Hearnshaw, H. (2004). "Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study." BMJ 328(7432): 140-141.
      This brief study demonstrates the different ways IRBs in various countries handle a protocol. The author suggests that much of the effort is time consuming and does nothing to help research participants.
http://bmj.bmjjournals.com/cgi/content/full/328/7432/140

Califf, R. M., M. A. Morse, et al. (2003). "Toward protecting the safety of participants in clinical trials." Controlled Clinical Trials 24(3): 256.
     This excellent paper reviews clinical research and analyzes the weaknesses in monitoring. Safety data are particularly problematic. They recommend strengthening data and safety monitoring boards, teaching investigators good clinical practices, more local scrutiny of single site studies, and careful oversight of multi-center studies.
http://www.sciencedirect.com/science/article/B6T5R-48KCM54
-2/2/72c360ccf7d1b393918aa883c7bd428c

Burman, W., P. Breese, et al. (2003). "The effects of local review on informed consent documents from a multi-center clinical trials consortium." Controlled Clinical Trials 24(3): 245.
     This interesting review of sending an approved centralized research protocol for local review resulted in many changes -- median 46/5 that added complexity but did not improve meaning. It took an average of 104 days to accomplish this. IRBs should read this article and take heed.

Dickenson, D. and J. Ferguson (2005). "Advisory Document for Retained Organs Commission." University of Birmingham, UK: Centre for Global Ethics.
     This document addresses the burning issue of retained organs and the rights of donors. They suggest a modified property rights approach to regulation of the practice.
http://www.globalethics.bham.ac.uk/consultancy/Retained_organs.htm

Miller, F. G. (2002). "Ethical Significance of Ethics-Related Empirical Research." J Natl Cancer Inst 94(24): 1821-1822.
     This editorial comments on an empirical study of oncologists' understanding of trials in which they participate. The author supports the idea of empirical ethics research and points out that it too can be excellent on trivial, well or poorly done.
http://jncicancerspectrum.oxfordjournals.org/cgi/content/full/jnci;94/24/1821

Franck, L. (2005). "Research with newborn participants: doing the right research and doing it right." J Perinatal and Neonatal Nursing 19(2): 177-86.
     This paper discusses the role of the neonatal nursing team in determining what research is ethical in the NICU and how the rights of the infants need to be protected.

Churchill, L., D. Nelson, et al. (2003). "Assessing Benefits in Clinical Research." IRB Ethics and Human Research 25(3): 1-8.
      These authors did an empirical study of what benefits were assessed by 43 IRBS by doing a taped standardized interview with a senior member or chair. The tapes were transcribed, anonymized, and analyzed. The results show considerable variability in approaches to determining potential benefits to research subjects.

Levine, C., R. Faden, et al. (2004). ""Special Scrutiny": A Targeted Form of Research Protocol Review." Ann Intern Med 140(3): 220-223.
      This interesting paper proposes that clinical research protocols with increased risk, especially with low benefit, studies of really novel compounds, and research with a somewhat questionable design should receive "special scrutiny" from the IRB. It's disappointing that they never mention DSMBs whose function is to examine research as it progresses nor the RSA prgram of GCRCs.

Shah, S., A. Whittle, et al. (2004). "How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?" JAMA 291(4): 476-482.
      Federal regulations allow children to be enrolled in clinical research only when IRB determines that the risks are minimal or a minor increase over minimal, or that the research offers a prospect of direct benefit. This study was designed to learn how IRBs actually determine risk vs benefitand to see whether they are consistent. They did a telephonic survey of IRB chairs and asked them 21 questions. They found that the only thing they generally agreed was minimally risky was a blood draw. They had a remarkably jaundiced eye toward what one would normally think as low risk interventions. They thought very kittlke of payment as a benefit, but did accept psychological benefit. There was great variance among IRBs. They suggest some guidelines about risk be applied broadly. This is an excellent experimental paper.

Slater, E. E. (2002). "IRB Reform." N Engl J Med 346(18): 1402-1404.
      An editorial detailing aspects of IRB reform that included a pilot NCI project on a single review of multicentric studies with local element reviewed locally.