An Evaluation of “Informed Consent” with Volunteer Prisoner Subjects

“Informed consent” sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a “free and informed consent” and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.     

Hepatitis A

Hepatitis A is a disease of worldwide distribution which occurs in endemic and epidemic form and is transmitted primarily by person-to-person contact through the fecal-oral route. Common source epidemics due to contamination of food are relatively common, and water-borne epidemics have been described less frequently. The presumed etiologic agent of hepatitis A has now been visualized by immune electron microscopic (IEM) techniques in early acute-illness-phase stools of humans with hepatitis A as well as in chimpanzees experimentally infected with material known to contain hepatitis A virus. In addition, several new serologic tests for the detection of antibody against hepatitis A virus have been described. These include complement fixation and immune adherence techniques. Current data suggest that hepatitis A is caused by a single viral agent lacking the morphologic heterogeneity of hepatitis B viral components and that there may be relative antigenic homogeneity between strains of virus recovered from various parts of the world. Serologic studies to date also indicate that hepatitis A virus is not a major contributing cause in post-transfusion hepatitis.     

Arbitration Agreements and Your Malpractice Coverage

With new legislation and favorable case law developments, many providers of health care services are turning to binding arbitration agreements as a partial solution to the medical malpractice crisis. Existing data indicate tremendous advantages can be gained from the use of such agreements, if they are carefully drawn to comply with new law, tailored to the particular situation in which they will be used and coupled with appropriate procedures to secure the intended benefits.Arbitration is not a substitute for insurance, but if a provider has taken the calculated risk of forgoing insurance he should not be without a carefully drawn binding arbitration agreement.     

A System for Evaluating and Treating Chronic Back Disability

Five methods of personality assessment are evaluated to provide guidance for the psychological treatment of patients with chronic back pain. Patient pain drawings, pentothal pain studies, stress score index, psychological testing with the Minnesota Multiphasic Personality Inventory (MMPI) and response to treatment challenge are used as measurements for evaluation. This evaluation gives the treating staff guidelines for individual treatment programs utilizing operant conditioning techniques. Using this approach, three fourths of the severely disabled patients seen have been successfully treated.     

A unique course in anthropology

The course in forensic anthropology presented at Florida State University is designed to train criminal investigators in the application of physical anthropological and archaeological techniques to the investigation of buried bodies. Modification of archaeological field techniques by experimentation using artificial graves allows the recovery of fragile and easy to overlook evidence and ensures the recovery of all possible material for analysis by the physical anthropologist. An introduction to physical anthropology enables the criminal investigator to effectively communicate his needs and understand the type of information required for adequate identification of remains by a physical anthropologist.     

Electron spin resonance spectrum of species “X” which may function as the primary electron acceptor in Photosystem I of green plant photosynthesis

Purified Photosystem I particles from spinach when reduced with 10 mM dithionite at pH 9 exhibited a 50% light reversible-ESR Signal 1 (P-700⁺) at about 10 K. It was possible to show by signal-averaging techniques that a light-reversible ESR spectrum concomitant with the reversible Signal 1 can be observed with approximate principal g factors at g = 2.07, g = 1.86 and g = 1.75.     

Increased brain myo-inositol 1-phosphate in lithium-treated rats

Lithium was found to produce a marked elevation in the levels of $\text{myo}$-inositol 1-phosphate in the cerebral cortex of treated rats. This effect was completely inhibited by atropine. A 40% reduction in the levels of $\text{myo}$-inositol 1-phosphate was observed when atropine was given alone.     

Water proton magnetic resonance studies of normal and sickle erythrocytes. Temperature and volume dependence.

The temperature and cell volume dependence of the NMR water proton line-width, spin-lattice, and spin-spin relaxation times have been studied for normal and sickle erythrocytes as well as hemoglobin A and hemoglobin S solutions. Upon deoxygenation, the spin-spin relaxation time (T2) decreases by a factor of 2 for sickle cells and hemoglobin S solutions but remains relatively constant for normal cells and hemoglobin A solutions. The spin-lattice relaxation time (T1) shows no significant change upon deoxygenation for normal or sickle packed red cells. Studies of the change in the NMR linewidth, T1 and T2 as the cell hydration is changed indicate that these parameters are affected only slightly by a 10-20% cell dehydration. This result suggests that the reported 10% cell dehydration observed with sickling is not important in the altered NMR properties. Low temperature studies of the linewidth and T1 for oxy and deoxy hemoglobin A and hemoglobin S solutions suggest that the "bound" water possesses similar properties for all four species. The low temperature linewidth ranges from about 250 Hz at -15 degrees C to 500 Hz at -36 degrees C and analysis of the NMR curves yield hydration values near 0.4 g water/g hemoglobin for all four species. The low temperature T1 data go through a minimum at -35 degrees C for measurements at 44.4 MHz and -50 degrees C for measurements at 17.1 MHz and are similar for oxy and deoxy hemoglobin A and hemoglobin S. These similarities in the low temperature NMR data for oxy and deoxy hemoglobin A and hemoglobin S suggest a hydrophobically driven sickling mechanism. The room temperature and low temperature relaxation time data for normal and sickle cells are interpreted in terms of a three-state model for intracellular water. In the context of this model the relaxation time data imply that type III, or irrotationally bound water, is altered during the sickling process.     

Theoretical calculations of the helix–coil transition of DNA in the presence of large,cooperatively binding ligands

Theoretical calculations are conducted on the helix–coil transition of DNA, in the presence of large, cooperatively binding ligands modeled after the DNA-binding proteins of current biological interest. The ligands are allowed to bind both to helx and to coil, to cover up any number of bases or base pairs in the complex, and to interact cooperatively with their nearest neighbors. The DNA is treated in the infinite homogeneous Ising model approximation, and all calculations are done by Lifson's method of sequence-generating functions. DNA melting curves are calculated by computer in order to expolore the effects on the transition of ligand size, binding constant, free activity, and ligand–ligand cooperativity. The calculations indicate that (1) at the same intrinsic free energy change per base pair of the complexes, small ligands, for purely entropic reasons, are more effective than are large ligands in shifting the DNA melting temperature; (2) the response of the DNA melting temperature to increased ligand binding constant K and/or free ligand activity L is adequately represented at high values of KL (but not at low KL) by a simple independent site model; (3) if curves are calculated with the total amount of added ligand remaining constant and the free ligand activity allowed to vary throughout the transition, biphasic melting curves can be obtained in the complete absence of ligand–ligand cooperativity. In an Appendix, the denaturation of poly[d(A-T)] in the presence of the drug, netropsin, is used to verify some features of the theory and to illustrate how the theory can be used to obtain numerical estimates of the ligand binding parameters from the experimental melting curves.