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Biomedical subjects

Christine Grady

Publications and source records attributed to Christine Grady.

36 records · Page 2Linked to original sources
PubMed2002

Descriptions of benefits and risks in consent forms for phase 1 oncology trials.

BACKGROUND: Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks. METHODS: To evaluate the written description of direct benefit as well as risk, all consent forms for 1999 phase 1 cancer trials were compiled from 80 percent of the National Cancer Institute-designated cancer centers and from six of eight large pharmaceutical developers of anticancer drugs. In each case, we evaluated the characteristics of the trial, the descriptions of the purpose and procedures of the research, the promise of benefit, the description of risks, and the description of alternatives. RESULTS: Of 272 forms, 268 explicitly mentioned that the trial was research, and 249 stated that the purpose of the trial was testing for safety. Nearly all forms (269) mentioned the right to withdraw from the trial. Almost all forms (260) referred to the experimental agent as "treatment" or "therapy." Only one consent form promised direct benefit to subjects. Most forms (181) mentioned death as a risk, and very few (14) mentioned cure as even a possible benefit. Most (229) stated that there was unknown risk involved and indicated that severe or permanent harms were possible (224). CONCLUSIONS: Consent forms for phase 1 oncology studies almost never promise direct benefit to subjects, rarely mention cure, and usually communicate the seriousness and unpredictability of risk. Although there is room for improvement, the substance of these forms is unlikely to be the primary source of misunderstanding by subjects in phase 1 oncology trials.

Biomedical Research↗
PubMed2002

Paying research subjects: an analysis of current policies.

BACKGROUND: Few data are available on guidelines used by research organizations to make decisions about paying subjects. OBJECTIVE: To analyze existing guidance regarding payment of research subjects and to identify common characteristics and areas for further research. DESIGN: Descriptive content analysis of policies. MEASUREMENTS: Written policies and rules of thumb about paying subjects from 32 U.S. research organizations. RESULTS: Of 32 organizations, 37.5% had written guidelines about paying subjects; all but 1 reported having rules of thumb. Few (18.8%) were able to provide a confident estimate of the proportion of studies that pay subjects. Organizations reported that investigators and institutional review boards make payment decisions and that both healthy and ill subjects in some studies are paid for their time (87%), for inconvenience (84%), for travel (68%), as incentive (58%), or for incurring risk (32%). Most organizations require that payment be prorated (84%) and described in the consent document (94%). CONCLUSIONS: Most organizations pay some research subjects, but few have written policies on payment. Because investigators and institutional review boards make payment decisions with little specific guidance, standards vary.

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PubMed2002

Ethics of clinical research in the developing world.

Many commentators believe that all clinical-trial participants must receive a level of care equivalent to the world's best. Using HIV/AIDS research as an example, we show how this 'Uniform Care Requirement' can undermine biomedical research aimed at improving global health, and then we point towards a more rational and balanced approach to ethical assessment.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Does it pay to pay? A randomized trial of prepaid financial incentives and lottery incentives in surveys of nonphysician healthcare professionals.

BACKGROUND: Monetary incentives in survey research may provide important gains from a methodological perspective in the control and reduction of survey error associated with potential nonresponse of participants. However, few studies have systematically investigated the use of monetary incentives or other methods to improve the response rates in the nonphysician clinician population. OBJECTIVE: To investigate differences in response rates to a mailed self-administered survey of nonphysician clinicians who were randomized to receive a prepaid monetary incentive, a postsurvey prize drawing, or no incentive. METHODS: A randomized controlled trial of financial incentives was conducted from November 2002 to February 2003. Nonphysician clinicians (nurse practitioners [NPs] and physician assistants [PAs]; N = 3,900) randomly selected to participate in a national ethics-related study were assigned randomly in equal allocations (n = 1,300 [650 NPs, 650 PAs]) to three incentive groups: (a) no incentive; (b) a $5 prepaid token incentive in the initial mailing; or (c) a chance to win one of ten $100 prize drawings upon completion and return of a self-administered survey. RESULTS: A $5 cash incentive increased survey response rates to an adjusted 64.2%: a 19.5 percentage point increase over the lottery group (44.7% response rate), and a 22 percentage point increase over the control group (42.2% response rate). DISCUSSION: A nominal cash incentive of $5 yields a significantly higher response rate from nonphysician providers than receiving either a lottery option or no incentive.

Adult↗
PubMedDate not supplied

Ethical conflict in nurse practitioners and physician assistants in managed care.

BACKGROUND: More patients are receiving healthcare services from nurse practitioners (NPs) and physician assistants (PAs). These providers are likely to be confronted with a variety of ethical issues as they balance quality care with their patients' rising cost concerns. However, very little is known about the ethical conflicts and causes of these conflicts experienced by these clinicians in their daily practice. OBJECTIVE: To identify ethical concerns and conflicts NPs and PAs encounter related to managed care in the delivery of primary care to patients and the factors that influence ethical conflict. METHODS: A cross-sectional self-administered mailed questionnaire was sent to 3,900 NPs and PAs randomly selected from primary care and primary care subspecialties in the United States (adjusted response rate, 50.6%). Respondents were surveyed on ethical issues and concerns, ethics preparedness, and ethical conflict. Bivariate and multiple linear regression analyses were used to evaluate predictors of ethical conflict. RESULTS: Insurance constraints were reported to have interfered with the ability to provide quality patient care by 72% of respondents, with 55.3% reporting daily to weekly interferences. Nearly half of respondents (47%) have been asked by a patient to mislead insurers to assist them in receiving care. A perceived obligation to advocate for patients, even if it means exaggerating the severity of a patient's condition, was the single most significant predictor of ethical conflict, explaining 25% of the variance. DISCUSSION: NPs and PAs are experiencing ethical conflict often associated with their perceived professional obligations to advocate for patients. Being well-prepared in ethics and having sufficient professional independence help clinicians balance the ethical complexities and demands of meeting patients' needs within a constrained healthcare system.

Adult↗