Ethical Parameters of Challenge Studies Inducing Psychosis With Ketamine

Tishler, Carl L.; Gordon, Lisa B.

doi:10.1207/s15327019eb0903_2

Cited by 11 publications

(8 citation statements)

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“…Some investigators have suggested that the methods section include detailed recruitment, financial remuneration, selection, and screening procedures for NHVs as well as long-term follow-up in high-risk challenge studies. 27,69 However, this practice has not been widely adapted. 27,69 A recent call was given to journal editors to issue guidelines for the discussion of ethical issues for publications, including procedures used to assess the capacity of volunteers to give consent and any safeguards adopted protecting vulnerable research subjects.…”

Section: Discussionmentioning

confidence: 99%

“…27,69 However, this practice has not been widely adapted. 27,69 A recent call was given to journal editors to issue guidelines for the discussion of ethical issues for publications, including procedures used to assess the capacity of volunteers to give consent and any safeguards adopted protecting vulnerable research subjects. 70 A standard regarding the discussion of ethical issues could contribute to protecting the rights and welfare of individuals volunteering as human research subjects and enhances public trust in research.…”

Section: Discussionmentioning

confidence: 99%

“…26 Investigators, research institutions, drug companies, and IRBs have raised concern about the lack of guidance and dialogue with respect to payment of volunteers. 5,20,27 A survey administered to 98 members of the Clinical section of the British Pharmacological Society found that only 53% of respondents had guidelines for the payment to volunteers. 28 Guidelines offered by ethics committees are incomplete 20 and differ widely in terms of their requirements.…”

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confidence: 99%

“…29 Consensus may be lacking because financial remuneration to research participants is rarely reported in research literature. 27 A cursory examination of 12 challenge studies administering ketamine to NHVs found that only 3 reported that the volunteers were paid for their participation, only 1 of which disclosed the amount of payment. [13][14][15][30][31][32][33][34][35][36][37] A systematic review of 10 journals published during 1997-1998 examined the disclosure of payment to volunteers and found that only 56 of 126 studies included details about the incentives offered.…”

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confidence: 99%

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The Recruitment of Normal Healthy Volunteers: A Review of The Literature on the Use of Financial Incentives

Tishler

Bartholomae

2002

The Journal of Clinical Pharma

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114

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Unresolved issues of ethical, methodological, and legal concerns in the use of normal healthy volunteers persist. Financial incentives in their recruitment offer a unique ethical dilemma because of questions surrounding payment. A review of literature was conducted to obtain research systematically examining volunteer motivation and the role offinancial incentives. The primary selection criterion was motivation and payment to volunteers; seven studies met the criterion for review. Studies that have systematically investigated volunteer motivation have found financial rewards to be an important motivator among normal healthy volunteers in their decision to participate in clinical trials. Also evident is that differences based on demographic characteristics exist in the motivation and rates of volunteerism. Ethical issues surrounding the use of normal healthy volunteers are discussed, with attention to the issue offinancial incentives (e.g., economically vulnerable volunteers, undue inducements). Regulations, guidelines, and recommendations are discussed with regard to volunteers and financial incentives.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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The Recruitment of Normal Healthy Volunteers: A Review of The Literature on the Use of Financial Incentives

Tishler

Bartholomae

2002

The Journal of Clinical Pharma

Self Cite

114

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“…Studies that involve withdrawing an individual from his or her current treatment ("washout" or "medication free" studies) or inducing behaviors (such as psychosis) may present unique risks to the research participant (Carpenter et al, 1997;Sharav, 1999;Tishler and Gordon, 1999;Roberts et al, 2003). Studies that involve withdrawing an individual from his or her current treatment ("washout" or "medication free" studies) or inducing behaviors (such as psychosis) may present unique risks to the research participant (Carpenter et al, 1997;Sharav, 1999;Tishler and Gordon, 1999;Roberts et al, 2003).…”

Section: Minimizing Risksmentioning

confidence: 99%

Ethics in Behavioral Genetics Research

DeCamp

Sugarman

2004

Accountability in Research

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As research in behavioral genetics uncovers the genetic contribution to human behavior, it will undoubtedly further our understanding of normal human variation in many behavioral traits, such as personality, intelligence, and sexuality. This research also shows great potential for the diagnosis, treatment, and prevention of mental illnesses. Recent findings underscore this potential and document the increasing validity of research methods--methods that in the past have led to mistaken inferences about genes "for" violent behavior and homosexuality. Although all research with human subjects requires adequate attention to its ethical aspects, certain ethical issues involved with behavioral genetics are particularly acute and deserve careful attention. This article reviews these selected major ethical issues arising in (1) the conduct of behavioral genetics research; and (2) the application of its research findings. While some of the ethical concerns in the latter category are likely to be of substantial importance and animate considerable popular concern, they currently fall outside the realm of traditional research review. Determining how to deal with these concerns should be a focus of future scholarly work.

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Acute S-ketamine application does not alter cerebral [18F]altanserin binding: a pilot PET study in humans

et al. 2007

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Modeling short-term psychotic states with subanaesthetic doses of ketamine provides substantial experimental evidence in support of the glutamate hypothesis of schizophrenia. Ketamine exerts its pharmacological effects both directly via interactions with glutamate receptors and indirectly by stimulating presynaptic release of endogenous serotonin (5-HT). The aim of this feasibility study was to examine whether acute ketamine-induced 5-HT release interferes with the binding of the 5-HT(2A) receptor (5-HT(2A)R) radioligand [(18)F]altanserin and positron emission tomography (PET). Two subjects treated with ketamine and one subject treated with placebo underwent [(18)F]altanserin PET at distribution equilibrium conditions. Robust physiological, psychopathological and cognitive effects were present at ketamine plasma concentrations exceeding 100 microg/l during >70 min. Notwithstanding, we observed stable radioligand binding (changes +/-95% CI of -1.0 +/- 1.6% and +4.1 +/- 1.8% versus -1.2 +/- 2.6%) in large cortical regions presenting high basal uptake of both, [(18)F]altanserin and ketamine. Marginal decreases of 4% of radioligand binding were observed in the frontal lobe, and 8% in a posteriorily specified frontomesial subregion. This finding is not compatible with a specific radioligand displacement from 5-HT(2A)R which should occur proportionally throughout the whole brain. Instead, the spatial pattern of these minor reductions was congruent with ketamine-induced increases in cerebral blood flow observed in a previous study using [(15)O]butanol PET. This may caused by accelerated clearance of unspecifically bound [(18)F]altanserin from cerebral tissue with increased perfusion. In conclusion, this study suggests that [(18)F]altanserin PET is not sensitive to acute neurotransmitter fluctuations under ketamine. Advantageously, the stability of [(18)F]altanserin PET towards acute influences is a prerequisite for its future use to detect sub-acute and chronic effects of ketamine.

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Ethical Parameters of Challenge Studies Inducing Psychosis With Ketamine

Cited by 11 publications

References 0 publications

The Recruitment of Normal Healthy Volunteers: A Review of The Literature on the Use of Financial Incentives

The Recruitment of Normal Healthy Volunteers: A Review of The Literature on the Use of Financial Incentives

Ethics in Behavioral Genetics Research

Acute S-ketamine application does not alter cerebral [18F]altanserin binding: a pilot PET study in humans

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