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The Iowa Supreme Court recently set forth guidelines concerning informed consent. The authors discuss formulation of procedure specific surgical consent forms which comply with Iowa Code requirements.
OBJECTIVE: To describe how local research ethics committees (LRECs) consider and apply research ethics in the evaluation of biomedical research proposals. DESIGN: A qualitative study was conducted using purposeful sampling, focus groups and a grounded theory approach to generate data and to analyse the work of the LRECs. SETTING AND PARTICIPANTS: 11 LRECs of the Mexican Institute of Social Security (IMSS). RESULTS: LRECs considered ethics to be implicit in all types of research, but that ethics reviews were only necessary for projects that included the direct participation of human beings. The LRECs appeared to understand the importance of consent, as in the completion of a consent form, but did not emphasise the importance of the process of acquiring 'informed' consent. The committees considered their main roles or functions to be: (a) to improve the methodological quality of research and to verify - if applicable - the ethical aspects; (b) to encourage personnel to undergo research training; (c) to follow-up research to oversee the adherence to norms and compliance with a specified research timetable. CONCLUSIONS: This study provides a valuable insight into how these LRECs understand the ethical review process. The emphasis of the committees was on rules, regulations, improving research methodology and research training, rather than a focus on efforts to protect the rights and well being of research subjects. The results encourage further normative and descriptive lines of investigation concerning education and the development of LRECs.
OBJECTIVE: To investigate the reasons for poor uptake of immunisation (non-immunisation) and the possible side effects of measles, mumps, and rubella vaccine in a catch up immunisation campaign during a community outbreak of measles. DESIGN: Descriptive study of reasons for non-immunisation and retrospective cohort study of side effects of the vaccine. SETTING: Secondary schools in South Glamorgan. SUBJECTS: Random cluster sample of the parents of 500 children targeted but not immunised and a randomised sample of 2866 of the children targeted. MAIN OUTCOME MEASURES: Reasons for non-immunisation; symptoms among immunised and non-immunised children. RESULTS: Immunisation coverage of the campaign was only 43.4% (7633/17,595). The practical problems experienced included non-return of consent forms (6698/17,595), refusal of immunisation (2061/10,897 forms returned), and absence from school on day of immunisation (1203/8836 children with consent for immunisation). The most common reasons cited for non-immunisation were previous measles infection (145/232), previous immunisation against measles (78/232), and concern about side effects (55/232). Symptoms were equally common among immunised and non-immunised subjects. However, significantly more immunised boys than non-immunised boys reported fever (relative risk 2.31 (95% confidence interval 1.36 to 3.93)), rash (2.00 (1.10 to 3.64), joint symptoms (1.58; 1.05 to 2.38), and headache (1.31 (1.04 to 1.65)). CONCLUSIONS: Many of the objections raised by parents could be overcome by emphasising that primary immunisation does not necessarily confer immunity and that diagnosis of measles is unreliable. Measles, mumps, and rubella vaccine is safe in children aged 11-15.
Before any clinical trial can begin to recruit patients, participating clinical centers must obtain approval from their institutional review board (IRB). When studies are federally funded, such as by the U.S. Department of Health and Human Services (DHHS), centers must also have or obtain a federal compliance agreement from the Office of Human Research Protections (formerly the Office for Protection from Research Risks [OPRR]). The Digitalis Investigation Group trial was a large, international, double-blind, DHHS-funded randomized trial on the effect of digoxin on mortality in heart failure. Due to the anticipated number of centers (>200), the study's data coordinating center (DCC) was requested to assume additional responsibilities that included: (1) acting as a liaison between the OPRR and all study centers; (2) reviewing and correcting all assurance statements before submission to the OPRR; (3) reviewing and approving all centers' informed consent forms; and (4) helping the many research-inexperienced centers to establish IRBs or to locate an IRB in their region that would accept IRB responsibility for them. Although a heavy burden was placed on the DCC, the IRB and OPRR approval process was probably shortened by many weeks at those centers not already possessing a federal compliance agreement. This enabled the study to be completed on schedule and within budget.
BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) are increasing concerns for First Nations peoples in Canada. Although hospital utilization for asthma and COPD among First Nations peoples has been increasing, the prevalence of asthma or wheezing is comparable to national averages. OBJECTIVES: A pilot study was conducted to determine the prevalence of impaired lung function in school-aged First Nations children. PATIENTS AND METHODS: A First Nations community in northern Alberta was selected to participate. Consent forms and a school health survey were completed by parents or guardians. Children with consent completed spirometry at school, and results were compared with predicted values. RESULTS: A total of 36 children participated (response rate 70.6%). Of these, 19.4% of parents reported that their child had received a physician diagnosis of asthma at some point in their life; only 28.6% had a parental report of still having asthma. Parents smoked in 73.1% of the children's homes. The mean (+/- SD) percentage of forced expiratory volume in 1 s (FEV1) over forced vital capacity (FVC) was 82.6%+/-6.9% (94.4%+/-0.08% of predicted). Evidence of airflow obstruction was found in 25% of the children. Parental report of the child ever having asthma was associated with impaired lung function (OR 3.20; P=0.033). Children in a home with reported mold exposure were less likely to have impaired lung function (OR 0.68; P=0.030). CONCLUSIONS: Many children in this study already have established airflow obstruction and may be at increased risk for asthma or COPD. Exposure to mold appeared to be protective. Further research is needed to evaluate the lung health concerns of this population.
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PURPOSE: The authors compared approaches to participants and methods of collecting buccal cell samples by mail in the Black Women's Health Study, a follow-up study of geographically dispersed African-American women. Outcomes of interest were within group participation rates, yield of DNA, and PCR success. METHODS: Six hundred fifty six participants were randomized to four groups: Groups 1 and 2 used the cheek swab method and Groups 3 and 4 used the mouthwash swish method. Groups 1 and 3 were mailed collection kits together with consent forms, whereas Groups 2 and 4 were mailed a kit only after returning a signed consent. RESULTS: Participation rates were similar regardless of the method used for sample collection or mailing of the kits: samples were returned by 40% of Group 1, 37% of Group 2, 36% of Group 3, and 35% of Group 4. The median DNA yield was 3693 ng/sample for the swab method and 10,077 ng/sample for the mouthwash swish method (p<0.001). PCR analyses were successful in 98% of mouthwash samples and 94% of swab samples. CONCLUSION: Because of its higher yield of DNA, the mouthwash swish method is preferable for collection of buccal cell samples by mail.
This article reviews factors relating to the removal of impacted third molars. It covers indications for surgery and how indications and surgical difficulty correspond with the age of the patient. The difficulty of the procedure depends not only on age, but on how the tooth is categorized radiographically (classification, position, angulation) and on the patient's facial characteristics (tapering versus compact facial form). The operator's familiarity with the anatomy of the surgical site is indispensable for uneventful third molar surgery. A signed consent form is necessary to meet medico-legal standards. With a diagnosis, treatment plan, and consent to proceed, these teeth are extricated from their sockets with a modicum of instruments, each one fulfilling a specific purpose. The surgical procedure, whether maxillary or mandibular, can be broken into separate segments for technique elaboration and refinement. These segments are flap development, bone removal, luxation, sectioning, tooth removal, and closure. Specific methods may vary among dental surgeons based on training and experience, but they all should correspond to basic and established principles of surgical technique. Some of these principles and techniques have been outlined in describing the removal of typical mandibular and maxillary third molar impactions.
BACKGROUND: Gastrostomy tubes are placed commonly in patients with limited life expectancy. However, it is unclear whether the process of informed consent is adequate in these patients. This study examined the quality of informed consent in hospitalized patients undergoing placement of gastrostomy tubes. METHODS: Retrospective review of the medical records of a cohort of 154 consecutive hospitalized adults undergoing placement of gastrostomy tubes in the context of chronic progressive illness, in the setting of a large community-teaching hospital. RESULTS: The medical record documented a procedure-specific discussion of benefits and burdens of and alternatives to tube feeding in only 1 of 154 patients. Only 12 of 33 definitely or probably competent patients signed the hospital consent form; in the remaining 21, a surrogate decision-maker signed the form. The cumulative 1-year mortality for this cohort was 50%. CONCLUSIONS: The quality of informed consent for placement of gastrostomy tubes was inadequate in a large community-teaching hospital. Indirect evidence from the literature suggests that these results are not unique to this institution. Physicians should become more familiar with the medical and ethical issues relevant to medically administered nutrition near the end of life, and institutions should develop procedures to improve the quality of decision-making for patients considering this intervention.
BACKGROUND: During the past decade, the use of stored tissue has become an object of increased ethical query. A Swedish biobank and a biotech company have been praised for solving the ethical problems with explicit informed consent procedures, and we decided to investigate donors' perceptions of the system. METHODS: A questionnaire was sent to a randomized sample of 1200 donors who had donated blood and signed informed consent forms. RESULTS: The response rate was 80.9%. Of the respondents, 64.5% were aware that they had consented to donate a blood sample, 55.4% thought that they had consented to donate phenotypic information, and 31.6% believed that they could withdraw their consent. Among respondents, 3.9% considered informing donors about the research objective as the most important ethical issue in relation to biobanks, and 5.6% were unsatisfied with the information they had been given. There was 85.9% acceptance of surrogate decision making by regional research ethics committees. CONCLUSIONS: Considering that the donors in this study were not always aware of their donation but generally were not unsatisfied with the information they had received, and that they did not rate being informed about the research objective as an important issue, informed consent seems to be an inadequate measure of public acceptance of biobank-based research.
OBJECTIVE: To determine if there are subgroups of cancer patients who differ on coping, psychological, and quality of life (QOL) measures, and to determine if these subgroups have a different course of distress and health following a cancer diagnosis. METHODS: Three hundred fifty-one individuals presenting to a multidisciplinary melanoma clinic completed a baseline questionnaire packet containing the Brief Symptom Inventory (BSI), the Medical Outcomes Survey Short-Form 36 (SF-36), Ways of Coping (WOC), State-Trait Anxiety Inventory (STAI), an informed consent form, and a demographic questionnaire. Participants subsequently completed measures at 2, 5, and 9 months after completion of their baseline assessment. A k-means cluster analysis was conducted using the subscales of the STAI, SF-36, and WOC. RESULTS: Four distinct clusters, psychologically unhealthy, physically unhealthy, combined psychologically and physically unhealthy, and healthy, were identified. These clusters differed on the General Severity Index (GSI) of the BSI and the General Health scale of the SF-36 at each of the four assessment points. The course of distress and general health was distinct for each cluster during the study, with combined and psychologically unhealthy clusters having greater levels of distress and combined and physically unhealthy clusters having poorer overall health. CONCLUSIONS: The findings from this study provide support for distinct subgroups of patients presenting with a diagnosis of cancer whose level of distress and general health vary greatly following a cancer diagnosis. Clinical interventions tailored to the level of psychological or physical impairment as determined by the cluster may result in better outcomes following cancer treatment.
A belief in the validity of informed consent is one of the most important consequences of the doctrine of autonomy in medical ethics. Truly informed consent requires full disclosure of all relevant information by the doctor, competence of the patient to appreciate what the information signifies, understanding of the facts and issues by the patient, a voluntary choice by the patient and an autonomous authorisation for treatment or entry into a trial. Each of these conditions is hard to fulfil. In particular, full autonomy cannot exist in illness, and this is acknowledged by the act of consultation. The issue is further complicated by the stochastic nature of biological systems and the responses to illness and treatment. Disclosure of likely outcomes is, of necessity, unsatisfactory when a patient seeks surety when entering the clinical process with a serious and life threatening disease. Neither strict logic nor the law provide answers to this problem. The legal and moral issues have become confused. This is unfortunate, because the legal concern often centres on avoidance of actions in law rather than on the more fundamental issue of benefit to the patient. There is a need to teach doctors that discussion is a necessary part of the doctor-patient relationship, that fully informed consent is seldom-if ever-possible, and that skill in understanding what the patient is seeking is more important than the development of rigid and legally "complete" consent forms.
The majority of a hospital-based population accepted to participate in a molecular screening project for familial breast cancer, giving their informed consent to blood sampling. Only 9.5% of patients declined to sign the consent form. Here we report the reasons for refusal and we critically review our methodological approach to obtain consent for a blood test for genetic research in a clinical setting.
BACKGROUND: Although use of the internal cardioverter defibrillator in selected high-risk patient groups has significantly improved survival, questions have arisen regarding its impact on psychological adjustment and quality of life. OBJECTIVES: To determine whether there was a difference in perceived quality of life of internal cardioverter defibrillator recipients before implantation, reported retrospectively, and after implantation. METHODS: Survey packets containing a demographic data form, a modified version of the Ferrans and Powers Quality of Life Index: Cardiac Version, and a consent form were mailed to internal cardioverter defibrillator recipients accrued from two hospitals; 70 patients comprised the convenience sample. RESULTS: No significant difference in perceived overall quality of life was revealed by before and after implantation scores of t tests or analyses of variance. Young, unemployed patients with multiple health problems were most at risk for quality of life deficits. Overall, recipients in this study appeared to adapt effectively to the stresses associated with the device. CONCLUSIONS: Our results suggest that the internal cardioverter defibrillator did not prolong life at a sacrifice to quality of life. These findings can help identify patients at increased risk for quality of life deficits.
We discuss key concepts and review 12 published research studies relevant to informed consent and decision-making capacity in the older population. The literature suggests that aging is associated with impaired decision-making capacity; the following additional factors amplify the detrimental effect of aging: lower vocabulary level, lower educational level, chronic medical illness (as in nursing home residents), and acute medical illness. Aging may be associated particularly with impaired comprehension of consent forms. We discuss guidelines for clinicians and researchers for improving the process of obtaining a truly informed consent.
This article reviews the special considerations necessary for adequate photography in a surgical practice. The selection of film, camera, lens, and flash is discussed. Major emphasis is on proper framing and composition of the subject matter. Recommendations are made concerning consent forms and filing of slides.
OBJECTIVES: To determine the effects of risk and payment on subjects' willingness to participate, and to examine how payment influences subjects' potential behaviours and risk evaluations. METHODS: A 3 (level of risk) x 3 (level of monetary payment), between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating. RESULTS: Monetary payment had positive effects on respondents' willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents' potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents' propensity to neglect to tell researchers about negative effects. CONCLUSIONS: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns--notably the potential for payments to diminish the integrity of a study's findings. Future research is critical to make sound decisions about the payment of research subjects.
"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.