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Biomedical subjects

Ezekiel Emanuel

Publications and source records attributed to Ezekiel Emanuel.

16 recordsLinked to original sources
PubMed2005

Are racial and ethnic minorities less willing to participate in health research?

BACKGROUND: It is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim. METHODS AND FINDINGS: We performed a comprehensive literature search to identify all published health research studies that report consent rates by race or ethnicity. We found 20 health research studies that reported consent rates by race or ethnicity. These 20 studies reported the enrollment decisions of over 70,000 individuals for a broad range of research, from interviews to drug treatment to surgical trials. Eighteen of the twenty studies were single-site studies conducted exclusively in the US or multi-site studies where the majority of sites (i.e., at least 2/3) were in the US. Of the remaining two studies, the Concorde study was conducted at 74 sites in the United Kingdom, Ireland, and France, while the Delta study was conducted at 152 sites in Europe and 23 sites in Australia and New Zealand. For the three interview or non-intervention studies, African-Americans had a nonsignificantly lower overall consent rate than non-Hispanic whites (82.2% versus 83.5%; odds ratio [OR] = 0.92; 95% confidence interval [CI] 0.84-1.02). For these same three studies, Hispanics had a nonsignificantly higher overall consent rate than non-Hispanic whites (86.1% versus 83.5%; OR = 1.37; 95% CI 0.94-1.98). For the ten clinical intervention studies, African-Americans' overall consent rate was nonsignificantly higher than that of non-Hispanic whites (45.3% versus 41.8%; OR = 1.06; 95% CI 0.78-1.45). For these same ten studies, Hispanics had a statistically significant higher overall consent rate than non-Hispanic whites (55.9% versus 41.8%; OR = 1.33; 95% CI 1.08-1.65). For the seven surgery trials, which report all minority groups together, minorities as a group had a nonsignificantly higher overall consent rate than non-Hispanic whites (65.8% versus 47.8%; OR = 1.26; 95% CI 0.89-1.77). Given the preponderance of US sites, the vast majority of these individuals from minority groups were African-Americans or Hispanics from the US. CONCLUSIONS: We found very small differences in the willingness of minorities, most of whom were African-Americans and Hispanics in the US, to participate in health research compared to non-Hispanic whites. These findings, based on the research enrollment decisions of over 70,000 individuals, the vast majority from the US, suggest that racial and ethnic minorities in the US are as willing as non-Hispanic whites to participate in health research. Hence, efforts to increase minority participation in health research should focus on ensuring access to health research for all groups, rather than changing minority attitudes.

Black or African American↗
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↗
PubMed2004

Interventions to improve research participants' understanding in informed consent for research: a systematic review.

CONTEXT: Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. OBJECTIVE: To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. DATA SOURCES AND STUDY SELECTION: A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. DATA EXTRACTION: Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results were also summarized. DATA SYNTHESIS: Thirty studies described 42 trials that met inclusion criteria. Of 12 trials of multimedia interventions, 3 showed significant improvement in understanding. Of 15 trials of enhanced consent forms, 6 showed significant improvement in understanding (all P<.05), but 5 of 6 trials were of limited quality, casting doubt on their practical relevance. Of 5 trials of extended discussion, 3 showed significant improvement in understanding (all P<.001) and 2 showed trends toward improvement (P=.054 and P=.08). Of 5 trials of test/feedback, all showed significant improvement in understanding (all P<.05) but were flawed in that they may have mistaken rote memorization for improvement in understanding. Another 5 trials were put into a miscellaneous category and had varying impact on understanding. Some demographic factors, particularly lower education, were associated with less understanding. Satisfaction and willingness to enroll were never significantly diminished by an intervention . CONCLUSIONS: Efforts to improve understanding through the use of multimedia and enhanced consent forms have had only limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants' understanding; however, further research is needed.

Biomedical Research↗
PubMed2002

The debate over research on stored biological samples: what do sources think?

BACKGROUND: The debate over informed consent for research on stored biological samples has enormous scientific implications. Unfortunately, there are no data on individuals' attitudes regarding when their consent should be obtained for such research. METHODS: Data were gathered using a telephone survey of 504 individuals living in the United States. Two cohorts were studied: (1) individuals who had participated in clinical research and contributed biological samples and (2) randomly selected Medicare recipients. RESULTS: Of the respondents, 65.8% would require their consent for research on clinically derived, personally identified samples; 27.3% would require it for research on clinically derived samples that are "anonymized." For research-derived samples, 29.0% of the respondents would require their consent if the samples retain personal identifiers; 12.1% would require it if the samples are anonymized before the research is conducted. Also, 88.8% would want to be informed of results of uncertain clinical significance, and 91.9% would not impose greater safeguards on future research on a different disease. CONCLUSIONS: Current practice and policy recommendations regarding research using stored biological samples may be inconsistent with sources' preferences in several respects. In particular, it appears that most sources want to control whether their samples are used for research purposes, are not concerned with the particular disease that will be studied, and want to receive results of uncertain clinical significance. Follow-up research will be needed to assess the generalizability of the current data.

Aged↗
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.

Advertising↗
PubMed2002

Views of potential subjects toward proposed regulations for clinical research with adults unable to consent.

OBJECTIVE: The authors' goal was to assess healthy individuals' attitudes toward five of the most prominent proposed safeguards regarding the consent process for research with adults unable to consent. METHOD: Telephone interviews were conducted with 246 individuals with a family history of Alzheimer's disease who had participated in clinical research. RESULTS: The majority of respondents said that they were willing to participate in research if they lost the ability to consent. Few completed a research advance directive. Many had discussed their preferences with their families, and the majority would allow their families to make research decisions for them. CONCLUSIONS: Enrolling individuals who are unable to consent in research that offers no potential for medical benefit is consistent with the preferences of at least some individuals. This suggests that such research should not be prohibited, provided there is sufficient evidence that it is consistent with the preferences of individual subjects. Requiring that such evidence be provided in a formal research advance directive may be unnecessarily restrictive. More research is needed to assess whether the findings in this group of subjects generalize to other groups.

Advance Directives↗
PubMedDate not supplied

Place of death: U.S. trends since 1980.

Place of death is one indicator of the state of end-of-life care. We examine trends in national death certificate data on place of death from 1980 to 1998. During these years the percentage of Americans dying as hospital inpatients decreased from approximately 54 percent to 41 percent. About 310,000 fewer people died in the hospital in 1998 than if the proportion of inpatient deaths had not changed since 1980. For certain diseases the change was much greater. In 1980 whites and African Americans died in the hospital in equal proportions, but in 1998 whites died as inpatients less often than African Americans. These racial differences and their implications deserve further study.

Black or African American↗
PubMedDate not supplied

Introduction to occupational medical ethics.

Most bioethical advice has focused on the individual physician-patient relationship. But the ethical dilemmas confronting occupational medicine are more complex, because of the influence of institutional and organizational structure. For example, consider conflicts of interest in managed care: Concerns about costs to employers are not just economic, to be outweighed by commitments to employee health, but also legitimate ethical concerns about fair allocation of resources among all employees. Furthermore, in occupational health research, rather than thinking of employees as a "vulnerable population" it may be more useful to regard them as a distinct community and apply the 23 specified protections of communities.

Beneficence↗