Altruism and the volunteer: psychological benefits from participating as a research subject.

Psychiatric assessment of potential volunteers for hazardous biomedical experimentation should include an assessment of the motivations underlying the altruistic action of volunteering. Screening goals include evaluation of informed consent as well as screening out experimental subjects who would be likely to be psychologically harmed by participation. This discussion of psychological issues to be considered, beyond those of informed consent and screening for severe psychopathology, originated in the psychiatric screening of the small group of original volunteers for the "Dobelle eye" Artificial Vision Project. These individuals entered the project over 20 years ago at a time when they could expect no tangible benefit from participation. Superficially altruistic behavior, such as volunteering for this project, serves multiple psychological functions and in a given clinical case, the determinants are often complex. A spectrum of altruistic behavior is suggested, based on interviews with these original subjects as well as from extensive evaluation of patients studied in the setting of psychoanalytic treatment with one of the authors (B.J.S.). We suggest that adaptive altruism can explain the finding that some volunteers gained actual psychological benefit from their participation. This unanticipated finding, that participating in research as an experimental subject can result in lasting improvement in self-esteem, is discussed. Suggestions are made for increasing the likelihood of such benefit. Ethical ramifications are addressed.

Artificial vision for the blind by connecting a television camera to the visual cortex.

Blindness is more feared by the public than any ailment with the exception of cancer and AIDS. We report the development of the first visual prosthesis providing useful "artificial vision" to a blind volunteer by connecting a digital video camera, computer, and associated electronics to the visual cortex of his brain. This device has been the objective of a development effort begun by our group in 1968 and represents realization of the prediction of an artificial vision system made by Benjamin Franklin in his report on the "kite and key" experiment, with which he discovered electricity in 1751.

Use of breathing pacemakers to suppress intractable hiccups of up to thirteen years duration.

To suppress intractable neurologic hiccups that were unresponsive to pharmacologic management, seven patients have been implanted with modern breathing pacemakers of our design and manufacture. These devices control excursions of the diaphragm by electrical stimulation of the phrenic nerve. The first five patients have been able to control their hiccups by electrical stimulation after periods of up to 13 years. Two additional patients have been recently implanted and results are still pending.

Macroporous hydrogel membranes for a hybrid artificial pancreas. I. Synthesis and chamber fabrication.

We report development of special macroporous semipermeable membranes and diffusion chambers made of polymerized 2-hydroxyethyl methacrylate (pHEMA), synthesized specifically to enclose living insulin-producing pancreatic islet cells for the treatment of diabetes. This material was selected to minimize the fibrotic encapsulation which has limited hybrid artificial pancreas efforts with other membranes, including Millipore and Nuclepore filters. The pore density and pore size distribution were dependent on the ratio of water to HEMA monomer and also on the crosslinker (EGDMA) concentration. A macroporous membrane resulted only when the ratio of water/HEMA monomer was greater than 50%. 125I-insulin permeability was studied in vitro. A technique is also described to fuse the membranes to form diffusion chambers used for implantation into diabetic rats.

Macroporous hydrogel membranes for a hybrid artificial pancreas. II. Biocompatibility.

A histological evaluation of the biocompatibility of a new porous hydrogel membrane made of 2-hydroxyethyl methacrylate (2-HEMA) was performed. Isolated membranes and diffusion chambers made of this material and filled with rabbit pancreas were implanted in diabetic rats for periods of up to 8 1/2 months. Histologic evaluation showed that this polymer elicits minimal tissue reaction within the first 7 weeks but some increase in granulation tissue and fibrosis thereafter. A component of this tissue reaction is neovascularization, and many blood vessels were noted immediately adjacent to the membrane's surface. Calcification of the membrane was also progressive but could be minimized by formulations resulting in the incorporation of acid groups throughout the hydrogel and on its surface. Diffusion chambers made of this new material show promise for use in a "hybrid" artificial pancreas for the treatment of diabetes.

Coronary artery anatomy of the goat.

The coronary arteries of the goat heart were studied using angiographic techniques and molds of the coronary vessel trees. Blood supplies to the left and right ventricles, interventricular septum, atrioventricular node, and apex of the caprine heart were studied. The goat possesses a left dominant pattern of coronary supply with relatively uniform coronary anatomy and may provide a good large animal model for testing cardiovascular assist devices.

Whole-organ incubation as a first step in the isolation of pancreatic islets from large animals.

Ninety-five porcine pancreases were incubated at temperatures of 0, 20, or 37 degrees C for periods of 1-32 h. After incubation at 37 degrees C for 2-4 h, islet cells retain their morphologic and functional integrity, whereas acinar cells become necrotic. Because of acinar destruction, the pancreas also becomes soft and amenable to mechanical separation with a simple new device. Temperature-controlled incubation therefore may be a useful first step in the isolation of islet cells from large animal pancreases.

Impact of regulations on artificial organs research.

From a research perspective, some of the primary problems created by the FDA regulations include: the amount of time necessary to comply with the regulations and to obtain FDA and IRB review of the studies. The cost of such delays may be great in terms of statistical death. Lack of understanding of the regulations on the part of investigators. Escalated costs and extra restrictions on the use of animals. Benefits of the regulations appear to be: better preclinical testing performed prior to initiating clinical trials, and improved testing protocols, both of which may result in lower risks to patients.

Artificial vision for the blind by electrical stimulation of the visual cortex.

Artificial vision for the blind may be feasible by interfacing a television camera with electronics stimulating the visual cortex. The status of a major collaborative effort involving the College of Physicians and Surgeons of Columbia University, the University of Utah, and the University of Western Ontario is reviewed. Results have been very encouraging, although much work remains to be done.