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At least 307 records · Page 17Linked to original sources
PubMed2005

Research with stored biological samples: what do research participants want?

BACKGROUND: There is widespread disagreement about the type of consent needed for research with stored biological samples. Many believe consent for each future use is required to respect individuals. Others worry this approach may block important research. METHODS: We analyzed 1670 consent forms signed by research participants at the Warren G. Magnuson Clinical Center, National Institutes of Health, between January 1, 2000, and May 31, 2002, that offer options for future research with participants' biological samples. The research participants were healthy volunteers, family members of affected individuals, and individuals with a broad range of medical conditions enrolled in clinical research studies with and without the prospect of direct medical benefit. RESULTS: Overall, 87.1% of research participants given the option chose to authorize future research on any medical condition. More than 85% permitted unlimited future research with their stored biological samples regardless of sex, age, geographic location, or whether the individual was affected by the disease being studied or a healthy volunteer. Only 6.7% of those given the option to refuse all future research did so. Although African Americans were less likely to permit future research, 75.0% of African Americans still authorized unlimited future research with their samples. CONCLUSIONS: Most research participants authorize the unlimited future research use of their biological samples when given the opportunity to do so. These findings suggest that providing research participants with a simple binary choice to authorize or refuse all future research might allow individuals to control use of their samples, simplify consent forms, and allow important research to proceed.

Biological Specimen Banks↗
PubMed1995

Feasibility and acceptability of a proposed infant feeding intervention trial for the prevention of type I diabetes.

OBJECTIVE: To determine the feasibility of a randomized double-blind controlled trial of an infant formula without intact cow's-milk protein for preventing type I diabetes in high-risk children. RESEARCH DESIGN AND METHODS: We surveyed 83 people who either were parents of a child with type I diabetes or were pregnant women with type I diabetes in the ambulatory diabetes and obstetrics clinics in a university hospital. After a written and verbal description of the cow's milk-diabetes hypothesis, participants were asked to sign a sham consent form. A questionnaire designed to explore factors affecting their decision to either sign or not sign the consent form, as well as infant-feeding patterns, was subsequently administered. RESULTS: Overall, 69.9% (95% confidence interval, 60.0-79.8%) consented to participation in the proposed randomized trial. The decision to consent was not affected by the degree of belief in the cow's milk-diabetes hypothesis, the child's risk of diabetes, the respondent's demographic data, or infant feeding habits. CONCLUSIONS: A randomized feeding intervention study is an acceptable and feasible way to determine whether avoidance of cow's-milk protein during the first 6 months of life prevents type I diabetes in North American children.

Animals↗
PubMed2004

Informed consent for genetic research.

BACKGROUND: Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. OBJECTIVE: To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome. DESIGN: Survey conducted between February 1, 2002, and March 31, 2003. SETTING: Academic, tertiary free-standing children's hospital. PARTICIPANTS: A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed. MAIN OUTCOME MEASURES: Reasons for refusal. RESULTS: Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study. CONCLUSIONS: The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.

Employment↗
PubMed1998

Reproductive outcome after methotrexate treatment of tubal pregnancies.

OBJECTIVE: To evaluate subsequent pregnancy outcomes in women who have been treated with methotrexate for tubal pregnancies. METHODS: Descriptive study of subsequent pregnancy outcomes in 170 women who were treated with methotrexate for tubal pregnancy at Brigham and Women's Hospital during 1989-1994. Patients who agreed to participate were administered a telephone interview. Fertility rates and outcomes were calculated for patients who tried to conceive after receiving methotrexate. RESULTS: One hundred four of the 170 women with tubal pregnancies identified during the study period returned their consent forms. The other 66 patients were either unable to be reached by phone, and/or their consent form was returned without a forwarding address. Ninety-four patients (90%) agreed to participate in the study. Eighty-two (87%) women tried to conceive after receiving methotrexate for their tubal pregnancies, and 57 (70%) were successful. Forty-six (81%) of the 57 women experienced intrauterine pregnancies, and 11 (19%) had recurrent tubal pregnancies. When the first subsequent postmethotrexate outcome was examined, there were 26 (46%) term births, 5 (9%) preterm births, 11 (19%) recurrent ectopics and 15 (26%) spontaneous abortions. Over the six-year study period, 42 (74%) women had at least one live birth. There were no congenital anomalies or stillbirths in the subsequent pregnancies. CONCLUSION: Pregnancy outcomes after methotrexate treatment for tubal pregnancy are comparable to reported experience with surgical therapy. Patients who are treated with methotrexate for tubal pregnancies can be assured that their methotrexate exposure should have no untoward effects on subsequent pregnancies.

Female↗
PubMed1984

Informed consent: patient information forms in chemotherapy trials.

Documentation of informed consent by patients entering clinical trials is an ethical and legal necessity. Federal regulations and judicial opinions have led to increasingly lengthy, detailed "consent" forms, yet published studies demonstrate that patients remain confused about the nature and anticipated consequences of study entry. It has been suggested that more detail may even alarm or further confuse patients. Seventy-five women undergoing chemotherapy for advanced breast cancer participated in this study which assessed patient preference for long-, medium-, or short-form length, and whether form length preference correlated with patient characteristics or indicators of patient autonomy in decision-making or physician dependency. Patient preferences for information were not predicted by the patient autonomy or physician dependency scores or by age, marital status, or level of education. The majority of patients expressed a preference for more detailed information about their treatment, yet a majority of patients given detailed forms answered questions basic to the study design incorrectly, irrespective of educational level. The increased detail included in the long forms was not reported to increase stress compared to the short forms. Patient information forms are a principal tool for informing patients for consent but if they are to perform their desired function they must be designed more carefully and evaluated more thoroughly than in the past.

Age Factors↗
PubMed1994

Development of a pregnancy policy for air medical personnel: an administrative approach.

Pregnancy of air medical personnel poses a unique challenge for the administration of air medical services. Pregnant staff vary in their approach to individual pregnancy and their desire to continue flight duties. Administrators are limited to actions that ensure optimal care for the patient regardless of the caregivers' health or condition. Air medical programs must balance what is acceptable for patient care and safety with what are legally acceptable practice restrictions. The Staff For Life helicopter service uses experts in obstetric care to evaluate the pregnant staff members' abilities to perform pre-determined physical duties associated with air medical care. A signed consent form acknowledging risk factors associated with air medical care ensures that the flight staff member has had a frank and honest discussion with her physician. The obstetric evaluation and consent form confirm for program administration a pregnant flight staff member's ability to function within her role and removes all ambiguity from the process.

Air Ambulances↗
PubMed2005

Informed consent: a patients' perspective.

The medico-legal issues surrounding informed consent are highly topical and contentious. Current attitudes to consent emphasize the high level of 'good medical practice' expected by a 'reasonable patient/parent'. The authors' objectives were to assess the levels of knowledge and information expected by patients and parents, prior to signing consent forms for a surgical procedure. Each patient or parent was asked a series of questions prior to signing a consent form. Answers were recorded on a standard questionnaire. More than 80 per cent of respondents were happy with the information provided in out-patients, however, over half of these could not list even one complication of their operation. Two-thirds of those surveyed sought information elsewhere, while over half expected to be informed of all known complications, even if the rate of complications was less than one per cent. In conclusion, the information provided by surgeons might not meet the expectations of today's informed patients.

Attitude to Health↗
PubMed1997

An evaluation of patients comprehension of orthopaedic terminology: implications for informed consent.

We conducted a prospective study into patient comprehension of orthopaedic terminology that commonly appears on consent forms. The majority of patients questioned were unsure of the meaning of simple terms such as 'fracture reduction' or 'internal fixation'. All the patients questioned had signed consent forms recently for such procedures in an acute orthopaedic unit. We conclude that many patients willingly consent to procedures that they do not fully understand. This implies that there is an element of trust involved in the process of giving consent. We believe that this aspect of the doctor-patient relationship should be legally respected.

Adult↗
PubMed2004

Informed consent: ethical implications in clinical practice.

PURPOSE OF REVIEW: The concept of involving pediatric patients in medical decision-making, in both clinical and research anesthesia and surgical care, has support from specialists involved in pediatric care. Production pressure in the workplace creates conflict between ethical anesthesia practice - such as obtaining informed consent - and time efficiency. Specialized documentation of anesthesia consent may increase efficiency but could weaken the consent process. Concerns with cost containment have led to interventional quality improvement activities that may constitute research and therein require informed consent. This review discusses these three consent issues as they relate to anesthesia care. RECENT FINDINGS: Children are more capable of participating in medical decision-making than previously thought. Despite the call for physicians to involve children in decision-making regarding their medical care, few physicians or parents do so. Quality improvement research potentially harmful to patients, achieved without patient knowledge or consent, may violate the Nuremberg Code. Opinions differ about the potential advantages and pitfalls of specific and separate anesthesia consent forms. SUMMARY: Anesthesiologists have ethical obligations to involve children in the medical decision-making process as much as the child's capacity allows, and to place patient advocacy in the informed consent process above production pressures. While a specific and separate anesthesia informed consent form may be useful, it should not undermine the process of informed consent or relegate the consent process to non-physician personnel. The informed consent process for anesthesia care remains the province and responsibility of the individual anesthesiologist.

Journal Article↗
PubMed2005

The Christchurch Tissue Bank to support cancer research.

AIM: To report on the development of a central resource of consented cancer tissues for researchers to use for ethically approved projects, and to describe the banking process. METHODS: The development of tissue banking in Christchurch, New Zealand is described, including the number and main types of samples collected. The consent forms have evolved with several new donor options added between 1996 and 2004. Since June 2004, disposal of tissues by a karakia (blessing) has been offered. Characteristics of each tissue including amount, location in the bank, and relevant clinicopathological data have been recorded prospectively in a detailed secure relational database. RESULTS: The changes in the consent form and donor options are described. Most donors (99.6%) consented to allow access to medical records (since May 2002); 98.3% to tissue being sent overseas (since May 2003), 97.4% to commercial research (since May 2003), and 35.6% requested disposal with a karakia. Since May 2003, 87% of donors have been Caucasian, 5.1% Maori, and the remainder composed of other categories as stated on the 2001 New Zealand census format. By March 2005, samples have been banked from more than 2000 donors. For each of the last 4 years, samples have been collected from more than 300 donors, including fresh-frozen tissue, DNA preparations, serum, plasma, and paraffin blocks. The predominant tissues are from donors with cancers of the breast, colon, urological, and gynaecological sites. CONCLUSIONS: The Christchurch Tissue Bank is a successful model for potential New Zealand-wide application, providing quality tissue samples for cancer research whilst appropriately addressing ethical, legal, and cultural aspects of their collection.

Humans↗
PubMed1988

Worster v. City and Hackney Area Health Authority, 19 June 1987.

After undergoing a sterilization at the defendant Health Authority, the plaintiff gave birth to a son. She sought damages from the defendant charging negligence in its failure to warn her that there was a small possibility that the sterilization would not be successful. Specifically, she argued that her signing of a consent form containing the acknowledgement that the sterilization could not be reversed amounted to a representation that she could have no more children and that this representation was made negligently since there was no qualification about lack of success. The High Court of the UK rejected this argument, holding that the consent form was not a representation that sterilization was certain, but merely consent to the operation with an acknowledgement that the intended effect was that she and her husband have no more children.

Demography↗
PubMed2005

Building informed consent for cholinesterase monitoring among pesticide handlers in Washington State.

BACKGROUND: Pesticide handlers in Washington State are predominantly Mexican and, therefore, require a culturally appropriate process of informed consent. In addition, members of this occupational group are vulnerable to coercion because of poverty, lack of insurance, inability to read, and employment status METHODS: To create a process of culturally competent informed consent for Washington State's cholinesterase monitoring program, we used focus groups to collect data about cultural beliefs, attitudes, knowledge, language, and traditions of Mexican-American pesticide handlers. With this information, we developed a final consent form and evaluated it using a 10-item test-retest questionnaire in a sample of 103 handlers. RESULTS: Using qualitative methods, we created English and Spanish consent forms that incorporated culturally defined risk information. Both the written and audiotape formats significantly improved comprehension; but, for subjects with less than 7 years of schooling, audiotapes in Spanish yielded significantly higher scores (mean comprehension score 7.0 vs. 6.1, t = - 2.2, P = 0.03). CONCLUSIONS: Culturally competent informed consent for particularly vulnerable populations of non-native speakers of English is possible. It requires both knowledge of specific cultural elements and the application of appropriate technology.

Adult↗
PubMedDate not supplied

Integrating routine HIV testing into a public health STD clinic.

OBJECTIVE: To integrate routine HIV testing into the services offered at a public health department STD clinic and document the rate of acceptance and rate of test positivity during the first 18 months. METHODS: Testing for HIV was added to the array of tests offered to all patients at the Maricopa County STD clinic. Patients were informed of this new option at registration and were provided with a consent form and instructions to read the form and sign it, unless they did not desire testing. STD clinicians were responsible for insuring that questions regarding testing were answered and that consent forms were signed. HIV prevention was integrated into the general STD preventive messages during the clinical encounter. RESULTS: Sixty-eight percent of patients accepted testing (12,176 of 17,875). Of these, 68 were HIV-positive, for a rate of 5.6 per 1,000. The positive rate for men was 8.6/1000 and for women 1.2/1,000. The rate for men who reported having sex with men (MSM) was 63.8/1,000. Fourteen of the HIV-positive MSM were co-infected with syphilis. Of the 68 who were HIV-positive, 58 (85.3%) were successfully located, informed of their test results, and referred for HIV treatment and support services. CONCLUSIONS: HIV testing can be included in the routine battery of tests offered at an STD clinic with high patient acceptance. Routine testing can discover those who are unaware of their HIV-positive status, providing an opportunity for early referral for treatment, counseling to avoid disease transmission, and notification of sexual contacts.

Adolescent↗
PubMed2005

Physicians' liability in obstetric and gynecology practice.

PURPOSE: Litigation in obstetric and gynecologic practice has arisen as an important issue. This article aims to highlight issues related to malpractice in obstetrics and gynecology in order to point out several important aspects of medical practice, which may offer adequate professional protection. METHODS AND MATERIAL: Search of the current relevant literature. RESULTS: The four most common clinical causes of medical litigation in obstetrics and gynecology are cases involving fetal distress, uterine rupture after a vaginal birth in a woman with a previous Cesarean section, shoulder dystocia, and misdiagnosis of breast cancer. Litigation raised in most of the cases is driven by bad outcomes and not by malpractice. Additionally, both juries and the public often expect perfection as the natural result of pregnancy and any deviation from this expectation has to be the result of someone's negligence. For this reason it has become mandatory for doctors in hospitals and private practices to acquire a sufficient knowledge relating to modem management, to document carefully in writing their procedural and management plans and to become familiar with the legal aspects of medical practice. Adequate communication and a written patient's consent form are of paramount importance. CONCLUSION: Maintenance of high standards in daily practice with continuous training, clear communication and a signed Patient's Informed Consent Form along with the appropriate documentation of any procedure carried out may provide professional safety to practicing obstetricians and gynecologists in case of medical litigation.

Europe↗
PubMed2006

Attitudes to consent--a national survey.

PURPOSE: The medicolegal case of Chester v Afshar (October 2004) raises important questions with regard to the consent process in medicine and surgery. If consent has to involve disclosure of all serious risks, regardless of frequency, how does a surgeon ensure the thoroughness of the consent procedure and minimise the risk of such litigation? Procedure-specific consent forms (PSCFs)--detailing all serious risks--are a possible solution. The aim of our study was to establish the frequency of the use of such consent forms throughout the UK. METHODS: A postal questionnaire of UK consultant British Association of Pediatric Surgery (BAPS) members was conducted. Members were asked if they used PSCFs for 4 commonly performed procedures in paediatric surgery: central venous access, inguinal herniotomy, orchidopexy, and pyloromyotomy. RESULTS: The response rate was 89% (108/122). We obtained at least one response from every centre involved in paediatric surgery (38/38) in the UK. Seventy-nine percent (85/108) of respondents do not use PSCFs, 19% (21/108) do use PSCFs, and 2% (2/108) forms were returned blank. Thirty-one percent (33/108) of respondents included comments regarding PSCFs. CONCLUSION: A medical negligence claim will succeed if the practitioner owes the patient a duty of care, there has been a breach of this duty, and that the breach caused a loss (causation). Our duty to the patient may now need to include disclosure of all risk regardless of frequency. PSCFs allow accurate and reproducible information for families about procedures. PSCFs currently have a low uptake amongst paediatric surgeons in the UK. The use of PSCFs for 4 procedures is currently under trial in our unit. It remains to be seen whether the success of further claims leads to an increase in their use nationally.

Attitude of Health Personnel↗
PubMed1998

Understanding informed consent.

Understanding and facilitating the informed consent process is our duty as perioperative nurses. Acting as patient advocates, we must determine if our patients have given "informed consent" prior to surgical treatment. When we witness our patients signing consent forms, we must be sure they are competent to sign; that they have spoken with the physician and have discussed the proposed procedure (including the risks, benefits and alternative treatments) and have had their questions answered; and have read the consent form they are being asked to sign. As nurses, we must become aware of our responsibilities related to informed consent. By understanding the concept of informed consent and its legal implications, we will be able not only to the facilitate informed consent process but also to fulfill our legal responsibilities.

Documentation↗
PubMed1993

Informed consent. The whole truth for patients?

Two misconceptions about informed consent concern the difference between the legal and moral justification for it, and the rationale for more rigorous consent for research than for "standard" therapy. Legally, informed consent for therapy is a risk-management tool that functions essentially as a release of liability. If the patient is informed of all expected or potential side-effects or toxicities of a treatment, he cannot sue because those side effects occur. The moral doctrine of informed consent is derived from a respect for the patient's autonomy as well as the patient's vulnerability. The physician's goal is not to minimize liability, but to help the patient make the best decision. These two goals are not necessarily incompatible, but they often lead to different attitudes toward informed consent and different decisions about what information needs to be shared with patients. If the goal is risk-management, then informed consent forms should be encyclopedic, providing the "whole truth" to patients. This would, however, not meet the moral goals of shared decision-making, because few patients could make sense of such data. Informed consent for research often leads to a different paradox. If a new therapy becomes available and a physician thinks it may benefit a patient, the physician may use it in an uncontrolled manner. This does not require the approval of an institutional review board and does not need the more rigorous approach to informed consent generally associated with research. In contrast, if the physician wants to evaluate the effectiveness of the same therapy carefully and intends to gather data to do so, he will need to describe his protocol, defend it before an institutional review board, and provide a more carefully written and closely scrutinized informed consent form. The paradox derives from the fact that the patient in the first, uncontrolled situation is inevitably at higher risk of harm than the patient in the second situation. The distinction between informed consent for treatment and informed consent for research is based on a distinction that is growing ever more cloudy and ever less relevant to the moral goals that informed consent seeks to achieve. Current standards for informed consent for research are, in many ways, counterintuitive and probably counter-productive.

Ethics, Medical↗