Biomedical & behavioral research includes studies which are designed to enhance the scientific information about the normal or abnormal physiology and development. The studies are designed to evaluate any new or existing medical product or intervention or procedure in perspective of usefulness or effectiveness or safety. These studies may be conducted on the individuals, groups or any aggregates. These researches are conducted with an objective to identify and confirm the scientific principles which are repeatable and demonstrable facts and theory, intended towards knowledge enhancement and improvement in human medical issues.
Biomedical and behavioural issues are subject to ethical-legal problems and are considered as situations which can have severe legal impacts alongwith ethical reasons suporting and against an identified sequence of actions. These sequence of actions are the ones which would be input to the decision making on a particular course of actions. Causes of Ethical dilemma in Biomedical and Behaviour research Behavior Research may involve the intervention resulting in the behavioral changes and evaluation of the changes.
The intervention could be measuring how the depression of a particular person or a group (particular age, gender, race, nationality etc) reduces after undertaking a medication or the effect hemodialysis on the psychiatric disorders. Similarly, physiological responses can be examined as a result of behavioral intervention like giving a biofeedback to reduce the blood pressure (BP) or using the hypnosis technology to reduce the weight. Similar to Behavior research, biomedical research also employs many methodologies and design of research.
The studies may include various therapy researches like surgical interventions, diet, drugs, exercise, or medical devices. There could be research in diagnostic procedures like prenatal diagnosis through various techniques like fetoscopy, chorionic villi testing etc. The research could be in the area of preventive measures like vaccination etc. The human body research on the various stages in the lifecycle like infancy, childhood, teenage and adult. As discussed above the various techniques of behavioral and medical research involves ethical and legal dilemma because all the testing procedures are applied in the “live” human bodies.
The repercussions of the researches are not clearly known and hence the impact of applying a new medication or surgery or fetal analysis can result in impacts which can be damaging and would not be easy to control. For example, fetal gender determination technique has resulted in the misuse of the technique to an extent that the gender ratios of many countries have become skewed in favour of either male or female. There are laws which have come up to prevent people from going for fetal analysis unless medically required. Another case to cite would be the controversy surrounding the stem cell research.
This research involves taking the pluripotent cells isolated directly from the inner cell mass of human embryos at the blastocyst stage. These embryos have been received from In Vitro Fertilization (IVF) clinics where the embryos were in excess of clinical need for fertility treatment; they can also be isolated from fetal tissue obtained from terminated pregnancies. The following pages discuss the ethical and legal issues around one of the case in stem cell research and the final decision taken by the expert committee on the treatment of the patient.
An overview of the ethics committee In order to assist the health care system to establish and maintain an ethical environment, the Hospitals constitute a multidisciplinary Ethics Committee. The broad objectives of the Ethics committee are: • To provide a forum for consideration and discussion of the ethical aspects of medical practice, health care delivery, and organizational responsibility. Physicians, patients, and their families can seek counsel on critical issues such as ventilator use, dialysis and feeding tubes from the Ethics Committee.
Whenever the medical, ethical and legal issues arise, the ethics committee is consulted to for resolving any dilemma. Usually, the Ethics committee of the hospitals is composed of a physician, a member of the clergy, a clinical social worker, a pharmacist, a nutritionist, an administrator and a legal expert. A description of Ethical dilemma A case of a patient has been tabled before the Ethics Committee. The patient is suffering from acute sickle cell anemia and hence the patient needs blood transfusion on a frequent basis to survive.
The family of the patient is concerned as someone from the patient’s family needs to accompany the patient for the transfusion every time and the patient is showing signs of weakness in spite of blood transfusion on regular basis. The patient is undergoing regular transfusions for last five years and hence able to survive but recently, patient’s regular physician Dr M has diagnosed unexpected low count of Red blood cells (RBCs) which can result in patient’s death if the frequency of the transfusion is not increased. Dr M also mentioned that frequency of transfusion increase my not give a solution which can bring a permanent relief.
Besides increasing costs, patient’s family is worried about the temporary nature of the cure. Their request for a permanent cure prompted Dr M to do some research on the disease and he found that the stem cell technology can be a solution though it is only in its nascent stage. Patient’s family agreed for the permanent cure through Stem Cell research but Dr M advised them to consult the Ethics Committee before going ahead for the treatment. Dr M forwarded the relevant case study with the background on the Stem Cell research and the possible solution to the Patient’s problem.
The case is described above and the background on the stem cell in following paragraph. The Stem cell technology is growing exponentially with the promise of curing the chronic malfunctioning of human body. The life threatening diseases which were so far thought to be in-curable through the use of traditional medicine can be thought of arms distance away from the cure. Hence, stem cell technology has the potential to revolutionize the area of medical science. The immunodeficiency diseases can also be treated through stem cell therapy. Stem cell therapy can also be used to treat Bone and cartilage mal-functioning .
Besides this Children having Type 1 diabetes also have shown significant improvements after stem cell treatment has been administered to them . Cancer ,Sickle cell anemia are the other diseases that have been cured through stem cell therapy. (Advances in the Stem cell research 2009) The dilemma facing the committee is on the harvesting technique for the pluripotent stem cells. The two methods of harvesting the stem cells for therapeutic usage are – harvest from an embryo or from an adult through somatic nuclear transfer. The issue with the first source is that it means destroying the embryo.
Although the scientists/doctors claim to be using only the rejected embryo due to fail pregnancies or any other reason, the possibility of planning to fail pregnancy can not be ruled out. On the other hand, it is important to note that the regenerative capability of adult human body is very much limited. The capacity of regeneration is only limited to some part of body while in other parts it is non existent. For example, the Red blood cells are regenerated by the stem cells in the bone marrow. Some amount of regeneration is possible in case of less burning of skins but if the damage is beyond certain limit, the skin does not regenerate.
Current research is highly focused on getting to the bottom of the reason why all parts of body do not have regenerative capability. The initial results show a good promise as there is increasing evidence that the stem cells are present in far more tissues and cells as originally envisaged. (Bonsor, Kevin, Conger, & Cristen, 2008) Though, the adult stem cells are identified to be present in almost all part of human body, including brain, bone marrow, skeletal muscle, skin, digestive systems, cornea, liver etc.
, these is still no dependent methodology to harvest them. Hence, summarily, the dilemma was whether to use the harvested stem cells from the embryo of a failed pregnancy or not and what are the risks associated with seeking the failed pregnancies. Resolving the Ethical dilemma using MORAL model The MORAL model (Guido, G. W. 2003) of ethical decision making was employed and its ethical implications were discussed along with the final decision and conclusions based on the same.
The reason for employing the MORAL model is as follows – • Technically, the process does not involve any “killing” of life rather it is simply harvesting the stem cells from the failed pregnancy • As such failed pregnancy embryos are used for biomedical research hence only the MORAL dilemma is the only one preventing the harvesting of the stem cells from an embryo of failed pregnancy • The MORAL dilemma and it’s resolution would take care of any issues related to “force” a pregnancy to “failure” to cure the disease concerned