The Helsinki Declaration is under revision. One suggested change concerns a paragraph about biobank and register-based research, which states:
- “For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse.”
The paragraph currently continues with the following exceptions:
- “There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee.” (My emphasis.)
The proposed revision is to delete the exception I emphasized. – Why? I speculate that the deletion is proposed to avoid perceived conflict with an earlier paragraph, stating that
- “the well-being of the individual research participant must take precedence over all other interests.”
In particular, the interests of research must not take precedence over the interests of the participant. But it might appear as if “…or would pose a threat to the validity of the research” does just that. The phrase seems to emphasize the interests of research.
In the latest issue of Science, CRB researchers Joanna Forsberg and Yusuke Inoue question the proposal to delete the exception. In a letter, “Beware Side Effects of Research Ethics Revision,” they point out that in biobank and register-based research, risks of participation are only minimal.
Human beings are “participants” in a markedly different sense when the research is done on their data or samples, rather than on themselves or their bodies.
The authors argue that “when the risks are minimal, it is not clear that the individual’s interests in having a say should automatically outweigh the good that can result from robust research.”
I think their views should be taken seriously. There is a risk that the effort to achieve verbal consistency neglects actual distinctions between forms of medical research. If the paragraphs that seem to conflict concern markedly different forms of research and markedly different forms of participation with markedly different risks – then an important exception might be sacrificed for the sake of an only apparent conflict.
My post last week tried to highlight a tension between human existence and biological life, using Henrietta Lacks as an example. She was a unique human being, existing in a human world; but the HeLa cells obtained from her cancer tumor function in laboratories all over the world as “bio-objects” representing biological life more generally.
This tension between a human world and a laboratory world, between human existence and biological life, could be questioned (as in a comment to the Swedish version of the post): There is no tension, for humans owe their “existence” to the biological processes of life. If cells didn’t organize human brains, there simply would be no “human existence.”
Biological life is fundamental: human existence should bow and scrape to its biological origins.
The tension could be questioned also from a humanistic perspective, however. On this view, the biological perspective is formed by humans. Human existence is the unnoticed condition for the biological notion of life. Once again there is no tension, for the biological notions of “cells” and “brains” owe whatever meaning and function they have to human existence.
Human existence is fundamental: the biological perspective should bow and scrape to its human origins.
Both attempts to reject the tension by determining who should bow humbly backfire. The tension is rejected by each party, but in opposed ways, making the tension surface instead as total intellectual war.
So let’s face the tension instead, and perhaps that’s what the article mentioned last week tried to do.
A new article reconsiders Henrietta Lacks and the immortal HeLa cells that were obtained from her rare cancer tumor in the 1950s; cells that still replicate and are used in biomedical laboratories all over the world:
The article is written by Anna Lydia Svalastog and Lucia Martinelli, both members of the Culture, Health and Bioethics network at CRB.
There is a lot going on in the article, making it difficult to summarize. As I understand it, though, the article focuses on two fields of tension when biological samples from humans are used in biomedical research – tensions between:
- being human; and representing biological life,
- the value of the one; and the value of the many.
Both fields of tension intersect in the case of Henrietta Lacks:
- Henrietta Lacks was a human being, existing in a human world; but HeLa cells function as “bio-objects” representing biological life.
- Henrietta Lacks was one unique individual; but HeLa cells have come to represent humanity.
These tensions highlight the interchange between research and society. We exist as human beings; but by donating samples to research, we also contribute to representing biological life. We are unique individuals; but through our samples, we also contribute to representing what is general.
The authors cite the European biobank infrastructure, BBMRI, as an approach to governance and ownership of knowledge and property that begins to address these tensions in interesting, new ways. The article also speaks in favour of interdisciplinary collaboration between the life sciences, the social sciences, and the humanities, to understand the fields of tension that arise when individual human beings contribute to medical research.