Adequacy of informed consent for lumbar puncture in a pediatric emergency department.

OBJECTIVE: To determine whether informed consent is adequately obtained by documentation of appropriate risks, benefits, alternatives, and procedure explanation for children who had a lumbar puncture (LP) in a pediatric emergency department (PED). METHODS: Authors agreed on the criteria for appropriate informed consent for LP, including risks and benefits of the procedure, alternatives to doing the procedure, explanation of the procedure including the purpose of the LP, and a signature of a witness. A retrospective chart review was done for all children who had LP during a 1-year period in a PED. Information documented on a general procedure consent form was analyzed. RESULTS: There were 336 patients who had LP in the PED during a 1-year period. Mean (SD) age of patients was 37.8 (61.9) months (median age, 1.6 months), and 56.5% were boys. Consent was obtained by attending physicians (18.9%), pediatric emergency medicine fellows (7.1%), residents (73.6%), and medical students (0.3%). Documented risks of the LP included back pain (19.3%), infection (88.2%), bleeding (86.5%), apnea for infants 1 year or younger (9.5%), and post-LP headache for children 10 years and older (44.9%). Benefits of the procedure were documented for 36.1%, alternatives for 12.5%, explanation of the procedure for 45.9%, purpose for 94.3%. There was no statistically significant difference for training level of person obtaining consent and risks documented. However, pediatric emergency medicine fellows documented benefits more frequently (P = 0.005), residents documented alternatives more frequently (P = 0.006), and attending physicians documented explanation of the procedure more frequently (P = 0.005). CONCLUSIONS: Risks, benefits, alternatives, and explanation of the LP procedure are not adequately documented on consent forms in the PED. Although the actual discussion with guardians is unknown, these data imply that informed consent may not have been properly obtained before the LP was performed. In the event of a complication and subsequent malpractice lawsuit, clinicians may be unable to demonstrate they adequately informed a guardian about the LP.

Determinants of family consent to tissue donation.

BACKGROUND: Family consent to tissue donation currently falls well below that for solid organ donation. Moreover, research suggests that Americans have limited understanding of tissue donation, an activity largely overshadowed by the more publicly visible organ donation. This research sought to identify determinants of families' consent to tissue donation. METHODS: Data collection included a brief, self-administered survey completed by tissue bank staff and telephone interviews with family for a sample of tissue donor-eligible deaths reported to a national sample of 16 United States Tissue banks from 2003 to 2006. Family members (N = 1,418) and tissue bank staff (n = 226) involved in the tissue donation decision participated in the research. RESULTS: The families of 1,015 (71.6%) tissue donor-eligible patients consented to tissue donation; 403 (26.8%) families refused. Results revealed a multitude of associations between study variables and the donation decision. A subsequent multivariable analysis identified determinants of family consent to tissue donation, including the discussion of key donation-related issues during the request (adjusted odds ratio [AOR], 17.22; 95% confidence interval [CI], 11.61-25.54), the quality of communication during the request (AOR, 12.39; CI, 7.76-20.02), families' tissue donation attitudes and knowledge (AOR, 10.01; CI, 6.47-15.50), families' initial reactions to the request (AOR, 7.86; CI, 5.13-12.05), families' advance notice of the request (AOR, 3.95; CI, 2.41-6.46), and patient and family sociodemographic characteristics (AOR, 3.32; CI, 2.01-5.48). CONCLUSIONS: Family consent to tissue donation is affected by many of the same variables influencing consent to solid organ donation. Recommendations for practice are provided.

A paradigm shift in the approach to families for organ donation: honoring patients' wishes versus request for permission in patients with Department of Motor Vehicles donor designations.

BACKGROUND: Recently, we reported a donation consent rate of only 80% for patients designated as donors with the Department of Motor Vehicles (DMV), which equaled missed opportunities for 17 potential transplant recipients during 3 months. We undertook the current study to increase our donation consent rate in patients with prior DMV donor designations. METHODS: In October 2006, we modified our approach for donor consent by asking to honor the patient's wishes rather than asking for permission. The consent rates from January through September 2006 (preinitiative) were compared with rates from October through April 2007 (postinitiative). RESULTS: During the preinitiative period, 66 approaches were made; 24 patients were registered as donors with the DMV (36%). In total, consent for donation was obtained from 43 families (65%). Only 20 of 24 (83%) families of patients with prior DMV designation donated, and 23 of 42 families of patients with no DMV designation donated (55%). One hundred forty-one organs were successfully transplanted (average 3.3 organs per procurement). Of 71 postinitiative approaches, 42 families donated (59%) and 125 organs were transplanted (average 3.0 organs per procurement). Consent for donation was obtained in 23 of 52 non-DMV-designated donors (44%). The families of all 19 DMV-designated donors consented for donation (100%). CONCLUSION: Modifying our approach to consent for organ donation to honor the patient's wishes based on DMV donor designation rather than ask for permission increased organ procurement in this population to 100%. However, further efforts are needed at the state and national levels regarding the recognition of first-person consent for organ donation.

An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent.

OBJECTIVES: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. METHODS: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. RESULTS: Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. CONCLUSIONS: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.