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Biomedical subjects

C Grady

Publications and source records attributed to C Grady.

At least 19 recordsLinked to original sources
PubMed2004

The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.

The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.

Clinical Trials as Topic↗
PubMed2002

Encoding and retrieval in aging and memory loss, a fMRI study.

Mild cognitive impairment (MCI) is a term for nondemented individuals with memory complaints and deficits greater than age-adjusted normal performance. Functional MRI (fMRI) may be a more sensitive method than other techniques to reveal functional abnormalities in individuals with MCI, only a proportion of whom progress to Alzheimer's disease (AD). fMRI was carried out while subjects (four MCI, five age-matched normal controls, and one AD) performed incidental encoding (deep and shallow) and recognition tasks for colored and black and white photographs contrasted to baseline fixation. fMRI revealed interesting dissociations between activation patterns and behavioral performance when comparing the MCI and AD to the NC.

Aging↗
PubMed2001

The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?

At a time when there was great attention and intense public controversy surrounding clinical (especially multinational) research, the 52nd general assembly of the World Medical Association (WMA) adopted the 5th revision of the Declaration of Helsinki (in October, 2000)-available at www.wma.net. These revisions are the most substantial adaptations since those adopted by the 29th WMA assembly in October, 1975. The commitment to revision of the declaration acknowledged that deficiencies and disagreements in interpretation needed to be corrected and that ethical standards evolve. Nevertheless, this revision process resulted in a controversial version of the declaration. Reports on the revisions have focused mainly on clinical trials that use placebos; but because of the role of the Declaration of Helsinki in the ethics of research, a more thorough examination is needed. Here, we analyse the process of revision and the major changes made to the declaration.

Ethics, Research↗
PubMed2001

The ethical challenge of infection-inducing challenge experiments.

Challenge experiments that induce infections in healthy volunteers are an important method for initial efficacy testing of candidate vaccines and for study of the pathogenesis of infectious diseases. Although these studies can be conducted safely for selected infectious diseases that are either fully treatable or self-limiting, they raise significant ethical issues. An ethical framework is offered for evaluating infection-inducing challenge experiments, which focuses on the scientific and public health rationale for conducting these studies, the risks that they pose and the ways in which these risks can be minimized, the symptoms experienced by healthy volunteers that may cause discomfort or distress, the exclusion of vulnerable research subjects, the informed consent process, the payment of volunteers, and the use of isolation of volunteers to prevent infection of others.

Bioethical Issues↗
PubMed2001

Money for research participation: does in jeopardize informed consent?

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make.

Adult↗
PubMed1999

Ethics and genetic testing.

The tremendous growth in knowledge about genes and genetic technologies will eventually enable us to know individual genotypes and susceptibilities to disease, perhaps even before birth. Each new genetic test developed raises serious issues for individuals and society on the circumstances under which genetic information should be sought and the uses that should be made of such information. Ethical reflection and analysis will help us to prepare for the responsible use of information about genotypes so that individuals, both now and in the future, are benefited and not harmed, so that justice is served, and so that confidentiality and privacy, and respect for the autonomy, dignity, and differences of each individual, are preserved.

Confidentiality↗
PubMed1997

A PET study of Turner's syndrome: effects of sex steroids and the X chromosome on brain.

Women with Turner's syndrome (TS) allow us to study the neurobiological associates of cognitive and behavioral abnormalities because they lack one/part of one X chromosome, and endogenous estrogen. We studied 13 healthy controls (mean age +/- SD, 28 +/- 6 years) and 16 TS subjects (mean age +/- SD, 26 +/- 6 years). We measured cognitive abilities using neuropsychological tests, and cerebral metabolic rates for glucose with positron emission tomography. Compared to controls, TS subjects had significant absolute hypermetabolism in most brain areas; however, normalized metabolism was significantly lower in TS subjects than controls in the insula and association neocortices bilaterally, and there were significant differences in functional metabolic associations of brain region pairs originating in occipital cortex bilaterally, and within the right hemisphere. There were significant correlations between right-left cognitive and metabolic asymmetries in the TS group. Also, within TS a preliminary analysis demonstrated "X chromosome dosage" effects in language ability and left temporal metabolism, asymmetry of right-left test scores, and parietal metabolism. We hypothesize that within TS: i) generalized brain hypermetabolism reflects global abnormalities in neuron packing; ii) neuronal abnormalities occur in association neocortex that differ in nature or extent from whole brain and are associated with significant differences in normalized metabolism; iii) cognitive deficits are related to brain metabolic abnormalities; and iv) social-behavioral problems may be related to abnormalities of brain metabolism. Moreover, in human brain the X chromosome involved in development of the association neocortices.

Adult↗
PubMed1997

Nutritional adaptation of women living with HIV: a pilot study.

The incidence of human immunodeficiency virus (HIV) infection in women worldwide is increasing rapidly. Assumptions about HIV-related immunologic and nutritional changes are primarily based on data derived from men infected with HIV. The article reports a pilot study designed to examine the immunologic and nutritional responses of a small group of women with HIV infection and to suggest the Roy adaptation model as a framework for understanding HIV-related changes in women. A cross-sectional descriptive design was used to study physiologic mode responses in women seropositive for HIV. Results indicated that the subjects had lower than normal total CD4+ counts. The mean body mass index and midarm muscle area of this cohort of women fell between the 50th and 75th percentiles, and the triceps skinfold thickness was slightly below the 50th percentile, compared with age-matched norms derived from NHANES II data. Although wasting and nutritional problems are common in men with HIV disease the results suggest that women at the midlevel of the disease may not yet have major problems with nutritional adaptation to HIV. Future studies using the Roy adaptation model with larger samples of women who are followed over time are needed to determine whether the decline in physiologic mode adaptation level noted in men infected with HIV is also experienced by women infected with HIV.

Adaptation, Physiological↗
PubMed1996

The metabolic topography of normal aging.

Normal aging is associated with the degeneration of specific neural systems. We used [18F] fluorodeoxyglucose (FDG)/positron emission tomography (PET) and a statistical model of regional covariation to explore the metabolic topography of this process. We calculated global and regional metabolic rates for glucose (GMR and rCMRglc) in two groups of normal subjects studied independently on different tomographs: Group 1--130 normal subjects (62 men and 68 women; range 21-90 years); Group 2--20 normal subjects (10 men and 10 women; range 24-78 years). In each of the two groups, the Scaled Subprofile Model (SSM) was applied to rCMRglc data to identify specific age-related profiles. The validity of these profiles as aging markers was assessed by correlating the associated subject scores with chronological age in both normal populations. SSM analysis disclosed two significant topographic profiles associated with aging. The first topographic profile, extracted in an analysis of group 1 normals, was characterized by relative frontal hypometabolism associated with covariate metabolic increases in the parietooccipital association areas, basal ganglia, mid-brain, and cerebellum. Subject scores for this profile correlated significantly with age in both normal groups (R2 = 0.48 and 0.33, p < 0.0001 for groups 1 and 2, respectively). Because of clinical similarities between normal motoric aging and parkinsonism, we explored the possibility of shared elements in the metabolic topography of both processes. We performed a combined group SSM analysis of the 20 group 2 normals and 22 age-matched Parkinson's disease patients, and identified another aging-related topographic profile. This profile was characterized by relative basal ganglia hypermetabolism associated with covariate decreases in frontal premotor cortex. Subject scores for this profile also correlated significantly with age in both normal groups (group 1: R2 = 0.30, p < 0.00001; group 2: R2 = 0.59, p < 0.01). Healthy aging is associated with reproducible topographic covariation profiles associated with specific neural systems. FDG/PET may provide a useful metabolic marker of the normal aging process.

Adult↗
PubMed1996

State of the science. HIV vaccine development.

Developing a vaccine able to prevent HIV infection would be a great benefit to the world. Vaccines have contributed to substantially reduced morbidity and mortality from several important infectious diseases. However, HIV has some characteristics that distinguish it from many other viruses and make vaccine development challenging. This article discusses scientific strategies, obstacles, and progress to date towards the development of a preventive HIV vaccine.

AIDS Vaccines↗
PubMed1995

Brain metabolic function in older men with chronic essential hypertension.

BACKGROUND AND METHODS. To determine the effects of hypertension on brain function, positron emission tomography (PET) studies using (18F)-2-fluoro-2-deoxy-D-glucose (FDG) were performed on a group of 17 otherwise healthy older hypertensive men (mean age +/- SD = 69 +/- 8 yr) and 25 age- and gender-matched controls. Subjects had medically treated essential hypertension for a minimum of 10 years (range = 10 to 24 yr) with no evidence of end-organ impairment from hypertension by routine clinical screening and by history. All hypertensive and control subjects were determined to be cognitively normal by extensive neuropsychological testing. The hypertensive subjects previously had been reported to have lateral ventricle enlargement and left hemisphere brain atrophy by quantitative MRI. PET data were analyzed using t-tests to look at group differences.

Aged↗