1. “Ethical and Human Rights Issues in Research on Mental Disorders That May Affect Decision-Making Capacity,”;Capron;N. Engl. J. Med.,1999
2. 28. Id. at 390.
3. 18. This charge is succinctly presented in the NBAC Report, supra note 17, at i: In this report, the National Bioethics Advisory Commission (NBAC) considers how ethically acceptable research can be conducted with human subjects who suffer from mental disorders that may affect their decisionmaking capacity; whether, in this context, additional protections are needed; and, if so, what they should be and how they should be implemented.… Although existing federal regulations for research involving human subjects provide special protection for certain populations that are regarded as particularly vulnerable, persons with mental disorders (who may have impaired capacity to make decisions about research participation) have not received any such special protections.
4. 20. Mental status is likely to fluctuate as a result of either internal stimuli (e.g., altered level of craving or occurrence of drug-associated memories) or external stimuli (e.g., verbal, visual, or auditory). The conduct of a proposed study may also affect mental status, e.g., does it involve the subject's drug of choice or is it “neutral” with respect to substance dependence?.
5. DO HEALTHY VOLUNTEERS INCREASE DRUG USAGE AFTER PARTICIPATION IN RESEARCH INVOLVING OPIOIDS AND NITROUS OXIDE?