Understanding Risks and Benefits in Research on Reproductive Genetic Technologies

Abstract

Research protocols must have a reasonable balance of risks and anticipated benefits to be ethically and legally acceptable. This article explores three characteristics of research on reproductive genetic technologies that complicate the assessment of the risk-benefit ratio for such research. First, a number of different people may be affected by a research protocol, raising the question of who should be considered to be the subject of reproductive genetic research. Second, such research could involve a wide range of possible harms and benefits, making the evaluation and comparison of those harms and benefits a challenging task. Finally, the risk-benefit ratio for this type of research is difficult to estimate because such research can have unpredictable, long-term implications. The article aims to facilitate the assessment of risk-benefit ratios in research on reproductive genetic technologies by proposing and defending some guidelines for dealing with each of these complicating factors.

Keywords:

• benefits
• genetic technology
• reproductive technology
• research
• risks

Notes

1. Additional provisions are included in the regulations for research with fetuses, pregnant women, and embryos. However, these provisions do not apply to most kinds of research on reproductive genetic technologies. Because the embryos that are used in such research are not yet implanted in a woman's uterus, they are not considered fetuses and the women who will receive the embryos are not yet pregnant. Further, existing guidelines on embryo research do not address embryos intended for implantation.

2. This they get from Levine (1986, p. 37).

3. This term covers both germ line gene therapy and germ line gene enhancement. See Resnik (2001, p. 1452).

4. Ooplasm transfer is considered by some to be a form of human cloning because it involves the replication of mitochondrial DNA. For the purposes of this article, however, ooplasm transfer is not considered an RGT because it is done with the purpose of relieving infertility rather than controlling the genetic characteristics of future children.

5. I will call these entities “future children” throughout the article as a matter of convenience. This title is not meant to confer any particular moral status to the gametes or the products of conception that are created throughout the process of RGT research.

6. This is a variation of Derek Parfit's non-identity problem (Parfit, 1984, pp. 351–61). This problem applies to both pre-conception and post-conception RGTs because even in post-conception RGTs (such a preimplantation genetic diagnosis), conception occurs differently than it otherwise would have.

7. The idea of discounting interests comes from Baruch Brody (2001).

8. Fertility drugs have long been suspected to cause an increased risk of ovarian and breast cancers, however, studies have found no evidence to support such a connection (Al-Shawaf et al., 2005).

9. Certainly, there are cases in which physical harms and benefits are subjective and difficult to predict or estimate. The risk-benefit ratio for such research can also be difficult to evaluate. These complications seem to be more prevalent, however, when considering these other types of harms.

World Medical Association.(2000). ‘Declaration of Helsinki’: WMA.

World Medical Association.(2005). ‘Protection of human subjects.” Code of Federal Regulations Title 45 Part 46.