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Organizations routinely ask patients to sign consent forms before using their photographic images in a medical journal or textbook. But can you use that same consent as permission to post the photograph on the Web? Here are the thoughts of some Webmasters on that subject.
New medical developments have increased the use of human tissue, especially for research purposes. The attention of lawyers concerned with research has traditionally focused on the protection of research subjects and on data-protection. Legal aspects of the secondary research use of human tissue are still unclear. On an international level consensus is growing that sources of tissue should consent to the secondary use of their tissue. We offer some guidelines for drafting consent forms for the research use of human biological materials, elaborating in a more concrete manner the rule of consent for the secondary use of tissue. Topics covered concern amongst others layered consent, new findings, protection of informational privacy, withdrawal of consent and commercialiZation.
OBJECTIVE: To evaluate current rules and regulations for educating parents about newborn screening. DESIGN: Cross-sectional survey. SAMPLE: Newborn screening program coordinators in all 50 states and the District of Columbia. MEASUREMENTS: Answers to a standardized semi-structured telephone survey in January 2004. RESULTS: Fifty programs provide standardized information about screening, and 32 of these have information available in multiple languages. Most programs (n=36) believe that parents should be informed about newborn screening as a part of prenatal care; however, none has rules or regulations requiring this. Five require documented informed consent; only one provides the consent form in a language other than English. Hospitals and birthing centers are required by many programs to educate families, including providing information (n=12), obtaining informed consent (n=5), informing parents of the right to refuse screening (n=13), and documenting refusal on institutionally developed forms (n=9). We found considerable variation in policy language across the newborn screening programs. CONCLUSIONS: The complexity of current newborn screening programs and the likelihood of expansion in the number of conditions on newborn screening panels present a unique opportunity and challenge for public health nurses to ensure that these programs are effective and that care is integrated.
Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.
The aim of this prospective observational study was to estimate the proportion of otolaryngology patients with poor reading skills, as a guide to information provision. The subjects were a consecutive series of 50 adult outpatients attending a general otolaryngology clinic at the Victoria Infirmary, Glasgow, and whose first language was English. Reading skills were estimated using the Rapid Estimate of Adult Literacy in Medicine. For comparison, the SMOG readability formula was used to estimate the reading skills required to understand the Department's 35 information leaflets, the standard elective admission notification letter and the surgical consent form. Fourteen (28 per cent) patients were found to have poor reading skills (8th grade or less). The surgical consent from required 11th grade reading ability, as did the standard admission letter, and the leaflets required 9th to 15th grade (graduate) reading ability (median 11th grade). Many patients could be expected to have difficulty understanding these written materials. Information must be written in plain English to be suitable for a wide range of patients, including those with poor reading skills.
OBJECTIVE: Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. DESIGN: Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. RESULTS: Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. CONCLUSIONS: Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits. The research audit is a valuable tool in improving research ethics performance but requires considerable resources.
BACKGROUND: In 2002-2003, as part of a pilot project, varicella vaccination was offered to susceptible students in grades 4 and 5 in schools whose health services are provided by a local community services centre in Montréal. This immunization campaign was merged with the hepatitis B immunization programme. OBJECTIVES: To calculate the proportion of grade 4 and 5 students susceptible to varicella; to calculate the proportion of susceptible students who agree to be vaccinated; to compare the proportion of susceptibles who agree to be vaccinated when varicella vaccination is offered with the first or the second dose of hepatitis B; and to assess whether a catch-up varicella immunization programme would affect the vaccine coverage of a concurrent hepatitis B vaccination programme. METHODS: The proportions of susceptible students and of parents of susceptibles who consented to vaccination were calculated. The proportions of parents of susceptibles who consented to vaccination were compared for both immunization strategies: varicella vaccination given with the first or second dose of hepatitis B vaccine. Logistic regression was performed to identify possible associations between consent to varicella vaccination and the various variables collected. Rates of vaccine coverage against hepatitis B after two doses were compared for the years 2000-2001 and 2002-2003. RESULTS: Of 3,856 registered students, 3,486 (90.4%) returned consent forms. Among the 3,272 students for whom information was available, 441 (13.5%) were susceptible, including 394 (89.3%) who consented to vaccination. The rates of vaccine coverage in the schools after two doses of hepatitis B vaccine were exactly the same for the 2000-2001 and 2002-2003 school years. CONCLUSION: Varicella vaccination of susceptible grade 4 and 5 students associated with a coincident hepatitis B vaccination campaign can be performed without negative impact on the hepatitis B vaccination programme.
This article discusses the process for obtaining genuine informed consent for the participation of human subjects in research in developing countries. We discuss the consent process in the light of recently published guidelines, the experience of nutrition and health research projects, and the ethics review process of the Instituto de Investigacion Nutricional with peri-urban and rural populations in Peru. We discuss the cultural context in relation to (i) who should be involved in the decision for participation, especially for research in children and in community settings; (ii) when to use written or verbal consent; (iii) the format and presentation of the consent form to ensure understanding by the target population; and (iv) the process of how and by whom information is given and consent is obtained. Common concerns of participants with regard to their involvement in research studies are presented, as well as aspects that participants find difficult to understand. Some specific concerns of conducting research with Indigenous Peoples are discussed. We recommend future research to further understand and implement informed consent processes to assure genuine and voluntary consent in different developing country contexts.
This paper is aimed at discussing the issue of proxy consent for medical research with children carried out in the context of developed countries. First, requirements for valid informed consent are reviewed, and differences with clinical practice highlighted. In the second part the findings from empirical studies, and implications for improving the consent process, are discussed. Perceived benefit for their child is the most important factor motivating parents to grant consent, but also a desire to contribute to medical research and benefit others are frequently mentioned. Abstract concepts such as randomization are more difficult to grasp and remember than practical issues. The type and style of the consent-seeking process (quality of the information, physician's attitude, allocated time, readability of consent forms) have an influence on how the invitation to participate is received. Rather than as a one-sided delivery of information, consent should be viewed as a continuous, two-way communication process developing in a context of transparency and partnership between the investigator and potential research subjects.
OBJECTIVES: Gastrointestinal endoscopy, like all diagnostic and therapeutic techniques, must be preceded by written informed consent. The aim of this study was to evaluate the patients' acceptance and understanding of the aim of informed consent as well as to determine their perception of the investigation. METHODS: For 2 months, informed consent forms were given together with a questionnaire to 221 consecutive patients who underwent diagnostic gastrointestinal endoscopy. RESULTS: Distribution of the patients according to level of education was: university graduated (6.5%), high-school graduate (21.1%) those who had completed primary school (48.6%) and those with no schooling (23.9%). The document was read by 144 patients (65.1%) and the attending physician had previously explained it to 69.6%. Informed consent was understood by 90.7% of the patients who read the document. Understanding was related to education (university and high-school graduates (83.3%) vs. those who had completed primary school or who had no schooling (60%); p < 0.005) and was not related to the information given by the attending physician. Patients' opinion on the aim of informed consent was: absolve the doctor of responsibility (42%), provide information in the patients' interests (51.1%) and senseless document (42%). Signing the document provoked fear in 20% of those surveyed. This fear was greater in patients who had not been informed by the attending physician (31.2% vs. 14.5%; p > 0.01). CONCLUSIONS: Informed consent is understood by most patients who read the form but a significant proportion perceive it as designed to defend the physician. When the technique is explained by the attending physician and the doctor performing the procedure, acceptance is increased and fear is reduced.
The courts and the physicians are engaged in assuring quality medical care to competent and incompetent patients. The evolving policy of informed consent improves medical decisionmaking by insisting that the patient's values be involved. The principle of beneficence, which the courts support in practice without using the word, is a compromise between strong paternalism and the unachievable goal of true autonomy in incompetent patients. The role of physicians in this model is that of technical advisor and facilitator rather than actual decisionmaker. Medical schools train physicians for this role anyway. In order for the patient or guardian to be a genuine decision-maker, he must be involved in the evaluation and treatment all along, not just at the point at which a consent form must be signed.
We report on the results of an empirical investigation on medical information before treatment with the aromatic retinoid etretinate. Evaluation of the returned questionnaires showed that most patients could still remember some or even several side effects one year after conclusion of therapy. A few other patients, however, had completely forgotten that both verbal and written information had been given. The study leads to two recommendations relevant for practical application: 1. with women capable of bearing children, the information given on the teratogenicity of the retinoids and necessary contraception must be documented in writing. 2. Duplicates of information sheets or consent forms should be handed out to the patients.
RATIONALE: The numbers of older persons with psychiatric disorders are expected to rise rapidly in coming decades, yet most studies of the safety and efficacy of treatments for such disorders have focused on younger adults. A substantial expansion in research involving older patients is needed to meet the treatment needs of this fast growing group. A critical issue in intervention research is ensuring a patient's decision-making capacity. Considerable heterogeneity exists in this regard even within diagnostic groups. Cognitive changes as well as increased complexity of medication regimens in elderly patients may make it particularly difficult for some older persons to fully understand, appreciate, and/or reason about the risks and benefits of participating in any particular study. OBJECTIVES: Empirical research into assessing and possibly improving decisional capacity is warranted in older people with severe mental illness. Such research may be accomplished through collaborations among specialists from various related disciplines and, importantly, with active involvement of community partners. METHODS: We present one model of this type of collaboration, the Bioethics Unit of an Intervention Research Center, comprising a multi-disciplinary team along with a Community Advisory Board. RESULTS: Preliminary studies in our Center suggest that older individuals with psychotic disorders vary considerably in their decisional capacity, and many subjects appear to be fully capable for consenting to research projects. Furthermore, the patients' level of understanding of the consent material can be improved significantly through repetition and clarification of key elements in the consent form. CONCLUSIONS: The decisional capacity for a given research protocol is not necessarily an unmodifiable trait, but can be enhanced with improvements in consenting procedures, even in older persons with psychotic disorders.
UNLABELLED: Patients who are approached to participate in clinical studies just before delivery may have insufficient time to make an informed decision and/or may feel pressured into participation. This study was designed to examine factors that influence parturients to consent or decline participation in an anesthesia study related to their delivery. Parturients who had been approached to participate in a continuing clinical obstetric anesthesia study were subsequently given a questionnaire that documented their reasons for consenting or declining participation. There were no demographic differences among the consenters (n = 166) and nonconsenters (n = 109). The most important factors in the patient's decision to consent were related to their understanding and perceived importance of the study and the potential benefit to other women. Forty-one (40. 6%) nonconsenters strongly considered their pain/discomfort a factor in declining participation. Only one patient felt some pressure to consent, suggesting that the overall environment was noncoercive. Logistic regression analysis demonstrated that patients who read the consent form completely, those who had participated in a previous research study, and those who were less anxious about participating were more likely to consent. IMPLICATIONS: Obtaining informed consent for obstetric anesthesia studies presents a challenge to the anesthesiologist. Results from this study suggest that the environment in which consent for obstetric studies is sought is not coercive. However, it is important that the anesthesiologist ensures that the patient fully understands the study and develops a rapport with the patient to allay any anxiety associated with her participation as a potential research subject.
The origins of informed consent come from philosophy, medical experimentation, the law, and contemporary trends in doctor and patient relationships. Every surgical patient signs an informed consent form but the literature would suggest that many times there is incomplete information conveyed by the physicians or understood by the patient. Informed consent should be considered as an expression of respect for patient autonomy and the patient education necessary for a truly informed consent should be considered a surgical virtue.
OBJECTIVE: To review psychiatrists' documentation of informed consent and present data on Canadian psychiatrists' attitudes and practices regarding documentation of the informed consent process. METHOD: We surveyed a stratified random sample of psychiatrists practising in Ontario, using a mailed self-report questionnaire. RESULTS: The response rate was 72%. Among respondents, 63% routinely documented the consent process, with younger respondents reporting more documentation than older ones. Although most respondents (77%) favoured recording the consent process, only 11% felt signed consent forms were necessary. CONCLUSION: There are differences in the self-reported documentation behaviour of younger and older psychiatrists. Psychiatrists should document the consent process in the clinical record.
Because of the procedure-oriented nature of their specialty, radiologists obtain informed consent from patients daily. This paper attempts to help the radiologist obtain informed consent without incurring malpractice liability by discussing the important legal concept of simple consent as distinguished from informed consent, the elements a patient must prove to succeed in court with an allegation of lack of informed consent, the varying state requirements about the amount of information the patient must be given, the persons who must obtain consent from the patient, and the persons who can give consent for the patient. Consent for IV injections of contrast medium and consent forms are discussed because of the current controversy on these subjects. Courts and state legislatures have usually addressed only specific aspects of informed consent. However, except for the amount of information that must be given the patient, the courts have been relatively uniform in their requirements. Therefore, it is likely that a state court faced with issues of informed consent about which no law exists in their own state will use the existing law in other states as a precedent and adopt similar rules. However, each radiologist must be familiar with the specific rules for informed consent that have been developed by the courts and legislatures in the state in which he or she practices.
The frequency of using self-applied (over-the-counter) fluoride products and prescribed supplemental fluorides, and the prevalence of fluorosis-like enamel lesions in the permanent dentitions of children living in an optimally fluoridated urban community were investigated. Subjects were selected randomly, and consent forms and questionnaires concerning fluoride usage and residency status were provided to guardians prior to examination. After a supervised tooth brushing event, 300 consenting subjects were examined by the principal investigator using Dean's index to assess levels of fluorosis-like lesions. The principal investigator was standardized with another investigator prior to the examinations to obtain an interexaminer agreement level of 97%, and an intraexaminer agreement level of 96%. Portable dental equipment was used during all examinations. Chi-square analysis indicated no statistically significant difference between the frequency of tooth brushing with a fluoridated dentifrice at an early age and the prevalence of fluorosis-like enamel lesions. However, there was a significant difference (P less than 0.05) between the prevalence of fluorosis-like lesions, and the frequency of using prescribed fluoride supplements and gels, and over-the-counter rinses.