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PubMed1990

Feasibility and efficacy of verbal consents.

Refusal rates for participation in geriatric research have been surprisingly high. This may be due in part to inherent difficulties with a written consent procedure. A simple, easily administered, standardized verbal consent procedure (VCP) for the institutionalized elderly was developed to address this problem. Of 114 patients eligible for enrollment in a study evaluating outcomes of group psychotherapy, 100 gave verbal consent. When written consent was requested, 60 signed immediately; 35, only after substantial coaxing. Five patients refused to sign a consent form, although verbally agreeing to participate. It is estimated that the number of study participants would have been reduced by 40% had written consent been required. The findings raise ethical and logistical issues pertaining to a verbal consent procedure.

Behavioral Research↗

PubMed2003

Quinacrine sterilization (QS): informed consent.

Informed consent is a basic human right for any medical procedure. It is particularly important that women know what is involved in any sterilization method, and how it will affect their health and their emotional life. Over 140,000 QS procedures have been performed in 34 countries. In no country has there been any formal effort to advance the acceptance of this method. Instead, satisfied users have been the promoters. Thoroughly informed consent is vital to patient satisfaction. A working group undertook an initiative to create an ideal consent form. The product of that initiative is presented.

Consent Forms↗

PubMed1989

Informed consent for clinical research in the emergency department.

Informed consent serves as the basis for a partnership between patients and physicians as they attempt to find better methods of diagnosis and treatment. Despite the importance of informed consent, this is an area of research that is frequently overlooked. In fact, an improperly designed consent form is the most common reason research protocols are rejected or approval is delayed. The essential elements of informed consent and problems obtaining informed consent from patients is an emergency department are reviewed.

Consent Forms↗

PubMed2000

Consent--who, what, where, when?

OBJECTIVE: An investigation of current practise for obtaining and documenting informed consent in Scottish Ear, Nose and Throat (ENT) departments. DESIGN: A telephone survey of junior representatives of each ENT department. Each junior was asked a series of questions regarding who discussed the operations with patients who signed the consent forms and whether any form of training was given. SETTING: May 1999. RESULTS: In 80% of cases the responsibility for taking written consent fell to the most junior members of staff. Consultants have a pre-operative discussion, with their patients most of the time but only rarely is this discussion documented. Training in the process of consent is given in only one of 15 departments. CONCLUSION: Despite increasing negligence claims and clear guidelines from the General Medical Council the responsibility for obtaining written consent from pre-operative patients still rests with the most junior medical staff of the ENT departments of Scotland. We suggest that this situation is neither prudent nor fair and have put forward two simple proposals to rectify the situation.

Consent Forms↗

PubMed1997

Ethical issues in genetic research: disclosure and informed consent.

As research to correlate genetic status with predisposition to disease has accelerated, so has the concern that participation in such studies creates the risk of genetic discrimination and emotional distress. There is a need to broaden disclosure during the consent process to ensure that potential subjects understand these risks and other issues and to address them in the consent form. We describe the broad approach that we have taken in regard to disclosure and consent in gene mapping studies.

Adult↗

PubMed1999

Barriers to informed consent.

OBJECTIVES: To provide oncology nurses with a review of barriers that may limit the ability of adults to provide informed consent. DATA SOURCES: Published articles, research studies, and review articles pertaining to informed consent and clinical research. CONCLUSIONS: Patient-centered barriers to informed consent (such as age, education, and illness) and process-centered barriers (such as content and readability of the consent form, timing of discussion, and amount of time allotted to the process) can affect an individual's ability to provide substantial informed consent. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be aware and knowledgeable of the various barriers to informed consent to minimize these barriers and to improve and facilitate the informed consent process.

Clinical Trials as Topic↗

PubMedDate not supplied

Informed consent: legal, behavioral, and educational issues.

The doctrine of informed consent is examined from legal, behavioral, and educational perspectives. A brief legal history of the doctrine is presented along with a discussion of contemporary standards of disclosure and the emerging right of the patient to understand informed consent disclosures. Behavioral and educational issues include the relationship between disclosure and patient anxiety, patient recall of disclosures, readability of consent forms, and alternatives to the traditional doctor-patient disclosure model. A role for the patient-health educator in strategies to improve both the consenting and informing processes of the informed consent requirement is suggested.

Cognition↗

PubMed2005

The informed consent process in a cross-cultural setting: is the process achieving the intended result?

This report is based on the experiences of Navajo interpreters working in a diabetes clinical trial and describes the problems encountered in translating the standard research consent across cultural and linguistic barriers. The interpreters and a Navajo language consultant developed a translation of the standard consent form, maintaining the sequence of information and exactly translating English words and phrases. After four months of using the translated consent, the interpreters met with the language expert and a diabetes expert to review their experiences in presenting the translation in the initial phases of recruitment. Their experiences suggest that the consent process often leads to embarrassment, confusion, and misperceptions that promoted mistrust. The formal processes that have been mandated to protect human subjects may create barriers to research in cross-cultural settings and may discourage participation unless sufficient attention is given to ensuring that both translations and cross-cultural communications are effective.

Adult↗

PubMed2004

Consent and confusion--who decides?

Current trends in the NHS promote patient rights including the right to accept or refuse surgery. Valid consent when the patient appears to have fluctuating competence can place theatre nurses in a difficult position. This article explores the legal framework in which the Department of Health consent forms work and looks at the NMC's Code of Professional Conduct for standards of practice.

Adolescent↗

PubMed1998

Inquiry into the potential value of an information pamphlet on consent to surgery to improve surgeon-patient communication.

OBJECTIVES: To find out how patients recently undergoing surgery experienced the consenting process and the response of these patients to a pamphlet on consent to surgery. To test the reaction of health professionals to the pamphlet. DESIGN: A pilot pamphlet was produced and a questionnaire was sent to patients inquiring about their consenting experience, and how the pamphlet might have helped them through the consent procedure. A pamphlet and a questionnaire were also sent to a random sample of the health professionals serving these patients. SUBJECTS: Patients and health professionals. RESULTS: 61% of patients returned the questionnaire. Knowledge about the consent procedure was shown to be limited. 49% were unaware that they had the right to insist that the surgeon could only perform the specified operation and nothing more. 83% were unaware that they could add something in writing to the consent form before signing. 28% of health professionals returned their questionnaire, most of whom thought that the pamphlet provided a useful contribution to surgeon-patient communication. CONCLUSION: Evidence shows that patients are not well informed about consenting to surgery and further information would provide much needed guidance on understanding their role in the consent procedure. The low response from the health professional study is perhaps an indication that at present this is an issue which is not seen as a priority.

Comprehension↗

PubMed1977

Informed consent in California. Latent liability without 'negligence'.

Informed consent is a legal obligation due from a physician to his patient, an obligation which may not be met by the physician's skillful treatment of his patient. It may only be met by the treating physician obtaining from his patient knowing authorization for carrying out the intended medical procedure. The physician is required to disclose whatever would be material to his patient's decision, including the nature and purpose of the procedure, and the risks and alternatives. The disclosures should be made by the physician to his patient, and not through use of consent forms which are not particular to individual patients. To minimize any subsequent claim by the patient that there was a lack of adequate disclosures, the physician should record in the patient's chart the circumstances of the patient's consent, and should not rely on the patient's unreliable ability to recall those circumstances.

California↗

PubMed2003

Physicians' liability in interventional radiology and endovascular therapy.

INTRODUCTION/OBJECTIVE: Modern practice in Radiology has rapidly changed over the last decades incorporating invasive techniques. Additionally, litigation in medical practice has arisen as an important issue. This article aims to highlight issues related to malpractice in interventional radiology and endovascular therapy in order to point out the importance of the written informed consent. METHODS AND MATERIAL: Search of relevant literature from the Pubmed. RESULTS: The role of radiologist has been greatly transformed over the last decades. He is not only entitled to participate in the diagnosis but also he undertakes therapeutic procedures, either alone or as a member of a team. Thus the radiologist is now more exposed to actions that maximize litigation risk. Adequate communication and a written consent form seem to be mandatory before any invasive radiological procedure. Patient should know in detail the benefits and the risks of the scheduled procedure and whether the proposed therapy is a new form of treatment or part of a randomized trial. DISCUSSIONS AND CONCLUSION: Interventional radiologist or physician is exposed to high litigation risk. This certainly requires an urgent adaptation of his practice and attitude to the new reality. Written patient's informed consent remains an integral part of the communication between physicians and patients, and importantly is offering professional protection along these lines.

Attitude of Health Personnel↗

PubMed1989

Informed consent for intravascular administration of contrast material: how much is enough?

To determine the usefulness of informed consent prior to the intravascular administration of contrast material, the authors evaluated four equal groups of patients with different degrees of counseling concerning risks and risk factors. Group 1 was given no information. Group 2 was informed of the common risks in a written statement. Group 3 was informed of all known risks in a written statement. Group 4 was informed of all known risks by means of physician counseling. The average times it took for the technologist (groups 1-3) or the physician (group 4) to counsel the patient and obtain informed consent were 1.7, 6.2, 13.6, and 11.4 minutes, respectively. Counseling by physicians would require approximately 7% of their professional time in a busy radiology department. On a postprocedure test, the patients in groups 1-4 scored on average 38.4%, 68.2%, 63.2%, and 69.8%, respectively. There was no statistical difference in the performance of groups 2-4 on the postprocedure test. If informed consent is to be obtained prior to intravascular administration of contrast material, use of a straightforward written consent form detailing the common risks and risk factors appears to be the best method.

Comprehension↗

PubMed2002

Valid informed consent: a process, not a signature.

Surgeons have dutifully used "consent forms" for most of the last century. But only in the last two decades have we begun to understand the difference between a patient's legalistically signed form and the meaningful process of communicating the reasons for considering surgical or other invasive intervention. Furthermore, we must be reasonably assured that the patient is legally competent, understands the situation and alternatives, and is not coerced (by family or medical professionals) in the decision-making. To accomplish this, time-consuming patient education and negotiation are necessary. To limit this process to a brief agreement that the procedure should be done and the patient is willing (as evidenced by a signature) is to return to paternalism. Little evidence suggests that such signing is valid. Of more importance, patients want and are owed a clear understanding of what is probably ahead including risks and preventive measures to limit complications. This article analyzes the components of "consent," suggests methods to ensure the validity of the agreement, and proposes that an educated patient benefits greatly by an appropriate process.

Communication↗

PubMed1996

Modified informed consent in a viral seroprevalence study in the Caribbean.

An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented with conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communites in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.

AIDS Serodiagnosis↗

PubMed1993

[Free and informed consent in dental practice].

The right to give or withhold free and informed consent to care is basic, but has been eroded. Lack of consent to treatment could result in a charge of the crime of battery. The parameters of free and informed consent include autonomy, veracity, beneficence, nonmaleficence and justice. Consent may be implied, expressed or written; consent may be withdrawn, exceeded or limited. Informed consent is considered in detail and guidelines are suggested for the dentist. The problems of implantology are presented including the question of prepared consent forms for this treatment. Capacity to consent is described with particular reference to children, the aged and the mentally impaired.

Adolescent↗

PubMed2004

Awareness of the process of informed consent among family practice patients in Karachi.

OBJECTIVE: To study the awareness of 'Informed Consent', among patients presenting to Family Physicians. METHOD: A cross-sectional study was carried out at the Community Health Centre, Aga Khan University Hospital, Karachi in July 2002. Written Consent was taken and confidentially was assured RESULTS: Out of the 100 patients interviewed, 80 agreed to participate in the study, forty-four men and thirty-six women. Approximately half the participants (45%) were graduates and 40% had less than five years of school education. The awareness of the process of 'informed consent' was observed in only 20% of the respondents, all in the educational category of graduates. CONCLUSION: A lack of awareness of informed consent was observed in patients attending the Community Health Centre, Aga Khan University, despite stringent institutional policies, which are adequately followed. To improve awareness, 'Health Education Programs' for the population are required with media support. Readability of written consent forms should be of class V level or less to give advantage to the less educated classes in the society. Local languages should be utilized for written and verbal consent. Public health programs should also be aimed at educating physicians, nurses and paramedics. Provisions should be made to legalise the process of taking consent.

Awareness↗

PubMed1995

How to do it. Get patients' consent to enter clinical trials.

Gaining patients' consent to enter clinical trials is essential, but not easy. Giving careful thought to the design of the study itself, information which patients receive, and the use of a signed consent form may all help. To be properly informed, patients need to know something about their condition, the proposed study, and alternative options. The type and amount of information will vary and investigators need to judge the level appropriate for each person. Patients should understand that taking part in a clinical trial is voluntary and that their decision will not affect the quality of care they receive. The process of obtaining consent requires time and good communication. Working with young, elderly, or mentally impaired patients, or those particularly vulnerable to coercion, requires special sensitivity to the potential dangers.

Clinical Trials as Topic↗