Risk, disclosure

While there is considerable overlap in the ethical issues in the fields of biomedical engineering and medicine, biomedical engineers also sometimes face ethical dilemmas that are unique to their profession. Issues such as safety, intellectual property ownership, risk disclosure, whistle blowing, and engineering professional codes of ethics are all examples. The Center for the Study of Ethics in the Professions at the Illinois Institute of Technology is a valuable resource in this regard, and maybe accessed online at http // ethics.iit.edu. In the following sections some brief case studies are offered for review and discussion. 

The latter view prevailed but generated yet another set of issues as to whether disclosure rules should be evaluated from the perspective of professionals or patients. Some courts took the narrower view of duty by ruling that professional standards should be used to determine what should be disclosed to patients. Although this theory of "lack of informed consent" was distinct from whether the health care provider had violated the standard of care, most courts, and many legislatures, confined the doctrine s operation to a very narrow set of circumstances consistent with the negligence standard underlying the standard of care in medical cases. Other courts took what is called the broader view and leaned toward the patient s perspective while requiring juries to impose the reasonable patient s view of risk rather than the particular patient s view of risks. 

A disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the participant and their important potential benefits and risks... 

Informed consent is in some sense the ethical cornerstone on which human subjects protection rests. It requires that individuals understand their part in a study and the potential consequences, and are free to choose to participate. As Levine has argued, the consent process should include specific elements an invitation to participate a statement of the purpose of the study the basis of participant selection and explanation of procedures, risks, and discomforts how untoward consequences will be handled the benefits of participation alternatives to participation financial consideration confidentiality opportunities for continuing disclosure and measures for ensuring that a person s decision to participate is voluntary (Levine, 1981). 

The need to deposit viable cultures of microorganisms to meet the legal requirement of providing a sufficient or enabling disclosure of the invention represents a substantial business risk of giving competitors a head start in their R D if no worthwhile patent protection is obtained ultimately. In other technical areas only information describing the invention is disclosed, and not actual physical materials that either embody the invention or that are very closely related to the invention. 

Service companies are always pleased to assist prospective buyers by providing specifications that are then written into a forthcoming water treatment bid request. This facility can be of genuine benefit to the buyer. However, and needless to say, where no buyer control is exercised, the temptation exists either to write the requirements tightly around the service company s products or to restrict the disclosure of certain operational and commercial information critical to competitors in their bid-price calculations. This practice can occur when the time comes to offer an existing tender for re-bid, and an existing vendor may risk losing its account. 

The committee s attention to those limitations and uncertainties is important for two reasons. First, full disclosure of limiting factors gives scientists and the public a fuller understanding of the reliability and credibility of biomonitoring results. It provides risk assessors with information needed to characterize risk conclusions fully, as called for by the National Research Council risk-assessment paradigm (NRC 1983 1994). Second, and equally important, the kinds of uncertainty define data gaps for immediate attention and related long-term research needs. 

Exemption 7 protects records or information compiled for law enforcement purposes when disclosure (a) could reasonably be expected to interfere with enforcement proceedings, (b) would deprive a person of a right to a fair trial or an impartial adjudication, (c) could reasonably be expected to constitute an unwarranted invasion of personal privacy, (d) could reasonably be expected to disclose the identity of a confidential source, (e) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be expected to risk circumvention of the law, or (f) could reasonably be expected to endanger the life or physical safety of an individual. 

VA, 363 male military veterans were randomly sampled and found to have a current prevalence of 32% for full PTSD and 10% for partial PTSD. Prevalence of PTSD varied as a function of risk and protective factors, including volunteering, physical symptoms during the tests, and prohibited disclosure. Veterans with full PTSD reported poorer physical health, a higher likelihood of several chronic illnesses and health-related disability, greater functional impairment, and higher likelihood of healthcare use than those with no PTSD. Veterans with partial PTSD also had poorer outcomes than did veterans with no PTSD in a subset of these domains. 

Of the commonly used therapeutic drugs, the greatest risks are encountered when clinicians prescribe topical steroids (for extended periods), systemic steroids, P blockers, miotic antiglaucoma agents, and oral carbonic anhydrase inhibitors (CAIs). Optometrists should be aware of the adverse effects that attend the use of these drugs and should warn patients accordingly. Disclosures should be documented in the patient record. 

The FDA s role is to assure that all advertising and promotion of prescription drugs is accurate, provides full disclosure of risks and is fairly balanced. There are two legal bases for FDA jurisdiction over all advertising and promotional materials and programs issued by or sponsored (i.e. funded) by drug companies. 

Basic professional development courses offered by SCHC are MSDS and Label Preparation Workshops Science, Toxicology and Industrial Hygiene for Hazard Communication and Hazard Determination Risk Assessment. Regulatory courses include Canadian Mexican Hazard Communication Pesticide Consumer Product Labeling Component Disclosure Requirements European Union Hazard Communication Transportation Classification Labeling HMIS/NEPA Labeling and International Chemical Control Laws. 

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