous value for breast cancer research, but it is essential that those donating to it understand what they are doing and simply not be motivated by the breast cancer advocacy community or the energy of a day like the Race for the Cure.

Summer Johnson, PhD