Undisclosed Future Testing

It is said that the pace of research is increasing. But really, it is the amount of information available to researchers that is increasing. Just as an example, high-throughput and other genomic sequencing advances are producing more information than can be individually examined; data repositories hold vast, never-before seen data, just waiting for someone to connect the dots.

However, we often need to connect those dots with information from living people, as not all advances occur in the clean realm of de-identified data. More importantly, even if gleaned in that realm, all advances come back to living people in some way. Research advances, and so does the understanding of ethical research.

Consent for research assumes the subject understands and is able to determine the risk/benefit ratio of the testing. In these situations, this testing can occur well after the sample collection, making that difficult or impossible. Moreover, research always has the chance of discovering something no one expected. If the researchers cannot predict where their research may lead, then how would the subject be aware of what testing is even possible? Can it be true that the possible risks of future testing are not knowable, and therefore cannot be minimized and balanced?

Clearly, however, there are a realm of risks, and ways to minimize and balance such risks. If de-identification is not possible, then merely appropriate security is required. Risks to community require discussions at the community level; it makes little sense to try to address concerns on a level discordant with the risks. For example, if given the chance individual Havasupai could have allowed their samples to be tested for “tribe origins,” but that would not have changed the community risk.

For some studies, not reporting results to individuals is a tidy solution to the dilemma of potentially harmful results. However, how could researchers report their findings without reporting from whom those findings came? Studying risk factors in populations, i.e., studying the risks of being in a certain population, would require reporting those risks found as being in that population. As the appreciation for those risks may only be known after the sample has been taken, and possibly even after the sample has been de-identified, risk assessment and management is an ongoing process, even just before publication, especially in this kind of research.

Truly, researchers understand these ethical issues, and almost all of the time, need no interference. Moreover, these are just some risks that are to be expected in the daily lives of people in the information age. Nevertheless, there will always be ethical issues, and new ones will emerge.

Currien MacDonald, M.D., CIP
Aspire Medical Director