• DOI:10.1162/152651604773067541
• Corpus ID: 12347121

A Response to Commentators on "Ethics of Research Involving Mandatory Drug Testing of High School Athletes in Oregon"

@article{Shamoo2004ART,
  title={A Response to Commentators on "Ethics of Research Involving Mandatory Drug Testing of High School Athletes in Oregon"},
  author={Adil E. Shamoo and Jonathan David Moreno},
  journal={The American Journal of Bioethics},
  year={2004},
  volume={4},
  pages={29 - 30}
}

• A. Shamoo, J. Moreno
• Published 1 January 2004
• Medicine
• The American Journal of Bioethics

Moreno 2004) is laced with anger that is largely misdirected. The more appropriate object of their disdain is the Office for Human Research Protections (OHRP), which imposed sanctions on the SATURN study. We urge readers to consult the OHRP determination letter of October 24, 2002 (http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/ oct02d.pdf). Rather than mentioning the OHRP investigation and the three determination letters that resulted, the authors cite the deliberations of the IRB that originally approved the protocol. The scandals and the sanctions levied on institutions in the past five years have all concerned protocols approved by their institutions’ IRBs (Shamoo 2001). Therefore, citing an IRB decision that has subsequently been found seriously wanting is not persuasive. Concerning our statement that the study began without IRB approval, Chiodo et al. also do not acknowledge that the OHRP found that substantial changes were made in the protocol without review by the IRB. Nonetheless, we take this opportunity to clarify some matters for the record.