Leonard H. Glantz

Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations:

0 nly 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to the samples.’ This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples. A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information (such as family history and cholesterol levels), and, if so, whether this means that it should receive special legal protection. Genetic information can be considered uniquely private or personal information, for at least three reasons: it can predict an individual’s likely medical future for a variety of conditions; it divulges personal information about one’s parents, siblings, and children; and it has historically been used to stigmatize and victimize individuals. The highly personal nature of the information contained in one’s DNA can be illustrated by thinking of DNA as containing an individual’s coded “future diary.”2 A diary is perhaps the most personal and private document an individual can create. It contains a person’s innermost thoughts and perceptions, and is usually hidden and locked to assure its secrecy. Diaries describe the past. The infor-

Physician Assessment of Patient Competence

OBJECTIVE: To determine if physicians know and can apply the legal standard for determining competence; to determine if physician assessment of competence varies by physician age or specialty.

The Doctor's Role in Discussing Advance Preferences for End‐of‐Life Care: Perceptions of Physicians Practicing in the VA

OBJECTIVES: Although previous studies have shown physicians support advance directives, little is known about how they actually participate in decision‐making. This study investigates (1) how much experience physicians have had discussing and following advance preferences and (2) how physicians perceive their role in the advance decision‐making process.

Conducting Research with Children: Legal and Ethical Issues

Research with children and mentally disabled individuals raises difficult legal and ethical issues. It is the obligation of researchers and those who review research to protect both the rights and welfare of research subjects. Ethicists, legal scholars, and national commissions have examined the circumstances under which it is acceptable to use incompetent people as research subjects, since they are unable to provide consent for participation. Furthermore, there is an extensive set of federal rules that govern the use of children as research subjects. Children may be used as research subjects after a careful weighing of risks and benefits, and as long as they participate in the decision to the extent they are able to do so. However, research projects that will not provide children with direct benefit, such as some placebo-controlled trials, raise particularly difficult issues concerning the protection of these subjects. While biomedical research is an important and socially desirable undertaking, it must proceed only when the rights and welfare of the subjects are scrupulously protected.

The Genetic Privacy Act and commentary

The Genetic Privacy Act is a proposal for federal legislation. The Act is based on the premise that genetic information is different from other types of personal information in ways that require special protection. The DNA molecule holds an extensive amount of currently indecipherable information. The major goal of the Human Genome Project is to decipher this code so that the information it contains is accessible. The privacy question is, accessible to whom? The highly personal nature of the information contained in DNA can be illustrated by thinking of DNA as containing an individual`s {open_quotes}future diary.{close_quotes} A diary is perhaps the most personal and private document a person can create. It contains a person`s innermost thoughts and perceptions, and is usually hidden and locked to assure its secrecy. Diaries describe the past. The information in one`s genetic code can be thought of as a coded probabilistic future diary because it describes an important part of a unique and personal future. This document presents an introduction to the proposal for federal legislation `the Genetic Privacy Act`; a copy of the proposed act; and comment.

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Risky Business: Setting Public Health Policy for HIV-Infected Health Care Professionals

An analysis of the restrictive proposals provoked by the case of Kimberly Bergalis and four other patients apparently infected with HIV during the course of dental treatment reveals that they resulted from an inability to evaluate appropriately the infinitesimal risk of HIV transmission from practitioner to patient. The proposals also resulted from an effort to create risk prevention policy without appreciating the distinction between regulating things or procedures, which have no human rights, and regulating people, who have rights that should not be infringed without serious justification. This analysis demonstrates that the proposed restrictive policies are not justified because they do nothing to prevent the spread of HIV, and they cause unnecessary and substantial harm to health care practitioners.

Rules for donations to tissue banks--what next?

The authors discuss two legal cases involving patients claiming property rights to human tissue used for research after the tissue was surgically removed or donated and a third involving a dispute between a researcher and a university over the ownership of tissue samples.

Concussion Management in United States College Sports Compliance With National Collegiate Athletic Association Concussion Policy and Areas for Improvement

Background: In 2010, the National Collegiate Athletic Association (NCAA) adopted its Concussion Policy and Legislation, which applies to more than 450,000 collegiate athletes annually. To date, there has been no examination of school-level compliance with the NCAA Concussion Policy. Purpose: To examine whether stakeholders at NCAA schools report that their school has a concussion management plan and whether existing plans are consistent with the NCAA policy. Also examined were stakeholders’ perceptions regarding concussion management at their institution and possible areas for improvement. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Surveys were sent by e-mail to coaches, sports medicine clinicians, and compliance administrators at all 1066 NCAA member institutions. Surveys asked population-specific questions about institutional concussion management. Individuals (N = 2880) from 907 unique schools participated in this survey. Results: Most respondents (n = 2607; 92.7%) indicated their school had a concussion management plan. Most schools had all (82.1%) or some (15.2%) respondents indicate a concussion management plan was present. When asked to indicate all individuals who could have final responsibility for returning athletes to play after a concussion, 83.4% selected team doctor, 72.8% athletic trainer, 31.0% specialist physician, 6.8% coach, and 6.6% athlete. Most respondents (76.1%) indicated that their institution had a process for annual athlete concussion education; 91.2% required athletes to acknowledge their responsibility to report concussion symptoms. Nearly all respondents (98.8%) thought their school’s concussion management plan protected athletes “well” or “very well.” Top categories suggested for improvement included better coach education (39.7%), increasing sports medicine staffing (37.2%), and better athlete education (35.2%). Conclusion: Although a large majority of respondents indicated that their school has a concussion management plan, improvement is needed. Compliance with specified components (eg, annual athlete education) lags behind the presence of the plan itself, and stakeholders had suggestions for areas in which improvements are needed. Increasing scientific evidence supporting the seriousness of concussion underscores the need for the NCAA to use its regulatory capabilities to ensure that athletes’ brains are safe.

Medicine and Human Rights: A Proposal for International Action

An international medical tribunal should be established with power to impose criminal sanctions against physicians who are guilty of crimes against humanity.