PubMed Health⌕ Search

Biomedical subjects

Christine Grady

Publications and source records attributed to Christine Grady.

At least 19 recordsLinked to original sources
PubMed2006

Exploring the ethics of clinical research in an urban community.

OBJECTIVES: We consulted with representatives of an urban community in Washington, DC, about the ethics of clinical research involving residents of the community with limited access to health care. METHODS: A semistructured community consultation was conducted with core members of the Health Partnership Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three research case examples were discussed; questions and probes (a predetermined question or series of questions used to further investigate or follow-up a response) guided the discussion. RESULTS: The community representatives who took part in the consultation were supportive of research and appreciated the opportunity to be heard. They noted the importance of respecting the circumstances, values, needs, and welfare of research participants; supported widely representative recruitment strategies; and cited the positive benefits of providing care or treatment to participants. Monitoring participants' welfare and ensuring care at a study's end were emphasized. Trust was a central theme; participants suggested several trust-enhancing strategies, including full disclosure of information and the involvement of advocates, physicians, and trusted church members. CONCLUSIONS: Several important strategies emerged for conducting ethical research in urban communities whose residents have limited access to health care.

Black or African American↗
PubMed2006

Patients' decision-making process regarding participation in phase I oncology research.

PURPOSE: This study assesses the decision-making process of patients enrolling in phase I oncology studies. PATIENTS AND METHODS: Participants were eligible if they had consented to participate in a phase I cancer study at one of five cancer centers, understood English, and were older than 18 years. Trained interviewers conducted structured in-person interviews. RESULTS: Of the 163 participants, 88% were white, 96% had health insurance, and 51% were college graduates or post graduates. Overall, 81% were aware of hospice, but only 6% had seriously considered hospice for themselves; 84% were aware of palliative care and 10% seriously considered it for themselves; and 7% considered getting no treatment at all. Overall, 75% reported moderate or a lot of pressure to participate in the phase I study because their cancer was growing, whereas 7% reported such pressure from the study investigators and 9% felt such pressure from their families. For 63% of patients, the most important information for decision making was that the phase I drug killed cancer cells; only 12% reported that the adverse effects of the drug(s) was the most useful information. More than 90% of patients said they would still participate in the study even if the experimental drug caused serious adverse effects, including a 10% chance of dying. CONCLUSION: Patients are aware of many alternatives to phase I studies, but do not seriously consider them. Very few experience pressure from family or researchers to participate in research. Their main goal is to fight their cancer, and almost no adverse effect, including death, would dissuade them from enrolling.

Aged↗
PubMed2006

Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study.

Controversy exists regarding an ethical requirement to make products proven effective in research available after the trial. Little is known about the views of several stakeholders. Phone or self-administered questionnaires were completed by 65 IRB/REC chairs, 117 investigators, and 500 research participants in a multinational HIV trial to assess their views about posttrial access to interventions proven effective in the study. A total of 83% of research participants, 29% of IRB/REC chairs, and 42% of researchers (p = 0.046) thought IL-2 should be guaranteed for every HIV-infected person in the world if proven effective. Most European and Latin American research participants thought IL-2 should be provided free, while North American, Australian, and Thai participants commonly said at a price the average person could afford (p < 0.001). Most IRB/REC chairs and researchers thought the CIOMS "reasonable availability" requirement applied to people in the country where the study was conducted and meant a drug should be available at a price the average person could afford and that host country governments had primary responsibility for making it available. Most research participants believe an HIV drug proven effective in research should be made available to everyone in the world who needs it. IRB/REC chairs and researchers were less expansive both in who and how they thought a drug should be guaranteed.

Adult↗
PubMed2006

The limits of disclosure: what research subjects want to know about investigator financial interests.

Research participants' views about investigator financial interests were explored. Reactions ranged from concern to acceptance, indifference, and even encouragement. Although most wanted such information, some said it did not matter, was private, or was burdensome, and other factors were more important to research decisions. Very few said it would affect their research decisions, and many assumed that institutions managed potential conflicts of interest. Although disclosure of investigator financial interest information to research participants is often recommended, its usefulness is limited, especially when participation is desired because of illness.

Attitude to Health↗
PubMed2005

Quality of parental consent in a Ugandan malaria study.

OBJECTIVES: We surveyed Ugandan parents who enrolled their children in a randomized pediatric malaria treatment trial to evaluate the parents' levels of understanding about the treatment trial and the quality of the parents' consents to allow their children to participate in the study. METHODS: We conducted 347 interviews immediately following enrollment at 4 Ugandan sites. RESULTS: A majority (78%) of the parents, most of whom where mothers (86%) had at most a primary school education. Of the participating mothers, a substantial percentage reported that they remembered being told about the study's purpose (77%), the required number of visits (88%), the risks involved (61%), treatment allocation (84%), and their ability to discontinue their children's participation (64%). In addition, most reported knowing the trial's purpose (80%) and the required number of visits (78%); however, only 18% could name possible side effects from the drugs being administered, and only 19% knew that children would not all be administered identical treatments. Ninety-four percent reported that they made the enrollment decision themselves, but 58% said they felt pressure to participate because of their child's illness, and 15% said they felt some type of pressure to participate from others; 41% reported knowing that they did not have to participate. CONCLUSIONS: The consent Ugandan parents provided to allow their children to participate in the malaria study was of mixed quality. Parents understood many of the study details, but they were not very aware of the risks involved or of randomization. Many parents felt that they could not have refused to participate because their child was sick and they either did not know or did not believe that their child would receive treatment outside of the study. Our results indicate that further debate is needed about informed consent in treatment studies of emergent illnesses in children.

Antimalarials↗
PubMed2005

An analysis of U.S. practices of paying research participants.

BACKGROUND: Despite controversy about paying research subjects, little is known about actual practices in the U.S., including what type of studies offer payment, to what type of subjects, and how amounts are determined. OBJECTIVE: To document current U.S. practices regarding payment to research subjects. METHODS: The protocols and consent forms of 467 studies offering payment to research subjects approved by 11 IRBs across the U.S. were reviewed to analyze how they describe and justify payment to subjects. RESULTS: Money was offered in a wide variety of study types, from short term physiologic studies to large clinical trials of therapeutic interventions, to both patient (61%) and healthy (24.4%) subjects or both (14.6%). Dollar amounts varied widely and were infrequently explicitly described as based on time (19%) or procedures (12%). Unexplained variation in dollar amounts occurred in similar studies or in the same (multi-site) study at different sites, and for similar procedures across studies sometimes even within one site. Although the range was wide ($5-$2000), total amounts were usually modest (overall median $155), and almost always described in the consent form (94.4%) and usually as pro-rated (73%). CONCLUSIONS: Both patient and healthy subjects are offered payment in a wide variety of types of research in the U.S. Variation in the dollar amounts offered is largely unexplained.

Choice Behavior↗
PubMed2005

Risks and benefits of phase 1 oncology trials, 1991 through 2002.

BACKGROUND: Previous reviews of phase 1 oncology trials reported a rate of response to treatment of 4 to 6 percent and a toxicity-related death rate of 0.5 percent. These results may not reflect the rates in current phase 1 oncology trials. METHODS: We reviewed all nonpediatric phase 1 oncology trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute between 1991 and 2002. We report the rates of response to treatment, of stable disease, of grade 4 toxic events, and of treatment-related deaths. RESULTS: We analyzed 460 trials involving 11,935 participants, all of whom were assessed for toxicity and 10,402 of whom were assessed for a response to therapy. The overall response rate (i.e., for both complete and partial responses) was 10.6 percent, with considerable variation among trials. "Classic" phase 1 trials of single investigational chemotherapeutic agents represented only 20 percent of the trials and had a response rate of 4.4 percent. Studies that included at least one anticancer agent approved by the Food and Drug Administration constituted 46.3 percent of the trials and had a response rate of 17.8. An additional 34.1 percent of participants had stable disease or a less-than-partial response. The overall rate of death due to toxic events was 0.49 percent. Of 3465 participants for whom data on patient-specific grade 4 toxic events were available, 14.3 percent had had at least one episode of grade 4 toxic events. CONCLUSIONS: Overall response rates among phase 1 oncology trials are higher than previously reported, although they have not changed for classic phase 1 trials, and toxicity-related death rates have remained stable. Rates of response and toxicity vary, however, among the various types of phase 1 oncology trials.

Antineoplastic Agents↗
PubMed2005

Payment of clinical research subjects.

Offering payment to clinical research subjects, in an effort to enhance recruitment by providing an incentive to take part or enabling subjects to participate without financial sacrifice, is a common yet uneven and contentious practice in the US. Concern exists regarding the potential for payment to unduly influence participation and thus obscure risks, impair judgment, or encourage misrepresentation. Heightening these concerns is the participation not only of adults but also of children in pediatric research trials. Thorough assessment of risks, careful eligibility screening, and attention to a participant's freedom to refuse all serve to reduce the possibility of compensation adversely affecting the individual and/or the study. Institutional review boards currently evaluate payment proposals with minimal guidance from federal regulations. Here, reasons for providing payment, payment models, ethical concerns, and areas for further research are examined.

Adult↗
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

Ethics of vaccine research.

Vaccination has attracted controversy at every stage of its development and use. Ethical debates should consider its basic goal, which is to benefit the community at large rather than the individual.

Ethics, Research↗
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↗