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Making Risk-Benefit Assessments of Medical Research Protocols

Published online by Cambridge University Press:  01 January 2021


Most medical experiments are reviewed by groups known as Institutional Review Boards (IRBs); according to every standard account of medical research ethics, an IRB should not approve an experiment unless it has an acceptable combination of risks and benefits. This requirement is often stated in different terms. Some codes say that an experiments benefits to individuals and society must outweigh its risks. Others say that the experiment must have a favorable risk-benefit ratio. The Code of Federal Regulations says that risks must be reasonable in relation to the expected benefits.

However, even though everyone agrees that an experiment must have an acceptable combination of risks and benefits, almost nothing has been said about what it would mean to weigh risks against benefits, compute risk-benefit ratios, or figure out if an experiments risks are reasonable.

Copyright © American Society of Law, Medicine and Ethics 2004

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Respectively, The Declaration of Helsinki, Section B, Item 18; The Belmont Report, Part C, Section 2 (1979); and 45 CFR § 46.111.a.2 (2001). I should note that the authors of The Belmont Report admit that talk of “balancing” and “risk-benefit ratios” is metaphorical, but offer no replacement for the metaphor.Google Scholar
45 CFR § 46.111.a.2 (2001).CrossRefGoogle Scholar
Here I assume that the expected value of not running the protocol will always be zero, since it represents no change in the status quo.Google Scholar
Improving Informed Consent for Research Radiation Studies, National Institutes of Health Radiation Safety Committee (October 17, 2001).Google Scholar
See, e.g., “1990 Recommendations of the International Commission on Radiological Protection,” ICRP Publication 60 (New York: Pergamon Press, 1991) (especially chapter 3).Google Scholar
I say “usually” because some protocols produce such spectacular results that one could judge them greatly efficacious even if there were no other medical knowledge about the same disease or procedure. The first uses of penicillin on syphilis were like this. The antibiotics cured the disease in almost everyone they were given to.Google Scholar
For an overview of the problems with such scales, see Nord, E., Cost-Value Analysis in Health Care: Making Sense out of Qalys(Cambridge: Cambridge University Press, 1999). Cf. Broome, J., “Qalys,” Journal of Public Economics 50 (1993): 149–167.CrossRefGoogle Scholar
See, e.g., Emanuel, E. Wendler, D. Grady, C., “What Makes Clinical Research Ethical?” JAMA 283 (2000): 27012717.CrossRefGoogle Scholar
Another principle I won’t consider is this: A protocol is moral only if it constitutes the best use of the resources that would be devoted to it. This may or may not be a principle governing the distribution of funds for medical research. But whether it is or not, my focus is on the principles that IRBs should use when assessing protocols, and IRBs are simply not equipped to make the comparative judgements required by this principle. They cannot be expected to think through all possible uses of research funds.Google Scholar
This definition of competence is drawn from Buchanan, A. Brock, D., Deciding for Others: The Ethics of Surrogate Decision Making (New York: Cambridge University Press, 1989): at 23ff. Buchanan and Brock’s definition also includes a requirement that the subject understand the nature of the options presented, but since I am treating informed consent as a separate requirement, it is not included here. In addition, because there is such a large literature on competence, I will say relatively little about the two conditions that are included in my definition.Google Scholar
It is worth nothing one other interaction between the agreement principle and the other standards for ethical research. The agreement principle says that a protocol is moral just in case some competent decision-makers would enter into the protocol, but it does not say how many decision-makers must be willing to do so. In particular, it does not require that there be enough competent decision-makers to adequately power the study. However, I take that requirement to be covered by another standard for ethical research — the one that says that in order for a study to be ethical, it must be scientifically valid.Google Scholar
See, e.g., Feinberg, J., The Moral Limits of the Criminal Law, Volume Three: Harm to Self (Oxford: Oxford University Press, 1986): 2797; Raz, J., The Morality of Freedom (Oxford: Oxford University Press, 1986).Google Scholar
See Mill, J. S., On Liberty (Indianapolis, IN: Hackett, 1978).Google Scholar
This example brings out a complexity in liberalism that was not discussed earlier. I have said that if an offer wouldn’t be accepted by an informed and competent decision-maker, then we should ban it. But another commonly-accepted liberal principle is that the government should not bother banning things that no one is going offer, or that no one would do anyway. On those grounds we might not bother banning the hand-feeding of the lions, even though such a ban would be justified by liberal principles.Google Scholar
One of those subtle points is that a limited voluntarist principle would normally include the requirement that acceptable decision-makers make voluntary and uncoerced choices. I have left those factors aside because they are not central to my discussion.Google Scholar
Consumer-safety legislation might have other rationales as well. It might be justified by an appeal to the unfair bargaining position between consumers and manufacturers. It also might be justified by appeal to utility.Google Scholar
The objection under consideration might be put forward by people of at least three different outlooks: (1) those who were consequentialists about morals in general; (2) those who felt that researchers who receive federal funds (and hence are regulated by IRBs) are bound, like the government itself, to work for the public good; and (3) those who felt that federal research money was allocated for the specific purpose of promoting the general good, and hence that researchers who receive federal funds are obligated to fulfill that purpose.Google Scholar
It is worth nothing that the requirement not to treat money as a benefit is distinct from the improvement principle as well. The improvement principle merely says that a protocol has acceptable risks and benefits only if it will do more good than harm, and that claim says nothing about what counts as a benefit.Google Scholar
For an extended discussion of these points, see Feinberg, J., The Moral Limits of the Criminal Law, Volume Four. Harmless Wrongdoing (Oxford: Oxford University Press, 1988): 176276; A. Wertheimer, Exploitation (Princeton: Princeton University Press, 1996): 278309.Google Scholar
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