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.^

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.)^

Waking Up to Sleep Medicine Education

Background: Sleep disorders are an important cause of morbidity among our population with billions of dollars spent on direct and indirect costs attributed to sleep disorders. In spite of raising prevalence and morbidity, surveys have shown inadequate education in sleep medicine at all levels at medical school. According to national sleep disorders research plan data, in 1990 about 37 % of medical schools did not offer any sleep education and of the schools which offered it, the average time devoted to sleep medicine was about 2 hours. Sleep disorders have found to be uniformly under diagnosed in primary care settings. [See PDF for complete abstract]

Putting It All Together

Putting it all together: technology design drivers to move your classroom from your campus to the world This workshop will introduce methodologies available for moving the current “classroom” mindset to a learning environment without boundaries. Participants will explore the design drivers necessary to create the technology supports for transcendent learning environments.

A Coordinated and Systematic Model for Adopting, Implementing and Maintaining Effective Sexual Health Education Programs in Schools

Getting evidence-based sexual health education activities into schools can be a complicated process. Working models that assist our educational system in the selection, implementation, and maintenance of effective school-based adolescent health programs are needed. Replicating sexual health programs in school-based settings: A model for schools provides a comprehensive and applied approach that engages all of the important stakeholders within a school district. The results from this study hold much potential to inform Texas and the nation about how a coordinated and practical model can assist school districts to increase the use of evidence-based programs addressing teen pregnancy prevention and sexual health issues.

Culturally sensitive cancer education: Effect on knowledge, cancer fatalism, and participation in mobile mammography screening among African-American women

Purpose. To evaluate the effectiveness of a culturally sensitive educational intervention that used an African American lay survivor of breast cancer to increase knowledge of breast cancer, decrease cancer fatalism, and increase participation in mobile mammography screening among African American women. ^ Design. Experimental pretest/posttest design. ^ Setting. Two predominantly African American churches in a large southwestern metropolitan city. ^ Sample. Participants included 93 African American women, 40 years of age and older. Participants were randomly assigned to an intervention group (n = 48) or a control group (n = 45). ^ Methods. Pretest and post-test measures included the Breast Cancer Knowledge Test and the Powe Fatalism Inventory. In addition, demographic and breast screening practices were collected by questionnaire. The intervention group received a breast cancer educational testimonial from an African American lay survivor of breast cancer, who answered questions and addressed concerns, while stressing the importance of taking responsibility for one's own health and spreading disease prevention messages throughout the African American community. The control group viewed the American Cancer Society “Keep In Touch” video prepared specifically for African American women. Participants in both groups were given culturally sensitive educational materials designed to increase knowledge about breast cancer, and were instructed on breast self-examination by an African American registered nurse, using ethnically appropriate breast models. In addition, after the post-test, all eligible participants were given an opportunity to have a free mammogram via a mobile mammography unit parked at the church. ^ Findings. Participants in the intervention group had a significant increase (p = .03) in knowledge of breast cancer and a significant decrease (p = .000) in fatalism scores compared to those individuals in the control group. The intervention group had a 61% participation rate in screening, while the control group had a 39% participation rate in screening. However, the difference was not statistically significant at the .05 level (p = .07). ^ Conclusions. Results demonstrate that culturally sensitive breast cancer education is successful in increasing knowledge and decreasing cancer fatalism. While there was a trend toward behavior change in the intervention group, more research needs to be done in this area. ^

The School Sealant Program: An evaluation of the oral health education component

Dental caries is a common preventable childhood disease leading to severe physical, mental and economic repercussions for children and their families if left untreated. A needs assessment in Harris County reported that 45.9% of second graders had untreated dental caries. In order to address this growing problem, the School Sealant Program (SSP), a primary preventive initiative, was launched by the Houston Department of Health and Human Services (HDHHS) to provide oral health education, and underutilized dental preventive services to second grade children from participating Local School Districts (LSDs). ^ To determine the effectiveness and efficiency of the SSP, a program evaluation was conducted by the HDHHS between September 2007 and June 2008 for the Oral Health Education (OHE) component of the SSP. The objective of the evaluation was to assess short term changes in oral health knowledge of the participants and determine if these changes, if any, were due to the OHE sessions. An 8-item multiple choice pre/post test was developed for this purpose and administered to the participants before and immediately after the OHE sessions. ^ The present project analyzed pre and post test data of 1,088 second graders from 22 participating schools. Changes in overall and topic-specific knowledge of the program participants before and after the OHE sessions were analyzed using the Wilcoxon's signed rank test. ^ Results. The overall knowledge assessment showed a statistically significant (p <0.001) increase in the dental health knowledge of the participants after the oral health education sessions. Participants in the higher scoring category (7-8 correct responses) increased from 9.5% at baseline to 60.8% after the education sessions. Overall knowledge increased in all school regions with the highest knowledge gains seen in the Central and South regions. Males and females had similar knowledge gains. Significant knowledge differences were also found for each of the topic specific categories (functions of teeth, healthy diet, healthy habits, dental sealants; p<0.001) indicating an increase in topic specific knowledge of the participants post-health education sessions. ^ Conclusions. The OHE sessions were successful in increasing the short term oral health knowledge of the participants. ^

The association between classroom characteristics and student physical activity in physical education classrooms

Background. With the rapid rise in childhood obesity, physical activity participation among young children has become the subject of much recent attention. Physical education classes have been specifically targeted as a method of providing opportunities for all children to be active. Unfortunately, student participation in moderate-to-vigorous physical activity during these classes still falls far below the current recommendations. While some research to date has reported the levels of activity among elementary-aged children, research is limited on the relationship between these activity levels and the environmental characteristics that exist within the PE classroom. ^ Purpose. The purpose of this study is to examine the association between specific classroom characteristics and contextual characteristics (lesson context, class size, class location, teacher gender, and teacher encouragement for PA) with elementary aged children's moderate-to-vigorous activity during PE class. ^ Methods. A secondary analysis of 211 3rd, 4th and 5th grade physical education classes amongst 39 elementary schools in Harris County, TX and 35 elementary schools in Travis County, TX was conducted using cross-sectional data from the evaluation of a school-based health program. Lesson context and student activity levels were measured using a direct observation measurement tool. Additionally, these variables were further analyzed against a number of classroom characteristics to determine any significant associations. ^ Results. Overall, elementary PE classes are still participating in low levels of moderate-to-vigorous physical activity averaging only 38% of class time. Additionally, close to 25% of class time is spent in classroom management. Male directed classes spent significantly more time in game activities and female directed classes spent more time in fitness, knowledge, and skill activities. Classes that took place outdoors were more active and spent more time in games than those that took place indoors. Significant correlations were demonstrated between class size and time spent in management context. Time spent in management context was also correlated with time spent sitting and standing. Additionally, positive correlations were demonstrated between time very active and teachers that praised students and encouraged physical activity among their classes.^

AN ANALYSIS OF THE RELATIVE INFLUENCE OF RACE, INCOME, EDUCATION, AND FOOD STAMP PROGRAM PARTICIPATION/NONPARTICIPATION ON THE FOOD AND NUTRIENT CONSUMPTION OF A NORTH FLORIDA URBAN CLINIC POPULATION IN CONJUNCTION WITH A SURVEY OF NUTRITION RELATED HABITS AND ATTITUDES

The relative influence of race, income, education, and Food Stamp Program participation/nonparticipation on the food and nutrient intake of 102 fecund women ages 18-45 years in a Florida urban clinic population was assessed using the technique of multiple regression analysis. Study subgroups were defined by race and Food Stamp Program participation status. Education was found to have the greatest influence on food and nutrient intake. Race was the next most influential factor followed in order by Food Stamp Program participation and income. The combined effect of the four independent variables explained no more than 19 percent of the variance for any of the food and nutrient intake variables. This would indicate that a more complex model of influences is needed if variations in food and nutrient intake are to be fully explained.^ A socioeconomic questionnaire was administered to investigate other factors of influence. The influence of the mother, frequency and type of restaurant dining, and perceptions of food intake and weight were found to be factors deserving further study.^ Dietary data were collected using the 24-hour recall and food frequency checklist. Descriptive dietary findings indicated that iron and calcium were nutrients where adequacy was of concern for all study subgroups. White Food Stamp Program participants had the greatest number of mean nutrient intake values falling below the 1980 Recommended Dietary Allowances (RDAs). When Food Stamp Program participants were contrasted to nonparticipants, mean intakes of six nutrients (kilocalories, calcium, iron, vitamin A, thiamin, and riboflavin) were below the 1980 RDA compared to five mean nutrient intakes (kilocalories, calcium, iron, thiamin and riboflavin) for the nonparticipants. Use of the Index of Nutritional Quality (INQ), however, revealed that the quality of the diet of Food Stamp Program participants per 1000 kilocalories was adequate with exception of calcium and iron. Intakes of these nutrients were also not adequate on a 1000 kilocalorie basis for the nonparticipant group. When mean nutrient intakes of the groups were compared using Student's t-test oleicacid intake was the only significant difference found. Being a nonparticipant in the Food Stamp Program was found to be associated with more frequent consumption of cookies, sweet rolls, doughnuts, and honey. The findings of this study contradict the negative image of the Food Stamp Program participant and emphasize the importance of education. ^

AN ASSESSMENT OF THE CURRENT STATUS OF MENTAL ILLNESS IN BENDEL STATE OF NIGERIA: IMPLICATIONS FOR PUBLIC MENTAL HEALTH POLICY AND EDUCATION

This descriptive study assesses the current status of mental illness in Bendel State of Nigeria to determine its implications for mental health policy and education. It is a study of the demographic characteristics of psychiatric patients in the only two modern western psychiatric facilities in Bendel State, the various treatment modalities utilized for mental illness, and the people's choice of therapeutic measures for mental illness in Bendel State.^ This study investigated ten aspects of mental illness in Bendel State (1) An increase of the prevalence of mental illness (psychiatric disorder) in Bendel State. (2) Unaided, unguided, and uncared for mentally ill people roaming about Bendel State. (3) Pluralistic Treatment Modalities for mentally ill patients in Bendel State. (4) Traditional Healers treating more mentally ill patients than the modern western psychiatric hospitals. (5) Inadequate modern western psychiatric facilities in Bendel State. (6) Controversy between Traditional Health and modern western trained doctors over the issue of possible cooperation between traditional and modern western medicine. (7) Evidence of mental illness in all ethnic groups in Bendel State. (8) More scientifically based and better organized modern western psychiatric hospitals than the traditional healing centers. (9) Traditional healers' level of approach with patients, and accessibility to patients' families compared with the modern western trained doctors. (10) An urgent need for an official action to institute a comprehensive mental health policy that will provide an optimum care for the mentally ill in Bendel State, and in Nigeria in general.^ Of the eight popular treatment modalities generally used in Bendel State for mental illness, 54% of the non-patient population sampled preferred the use of traditional healing, 26.5% preferred the use of modern western treatment, and 19.5% preferred religious healers.^ The investigator concluded at this time not to recommend the integration of Traditional Healing and modern western medicine in Nigeria. Rather, improvement of the existing modern western psychiatric facilities and a proposal to establish facilities to enable traditional healing and modern western medicine to exist side by side were highly recommended. ^

Sudden Infant Death disparities: A systematic review on health education and policy recommendations for decreasing Sudden Infant Death in the African-American community

Objective: To perform a systematic review of the literature on SIDS and SUID deaths concentrated in the African-American community, describe health education and policy recommendations and recommend a new approach that may aid in decreasing the disparity of infant mortality in the African-American community. ^ Methods: The PubMed database was systematically searched to identify relevant articles for final review and analysis. Using the CASP 2006 system to critique literature, twelve articles were found that met inclusion and exclusion criteria. ^ Results: Evidence in the literature confirmed there was a current disparity among African Americans' infant mortality rates in comparison to other US ethnic groups. The underlying reasons for these disparities included the following maternal and infant characteristics: mothers younger than eighteen, having more than one live infant, having a high school education or less, never been married, and have infants born preterm or with low birth weight. Maternal smoking, substance abuse, and breastfeeding did not have a significant impact on infant sleep environments among African Americans. ^ Conclusion: Tailored health education programs at the community level, better access to pre-pregnancy and prenatal care, and increased maternal perception of risk that is relevant to the infants sleeping environment are all possible solutions that may decrease African American infant mortality rates.^