IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies

Luebbert, Rebecca; Tait, Raymond C.; Chibnall, John T.; Deshields, Teresa L.

doi:10.1525/jer.2008.3.1.15

Cited by 25 publications

(23 citation statements)

References 36 publications

(35 reference statements)

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“…If research ethics committees or institutional review boards (IRBs) make the assumption that involuntarily admitted psychiatric patients cannot voluntarily give consent to participate in research, research about this vulnerable population will not occur. Luebbert et al (2008) found potential bias in how IRBs evaluate decisional capacity and vulnerability to coercion in psychiatric patients by virtue of their psychiatric status. Given these findings, it is not unreasonable to think that adding the label of "involuntarily admitted" to a psychiatric patient may add to this bias, resulting in IRBs being less willing to allow research with this population.…”

mentioning

confidence: 99%

Voluntariness to Consent to Research in a Voluntarily and Involuntarily Hospitalized Psychiatric Population

Veer

Drachman

Ahad

et al. 2011

Journal of Empirical Research on Human Research Ethics

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The purpose of our study was to examine rates of consent to participate in research in voluntarily and involuntarily hospitalized psychiatric patients in order to evaluate factors that may influence the decision to participate in research. We used logistic regression models to evaluate differences and found that involuntary patients were less likely to consent to participate. After adjustment for covariates, we found that consent rates did not differ between the involuntary and voluntary population, but that lower Global Assessment of Functioning (GAF) scores and psychosis negatively affected the decision to consent to research. We discuss the implications of our findings.

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mentioning

confidence: 99%

Voluntariness to Consent to Research in a Voluntarily and Involuntarily Hospitalized Psychiatric Population

Veer

Drachman

Ahad

et al. 2011

Journal of Empirical Research on Human Research Ethics

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“…There are a few studies showing overly assiduous protection of subjects with psychiatric illness-for example, a study using vignettes reported that IRB members inflated the coercion vulnerability and legal risk of mentally ill research subjects (Luebbert et al 2008). An interesting experiment more than 30 years ago found that IRBs brought social or political biases to the assessment of social risks (Ceci et al 1985), which remains a plausible concern.…”

Section: Discussionmentioning

confidence: 99%

Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?

Burris¹,

Davis²

2009

The American Journal of Bioethics

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Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator's concern that drug users were subject to serious social risks in the site localities, but also suggested that participation in research posed little or no marginal increase in risk and might even have a protective effect. Our experience shows that it is feasible to inform IRB deliberations with actual data on social risks, but also raises the question of whether and when such research is an appropriate use of scare research resources.

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“…Ashcraft and Krause found that surveyed investigators believe IRB members sometimes exaggerate the risks of research (2007). Luebbert also speculated that familiarity or the lack thereof may have played a role in IRB members' judgments of the risks of research involving psychiatric patients in a survey research project (Luebbert et al, 2008).…”

Section: What Do We Know? Research Implicationsmentioning

confidence: 99%

How Do IRB Members Make Decisions? A Review and Research Agenda

Pritchard

2011

Journal of Empirical Research on Human Research Ethics

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Many factors have been found to influence the nature and quality of the human research ethics review process. These are reviewed along with discussion of ways in which normal psychological characteristics and group decision-making processes may affect the decisions of institutional review board (IRB) members when reviewing proposed research activities, and may contribute to the acknowledged variability of IRB responses to identical research proposals. Three salient features of human judgment and decision-making illuminated by the existing psychological research literature are used to illustrate this idea: Research findings related to (a) risk perception and acceptance, (b) the standards people use to make decisions, and (c) some nonrational influences on group decision-making suggest how psychological characteristics may affect some outcomes of convened IRB meetings. Recognizing such influences may enable the improvement of IRB decision-making.

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IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies

Cited by 25 publications

References 36 publications

Voluntariness to Consent to Research in a Voluntarily and Involuntarily Hospitalized Psychiatric Population

Voluntariness to Consent to Research in a Voluntarily and Involuntarily Hospitalized Psychiatric Population

Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?

How Do IRB Members Make Decisions? A Review and Research Agenda

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