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Biomedical subjects

Carol Levine

Publications and source records attributed to Carol Levine.

At least 19 recordsLinked to original sources
PubMed2006

Risk in drug trials.

Explore the source record for details and available documents.

Antibodies, Monoclonal↗
PubMed2006

HIPAA and talking with family caregivers: what does the law really say?

The Health Insurance Portability and Accountability Act of 1996 (PL 104-191), known as HIPAA, has confused and unnecessarily alarmed many conscientious health care providers. Nurses in particular are likely to be on the front line of family caregivers' inquiries, because physicians are often difficult to reach and because family caregivers look to nurses as sources of reliable information. A major retraining of health care providers at all levels is needed to dampen the "HIPAA scare" and clarify what HIPAA does and does not say about communication with family caregivers.

Caregivers↗
PubMed2006

"This case is closed": family caregivers and the termination of home health care services for stroke patients.

Policies promoting home- and community-based services and disease management models implicitly rely on family care, still the bedrock of long-term and chronic care in the United States. The United Hospital Fund studied family caregivers of stroke and brain injury patients when home care cases were opened and closed and found that even with short-term formal services, family caregivers provided three-quarters of the care. Patients' mobility impairments and Medicaid eligibility were the main factors in determining the amount and duration of formal services. Between one-third and one-half of family caregivers reported being inadequately prepared for the case closing. At all stages, family caregivers expressed significant isolation, anxiety, and depression. Therefore, home care agency practice and public policies should provide better education, support, and services for family caregivers.

Caregivers↗
PubMed2005

Young adult caregivers: a first look at an unstudied population.

OBJECTIVES: We examined the prevalence, characteristics, and responsibilities of young adults aged 18 to 25 years who are caregivers for ill, elderly, or disabled family members or friends. METHODS: We analyzed 2 previously published national studies (from 1998 and 2004) of adult caregivers. RESULTS: Young adult caregivers make up between 12% and 18% of the total number of adult caregivers. Over half are male, and the average age is 21. Most young adults are caring for a female relative, most often a grandmother. Young adult caregivers identified a variety of unmet needs, including obtaining medical help, information, and help making end-of-life decisions. CONCLUSIONS: Analysis of these 2 surveys broadens our understanding of the spectrum of family caregivers by focusing on caregivers between the ages of 18 and 25 years. The high proportion of young men raises questions about the appropriateness of current support services, which are typically used by older women. Concerted efforts are essential to ensure that young adults who become caregivers are not deterred from pursuing educational and career goals.

Adolescent↗
PubMed2005

Family caregiver research and the HIPAA factor.

Research in family caregiving recently has become more challenging because of the strict protection of privacy mandated in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. We ask when should Institutional Review Boards (IRBs) follow HIPAA rules to the letter and when might they use the waiver option? What is the appropriate balance between the goals of protecting the privacy of patients' personal health information and facilitating family-caregiver research that may benefit them and others? More particularly, should patients be gatekeepers for caregiver participation in minimal-risk research? We describe one approach that successfully met HIPAA criteria and also allowed high-quality research. In developing protocols and applying for IRB approval, researchers must be as familiar with HIPAA regulations as they are with IRB standards. Finally, we recommend changes in the review process that may facilitate research efforts with family caregivers while protecting important privacy interests.

Brain Injuries↗
PubMed2005

Acceptance, avoidance, and ambiguity: conflicting social values about childhood disability.

Advances in medical technology now permit children who need ventilator assistance to live at home rather than in hospitals or institutions. What does this ventilator-dependent life mean to children and their families? The impetus for this essay comes from a study of the moral experience of 12 Canadian families--parents, ventilator-dependent child, and well siblings. These families express great love for their children, take on enormous responsibilities for care, live with uncertainty, and attempt to create "normal" home environments. Nevertheless, they experience social isolation, sometimes even from their extended families and health care providers. Their lives are constrained in many ways. The challenges faced by parents of technology-dependent children raise questions of justice within society and within families.

Adolescent↗
PubMed2004

Oversight of human participants research: identifying problems to evaluate reform proposals.

The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional societies, and others are proposing remedies based on the assumption that the main problems are researchers' conflict of interest, lack of institutional review board (IRB) resources, and the volume and complexity of clinical research. Developing appropriate reform proposals requires carefully delineating the problems of the current system to know what reforms are needed. To stimulate a more informed and meaningful debate, we delineate 15 current problems into 3 broad categories. First, structural problems encompass 8 specific problems related to the way the research oversight system is organized. Second, procedural problems constitute 5 specific problems related to the operations of IRB review. Finally, performance assessment problems include 2 problems related to absence of systematic assessment of the outcomes of the oversight system. We critically assess proposed reforms, such as accreditation and central IRBs, according to how well they address these 15 problems. None of the reforms addresses all 15 problems. Indeed, most focus on the procedural problems, failing to address either the structure or the performance assessment problems. Finally, on the basis of the delineation of problems, we outline components of a more effective reform proposal, including bringing all research under federal oversight, a permanent advisory committee to address recurrent ethical issues in clinical research, mandatory single-time review for multicenter research protocols, additional financial support for IRB functions, and a standardized system for collecting and disseminating data on both adverse events and the performance assessment of IRBs.

Accreditation↗
PubMed2004

"Special scrutiny": a targeted form of research protocol review.

Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) research that involves initial experiences of translating new scientific advances into humans, especially when the intervention is novel, irreversible, or both; 2) research with a known or credible risk for significant harm (death or serious disability are the clearest examples) to research participants as a consequence of the experimental intervention and with no potential for offsetting direct medical benefit; or 3) research with a protocol that raises ethical questions about research design or implementation for which there is no consensus. Special scrutiny recognizes that not all research protocols are equally ethically challenging and aims to provide appropriate protection for all research participants.

Ethical Review↗
PubMed2004

The concept of vulnerability in disaster research.

The concept of vulnerability in research derives from a specific set of historical circumstances relating to abuses in biomedical research. Now so many people and groups have been labeled vulnerable that the concept has lost much of its force. In disaster research, participants should not be automatically considered vulnerable unless they are legally designated as such, for example, children. Instead specific aspects of the research should be thoroughly examined. Examples are the potential for the participants to be pressured to participate in several protocols, political or social turmoil surrounding the disaster, and cognitive impairments or mental health problems. In addition to a careful consent process, there should be procedures in place to provide assistance to participants who experience serious distress.

Adult↗
PubMed2004

The limitations of "vulnerability" as a protection for human research participants.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.

Child↗
PubMed2002

When the caregiver needs care: the plight of vulnerable caregivers.

OBJECTIVES: This study examined the characteristics, activities, and challenges of high-risk informal caregivers. METHODS: Telephone interviews were conducted with a nationally representative cross-section of 1002 informal caregivers. Vulnerable caregivers with poor health or a serious health condition were compared with nonvulnerable caregivers. RESULTS: Thirty-six percent of caregivers were vulnerable. Compared with nonvulnerable caregivers, vulnerable caregivers were more likely to have difficulty providing care, to provide higher-intensity care, to report that their physical health had suffered since becoming a caregiver, to be aged 65 years or older, to be married, and to have less than 12 years of education. CONCLUSIONS: Reliance on informal caregivers without considering the caregiver's ability to provide care can create a stressful and potentially unsafe environment for the caregiver and the care recipient.

Adult↗