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AIDS:
doi: 10.1097/QAD.0b013e32833d4379
Correspondence

Response to ‘Ethics and the standards of prevention in HIV prevention trials’

Padian, Nancy Sa,b; McCoy, Sandra Ia; Balkus, Jennifer Ec; Wasserheit, Judith Nd

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aInstitute of Business and Economic Research, USA

bSchool of Public Health, University of California, Berkeley, California, USA

cDepartment of Epidemiology, USA

dDepartment of Global Health, University of Washington, Seattle, Washington, USA.

Received 8 June, 2010

Accepted 16 June, 2010

Correspondence to Dr Sandra McCoy, MPH, PhD, F502 Haas Building, University of California, Berkeley, CA 94720, USA. Tel: +1 510 332 6612; e-mail: smccoy@berkeley.edu

We applaud the excellent letter by Sugarman and Grace [1] in this issue of the journal. They are correct; having ethical standards to which we all agree is essential. We would like to highlight one criterion for determining control-group services delineated in their letter and in the HIV Prevention Trials Network's Ethics Guidance Document: that the control programme be ‘practically achievable as a standard in the local setting’ [2]. By achievable, we assume that this also means sustainable. In many of the trials we reviewed [3], the services in the control arm, although perhaps theoretically achievable as a local standard, were not sustained after the trials were completed, nor was there any explicit plan or commitment to do so. It seems then, that this critical ethical criterion was not met in these cases. Because such comparisons do not reflect the effect of the intervention compared with the true standard in the local setting before, during, or after the study, such trials are also compromised from a methodological standpoint. In the future, the HIV prevention research community should consider either comparisons to the existing local standard, or the provision of a feasible, well documented plan for the sustainability of proposed new services as a measure of both the ethical and methodological appropriateness of interventions in control groups.

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References

1. Sugarman J, Grace WC. Ethics and the Standards of Prevention in HIV Prevention Trials. AIDS 2010; 24:2298–2299.

2. Rennie S, Sugarman J. HIV Prevention Trials Network Ethics Guidance Document for Research. HPTN Ethics Working Group 2010. http://www.hptn.org/web%documents/EWG/HPTNEthicsGuidance020310.pdf; [Accessed 26 June 2010]

3. Padian NS, McCoy SI, Balkus JE, Wasserheit JN. Weighing the gold in the gold standard: challenges in HIV prevention research. AIDS 2010; 24:621–635.

© 2010 Lippincott Williams & Wilkins, Inc.

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