Federally regulated institutional review boards: The aspects of a "model" IRB---Is the current system in need of a tune up or complete overhaul?

Institutional Review Boards (IRBs) are the primary gatekeepers for the protection of ethical standards of federally regulated research on human subjects in this country. This paper focuses on what general, broad measures that may be instituted or enhanced to exemplify a "model IRB". This is done by examining the current regulatory standards of federally regulated IRBs, not private or commercial boards, and how many of those standards have been found either inadequate or not generally understood or followed. The analysis includes suggestions on how to bring about changes in order to make the IRB process more efficient, less subject to litigation, and create standardized educational protocols for members. The paper also considers how to include better oversight for multi-center research, increased centralization of IRBs, utilization of Data Safety Monitoring Boards when necessary, payment for research protocol review, voluntary accreditation, and the institution of evaluation/quality assurance programs. ^ This is a policy study utilizing secondary analysis of publicly available data. Therefore, the research for this paper focuses on scholarly medical/legal journals, web information from the Department of Health and Human Services, Federal Drug Administration, and the Office of the Inspector General, Accreditation Programs, law review articles, and current regulations applicable to the relevant portions of the paper. ^ Two issues are found to be consistently cited by the literature as major concerns. One is a need for basic, standardized educational requirements across all IRBs and its members, and secondly, much stricter and more informed management of continuing research. There is no federally regulated formal education system currently in place for IRB members, except for certain NIH-based trials. Also, IRBs are not keeping up with research once a study has begun, and although regulated to do so, it does not appear to be a great priority. This is the area most in danger of increased litigation. Other issues such as voluntary accreditation and outcomes evaluation are slowing gaining steam as the processes are becoming more available and more sought after, such as JCAHO accrediting of hospitals. ^ Adopting the principles discussed in this paper should promote better use of a local IRBs time, money, and expertise for protecting the vulnerable population in their care. Without further improvements to the system, there is concern that private and commercial IRBs will attempt to create a monopoly on much of the clinical research in the future as they are not as heavily regulated and can therefore offer companies quicker and more convenient reviews. IRBs need to consider the advantages of charging for their unique and important services as a cost of doing business. More importantly, there must be a minimum standard of education for all IRB members in the area of the ethical standards of human research and a greater emphasis placed on the follow-up of ongoing research as this is the most critical time for study participants and may soon lead to the largest area for litigation. Additionally, there should be a centralized IRB for multi-site trials or a study website with important information affecting the trial in real time. There needs to be development of standards and metrics to assess the performance of the IRBs for quality assurance and outcome evaluations. The boards should not be content to run the business of human subjects' research without determining how well that function is actually being carried out. It is important that federally regulated IRBs provide excellence in human research and promote those values most important to the public at large.^

Factors associated with the retention of HIV-infected children in care in Botswana

Lost to follow up (LTFU) in the care and treatment of HIV/AIDS represents a particularly problematic aspect when evaluating the success of treatment programs. Identifying modifiable factors that lead to LTFU would be important if we are to design effective retention interventions. The purpose of this study was to identify the challenges faced by children seeking care and treatment at a large HIV Clinic in Botswana. In order to identify those factors, we used mixed methods from different sources of information available at the Baylor Clinic. The first method involved a case-control study through which we interviewed a select representation of children 1-18 years who, at some point in time, have attended clinic at Baylor Clinic in Gaborone, Botswana. We document this in detail using the first journal article. We defined LTFU as patients who had not attended clinic for more than 6 months at the onset of the study; the comparison group was recruited from among those who have attended clinic at any point in the 6 months leading to the start of study. Factors were compared between the cases and controls. The second methodology involved conducting in-depth interviews with health providers to elicit their opinions and experiences dealing with patients at the at the Baylor clinic in general and the LTFU patients in particular. We document this methodology and its findings in the second journal article. ^ We found that most patients that are LTFU failed to engage with the clinic. Most of the LTFU made only one visit to the clinic (47.66%) as compared to less than 1% in the control group (P<0.01, 2-tailed Fisher's exact test). Among the interviewed patients, psychosocial factors such as stigma, religious beliefs, child rebellion and disclosure of HIV status concerns were characteristic of the LTFU population, but psychosocial issues were not cited among the comparison group. We also found that these psychosocial aspects of the patients point towards a bigger problem of mental health that needs to be addressed. Socioeconomic factors such as lack of transport, school-related activities and forgetting check-up dates were cited predominantly by the controls than cases. ^ From these findings, there is need to target interventions towards engaging pediatric patients at their initial clinic visit. Such interventions would focus on psychosocial support, as well as involving faith-based organizations in planning joint responses.^

Conceptual Bases of the Planning Process in Family Preservation/Family Support State Plans

Congress and the Department of Health and Human Services (DHHS) intend for the Family Preservation and Support Act of 1993 (P.L. 103-66) to catalyze major reforms in state human services systems. DHHS and numerous other institutions developed conceptual and procedural guidance for the states' planning processes. Review of the planning dimensions of participation and expertise reveals that major emphases on stakeholder participation and technical planning processes obscure the need for expertise in family preservation and family support.

Food Insecurity and the Behavioral and Intellectual Development of Children: A Review of the Evidence

Background: Given that an alarming 1 in 5 children in the USA are at risk of hunger (1 in 3 among black and Latino children), and that 3.9 million households with children are food insecure, it is crucial to understand how household food insecurity (HFI) affects the present and future well-being of our children. Purpose: The objectives of this review article are to: (i) examine the association between HFI and child intellectual, behavioral and psycho-emotional development, controlling for socio-economic indicators; (ii) review the hypothesis that HFI is indeed a mediator of the relationship between poverty and poor child development outcomes; (iii) examine if the potential impact of HFI on caregivers’ mental health well-being mediates the relationship between HFI and child development outcomes. Methods: Pubmed search using the key words “food insecurity children.” For articles to be included they had to: (i) be based on studies measuring HFI using an experience-based scale, (ii) be peer reviewed, and (iii) include child intellectual, behavioral and/or socio-emotional development outcomes. Studies were also selected based on backward and forward Pubmed searches, and from the authors’ files. After reviewing the abstracts based on inclusion criteria a total of 26 studies were selected. Results: HFI represents not only a biological but also a psycho-emotional and developmental challenge to children exposed to it. Children exposed to HFI are more likely to internalize or externalize problems, as compared to children not exposed to HFI. This in turn is likely to translate into poor academic/cognitive performance and intellectual achievement later on in life. A pathway through which HFI may affect child development is possibly mediated by caregivers’ mental health status, especially parental stress and depression. Thus, HFI is likely to foster dysfunctional family environments. Conclusion: Findings indicate that food insecure households may require continued food assistance and psycho-emotional support until they transition to a “stable” food secure situation. This approach will require a much better integration of social policies and access to programs offering food assistance and mental health services to those in need. Findings also fully justify increased access of vulnerable children to programs that promote early in life improved nutrition as well as early psycho-social and cognitive stimulation opportunities.

Bexar County's dental safety net for children: An estimate of our current capacity and need

Introduction. It has been well established that poor uninsured children lack access to dental care and have greater dental needs than their insured counterparts. ^ Objective. To assess the capacity of Bexar County's dental safety net to treat children. To assess the dental needs of Bexar County children ages 0-18 who are uninsured or are Medicaid or SCHIP recipients. ^ Methods. Information was requested from dental safety net clinics that treat children ages 0-18. Data from the census, NHANES and other sources was used to estimate the dental needs. ^ Results. The capacity of the current safety net to treat children is 33,537 patient encounters per year. The dental needs of the community are 227,124 patient encounters per year. ^ Conclusion. The results of the study indicate that Bexar County is not prepared to treat the dental needs of the underserved children in San Antonio.^

Household risk factors and the health and nutritional status of children in rural Honduras

During this cross-sectional study, both quantitative and qualitative research methods were used to elucidate the role that household environment and sanitation play in the nutritional status of children in a rural Honduran community. Anthropometric measurements were taken as measures of nutritional status among children under five years of age, while interviews regarding the household environment were conducted with their primary caregivers. Community participatory activities were conducted with primary caregivers, and results from water quality testing were analyzed for E. coli contamination. Anthropometric results were compared using the 1977 NCHS Growth Charts and the 2006 WHO Child Growth Standard to examine the implications of using the new WHO standard. The references showed generally good or excellent agreement between z-score categories, except among height-for-age classifications for males 24-35.9 months and weight-for-age classifications for males older than 24 months. Comparing the proportion of stunted, underweight, and wasted children, using the WHO standard generally resulted in higher proportions of stunting, lower underweight proportions, and higher overweight proportions. Logistic regression was used to determine which household and sanitation factors most influenced the growth of children. Results suggest only having water from a spring, stream, or other type of surface water as the primary source of drinking water is a significant risk factor for stunting. A protective association was seen between the household wealth index and stunting. Through participatory activities, the community provided insight on health issues important for improving child health. These activities yielded findings to be harnessed as a powerful resource to unify efforts for change. The qualitative findings were triangulated with the quantitative interview and water testing results to provide intervention recommendations for the community and its primary health care clinic. Recommendations include educating the community on best water consumption practices and encouraging the completion of at least some primary education for primary caregivers to improve child health. It is recommended that a community health worker program be developed to support and implement community interventions to improve water use and household sanitation behaviors and to encourage the involvement of the community in targeting and guiding successful interventions. ^

The role of social support in HIV prevention among young Latino men who have sex with men

The purpose of this formative study was to determine and prioritize the HIV-prevention needs of Latino young men who have sex with men (YMSM) in Chihuahua (Mexico), Texas, and California, based on YMSM and service provider perceptions of the factors affecting the assimilation and implementation of HIV-preventive behaviors. These factors included: perceived social support, identification of the modes of HIV transmission, perceived risk of HIV, perceived norms and attitudes of peers.^ The study, drawn from a secondary data set, was a convenience sample of providers (n=8) and clients (n=15). Participants completed face-to face interviews and a survey instrument. Interviews were analyzed to identify common themes and congruence among client groups, and among clients and providers. Providers’ understanding of theoretical constructs of interventions was also assessed. Survey data were analyzed to determine variable frequencies and their congruence to the qualitative analysis. ^ The results revealed several differences and many commonalities in the assimilation of protective messages. Client and provider perceptions were congruent across all domains. Providers demonstrated intuitive command of theoretical concepts but inconsistently verbalized their application. Both clients and providers recognized Latinos possessed high HIV-knowledge levels, despite inconsistent protective behaviors. Clients and providers consistently identified important reasons leading to inconsistent protective behaviors, such as: lack of access to targeted information and condoms, self-esteem, sexual identification, situational factors, decreased perceived HIV-risk, and concerns about homophobia, stigma, and rejection. Other factors included: poverty, failure to reach disenfranchised populations, and lack of role models/positive parental figures. The principal conclusion of the study was that there is a need for further study to understand the interrelationship between larger socioeconomic issues and consistent protective behaviors.^

MEETING THE NEEDS OF HANDICAPPED CHILDREN: A STUDY OF EDUCATIONAL AND HEALTH CARE SERVICES PROVIDED TO PRE-KINDERGARTEN CHILDREN IN THE HOUSTON INDEPENDENT SCHOOL DISTRICT EARLY CHILDHOOD PROGRAM FOR THE HANDICAPPED (PARENT SATISFACTION, FUNCTIONAL STATUS, PSYCHOSOCIAL DEVELOPMENT)

The Education for All Handicapped Children Act of 1975, P.L. 94-142, created a new challenge for the nation's public school systems. During 1982-1983, a national study, called the "Collaborative Study of Children with Special Needs", was conducted in 5 metropolitan school districts to evaluate the effectiveness of education and health care services of children in kindergarten to 6th grade being provided under P.L. 94-142 programs. This dissertation (the Substudy) was undertaken to augment the findings of the Collaborative Study. The purpose of this study was to develop a database to provide descriptive information on the demographic, service and health characteristics of a small group of 3 and 4 year old handicapped children served by the Houston Independent School District (HISD) during 1982-1983.^ The study involved a stratified sample of 105 three and four year old children divided into 3 groups according to type of handicapping condition.^ The results of the study gave a clearer picture of the demographic characteristics of these Pre-K children. Specifically, sex ratio was approximately one, lower than the national norm. Family and socioeconomic characteristics were assessed.^ The study used an independence/dependence index composed of 11 items on the parent questionnaire to assess the level of functional independence of each child. An association was found between index scores and parent-reported effects of the child on family activity. Parents who said that their child's condition had affected the family's job situation, housing accomodations, vacation plans, marriage, choice of friends and social activities were also more likely to report less independence in the child. In addition, many of the Substudy children had extensive care-taking needs reflected in specific components of the index such as dressing, feeding, toileting or moving about the house.^ In general the results of the Pre-K Substudy indicate that at the early childhood level, the HISD special education program is functioning well in most areas and that parents are very satisfied with the program. (Abstract shortened with permission of author.)^

Understanding mental illness in Nigeria: Bringing culture and traditional medicine into mental health policy

One of the major challenges in treating mental illness in Nigeria is that the health care facilities and mental health care professionals are not enough in number or well equipped to handle the burden of mental illness. There are several barriers to treatment for individual Nigerians which include the following: such as the lack of understanding of the root causes of mental illness, lack of financial support to get mental treatment, lack of social support (family, friends, neighbors), the fear of stigmatization concerning being labeled as mentally ill or being in association with the mentally ill, and the consultation of traditional native healers who may be unknowingly prolonging illness, rather than addressing and treating them due to lack of formal education and standardization of their treatments. Another barrier is the non-health nature of the mental health services in Nigeria. Traditional healers are essentially the mental health system. The elderly, women, and children are the most vulnerable groups in times of strife and hardships. Their mental well-being must be taken into account as well as their special needs in times of personal or societal crisis. ^ Nigerian mental health policy is geared toward forming a mental health system, but in actuality only a mental illness care system is the observed result of the policy. The government of Nigeria has drafted a mental health policy, yet its actual implementation into the Nigerian health infrastructure and society waits to be materialized. The limited health legislation or policy implementations tend to favor those who have access to these urban areas and the facilities' health services. Nigerians living in rural areas are at a disadvantage; many of them may not even be aware of services available to help them understand and treat mental illness. Perhaps, government driven health interventions geared toward mental illness in rural areas would reach an underserved Nigerians and Africans in general. Issues with political instability and limited infrastructure often hinder crucial financial resources and legislation from reaching the people that are truly in need of governmental leadership in regards to mental health policy.^ Traditional healers are a severely untapped resource in the treatment of mental illness within the Nigerian population. They are abundant within Nigerian communities and are meeting a real need for the mentally ill. However, much can be done to remove the barriers that prevent the integration of traditional healers within the mental health system and improve the quality of care they administer within the population. Mental illness is almost exclusively coped with through traditional medicine practices. Mobilization and education from each strata of Nigerian society and government as well as input from the medical community can improve how traditional medicine is utilized as a treatment for clinical illness and help alleviate the heavy burden of mental illness in Nigeria. Currently, there is no existing policy making structure for a working mental health system in Nigeria, and traditional healers are not taken into account in any formulation of mental health policy. Advocacy for mental illness is severely inadequate due to fear of stigmatization, with no formally recognized national of regional mental health association.^

Partnering with Parents: Promising Approaches to Improve Reunification Outcomes for Children in Foster Care

Family reunification is one of the central tenents of the child welfare system, yet research supporting effective practices to promote safe reunifications is limited. As a departure from previous initiatives, the Parent Partner (PP) program enlists as staff mothers and fathers who have experienced child removal, services, and reunification. This study examines outcomes for children served by the PP program. The experimental group includes 236 children whose parents were served by a Parent Partner and a matched comparison group of 55 children whose parents were served by the public child welfare agency in 2004, before the Parent Partner program was established. Cases were examined 12 months following case opening to determine reunification status. Results from the outcome study indicate that reunification may be more likely for children whose parents were served by Parent Partners. Although there are limitations to the data, findings from this study suggest that the Parent Partner model may hold promise as a child welfare intervention designed to support reunification.

A model of factors determining levels of public support for health care policy in the United States

Public preferences for policy are formed in a little-understood process that is not adequately described by traditional economic theory of choice. In this paper I suggest that U.S. aggregate support for health reform can be modeled as tradeoffs among a small number of behavioral values and the stage of policy development. The theory underlying the model is based on Samuelson, et al.'s (1986) work and Wilke's (1991) elaboration of it as the Greed/Efficiency/Fairness (GEF) hypothesis of motivation in the management of resource dilemmas, and behavioral economics informed by Kahneman and Thaler's prospect theory. ^ The model developed in this paper employs ordered probit econometric techniques applied to data derived from U.S. polls taken from 1990 to mid-2003 that measured support for health reform proposals. Outcome data are four-tiered Likert counts; independent variables are dummies representing the presence or absence of operationalizations of each behavioral variable, along with an integer representing policy process stage. Marginal effects of each independent variable predict how support levels change on triggering that variable. Model estimation results indicate a vanishingly small likelihood that all coefficients are zero and all variables have signs expected from model theory. ^ Three hypotheses were tested: support will drain from health reform policy as it becomes increasingly well-articulated and approaches enactment; reforms appealing to fairness through universal health coverage will enjoy a higher degree of support than those targeted more narrowly; health reforms calling for government operation of the health finance system will achieve lower support than those that do not. Model results support the first and last hypotheses. Contrary to expectations, universal health care proposals did not provide incremental support beyond those targeted to “deserving” populations—children, elderly, working families. In addition, loss of autonomy (e.g. restrictions on choice of care giver) is found to be the “third rail” of health reform with significantly-reduced support. When applied to a hypothetical health reform in which an employer-mandated Medical Savings Account policy is the centerpiece, the model predicts support that may be insufficient to enactment. These results indicate that the method developed in the paper may prove valuable to health policy designers. ^

Access to health care among children in the U.S.: Use of health inequalities measures to evaluate progress in reduction of disparities from 1997 to 2005

Much of the literature on disparities in access to health care among children has focused on measuring absolute and relative differences experienced by race/ethnic groups and, to a lesser extent, socioeconomic groups. However, it is not clear from existing literature how disparities in access to care may have changed over time for children, especially following implementation of the State Children’s Health Insurance Program (SCHIP). The primary objective of this research was to determine if there has been a decrease in disparities in access to care for children across two socioeconomic groups and race/ethnicity groups after SCHIP implementation. Methods commonly used to measure ‘health inequalities’ were used to measure disparities in access to care including population-attributable risk (PAR) and the relative index of inequality (RII). Using these measures there is evidence of a substantial decrease in socioeconomic disparities in health insurance coverage and to a lesser extent in having a usual source of care since the SCHIP program began. There is also evidence of a considerable decrease in non-Hispanic Black disparities in access to care. However, there appears to be a slight increase in disparities in access to care among Hispanic compared to non-Hispanic White children. While there were great improvements in disparities in access to care with the introduction of the SCHIP program, continuing progress in disparities may depend on continuation of the SCHIP program or similar targeted health policy programs. ^

Helicobacter pylori infection and the effect on growth in a cohort of children in the US/Mexico border

Helicobacter pylori (H. pylori) is an S-shaped or curved gram-negative bacterium that is mostly found in the human stomach. H. pylori causes gastritis in adults and children, which can lead to gastric ulcers or risk of cancer. Transmission of this bacterial infection remains to be unknown but is mostly acquired during childhood. Little is known about the effect H. pylori has on growth in children. Although some studies have reported that H. pylori is associated with subnormal growth, the association of H. pylori with growth retardation and malnutrition is poorly described. Data from this study comes from The Pasitos Cohort Study which draws its population from three border communities which include Socorro and San Elizario in Texas, as well as Ciudad Juarez, Chihuahua, Mexico. Birth documentation was obtained for 803 infants and 472 entered follow-up. This cohort study allowed us to assess the growth of children from 6 months to the seventh anniversary, and describe the prevalence of underweight, short stature and overweight in the study population. We also tested the hypothesis that children in the Pasitos Cohort Study who were ever infected with H. pylori show an increased risk of growth retardation or malnutrition at 66 months of age. Using the 2000 CDC Growth Reference, we found that the mean BMI of the study population increased as children grew older, while the mean of their height for age decreased slightly. The proportion of children who were classified as of short stature was under 5%, while those considered underweight were less than 10% at selected six-months of age intervals. Using the subset of children who were 66 months of age we found that the risk of underweight was higher among those who ever tested positive for H. pylori infection using the urea breath test; however, due to small numbers of children with 'wasting' this difference was not statistically significant. Moreover, since the six cases of under weight occurred among children of low socio-economic status we could not rule out potential confounding. The risk of developing short stature was not different among those ever infected and those who never tested positive for H. pylori infection. ^

The prevalence of food insecurity and associated factors among households with children in Head Start programs in Houston, Texas and Birmingham, Alabama

The purposes of this study were to determine the prevalence of food insecurity and factors associated with food insecurity among households with children enrolled in Head Start programs in Houston, Texas, and Birmingham, Alabama. This cross-sectional study utilized data gathered from 688 households recruited by convenience sample from two Head Start districts in each city. Interviewers collected data from primary caregivers on demographic characteristics, dietary intake, and the six-item USDA food security module. Chi-square and logistic regression analysis were used to determine the association of food security and demographic characteristics. Comparison of means was used to analyze the association between the child's fruit and vegetable intake and the household's food security status. The prevalence of food insecurity among the sample was 34.9% (95% CI: 31.3%, 38.5%). Characteristics associated with food insecurity were the caregiver's national origin (Foreign-born (ref.) v. U.S.-born, adjusted OR = 0.36, 95% CI: 0.14, 0.94), gender of the child (male (ref.) v. female, adjusted OR = 1.44, 95% CI: 1.03, 2.01), and city of residence (Birmingham (ref.) v. Houston, adjusted OR = 0.20, 95% CI: 0.10, 0.39). Children in food insecure households consumed more daily servings of fruits and vegetables on average (mean = 2.44) than children in food secure households (mean = 2.16, p = 0.04). ^

Defining barriers in caring for seriously-ill children in a resource-limited setting: An observational study of 2 children's hospitals in Haiti

Background. According to the WHO 2007 country report, Haiti lags behind the Millennium Development Goal of reducing child mortality and maintains the highest under-5 mortality rate in the Western hemisphere. 3 Overall, few studies exist that seek to better grasp barriers in caring for a seriously ill child in a resource-limited setting and only a handful propose sustainable, effective interventions. ^ Objectives. The objectives of this study are to describe the prevalence of serious illnesses among children hospitalized at 2 children's hospitals in Port au Prince, to determine the barriers faced when caring for seriously ill children, and to report hospital outcomes of children admitted with serious illnesses. ^ Methods. Data were gathered from 2 major children's hospitals in Port au Prince, Haiti (Grace Children's Hospital [GCH] and Hopital d l'Universite d'Etat d'Haiti [HUEH]) using a triangulated approach of focus group discussions, physician questionnaires, and retrospective chart review. 23 pediatric physicians participated in focus group discussions and completed a self-administered questionnaire evaluating healthcare provider knowledge, self-efficacy, and perceived barriers relating to the care of seriously ill children in a resource-limited setting. A sample of 240 patient charts meeting eligibility criteria was abstracted for pertinent elements including sociodemographics, documentation, treatment strategies, and outcomes. Factors associated with mortality were analyzed using χ2 test and Fisher exact test [Minitab v.15]. ^ Results. The most common primary diagnoses at admission were gastroenteritis with moderate dehydration (35.5%), severe malnutrition (25.8%), and pneumonia (19.3%) for GCH, and severe malnutrition (32.6%), sepsis (24.7%), and severe respiratory distress (18%) for HUEH. Overall, 12.9% and 27% of seriously ill patients presented with shock to GCH and HUEH, respectively. ^ Shortage of necessary materials and equipment represented the most commonly reported limitation (18/23 respondents). According to chart data, 9.4% of children presenting with shock did not receive a fluid bolus, and only 8% of patients presenting with altered mental status or seizures received a glucose check. 65% of patients with meningitis did not receive a lumbar puncture due to lack of materials. ^ Hospital mortality rates did not differ by gender or by institution. Children who died were more likely to have a history of prematurity (OR 4.97 [95% CI 1.32-18.80]), an incomplete vaccination record (OR 4.05 [95% CI 1.68-9.74]), or a weight for age ≤3rd percentile (OR 6.1 [95% CI 2.49-14.93]. Case-fatality rates were significantly higher among those who presented with signs of shock compared with those who did not (23.1% vs. 10.7%, RR=2.16, p=0.03). Caregivers did not achieve shock reversal in 21% of patients and did not document shock reversal in 50% of patients. ^ Conclusions. Many challenges face those who seek to optimize care for seriously ill children in resource-limited settings. Specifically, in Haiti, qualitative and quantitative data suggest major issues with lack of supplies, pre-hospital factors, including malnutrition as a comorbidity, and early recognition and management of shock. A tailored intervention designed to address these issues is needed in order to prospectively evaluate improvements in child mortality in a high-risk population.^