Tuesday, February 12, 2013

Embryonics Anonymous: Does Embryonic Stem Cell Research Require Consent?



Embryonic stem cell (ESC) research is undoubtedly one of the most heated bioethical issues in America today. While proponents of ESC research maintain that it will lead to considerable medical advances, detractors of the project contend that the practice is unethical in principle since it involves the deliberate destruction of human embryos, which they argue are humans who possess moral worth. While this controversy probably will not subside any time soon, another difficulty for current ESC research in the United States has arisen based on the possible lack of consent in certain cell lines.

In 2009, President Obama issued an executive order to the National Institutes of Health allowing for the federal funding of research on 198 human ESC lines approved by the National Institutes of Health. According to Rockefeller University researcher administrators Amy Wilkerson, Kathaliya Wongsatittham, and bioethicist Josephine Johnston in letter to the publication Cell Stem Cell, however, there is no evidence that any consent was given by the gamete donors for the use of their egg and sperm in originating 50 of these cell lines.

While Wilkerson has expressed that neither she nor her co-authors think that these cell lines should be removed from the registry due to this discovery, I think that a good argument can be made to the contrary using principles widely accepted by medical researchers. For instance, The Declaration of Helsinki of 1964 states in paragraph 25:

“For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse. 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.”

From this paragraph, it can be plausibly inferred a fortiori that experimentation and manipulation of identifiable human material requires consent as well since it is required for less important uses such as collection, analysis, and so on. Moreover, it is unlikely that obtaining consent for the use of gametes to produce embryos would have been impossible or impractical as it had been done for a number of other cell lines. Hence, as the ethics committee overseeing ESC research at Rockefeller University and two related institutions has also concluded. this appears to be a clear case of an ethical violation on part of the cell line providers involved, which warrants prohibiting future usage of these lines by researchers. I would advocate going further and simply removing these lines from the registry in order to eliminate the possibility any potential misuses of the cell lines in the future.

Wilkerson and her co-authors have indicated that their goal has been to inform other research ethics committees about the lack of evidence for consent in the origination of these cell lines. Hopefully, then, these other committees will take a harder stance against the use of these lines and the breach of ethics behind their creation.

1 comment:

Manuel said...

I'm curious, when reading this, of the purpose behind ending research using these lines. We disagree on the basic premise that embryonic stem cell research is morally problematic, but even granting you that, I do not see disposing of these lines as the best alternative currently available to us.

Under this assumption, let's consider where we stand today: a double moral wrong has been committed. Not only has an embryo's life been terminated for the extraction of admittedly valuable stem cells, but this has transpired without the consent of the individuals who generated this embryo. We are left with valuable lines of embryonic stem cells which we obtained immorally. Is it morally better for us to now dispose of those lines instead of using them?

There are several compelling reasons to believe otherwise:

For one, the use of these lines could conceivably lead to advances that save lives, while disposing of them will certainly lead to none. Even accepting that two moral wrongs have transpired, these moral wrongs are what an economist might call sunk costs. Yes, something bad has occurred, but nothing we do can change that.

Since we are accepting that it is morally wrong to harvest stem cells, another important moral good comes from using these stem cell lines. Suppose some researcher could have used these, but they have been removed from the registry; what is she to do? Very likely, she will look for another source. Perhaps she will use one of the cell lines that has already been harvested, but perhaps those will not be of use to her. She might then harvest new stem cells, committing another serious moral wrong.

There is good reason to be cautious, however. I think everyone agrees there are considerable problems with harvesting these stem cells without consent. While we want to make the best use of the stem cell lines now that they have been inappropriately used, we do not want to encourage similar future behavior. We thus need to ensure that a scientist faced with the question of whether to conduct research with donor gametes is not tempted to do so because we continue to use these lines. The scientists who played roles in developing these stem cell lines without consent should thus be punished. I'm not sure who, exactly would dole out these punishments, but I assume the institutions involved ought to have some process to ensure their scientists are following ethical guidelines; each institution should take their responsibility to be ethical seriously, and thus ought to punish individuals like these when appropriate.