This study evaluates functional recovery after transplanting human bone marrow-derived stromal cells (BMSCs) into contusion models of spinal cord injury (SCI). The authors used a high-throughput process to expand BMSCs and characterized them by flow cytometry, ELISA, and gene expression. They found that BMSCs secrete neurotrophic factors and cytokines with therapeutic potential for cell survival and axon growth. In adult immune-suppressed rats, mild, moderate, or severe contusions were generated using the MASCIS impactor. One week following injury, 0.5 to 1 x 106 BMSCs were injected into the lesioned spinal cord; control animals received vehicle injection. Biweekly behavioral tests included the Basso, Beattie, and Bresnahan Locomotor Rating Scale (BBB), exploratory rearing, grid walking, and thermal sensitivity. Animals receiving moderate contusions followed by BMSC grafts showed significant behavioral recovery in BBB and rearing tests when compared to controls. Animals receiving BMSC grafts after mild or severe contusion showed trends toward improved recovery. Immunocytochemistry identified numerous axons passing through the injury in animals with BMSC grafts but few in controls. BMSCS were detected at 2 weeks after transplantation; however, at 11 weeks very few grafted cells remained. The authors conclude that BMSCs show potential for repairing SCI. However, the use of carefully characterized BMSCs improved transplantation protocols ensuring BMSC, survival, and systematic motor and sensory behavioral testing to identify robust recovery is imperative for further improvement.

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?

This article examines and critiques the use of the term "vulnerability" in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: "consent-based vulnerability,""risk-based vulnerability," and "justice-based vulnerability."

Section A: The nature, duration and purpose of study.Your child is invited to participate in a single follow-up visit between the age of six years, four months and seven years, two months of age (school age) for children who were enrolled in the SUPPORT MRI study. As you may recall, that study did an extra brain ultrasound at the time that your child's near-term brain MRI was done for routine care. The purpose was to compare the findings of early and near-term ultrasounds and near-term MRI to determine if one way of imaging gives more useful information than the other. The primary purpose of the study is to examine the children at school age and determine whether near-term MRI is better than ultrasound in predicting developmental outcome. The second purpose is to evaluate the weight, height, body measurements and blood pressure. During the clinic visit, the interviews for you as a parent will take about 1 ½ -2 hours and the time to evaluate your child will take about 3½ hours, including breaks. The interviews with you will be at the same time your child is being tested so the whole visit will last about 3½ hours.SUPPORT school age follow-up, funded by the National Institutes of Health, is being conducted at Women and Infants Hospital and 14 other medical centers across the country. About 500 children and their parents are expected to participate. Sixty-one children are eligible to participate at Women and Infants Hospital. Section B:The means by which it is conducted. The evaluation will include: For child:Weight and height will be measured using a standard scale, blood pressure will be obtained with the cuff method and the abdomen will be measured.A small measuring tool will be used to determine the thickness of the right arm, back and abdomen.A detailed neurological examination will be done to look at muscle strength, coordination, balance and ability to walk; a test of number skills and word identification will be conducted; a test of problem solving with words, blocks and pictures will be done; a test evaluating vision problem solving skills and ability to pay attention will be carried out. For parent:If your child cannot be evaluated by the last two tests, you will be asked to answer questions about the daily living activities of your child in the areas of self-care, mobility, communication, and understanding.In addition, you will be asked to complete questionnaires about your household and your child's overall health, education, and activities away from school.You will be asked questions about your child's medical history, including the recent vision and hearing tests.Section C. The possible benefit or lack of benefit to my child.All results of the tests will be shared with you and forwarded to you or your child's personal physician if requested. You will be reimbursed $25 for your time and your child will receive a small gift such as a book valued at ~ $5.00. Section D: The potential risks, and discomforts.There are no known risks to participating in the medical/neurological and developmental testing of ...

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