How "Informed" Should "Informed Consent" Be?

As informed as you can possibly make it, of course.

I've been thinking about "informed consent" a lot lately, ever since I read the first articles and reviews about "The Immortal Life of Henrietta Lacks". Rebecca Skloot's nonfiction account of the culturing of cervical cancer cells taken from Lacks -- without her permission -- in 1951 is transfixing. (New York Times book reviews are here and here; a "health" section article is here)

Skloot's book reminds us just how recent some concerns about informed consent are. Henrietta Lacks died in Johns Hopkins Hospital's "colored ward"; she and her family were never asked about the research use of her cells, nor were they ever compensated financially (as reviewer Lisa Margonelli noted, "HeLa [as the cells are known, from the first two letters of Lacks' first and last names] has helped build thousands of careers, not to mention more than 60,000 scientific studies, with nearly 10 more being published every day...").

Skloot's book (quoting Margonelli again) criticizes "science that insists on ignoring the messy human provenance of its materials. 'Scientists don't like to think of HeLa cells as being little bits of Henrietta because it's much easier to do science when you dissociate your materials from the people they come from,' a researcher named Robert Stevenson tells Skloot in one of the many ethical discussions seeded throughout the book."

We like to think things have changed since the early '50s. Not only would Ms. Lacks no longer have been required to stay in the hospital's "colored ward", but we would certainly ask her permission today. Anyone who has been treated for almost anything these days is familiar with the "sign here" routine of consent forms.

But how much have things really changed?

Today's Times carries an article by Amy Harmon on the payment of $700,000 by Arizona State University to members of the Havasupai tribe in settlement of complaints about the misuse of tribal members' blood samples. The university will also return blood samples and provide other forms of assistance to the tribe.

According to the article, members of the Havasupai tribe provided blood samples to university researchers in 1990, "in the hope that they might provide genetic clues to the tribe's devastating rate of diabetes." A broad consent form was prepared, and donors signed that form. Later, the tribal members learned that the blood samples had been used to study for genetic variants that would be linked to diabetes, but also for schizophrenia, metabolic disorders, alcoholism, and more. Studies were published reporting "a high degree of inbreeding" and that "the tribe's ancestors had crossed the frozen Bering Sea to arrive in North America", and more.

All of it interesting research, no doubt, and some of it valuable, but all of it unethical.

The geneticist responsible for the original studies, Dr. Therese Markow, now a professor at the University of California, San Diego, insisted that she was "doing good science", and that those who have complained "failed to understand the fundamental nature of genetic research, where progress often occurs from studies that do not appear to bear directly on a particular disease."

The consent forms were purposely broad, Dr. Markow said, because "English was a second language for many Havasupai, and few of the tribe's 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors."

Should I list all the things that are wrong with the previous paragraph? Well, for starters:

• If you are genuinely concerned about the English-language skills of your prospective donors, how about having the forms translated into their native language, or at the very least providing skilled translators?
• If you're planning on using the samples for more than one test, tell the prospective donors. Maybe you don't know where the research might take you. Tell them that, too.
• Is the Havasupai culture one that encourages asking questions of people perceived to hold power or not? If not, you could ask, "Do you have any questions?" until the cows come home, and never hear any. That wouldn't mean that there were no questions.

It was only by sheer accident that the misuse of Havasupai blood samples was discovered, according to the Times article. One tribe member, who had attended college, was visiting at the University and was invited to a student's doctoral presentation. The research on which that dissertation was based was derived from research with the Havasupai DNA. The tribal member "understood little of the technical aspect, but what she heard bore no resemblance to the diabetes research she had pictured when she had given her own blood sample years earlier."

During the post-presentation question period, she asked whether he had permission to use the donated tribal blood for this purpose.

"The presentation was halted. Dr. Markow and the other members of the doctoral committee asked the student to redact that chapter from his dissertation."

Could anything be more damning?

But it's not just cultural and language barriers that all too often make "informed consent" anything but. There's also timing.

When a friend underwent surgery a few years ago, just before being wheeled into the operating room, already hospital-gowned and mentally prepared, he was handed a clipboard and pen to sign the "consent form" permitting the surgeon to use tissue removed in the operation for research purposes.

If he hadn't signed, the operation wouldn't have gone forward. So of course he did. But let's not pretend that his experience was "informed consent."

Research needs to be done. But not by trampling over the human subjects who make that research possible. Even if it's just in the name of "efficiency".