By Anne Meade, senior manager for website and social media
Not that long ago, genome sequencing was something most people did not have as an option available to them. Fast-forward 13 years later from when the human genome was first sequenced for $3 billion, and companies have announced that that they have machines available that "can sequence the genetic code of a human cell for $1,000." As genome sequencing has become more affordable and accessible, an ethical challenge becomes helping people interpret what their results mean to them, their health, and their futures.
In her interview for People and Perspectives, Carol Weil, program director for ethical and regulatory affairs at the National Cancer Institute, discusses the importance of context when assessing the risk of returning research results to participants. If people take part in research and want to be informed of the results garnered during the course of that research, one could argue they have that right. But the lack of understanding they possess about the information—and its current applicability to known diseases and conditions—can be anxiety-producing. Weil explains that advancements in technology mean it is not complicated to provide the information, but the value of the information and its interpretation can be difficult – "Is there a way to tell someone something that doesn't provoke more anxiety and cause more harm?"
Weil admits that there are various schools of thought about this and that there is no single answer applicable to every situation. You are going to find different answers in different contexts.
"The kinds of things that you would do in an observational cohort study in terms of collecting biospecimens and returning research results might be very different than the kinds of things you would do in a, say, a targeted genetic study where you have a rare disease population…I don't think it’s such a bad thing that you have different answers in different contexts…context is key." [Emphasis added]
Often, thinking about risk and research might focus on the actual study itself, but there can be risks beyond that. In the example above, researchers risk creating greater fear or stress by providing results that may not have documented relevance to a participant's current health or future well-being. The answers are going to be different for different populations and different studies. Standards of care as they are defined in medical practice can be difficult to apply to some ethical dilemmas. As Weil notes, "The key is to ensure that the participants that are involved in the research in the study understand what the choices are, and have accepted them if they've enrolled in the research."
Watch Carol's five-minute excerpt where she discusses this topic or watch her full video, which outlines her belief in the need for comprehensive discussions about research ethics and regulatory oversight.