Ruth L. Fischbach

Domestic violence and mental health: Correlates and conundrums within and across cultures.

Gender-based violence, only recently emerging as a pervasive global issue, contributes significantly to preventable morbidity and mortality for women across diverse cultures. Existing documentation suggests that profound physical and psychological sequelae are endemic following intimate partner violence. The presentation of domestic violence is often culture specific. A new lexicon, prompted by the expansion of human rights analysis, describes particular threats to local women including dowry deaths, honor murder, saiti, and disproportional exposure to HIV/AIDS as well as globally generic perils including abuse, battering, marital rape, and murder. While still fragmentary, accruing data reveal strengthening associations between domestic violence and mental health. Depression, stress-related syndromes, chemical dependency and substance (ab)use, and suicide are consequences observed in the context of violence in womens lives. Emerging social, legal, medical, and educational strategies, often culture specific, offer novel local models to promote social change beginning with raising the status of women. The ubiquity, gravity, and variability of domestic violence across cultures compel additional research to promote the recognition, intervention, and prevention of domestic violence that are both locally specific and internationally instructive.

Stem cells: science, policy, and ethics

Human embryonic stem cells offer the promise of a new regenerative medicine in which damaged adult cells can be replaced with new cells. Research is needed to determine the most viable stem cell lines and reliable ways to promote the differentiation of pluripotent stem cells into specific cell types (neurons, muscle cells, etc). To create new cell lines, it is necessary to destroy preimplantation blastocysts. This has led to an intense debate that threatens to limit embryonic stem cell research. The profound ethical issues raised call for informed, dispassionate debate.

Bioethical Considerations in Translational Research: Primate Stroke

Controversy and activism have long been linked to the subject of primate research. Even in the midst of raging ethical debates surrounding fertility treatments, genetically modified foods and stem-cell research, there has been no reduction in the campaigns of activists worldwide. Plying their trade of intimidation aimed at ending biomedical experimentation in all animals, they have succeeded in creating an environment where research institutions, often painted as guilty until proven innocent, have avoided addressing the issue for fear of becoming targets. One area of intense debate is the use of primates in stroke research. Despite the fact that stroke kills more people each year than AIDS and malaria, and less than 5% of patients are candidates for current therapies, there is significant opposition to primate stroke research. A balanced examination of the ethics of primate stroke research is thus of broad interest to all areas of biomedical research.

The patient and practitioner as co-authors of the medical record.

Health care professionals traditionally have resisted patient access to medical records. There is evidence, however, that the patients medical record can promote improved communication between patient and practitioner. In an exploratory study, patients in a primary care office practice collaborated with their health care professionals in the authorship of their records. Co-authorship was effective in conveying more complete, accurate, and mutually understandable information. The patient-held copy of the record served as an adjunct to this collaborative process. The potential problems and prospects arising from this strategy are discussed.

A paradigm for inpatient resuscitation research with an exception from informed consent

Objective:Resuscitation research with an exception from informed consent (EFIC) has not been reported in the inpatient or pediatric setting, and little practical information exists to guide application of EFIC regulations to inpatient or pediatric research. The objective of this study was to assess the feasibility of conducting inpatient pediatric resuscitation research with EFIC using handouts to communicate with parents of potential participants and to determine how many parents would likely allow their child to participate in such research. Design:Verbal questionnaire. Setting:Pediatric intensive care units. Participants:Parents of pediatric intensive care unit patients. Interventions:Three one-page handouts described proposed studies; version 1 described a trial of a new medication given during cardiac arrest, and versions 2a and 2b described of a trial of induced hypothermia, with version 2a in paragraph format and version 2b in bullet format. We asked parents of pediatric intensive care unit patients to review the handouts, and then we administered a verbal questionnaire to assess parental reactions to the handouts and to determine how many parents would allow their child to participate. Measurements and Main Results:One or both parents of 91 patients were asked to participate; 100% agreed. Sixty-three percent said they would likely allow their child to participate in resuscitation research with EFIC if they were given a prospective opportunity to opt out. Parents who reviewed version 2b (bullet format) were more likely than parents who reviewed version 2a (paragraph format) to say that they would let their child participate. Parents were more supportive of a trial of induced hypothermia than of a trial of a new medication given during cardiopulmonary resuscitation. Parents endorsed conducting the community consultation process for inpatient resuscitation research with families and healthcare providers of critically ill patients. Conclusions:Inpatient pediatric resuscitation research is feasible using handouts to inform parents of a study and provide a prospective opportunity to opt out. Succinct, bullet-format handouts will yield higher participation rates than paragraph-format handouts.

The Critical Role of Religion: Caring for the Dying Patient from an Orthodox Jewish Perspective

BACKGROUND AND OBJECTIVE Culturally competent medical care for the dying patient by families and health care professionals is a challenging task especially when religious values, practices, and beliefs influence treatment decisions for patients at the end of life. This article describes end-of-life guidelines for hospital health care professionals caring for Orthodox Jewish patients and their families. Religious perspectives on advance directives, comfort care and pain control, nutrition and hydration, do not resuscitate/do not intubate (DNR/DNI), and extubation are often unfamiliar to the American medical community. DESIGN The guidelines for the care of the dying Orthodox Jewish patient were mutually agreed upon by the authors, recognized authorities in medicine, ethics, and Jewish law, who presented their perspectives during a 1-day symposium and who participated in an active working-group session. CONCLUSIONS Care of the religious patient close to death is enormously complex especially when balancing religious obligations, the role of the rabbi, medical procedures, and personal preferences. These guidelines address from a religious perspective profound issues such as the definition of death, organ donation, and caring for the patient at lifes end. The guidelines can be useful for any hospital that serves an Orthodox Jewish population.

Is there concordance in attitudes and beliefs between parents and scientists about autism spectrum disorder

There is no reported investigation comparing concordance in attitudes and beliefs about autism spectrum disorder between parents of children with autism spectrum disorder and scientists who research autism spectrum disorder. To investigate the level of concordance between these groups on causes of autism, priorities of research, perceived stigma, and disclosure of genetic test results, telephone interviews were conducted. Parents (n = 502) were recruited from the Simons Simplex Collection, and research scientists (n = 60) were recruited from investigators funded by the Simons Foundation. Response rates were notable (parents 91%, scientists 80%). Parents and scientists differed significantly regarding beliefs of the likely major cause of autism (p = 0.007) and priorities for further research (p < 0.001). Scientists believed in genetic causes while many parents believed in vaccines as the cause of autism. Parents (37%) were more likely to hesitate vaccinating their child (p < 0.001). In contrast, there was strong concordance regarding extent of perceived stigma (95% vs 92%) and preferences for disclosure of genetic test results, including incidental findings. While scientists believed communication important, paradoxically fewer than half reported it important for scientists to communicate directly with parents. Better communication between parents and scientists should improve mutual understanding and ultimately the health and well-being of children with autism spectrum disorder and their families.

The ombudsman for research practice

We propose that institutions consider establishing a position of “Ombudsman for Research Practice”. This person would assume several roles: as asounding board to those needing confidential consultation about research issues — basic, applied or clinical; as afacilitator for those wishing to pursue a formal grievance process; and as aneducator to distribute guidelines and standards, to raise the consciousness regarding sloppy or irregular practices in order to prevent misconduct and to promote the responsible conduct of research. While there are compelling features to this position, many complex issues need to be considered and resolved. We invite readers to respond to questions we raise in the text.

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution.

Adverse events (AEs) and serious adverse events (SAEs) are important outcomes of any intervention study yet are under-researched. Vague and variable definitions and substantial underreporting make comparisons of risk between studies difficult and evaluation of the safety of a particular intervention almost impossible. These realities may deter researchers from studying at-risk populations. Suicidal behavior is an adverse event in any study, and potentially a very serious one. Thus the issues of reporting and definition are particularly salient for researchers who work with populations at risk for suicidal behavior, especially when the suicidal behavior is the outcome of interest. We conducted a qualitative study with experienced suicide researchers and intervention experts to delineate the issues related to reporting serious adverse events faced by investigators conducting trials in suicide prevention. Participants from multiple sites were interviewed by phone, interviews transcribed and coded for definition and reporting issues and suggested solutions. A narrative synthesis was prepared and validated by all participants. Participants highlighted the difficulties in defining AEs and SAEs and stressed the importance and complexity of ensuring the AE was related to the study and reported properly, and were in agreement about the consequences of AEs to both institutions and individuals. Participants identified the need for the development of clear and consistent AE definitions and reporting requirements. Clear and consistently applied definitions of adverse and serious adverse events and reporting requirements would enhance the comparability of intervention studies in suicidal populations.

Ethical Challenges in Biodefense and Bioterrorism

The threat of a bioterrorist attack is very real and could occur in any country at any time. Today, various governmental agencies in the United States are engaged in biodefense preparedness and response. There is a great need, however, to address ethical challenges in biodefense. In this article, we present diverse bioethical issues associated with bioterrorism and propose various recommendations regarding how to address these challenges.