What's New in Life Science Research

Here, we need to turn to the Belmont Report, which lays out the U.S. government's guidelines for the protection of human research subjects. It identifies three basic ethical principles that must guide research with human subjects: respect for persons, beneficence, and justice.

The Belmont Report describes respect for persons in terms of respecting the autonomy of the human subject -- that is, her ability to set and pursue her own ends. Ethical research does not use the human subject as a mere means to pursue a particular piece of knowledge. Rather, it requires letting the human subject decide on the basis of good information whether to participate in the research. This is why informed consent is so important. In cases where research subjects have diminished capacity to exercise free choice and/or to understand the information necessary to make good choices, researchers take on additional obligations to protect the subjects.

Beneficence describes the researchers' duty to avoid harms to and secure the well-being of the human subjects of their research. This includes maximizing the possible benefits and minimizing the possible harms of a particular intervention. Generally, in biomedical research, these risks and benefits are understood in terms of what will happen to the health of the human subject with the intervention or without it. If an intervention introduces too much risk of harm, or too little chance of benefit given the potential harm, it crosses an ethical line.

Finally, the principle of justice means that the risks and benefits involved in producing scientific knowledge with human subjects and in using that knowledge, once produced, need to be fairly distributed. Among other things, this means that you ought not to rely on research subjects from a socioeconomic class that will be unable to afford the treatments produced by your research. (You can't dodge this ethical bullet by drawing all your research subjects from the ranks of the well-to-do, since participation in clinical trials may itself be a good that ought to be fairly distributed.)

How do these basic ethical principles come into play in research to develop reproductive cloning, therapeutic cloning, and SCNT-based stem cell production?

Beneficence requires researchers to account for the potential benefits of the treatments they are trying to develop, but also to account for the potential harms and to ensure that these do not outweigh the benefits. Some of the harms include the stresses on the bodies of the women donating the ova needed for SCNT. Ovum donation is not like sperm donation -- they don't send you off to a cubicle with a plastic cup and a skin magazine. Rather, it involves surgical extraction after being dosed with hormones. As described by women I knew in school who were egg donors, in the short term the process could be pretty miserable. I do not know how much research there has been about longer term impacts on the health of egg donors.

The cost-benefit calculation also needs to take account of the fact that, so far, each successful SCNT requires multiple ova. And, in terms of expected benefit, researchers will need to take an honest look at their track record to date, rather than counting on being able somehow to make happen in the lab what looks like it should be possible on paper. As Marcy Darnovsky writes:

Remember Hwang Woo-suk, the Korean cloning scientist whose published claims of producing stem cells with SCNT turned out to be fraudulent? Hwang also lied about having found a way to reduce the number of eggs required for SCNT. When a real count was made, it turned out that he'd used over 2200 eggs collected from 119 women. He'd neglected to properly inform many of them about the risks. He'd coerced some of them - including junior researchers in his own lab - to have their eggs extracted. And in violation of Korean law, he'd paid more than half of them - several said they'd agreed because they desperately needed money. Twenty percent of the women whose eggs he'd used experienced serious adverse reactions, and 16 were hospitalized.

Here Hwang runs afoul of both beneficence and respect for persons -- coercion is clearly a violation of your human subject's autonomy. (And yes, the person who provides material like ova for your research counts as a human subject that the researcher has an ethical obligation to protect.) This isn't the only way you could violate an egg donor's autonomy -- misleading her about the risks involved in donation, or the potential benefits to her of the research, or about what the donated ova are being used for would also violate the principle of respect for persons. So, you need to be able to provide this information to the donor (communicated so she can understand it) as well as establishing that her consent is freely given.

Trying to provide a benefit to the subject that will outweigh the harms of participating -- say, by offering a nice monetary sum for participation -- can end up creating situations that may also undermine the subject's ability to exercise a free choice. Again, from Marcy's post:

The prospect of an increased demand for eggs raised concerns early on about exploiting economically vulnerable women - and that was before the current economic collapse. That's why a number of countries (including Canada, France, China), states (including California), and scientific bodies (including the National Academies of Sciences) have ruled or recommended that women who provide eggs for cloning-based research be reimbursed for their expenses, but not paid more than that.

Eggs-for-pay could be economically coercive -- if there are no jobs where you are and you have to keep your kids fed and housed and clothed, undertaking significant harm to your body and health for money may seem like one of your only options. This is problematic from the point of view of respect for persons. It's also problematic from the point of view of justice -- poor women bear the costs inherent in being egg donors, while women in better economic shape do not. Especially if the knowledge and technologies developed from cloning research end up being commercialized, this creates a situation where the harms undertaken to create the treatments are borne by people who do not get to share in the benefits of the treatment.

The questions of justice here need to guide researchers not just in considering the sources of materials like ova, but also in selecting participants in clinical trials (e.g., of therapies using SCNT-derived stem cell). Indeed, to the extent that public money supports any of this research, there's a reasonable argument that the resulting knowledge and treatments ought to be a public resource rather than a private commercial good.

I'm not saying that human SCNT is a non-starter. Instead, if this is an avenue researchers want to pursue, we must ask the questions:

• What will be the benefits of this research? What will be the costs (especially, the costs to the human subjects of the research)?


• Who will benefit from the knowledge and applications this research produces? Who will bear the costs?


• What steps are being taken to protect the health and the autonomy of the human subjects of this research?

If researcher can answer these questions in ways that demonstrate that their research is guided by the three basic ethical principles of Belmont -- and if they can work out those pesky technical details -- then we might get somewhere with cloning.