Biomedical subjects
Rebecca D Pentz
Publications and source records attributed to Rebecca D Pentz.
Research on stored biological samples: views of African American and White American cancer patients.
Proposals on consent for research with biological samples should be informed by empirical studies of individuals' views. Studies to date queried mostly white research subjects. The aim of this study was to compare the views of two groups of patients: cancer patients at a university clinic (Winship Cancer Institute at Emory Healthcare) and cancer patients at an inner city county hospital (Grady) who were given the option of tissue banking. Overall, 315/452 (70%) patients completed the survey. The Grady cohort was 86% African American; the Winship cohort was 82% White. The vast majority (95%) of individuals in both cohorts agreed to provide a biological sample for future research. Both cohorts were willing for their samples to be used to study cancer and other diseases, including Alzheimer disease. Few participants preferred to control the disease to be studied (10%) or wished to be contacted again for consent for each future research project (11%). In our sample, almost all clinical patients, regardless of site of care, ethnicity or socioeconomic status, were willing to provide a biological sample for research purposes and allow investigators to determine the research to be done without contacting the patients again. These findings support the recommendation to offer individuals a simplified consent with a one-time binary choice whether to provide biological samples for future research.
Healthy sibling donation of G-CSF primed stem cells: a call for research.
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Involving children with cancer in decision-making about research participation.
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Evaluation of a decision aid for families considering p53 genetic counseling and testing.
PURPOSE: Li-Fraumeni syndrome (LFS) is associated with p53 germline mutations, and carriers are at increased risk for multiple primary cancers. We evaluated outcomes following the administration of a video-based decision aid (DA) prior to clinical p53 genetic counseling and testing among persons who had previously participated in cancer genetics research. METHODS: Fifty-seven individuals at risk for a known p53 mutation completed baseline and post-DA measures of psychological outcomes, plus knowledge and attitudes regarding p53 genetic testing. Counseling and testing uptake also was recorded. RESULTS: At baseline, multivariate analysis showed that greater testing intention was associated with lower decisional conflict (P < 0.01). Compared with baseline data, multivariate analyses of post-DA outcomes showed that knowledge about LFS and genetic testing increased and decisional conflict related to testing decreased (P < 0.001). Mean cancer worries scores decreased among all participants (P < 0.001), and mean depression scores decreased for males (P < 0.05). Thirty-nine (68%) completed pre-test genetic counseling and 23 (40%) subsequently gave a blood sample for clinical genetic testing. CONCLUSION: This intervention was useful as an initial outreach and educational method for families considering p53 genetic testing, and may improve knowledge about LFS as well as psychological outcomes.
Ethics guidelines for research with the recently dead.
The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.
Hereditary nonpolyposis colorectal cancer family members' perceptions about the duty to inform and health professionals' role in disseminating genetic information.
This study's aim was to ascertain hereditary nonpolyposis colorectal cancer (HNPCC) families' views on the duty to inform with particular focus on the role of health professionals in disseminating familial genetic information. Eighty members of 16 families with a clinical or molecular diagnosis of HNPCC completed qualitative interviews regarding views on family members' right to know and who should disseminate familial genetic information. Most indicated that everyone in the family should know about the presence of a mutation in the family, with family members themselves being the preferable informant, supported by health professionals who were seen as helpful in overcoming barriers. All but one respondent indicated that if a parent did not test and presumably did not inform his/her child about the family mutation, the child should be informed by other family members or by a health professional. Many were attuned to confidentiality concerns, but judged them to be outweighed by the importance of family members knowing about the mutation and undertaking proper surveillance. Respondents were more private about the disclosure of individual results to other family members, clearly distinguishing personal results from familial genetic information. These families with a hereditary colon cancer syndrome favor open sharing of genetic information within the family, and desire the supportive involvement of health care professionals in disseminating genetic information.
Designing an ethical policy for bone marrow donation by minors and others lacking capacity.
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The poster child for the need for central review of research protocols: the Children's Oncology Group.
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Spreading it around: money for researcher and research participants.
There is a consensus that inducements for participants in research studies are ethically permitted as long as they are not "undue." The subject of inducements for investigators has not been ethically analyzed. This essay outlines the three models for compensation suggested by Dickert and Grady--market model, reimbursement model and wage-payment model--and argues that this analysis can be fruitfully applied to remuneration for investigators. Currently, investigators are compensated according to the market model, resulting in undue inducement. Investigators should be compensated according to the wage-payment model, as skilled workers, at the rate an internist earns per hour. The wage-payment model avoids undue inducement, but compensates investigators, particularly non-academic investigators who are not salaried, for their time and effort. However, additional safeguards must be erected: investigators must demonstrate research competency for the studies they are to manage; they must understand research ethics; all investigators must be routinely audited; and subjects must be informed of all remuneration that investigators receive.
Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial.
PURPOSE: To describe prospective participants' initial source of information about, understanding of, and motivation to participate in a phase I clinical trial of the antiangiogenesis agent human recombinant endostatin. PATIENTS AND METHODS: We surveyed 100 of 130 persons referred to the endostatin trial between October 1999 and November 2000 and analyzed media coverage of the agent from 1997 to 2000. RESULTS: Forty-seven percent of survey respondents first heard about the trial from media reports. Fifty-one percent of these subsequently contacted their physicians. Thirty-three percent of respondents correctly understood the purpose of the trial. Seventy-nine respondents were interviewed before they met trial investigators to discuss the trial. Of these, those who first heard about endostatin from the media were five times more likely to understand correctly the trial's purpose than those who first heard from other sources. Seventy-four percent (70 of 95) of respondents cited hope for personal benefit as the main reason for their willingness to enroll. Those who first heard about endostatin from the media were no more motivated by hope of personal benefit (77%) than those who first heard from other sources (71%) (P =.46). Ninety-nine percent of all respondents cited "joining the study gives me hope" as a contributing factor in their decision making about the trial. CONCLUSION: Media coverage prompted prospective participants to contact their physicians but did not seem to hinder understanding nor could it be shown to heighten their hope for personal benefit.
Discussion of the do-not-resuscitate order: a pilot study of perceptions of patients with refractory cancer.
Do not resuscitate (DNR) discussions are difficult for physicians and patients alike, resulting in DNR orders being written shortly before death. To understand the patients' point of view, interviews about the perception of DNR discussions were conducted as a pilot study. Fourteen patients with refractory cancer were asked to rank the favorability of DNR discussion scenarios on a Likert scale with 1 meaning most unfavorable and 7 meaning most favorable. The most favorable scenarios were assurance that pain will be controlled (6.9); assurance of nonabandonment (6.9); information about hospice care (6.6); and DNR discussion conducted by attending physician (6.6). The least favorably rated scenarios were delivery of recommendation by physician with whom patient had had no prior contact (1.8); presence of unknown medical personnel with physician (2.0); refusal of physician to answer questions (2.1); and agreement between physician and patient to discuss only positive aspects of patient's case (2.1). This study supports the importance to the patient of a supportive relationship with the attending physician who is both attuned to the need for comprehensive palliative care and is honest about the prognosis.
Steps toward mapping the human vasculature by phage display.
The molecular diversity of receptors in human blood vessels remains largely unexplored. We developed a selection method in which peptides that home to specific vascular beds are identified after administration of a peptide library. Here we report the first in vivo screening of a peptide library in a patient. We surveyed 47,160 motifs that localized to different organs. This large-scale screening indicates that the tissue distribution of circulating peptides is nonrandom. High-throughput analysis of the motifs revealed similarities to ligands for differentially expressed cell-surface proteins, and a candidate ligand-receptor pair was validated. These data represent a step toward the construction of a molecular map of human vasculature and may have broad implications for the development of targeted therapies.
The vagaries of informed consent: experiences in oncologic care.
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Issues, both ethical and practical, in the development and conduct of chemoprevention trials.
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The newly and nearly dead.
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Revisiting ethical guidelines for research with terminal wean and brain-dead participants.
Some research is too risky to be conducted on anyone with a life expectancy of more than a few hours. Yet under some circumstances, the research can still be carried out by using subjects who are either brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.