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PubMed2006

Organ procurement organizations Internet enrollment for organ donation: abandoning informed consent.

BACKGROUND: Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. METHODS: An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. RESULTS: There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20-47), 79% (57-86), and 75% (50-100), respectively. The informed consent score was 0% (0-33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. CONCLUSION: The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

Brain Death↗
PubMed2006

Variations in consenting practice for laparoscopic cholecystectomy.

INTRODUCTION: To compare the variations in consenting practice amongst trainees and consultant surgeons for laparoscopic cholecystectomy with specific reference to the documentation of significant risks of surgery. PATIENTS AND METHODS: A proforma was devised which included significant and/or commonly recognised complications of laparoscopic cholecystectomy. This was then cross-referenced with the consent forms for the 80 patients included in the study and the documented risks explained in each case were noted. RESULTS: The results showed that there is considerable variation between the three grades of clinicians involved in obtaining a patient's consent for laparoscopic cholecystectomy. There was a clear difference in emphasis of the significant complications depending on the seniority of the consenter. Over 80% of the consents in this study were still being obtained by junior staff. CONCLUSIONS: More often than not, patients are not provided with consistent information to make an informed choice. We suggest that a preprinted consent form will provide a more uniform approach to consenting practice for laparoscopic cholecystectomy.

Cholecystectomy, Laparoscopic↗
PubMed1997

Participation bias in a sexuality survey: psychological and behavioural characteristics of responders and non-responders.

BACKGROUND: Few studies of sexual attitudes and behaviour have quantified the direction and magnitude of participation bias, primarily because information on non-responders is difficult to obtain in cross-sectional surveys. METHOD: Australian adult twins (n = 9112) aged 17-52 years enrolled in a national, longitudinal research register were asked to participate in a postal survey concerning their sexual behaviour and attitudes. Individual consent was determined by separate return of a consent form; 27% explicitly refused, 19% initially agreed to receive a questionnaire, but subsequently did not return consent forms and 52% explicitly consented. Participation data were matched to social, psychological and behavioural information in a longitudinal data set. RESULTS: People who explicitly consented had higher levels of education, attended church less often, had less conservative sexual attitudes and voting preferences, were more likely to smoke cigarettes and drank alcohol more often than people who explicitly refused. On standard personality scales, responders were more novelty-seeking and reward-dependent and less harm-avoidant than refusers. Structured psychiatric telephone interview data from 3674 individuals showed that, compared to refusers, responders had higher lifetime prevalence of major depression, alcohol dependence and childhood conduct disorder and also reported an earlier age at first sexual intercourse and higher rates of sexual abuse. In general, those who had initially agreed to receive the sex questionnaire but were subsequently lost were more similar to consenters than to refusers. CONCLUSIONS: Effect sizes on most measures were small. The broad profile suggests that postal surveys of sexual attitudes and behaviour may overestimate sexual liberalism, activity and adversity, although this bias should not seriously compromise population estimates.

Adolescent↗
PubMed2001

Monitoring clinical research: report of one hospital's experience.

Monitoring of research by research ethics boards has been recommended by various organizations that fund clinical studies and by other groups. However, little evidence has been reported on the processes, costs and outcomes of these activities, information that would be helpful to guide the boards in their current work and future policies. We report here 3 years of monitoring experience by the research ethics board of a 313-bed university-affiliated community hospital. Activities newly implemented at the beginning of the study period included the use of recruitment logs, audits of completed consent forms and interviews with research subjects. Over the study period, we monitored 33 protocols, through 188 consent form audits and interviews with 17 research subjects. In addition, 26 of 34 research investigators and collaborators responded to a survey about the monitoring. In general, the investigators were supportive of monitoring activities, but most were not willing to contribute financially. The types of monitoring we conducted are feasible and may be suitable (or could be adapted) for use in other institutions.

Clinical Protocols↗
PubMed1998

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

OBJECTIVES: To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. DESIGN: Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. MEASUREMENTS: Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. RESULTS: A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). CONCLUSIONS: A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.

Adult↗
PubMed2006

The sham ECT literature: implications for consent to ECT.

The author reviewed the placebo-controlled literature on electroconvulsive therapy (ECT) for depression. No study demonstrated a significant difference between real and placebo (sham) ECT at 1 month posttreatment. Many studies failed to find a difference between real and sham ECT even during the period of treatment. Claims in textbooks and review articles that ECT is effective are not consistent with the published data. A large, properly designed study of real versus sham ECT should be undertaken. In the absence of such a study, consent forms for ECT should include statements that there is no controlled evidence demonstrating any benefit from ECT at 1 month posttreatment. Consent forms should also state that real ECT is only marginally more effective than placebo.

Consent Forms↗
PubMed2003

Consent processes in common nose and throat procedures.

The NHS Plan identified the need for changes in consent practice, and led to the issuing of a model consent policy and standard consent forms for use in the NHS. The aim of this study was to determine current consent practices for common rhinology and laryngology procedures. A telephone survey was conducted of 40 otolaryngology Senior House Officers (SHOs) across England and Wales, asking about local consent procedure, and the specific complications discussed before common operations. The responsibility for routine consenting belonged to SHOs in 95 per cent of departments. Model NHS consent forms were used in 72.5 per cent and information sheets given to patients in 25 per cent of departments. The specific operative risks mentioned to patients by the SHOs showed great variability. The provision of standardized consent protocols for each operation, together with information sheets and the model NHS forms, could aid juniors involved in consent and prove beneficial to our patients.

Endoscopy↗
PubMed2005

Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome.

BACKGROUND: Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule has the potential to affect data collection in outcomes research. METHODS: To examine the extent to which data collection may be affected by the HIPAA Privacy Rule, we used a quasi-experimental pretest-posttest study design to assess participation rates with informed consent in 2 cohorts of patients eligible for the University of Michigan Acute Coronary Syndrome registry. The pre-HIPAA period included telephone interviews conducted at 6 months that sought verbal informed consent from patients. In the post-HIPAA period, informed consent forms were mailed to ask for permission to call to conduct a telephone interview. The primary outcome measure was the percentage of patients who provided consent. Incremental costs associated with the post-HIPAA period were also assessed. RESULTS: The pre-HIPAA period included 1221 consecutive patients with acute coronary syndrome, and the post-HIPAA period included 967 patients. Consent for follow-up declined from 96.4% in the pre-HIPAA period to 34.0% in the post-HIPAA period (P<.01). In general, patients who returned written consent forms during the post-HIPAA period were older, were more likely to be married, and had lower mortality rates at 6 months. Incremental costs for complying with the HIPAA Privacy Rule were $8704.50 for the first year and $4558.50 annually thereafter. CONCLUSIONS: The HIPAA Privacy Rule significantly decreases the number of patients available for outcomes research and introduces selection bias in data collection for patient registries.

Acute Disease↗
PubMed1987

Informed consent in emergency care: illusion and reform.

Many patients seeking care in the modern emergency center are capable of participating in treatment decision making. In the traditional emergency center consent process, the patient or a surrogate is asked to sign a general consent form purporting to authorize any treatment the emergency physician deems necessary. We discuss the ethical and legal inadequacy of this procedure. In addition, we present the results of a questionnaire assessing the comprehension of emergency center patients who participated in the general consent process. We found that few patients understood the purpose of the consent form and that patients in general had little understanding of their decision making authority. In light of our analysis and findings, we offer suggestions for improving the emergency center consent process.

Adolescent↗
PubMed2005

Written parental consent in school-based HIV/AIDS prevention research.

OBJECTIVES: We examined the process of obtaining "active," written parental consent for a school-based HIV/AIDS prevention project in a South African high school by investigating (1) parental consent form return rates, (2) parents' recall and knowledge of the research, and (3) the extent to which this consent procedure represented parents' wishes about their child's involvement in the research. METHODS: This cross-sectional descriptive study comprised interviews with parents of children in grades eight and nine in a poor, periurban settlement in Cape Town. RESULTS: Within 2 weeks, 94% of 258 parents responded to a letter requesting written consent and of those, 93% consented, but subsequent interviews showed that 65% remembered seeing the consent form. At the end of the interview, 99% consented to their child's participation. CONCLUSIONS: These findings challenge many of the assumptions underlying active written parental consent. However, they should not be used to deny adolescents at high risk of HIV infection the opportunity to participate in prevention trials. Rather, researchers together with the communities in which the research is undertaken need to decide on appropriate informed consent strategies.

Adolescent↗
PubMed2003

Informed consent for interventional radiology procedures: a survey detailing current European practice.

PURPOSE: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. METHODS: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms and written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention, the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. RESULTS: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%), non-academic (40.5%) or private (2.8%). Depending on the procedure, in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The majority of respondents were satisfied with their level of explanation regarding indications for treatment (69.3%) and the procedure (78.7%). Fifty-nine percent felt patients understood alternative treatment options. Only 37.8% of radiologists document possible complications in the patient's chart. Comments from respondents indicated that there is insufficient time for radiologists to obtain consent in all patients. Suggestions to improve current local policies included developing the role of radiology nursing staff and the use of radiology outpatient clinics. CONCLUSIONS: More than 50% of respondents are unhappy with their policies for obtaining informed consent. Interventional societies have a role to play in advocating formal consent guidelines.

Attitude of Health Personnel↗
PubMed1994

Informed consent: an evaluation of patients' understanding and opinion (with respect to the operation of transurethral resection of prostate).

The ability of patients to understand and recall information given prior to obtaining written consent was assessed in 55 patients who were due to undergo the operation of transurethral resection of prostate. The patients were also asked their opinion on informed consent. Most patients knew the position of the prostate and the purpose of the operation. Some aspects of the postoperative management and complications were less well remembered. In particular, 18% of the patients could not remember the possibility of retrograde ejaculation despite efforts to emphasize this. Of the patients who returned their questionnaires, 41% did not mind what happened to them provided they were made better; 54% trusted their doctor to do the right thing and did not think detailed explanation was important; 62% felt that consent forms are to protect the doctor's right; still most patients felt that consent forms were necessary. Sub-groups comparison showed no relationship between patients' attitude and their ability to recall information.

Aged↗
PubMed2004

Genetic research & human biological samples: some legal and ethical considerations.

This paper examines the medico-legal and medico-ethical issues that ethics committees and researchers will have to consider when examining proposals pertaining to non-therapeutic genetic research. This paper is limited to the examination of issues that relate to those individuals who donate bodily/DNA samples for the purposes of non-therapeutic genetic research. The issues that arise are those of (i) informed consent and those with diminished capacity (ii) the drafting of consent forms as they relate to genetic research (iii) confidentiality, genetic research with non-EU countries and the implications of the EC Directive on the Protection of Data: 95/46/EC and (iv) an examination of international ethical guidelines. The paper concludes with (i) a summary of the main points of concern that ethics committees must consider before the approval of genetic research (ii) the manner in which consent forms must be drafted and (iii) a brief look at medico-legal issues that will become important and will have to be considered in Ireland in the near future in relation to genetic research.

Confidentiality↗
PubMed1993

Ethical dilemmas in continuing a zidovudine trial after early termination of similar trials.

Ethical dilemmas caused by external events and an interim subset analysis raised concerns about continuing a long-term VA clinical trial comparing early with later zidovudine therapy for symptomatic human immunodeficiency virus (HIV) infection. The first external event was the early termination of other, apparently similar, trials conducted by the AIDS Clinical Trials Group (ACTG) and the announced clear benefits for the zidovudine-treated patients. Interim analysis of the VA trial at this time did not show similar benefits. Subset analyses were performed to explore factors that might explain the different results. These suggested a difference in response to zidovudine in white and minority groups. The Data Monitoring Board and a special advisory panel reviewed these data and concluded that, since the VA results were neutral overall and the subset analyses based on small numbers, the trial should continue. By conference call, the study cochairmen and biostatistician discussed this decision with study personnel without revealing interim results, and study personnel passed the information on to patients at the participating centers. The second event was in March 1990, when the Food and Drug Administration (FDA) approved earlier use of zidovudine, which applied to patients still in the VA trial. Patients were asked to reaffirm their participation by signing a new informed consent that explained the findings reported by the ACTG, the FDA-approved revised recommendations, and the rationale for continuation of the VA trial. The consent form emphasized that continued masked therapy was optional and that unmasked treatment and follow-up would be provided to patients requesting it. Seventy-four percent of the participants chose to continue masked therapy. We conclude that when new external data are announced, informed participation in a long-term clinical trial may require a revised consent form and that it is ethical and practical to present this without disclosure of interim study results.

Acquired Immunodeficiency Syndrome↗
PubMed1996

Offering patients entry in clinical trials: preliminary study of the views of prospective participants.

OBJECTIVE: To ascertain attitudes to different methods of obtaining informed consent for randomised clinical trials (RCTs). DESIGN: Structured interviews with members of the public, medical secretaries and medical students. SETTING: The public were approached in a variety of public places. Medical secretaries and students were approached in their place of work. SUBJECTS: Fifty members of the public, 25 secretaries and 25 students. MAIN OUTCOME MEASURES: Views on RCTs were elicited, with particular emphasis on how subjects thought the concept of randomisation should be explained. Each participant was presented with descriptions of proposed clinical trials and asked to select his or her preference from a range of options. RESULTS: Written information was preferred over verbal information in 91% of replies. Most respondents (86%) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour of explanations that were less explicit about the play of chance (ANOVA; p = 0.0004). Eighty-three per cent of participants thought that randomised trials were morally acceptable when there was no prior medical preference between treatments. However, over half (55%) thought they would find it upsetting to be offered entry in such a trial and a quarter thought the outcome of treatment might be adversely affected. CONCLUSIONS: Our results offer some support for the idea that "economy with truth" is less unsettling than a frank description of the stark reality of what randomisation means. It is a matter of debate as to whether, if we are correct, autonomy should have precedence over beneficence. The offer of entry in a clinical trial is likely to affect the experience of care for many people, especially if the process of randomisation is described explicitly. Potential participants should be given a detailed written explanation of the rationale for the trial and be asked to sign a consent form if they agree to take part.

Analysis of Variance↗
PubMed2006

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.

BACKGROUND: A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. METHODS: To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. RESULTS: Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade. CONCLUSION: The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.

Attitude↗
PubMed1997

Legal and ethical considerations of informed consent.

The law of informed consent remains ineffective at resolving patient comprehension issues primarily because differing interpretations exist regarding who is responsible for the duty to inform. Court cases continue to set precedents for practicing physicians and other health care providers; however, other measures can be applied for effectual patient advocacy. Health care personnel should rewrite typical consent forms in simpler terms, use larger print, and create duplicate copies. If patients are given copies of the permits they sign, the can reread the forms at home when they are more comfortable. For true autonomy to exist in informed consent for surgical procedures, consent forms should contain patients' primary languages whenever possible, or an adequate interpreter should be made available. Surgeons, nurses, and other health care providers must become aware of their responsibilities related to informed consent for treatment. It is necessary for health care personnel to develop and use effective communication techniques and remember that although some patients are more visually attuned to new information, other patients may benefit more from listening or reading. The cases in this article show that a patient's autonomy is part of the informed consent process and the duty to inform the patient lies with the person performing the procedure. A more important issue, however, involves the patient's comprehension of the information given, because without it, the patient cannot achieve true autonomy in making decisions. Ensuring that all elements of informed consent are met to obtain informed consent will result in fewer malpractice claims, greater patient satisfaction, and an improved professional image. Nevertheless, nurses should make themselves aware of the state laws in which they practice, including their nurse practice acts. They then should advocate for patient rights by encompassing all elements of informed consent.

Ethics, Medical↗