About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

5 Am. J. Bioethics 1 (2005)

handle is hein.journals/ajbio5 and id is 1 raw text is: Reflections on 'Rethinking Research Ethics' Robert J. Levine, Yale University Rosamond Rhodes presents us with a very interesting and provocative proposal for the recruitment of research subjects-a form of conscription (Rhodes 2005). She ar- gues that adoption of this proposal would help correct our current overemphasis on informed consent and on the pro- tection of vulnerable persons and mitigate the adverse con- sequences of this overemphasis. It is not clear whether she wishes to have her proposal considered as a policy that would be adopted officially as a replacement for current policies for the recruitment of research subjects or whether, instead, she intends primarily to stimulate discussion (Beauchamp 2005). If she aspires to replace current policies and prac- tices for the recruitment of research subjects, she will surely be disappointed. If, on the other hand, she wishes only to provoke reflection on her concerns, she has already begun to succeed. Her article has already had the salutary effect of eliciting several valuable commentaries, also published in this issue of AOB. THE ROLE OF RESEARCH SUBJECT RECONSIDERED I will not detail my reasons for predicting that this proposal of a system of conscription of research subjects is destined to miscarry. There is sufficient discussion of this in the commentaries in this issue ranging from practical reasons that this proposal would fail (e.g., Sharp and Yarborough 2005) to ethical reasons that this proposal should fail (e.g., Simmerling and Schwegler 2005). Two commentators reached conclusions that prompt me to recall a proposal I offered in the 1970s-that it might be appropriate to view the role of research subject as a job (Levine 1976a). Allhoff (2005) addresses Rhodes' concern that those who reap the benefits of research subject without participat- ing as subjects should be seen as 'free-riders'. He con- cludes that, as long as research subjects are remunerated adequately, such branding is unwarranted. Commentators Wachbroit and Wasserman conclude that research par- ticipation should be seen as a valuable civic activity, like school tutoring, volunteer fire-fighting, and neighborhood patrolling. Like those other activities, it is a way for indi- viduals to serve a community from which they derive many benefits (Wachbroit and Wasserman 2005, 49). I would add that while it is good if we can have people volunteer their services as (e.g.) school tutors and fire-fighters, it is also necessary and ethically acceptable to consider teach- ing and fire-fighting as jobs and to pay people for doing them. A full discussion of the role of research subject as a job is beyond the scope of this editorial. I believe, as I did in 1986, that most IRBs, as they consider appropriate levels of cash payments, view the role of research subject as an ordinary job generally requiring relatively unskilled workers. Wages are determined by customary market factors in that they are established at sufficiently high rates to attract suitable num- bers of subjects... This seems appropriate to me for the vast majority of research projects in which persons capable of in- formed consent volunteer to assume such burdens as minimal risk. (Levine 1986, 83) For all research involving human subjects there should be a system of no-fault compensation for research-induced in- jury (Levine 1986, 155ff). This is particularly important if we would extend the role of research subject as a job to research in which the level of risk is more than a minor increase above minimal risk. As well, in research present- ing more than a minor increase above minimal risk, we should take seriously Beauchamp's proposition regarding stipends for the subjects: The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement to an unwelcome participation in research (Beauchamp 2005, 33). CONCEPTUAL ISSUES Rhodes identifies four issues (she calls them 'accepted re- search dogmas') as targets for her dispute; these are: 1) the primacy of informed consent, 2) protection of the vulnera- ble, 3) the substitution of beneficence for research's social purpose, and 4) the introduction of an untenable distinction between innovation and research (Rhodes 2005). I agree that informed consent gets more than its share of attention in contemporary discussions of research ethics and that its documentation on consent forms dominates the process of review by institutional review boards at the expense of other equally or more important matters (Levine 1986, 134ff). I also agree that in some cases the definition of who is to be considered vulnerable is expanded beyond reasonable bounds and that some of the protections required by regu- lations are excessive and counterproductive (Levine 1986, 291ff; Levine 1995); I will not now discuss these issues fur- ther. I do not agree that beneficence has been substituted for research's social purpose or that the distinction between innovation and research is untenable. On these two topics Rhodes has misunderstood the Belmont Report. In its commentary on the principle of beneficence in the Belmont Report, the National Commission wrote: The obligations of beneficence affect both individual inves- tigators and society at large, because they extend both to particular research projects and to the entire enterprise of The American Journal of Bioethics, 5(1): 1-3, 2005 Copyright g Taylor & Francis, Inc. ISSN: 1526-5161 print / 1536-0075 online DOI: 10.1080/15265160590944076 ajob 1 Get Edito

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most