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. ^