Factors Influencing IACUC Decision Making: Who Leads the Discussions?

Decisions about the appropriate use of animals in research are largely made by Institutional Animal Care and Use Committees (IACUCs). Several commentators claim that scientists exert excessive influence on IACUC decisions. We studied 87 protocol reviews from 10 IACUCs to assess whether any group of participants appeared to dominate the protocol discussions. Audio recordings of the meetings were coded to capture the topics of the discussions. We found that animal research scientists made the largest total number of topic mentions while community members made the fewest. On a per person basis, chairpersons and attending veterinarians made the most mentions. Scientists presented the largest number of protocols, and the subsequent discussions tended to contain the same topics mentioned in the presentations. The large number of protocols presented by scientists and their total number of comments made during protocol discussions suggest that scientists may significantly influence IACUC decision making.

Decision Making and the IACUC: Part 1- Protocol Information Discussed at Full-Committee Reviews.

IACUC protocols can be reviewed by either the full committee or designated members. Both review methods use the principles of the 3 Rs (reduce, refine, replace) as the overarching paradigm, with federal regulations and policies providing more detailed guidance. The primary goal of this study was to determine the frequency of topics discussed by IACUC during full-committee reviews and whether the topics included those required for consideration by IACUC (for example, pain and distress, number of animals used, availability of alternatives, skill and experience of researchers). We recorded and transcribed 87 protocol discussions undergoing full-committee review at 10 academic institutions. Each transcript was coded to capture the key concepts of the discussion and analyzed for the frequency of the codes mentioned. Pain and distress was the code mentioned most often, followed by the specific procedures performed, the study design, and the completeness of the protocol form. Infrequently mentioned topics were alternatives to animal use or painful or distressful procedures, the importance of the research, and preliminary data. Not all of the topics required to be considered by the IACUC were openly discussed for all protocols, and many of the discussions were limited in their depth.

The participation of community members on medical institutional review boards.

The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.

Disparities in opioid prescribing for patients with psychiatric diagnoses presenting with pain to the emergency department.

BACKGROUND: The goal of this investigation is to discover whether or not patients with psychiatric diagnoses are less likely to be prescribed opioids for pain in emergency departments compared with other patients. METHODS: Pain-related visits to US emergency departments were identified using reason-for-visit and physician diagnosis codes for 13 years (1993-2005) of the National Hospital Ambulatory Medical Care Survey. The outcome measure was the prescription or administration of an opioid analgesic. RESULTS: Roughly 10 million pain-related visits were made by persons with psychiatric diagnoses in the USA between 1993 and 2005. Across all years, only 18% (95% CI 16 to 20) of pain-related visits by patients with psychiatric diagnoses resulted in an opioid prescription, whereas 33% (95% CI 32 to 34) of visits by other patients did. Lower prescription rates for patients with psychiatric diagnoses were seen for every year of the survey and this difference occurred at every level of pain severity. Controlling for confounding factors did not attenuate this difference. In a multivariate model, patients with psychiatric diagnoses were about half as likely as other patients to be prescribed opiates (adjusted OR 0.49; 95% CI 0.44 to 0.56). Major limitations of the study include the uncertain precision of psychiatric and drug/alcohol diagnoses and the lack of detail about each patient visit. CONCLUSION: Having a psychiatric diagnosis was associated with a lower likelihood of receiving an opioid among persons presenting with pain to the ED.

Categorizing temporal patterns of arrest in a cohort of adults with serious mental illness.

Temporal patterns of arrest among mental health systems' clientele have not been well explored. This study uses "trajectory analysis," a methodology widely employed by criminologists exploring patterns of desistence in offending, to examine patterns of criminal justice involvement in a cohort of mental health service recipients. Data for this study are from a statewide cohort of individuals who received services from the Massachusetts Department of Mental Health in 1991 (N = 13,876) and whose arrests were followed for roughly 10 years. Zero-inflated Poisson trajectory analysis applied to cohort members having two or more arrests identified five trajectories with widely varying arrest patterns. Analysis of differences in the composition of the five trajectory-based groups revealed few between-group differences in members' demographic and service use characteristics, while certain offense types were disproportionately prevalent among particular trajectory-based groups. The implications of these findings for understanding criminal justice involvement in this population and the utility of the trajectory model for system planning are discussed.

Self-reported lifetime psychiatric hospitalization histories of jail detainees with mental disorders: comparison with a non-incarcerated national sample.

Lack of access to hospitalization is an often-cited risk factor for incarceration among persons with severe mental illness. This proposition is examined by comparing self-reports of lifetime psychiatric hospitalization histories of mentally ill jail inmates with data from a national sample of non-incarcerated mentally ill. Roughly 52% of mentally ill jail detainees reported at least one psychiatric hospitalization, a rate nearly three times that of the comparison group. The data call into question the notion that mentally ill jail inmates have reduced access to psychiatric inpatient treatment, without addressing the adequacy of the treatment received. Longitudinal studies are needed to explore temporal relationships to better understand the relationship between mental health treatment and criminal justice involvement.