Does a doctor need consent before testing an experimental drug on you? Accessing your medical records for a health study? Using excess blood collected during your routine health check for a genetic study?
The answer to all of these questions is no — as long as certain requirements are fulfilled.
“The key issue is identification,” said Nicholas H. Steneck, PhD, director of the research ethics and integrity program of the Michigan Institute for Clinical and Health Research at the University of Michigan. “So as long as I don’t know who you are, I can use your blood. And under the right circumstances — if you’re not conscious, and the drug is something that might help you in an emergency setting — I can test that on you.”
But the process of patient consent can bring up a handful of ethical quandaries for patients and physicians alike. The keynote speaker at the 2014 CTSI Symposium, Steneck provided a brief history of the consent process, and discussed some potentially tricky consent situations that researchers can encounter.
“Current consent systems have serious weaknesses — I don’t think I’m telling anybody anything that they don’t know at this point,” said Steneck. “It’s an area where there’s lots of interesting work to be done and lots of challenges.”
Informed consent was written into law after many controversial studies came to light in the early-to-mid 20th Century. Fallout from the studies was so explosive that some have become ingrained in popular culture — an Emmy-award-winning HBO movie was made about the Tuskegee syphilis experiments, while a 1989 Billy Joel single references the “children of thalidomide.”
Though the Common Rule was put in to place in 1981, Steneck also touched on several more contemporary examples, including that of a Columbia University professor who in 2001 attempted to measure customer service responses by sending phony letters to hundreds of New York City restaurants alleging food poisoning.
“Can you imagine what happens if you send a letter to a five-star restaurant in New York City saying you got food poisoning?” said Steneck. “Columbia University was flooded with ‘We’re going to sue you,’ once they found out. Never a clue on the part of this researcher that he had to get informed consent on that.”
But most breaches aren’t quite so egregious. Many stem from well-meaning attempts to provide information that isn’t properly understood by subjects. Consent forms that use overly complicated language are a common culprit.
“How can you turn out a 20-page form written in 12th grade language and say with a straight face ‘We are providing informed consent to our subjects,’” said Steneck. “It’s a quandary because there are reasons why those forms are that long. There are reasons you have to include that much information. What do we do about that?”
The simplest fix is to improve an informed consent form’s readability. Creating a consent form that is encompassing yet readable can be a challenge, but using simpler language — less challenging vocabulary words and shorter sentences — can measurably improve understanding.
Steneck showed one consent form that began with a checklist which covered all of the necessary elements. At the top, it covered the IRB approval, and followed that with the elements of consent, HIPAA notices, options, and record. Each section was clearly laid out, and every element fit on one page.
Accompanying the one-page consent form in Steneck’s example was an information pamphlet explaining the study, and showing a visual representation of a BioLibrary, which likened it to a traditional library.
A study conducted by Steneck’s team showed that separating these two steps can create a high level of understanding — 89 percent of participants scored perfectly when asked about their level of comprehension.
“The idea here is we do the informing process separate from the consenting process,” said Steneck. “But it’s a change. The process of moving the understanding outside the consent form, I understand is a risky one. It’s a risky one for the people who are responsible for assuring that we’re following the Common Rule.”
Under current conditions, this type of separation isn’t ideal. A participant could potentially file a lawsuit and claim that they never received the informational pamphlet.
It’s here where an electronic consent form could potentially bridge the gap, but that can create other obstacles, such as added costs, privacy concerns and logistical issues such as the need to sterilize an iPad every time a new participant uses it.
Regardless, the informed consent process needs to be improved, said Steneck.
“As in all areas, researchers need to get on top of this, administrators need to get on top of this, before somebody else gets on top of it and tells us what we have to do,” he said.
The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry. To view the Symposium in its entirety, click here.