A new article in The American Journal of Bioethics attempts to take the discussion about incidental findings in genomics research a step further by asking:
- “Assuming there is a duty to disclose significant incidental findings, might there be an obligation for researchers to actively look for these findings?”
The authors use an ancillary care model as a framework for their discussion. Ancillary care means care for research participants that is not required directly by sound science; not required to conduct a trial safely, for example, or to manage subject injury. The model was originally developed for research in developing countries.
The authors see ancillary care as the best perspective on incidental findings: a duty to disclose incidental findings is best justified as an ancillary-care obligation. The question in the article, then, is the following. If the ancillary care model implies a duty to disclose stumbled-upon incidental findings, does it imply also a duty to actively look for such findings?
To answer the question, three criteria are formulated all of which must be satisfied simultaneously to support a duty to look for incidental findings:
- Benefit: the genetic information sought must be beneficial for the patient.
- Uniqueness of access: researchers must be in a unique position to look for, assess and provide the genetic information.
- Burden: analyzing the genome for incidental findings must not take too much time, effort and resources from research.
Using these criteria, the authors conclude that currently there is no obligation to look for incidental findings in genomics research. Although uniqueness of access is high (genomic techniques are available primarily through research), benefit is low and burden high.
This may change in the future, the authors speculate, when better knowledge and technology make benefit high and burden low, and the technology still is available primarily through research. In such a scenario there would be an obligation to look for incidental findings. In the distant future, however, when genomic techniques are available also in clinical care, the obligation to look for incidental findings once again disappears.
In my view, this attempt to take the discussion a step further suffers from two major shortcomings that pertain already to the assumption that the ancillary care model could imply an obligation to disclose stumbled-upon incidental findings in genomics research.
Genomics research often is carried out as biobank research where the researcher’s relation to participants does not resemble a doctor-patient relationship. The researcher is not necessarily a physician and may work with samples collected years ago by others. The basic idea in the ancillary care model that “medical researchers must strike a balance between their obligations to medicine and those to research” is not obvious in many forms of large-scale biobank research.
Moreover, incidental findings in genomics research typically mean highly complex genetic risk information. It is not entirely clear, at least not to me, if the notion of, for example, actionability, has the same meaning for a discovered disease as for a discovered increased genetic disease risk.
An illuminating and realistic discussion about incidental findings in genomics research must, I believe, specifically address the biobank-infrastructural context of much genomics research, and the complex nature of genetic risk information.
If the ancillary care model generally is the best perspective on incidental findings, the applicability of this model to characteristic forms of genomics research would have deserved more careful attention.
How does one look for incidental findings? Isn’t the whole point of incidental findings that they are findings that nobody is looking for? I think it would be good to use a different word here… What the authors seem to be discussing is a duty to look for genetic variants that are/may be associated with disease. This seems to imply a duty of researchers to “screen” the samples that they use for findings that healthcare does not have a duty to search for. In fact, in the context of healthcare incidental findings are (in general) deliberately avoided, by not doing tests when there is no clinical reason to do them. Is the duty of care more extensive in biobank research?
Thanks for that pertinent remark! Do you have a diagnosis of WHY there is an inclination to look for biobank duties to provide care that go beyond even those of healthcare? Does it have to do with attitudes to genetics? Does it have to do with a perspective of protecting research participants’ interests that easily is exaggerated?
Maybe it is a way of (over)compensating participants to make sure that they are not being “exploited”? Which has become important following previous scandals and wrongdoings (of a very different kind) in medical research??? No diagnosis – just a thought…
You may be right, research ethics probably runs the risk of sometimes exaggerating its task and becoming one-sided advocacy. Your remark that not even healthcare provides the kind of healthcare services that are discussed with regard to incidental findings calls for attention to this risk.