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PubMed1994

Informed consent: questionnaire survey of British otolaryngologists.

This postal questionnaire of British otolaryngologists has shown that most strive to obtain true informed consent when recommending surgery. The consent form is usually signed on the ward or at a pre-admission clinic and witnessed by a house officer. One-third of house officers received no instructions about what to discuss at this time, however, most consultants keep some record of what was discussed. A quarter of surgeons use information sheets, those not using them are more likely to anticipate problems with their use. An assessment of which complications are usually discussed is given. Comparison with a similar study shows increased disclosure of complications, perhaps a more defensive approach in surgical practice is developing.

Consent Forms↗

PubMed2006

Informed consent for research and authorization under the Health Insurance Portability and Accountability Act Privacy Rule: an integrated approach.

Researchers have found that implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is having a negative impact on clinical research. This impact traces, in part, to many research institutions complying with HIPAA by adding lengthy, complex language to their research consent documents. The addition of extensive language burdens institutional review boards and may undermine participants' understanding of the research in which they take part. Comparative analysis reveals, however, that the addition of lengthy text often is unnecessary. The U.S. federal requirements for informed consent for human subjects research and the HIPAA Privacy Rule's requirements for individual authorization overlap substantially. Hence, consent forms that satisfy the U.S. federal regulations for human subjects research need only minimal additional text to also satisfy the authorization requirements under the HIPAA Privacy Rule.

Biomedical Research↗

PubMed2003

Informed consent for cataract surgery: what patients do and do not understand.

PURPOSE: To determine patients' understanding and opinions about the usefulness of the informed consent (IC) document for cataract surgery and evaluate the deterioration in the effectiveness of verbal and written IC over time. SETTING: Academic tertiary care center. METHODS: Multiple-choice questionnaires addressing specific information about cataract surgery were distributed to patients. The questionnaires covered topics such as treatment, risk, and outcome probabilities (assessed preoperatively and postoperatively); terminology commonly used in IC; and patients' opinions about IC. Scores were calculated and compared using paired and unpaired t tests. RESULTS: Twenty-six patients thought that their legal autonomy would be waived by signing a consent form. Patients who took part in a standardized discussion of IC before testing scored 73.4% versus 23.4% in a control group who received no IC counseling (P<.001). Patient recall of outcome probabilities significantly decreased between preoperative and postoperative testing (61.2% to 44.0%) when IC was given verbally but improved to 75.0% when patients were given written information to take home. CONCLUSIONS: Patients about to consent to cataract surgery had a reasonable grasp of basic terminology. A standardized IC discussion was effective in educating patients. Patients considered IC to be important and expected all pertinent information to be communicated. Patient recall of outcome probabilities was poorer than that of nonnumeric facts; however, memory decay may be slowed by providing supporting take-home literature.

Adult↗

PubMed1982

Inconsistency and institutional review boards.

To assess the adequacy of peer review for research on human subjects, identical research protocols in oncology and anesthesiology were submitted to 32 institutional review boards (IRBs) at major universities with medical colleges. Each of the protocols posed serious ethical issues, contained flaws in scientific design, and provided an incomplete consent form. Twenty-two IRBs participated in the investigation, which revealed (1) consistency in the nonapproval of the three protocols, (2) substantial inconsistency among IRBs in the reasons offered in support of similar decisions, and (3) substantial inconsistency in the application of ethical, methodological, and informed-consent standards for individual review boards. This evidence suggests that revision of the protocols to satisfy particular objections would result in approval of flawed investigations.

Clinical Trials as Topic↗

PubMed2006

Impact of institutional review board practice variation on observational health services research.

OBJECTIVE: To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. DESIGN: Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. PRINCIPAL FINDINGS: Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. CONCLUSIONS: Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

Ethics Committees↗

PubMed1998

Informed consent: assessment of comprehension.

OBJECTIVE: The authors designed and evaluated a structured and rigorous informed consent procedure involving subjects with schizophrenia. METHOD: Informed consent forms were read and explained to 49 schizophrenic patients participating in ongoing clinical treatment research trials. The subjects answered a questionnaire relating to each research protocol. Protocol procedures were reiterated until the patients answered 100% of the questions correctly. Subjects were asked the same questions 7 days later to ascertain how much of the information they had retained. RESULTS: The patients' median score on the first trial of the informed consent questionnaire was 80% correct. To achieve 100% correct responses, 53% of the patients required a second trial of the questionnaire, and 37% of them required three or more trials. Scores improved between the first trial and the trial on day 7. Ninety-six percent of the subjects felt adequately informed, 66% reported participating in the research protocol for personal reasons, and 34% reported participating at the suggestion of others. CONCLUSIONS: These findings demonstrate that when adequate informed consent procedures are established, schizophrenic research subjects are able to understand and retain critical components of informed consent information.

Adult↗

PubMed1994

Consent to treatment: somebody's moved the goalposts.

It is timely to consider the issue of consent to treatment in clinical oncology in a period of changing expectations where signed consent has become obligatory. Consent has a dual purpose to protect patient and doctor; if one is achieved without the other then the task is incomplete. In terms of meaningful consent the consent form is of relatively little value and it is necessary to appreciate that, if patients are to truly exercise their right of choice, they need information in ways and in situations which may mean oncologists having to alter their work practices. Oncologists work without necessarily knowing what other oncologists do or do not tell their patients, or of what ought to be told. It is unlikely that the probable wide variations for similar patients across the country will be tolerated in the future and this should act as an incentive to arrive at agreed guidelines which are protective of all the legitimate interests. The problems and the possible solutions are discussed.

Communication↗

PubMed1990

Impact of medical hospitalization on treatment decision-making capacity in the elderly.

A growing population of hospitalized elderly will need to make an increasing number of treatment decisions. No generally accepted criteria currently exist to assess the decision-making capacity of these elders. In this study, three hypothetical clinical vignettes were developed to assess treatment decision-making capacity in 25 presumably competent, medically ill, nondistressed, hospitalized elders and 25 healthy, age- and education-matched controls. The patients' understanding of the vignettes was evaluated and compared with their understanding of a standard consent form; with their performance on a mini-mental state examination; and with physician judgements about their decisional capacity. Vignette results indicate a significant difference between study and control groups in understanding of key treatment issues. Healthy controls demonstrated a better understanding of these issues. Twenty-eight percent of the patients had significant decisional impairments by vignette assessment but were not identified by mental status scores or physician judgments. Results suggest that presumably competent, medically ill elders may be at risk for developing decisional impairments during hospitalization for acute illness. Obtaining informed consent directly from many of these patients may not be feasible.

Aged↗

PubMed1987

Informed consent: the physicians' perspective.

Using the current controversy in breast cancer treatment as a model, this paper reports on physicians' attitudes and behavior in the use of informed consent. Findings are based on a survey of 170 oncologists from eight countries and representing three medical specialties. Physician responses indicate that they regarded informed consent as an intrusion into the doctor-patient relationship. Problems identified by the physicians included: decreasingly effective doctor-patient communication; less personalized relationships with patients and curtailed freedom with regard to disclosure procedures. They also viewed the informed consent regulation as having a negative impact on their patient care. The constraints of obtaining informed consent reduced physicians' willingness to participate in scientific experiments. The consent form was seen to highlight their dual role as care-giver and scientific investigator, making them uncomfortable in dealing with patients. These findings demonstrate the ways in which legal restrictions associated with the introduction of new technologies critically affect the practice of medicine.

Breast Neoplasms↗

PubMed1992

Ethical issues in interviewing.

A study of the help-seeking behaviours of alcohol dependent and problem drinking women raised a number of ethical issues. It had been anticipated that the design of the study and the construction and approval of appropriate consent forms would eliminate the majority of problems. While this was true, a number of unforeseen points emerged during the course of the study related to interviewing women, discussing emotive issues and the responsibilities of the researcher vis-à-vis their samples. This paper discusses the issues raised using specific examples drawn from the research study.

Alcoholism↗

PubMed1984

Informed consent for investigational chemotherapy: patients' and physicians' perceptions.

One hundred forty-four patients and 68 physicians at three cancer centers were studied for their perceptions of the consent procedure, in which they participated one to three weeks earlier, for chemotherapy by one of 65 investigational protocols. Patients recalled the procedure positively and relied heavily on physician's advice. They felt most physicians wanted them to accept; 29% felt their participation in the decision was not encouraged. Primary reasons for accepting were trust in the physician, belief the treatment would help, and fear the disease (viewed as highly serious) would get worse without it. Nearly a fourth did not recall the information given that treatment was investigational. The consent form played no role in decision-making for 69%. Physicians believed therapeutic benefits would exceed potential problems for most patients; they viewed 41% of the patients as less than eager for details of treatment, a third as avoiding the seriousness of the discussion, and a third as passive in decision-making. The perceptual set of both parties places inadvertent constraint on patients' autonomy in decision making.

Adult↗

PubMed1994

Response to venepuncture for monitoring in primary schools.

The feasibility and acceptability of collecting blood from children by venepuncture was assessed in a sample of 593 children from seven primary schools in Canterbury. Venepuncture is necessary to obtain blood for the measurement of haemoglobin, ferritin, and cholesterol in line with Department of Health surveys in England. Return of consent forms was 87%; 75% of parents in the total sample allowed their child to be tested. Response rates differed between schools. Only 4% of eligible children refused to participate at the time of testing. In 22 (3.7%) children a blood sample could not be obtained or the volume was insufficient for analysis. There was a significant difference in the failure rate between phlebotomists. Venepuncture in the school setting was technically feasible and acceptable. The reluctance of some groups in the community to participate may bias the sample.

Bloodletting↗

PubMed2003

Physicians' liability in ophthalmology practice.

PURPOSE: The aims of this paper are to point out the importance of coherence in established guidelines in daily practice, highlight the value of signed patient informed consent forms and stress the value of a good understanding of the law, while focusing on issues related to malpractice in ophthalmology. METHODS: Search of the current relevant literature. RESULTS: The most common causes of medical litigation in ophthalmology are related to LASIK surgery, cataract surgery, glaucoma care, radial keratotomy for myopia reduction and failure to diagnose binocular vision anomalies in children and adults in a timely fashion. The litigation raised in most cases is driven by unfavourable outcomes and not by malpractice. CONCLUSION: Maintenance of high standards in daily practice, with continuous training and clear communication along with the appropriate documentation of any procedure carried out, may improve the professional safety of practising eye specialists in the event of medical litigation. Although the use of patient informed consent varies substantially among European countries, it may serve as useful evidence in the physician's defence.

Consent Forms↗

PubMed2006

[Quality of a non-subsidised multicentre randomised trial in non-academic hospitals; an audit].

OBJECTIVE: To determine whether a randomised clinical trial in general hospitals can be performed in a reliable way without financial support. DESIGN: Descriptive. METHOD: The trial involved 1040 patients in whom an inguinal hernia had been corrected with a propylene mat in the period 1998-2003. They were randomised to either a single dose of prophylactic antibiotics or a placebo. The primary outcome measure was 'wound infection during the 3 months after the operation'. The audit concerned 98 patients, chosen at random, for whom 3 investigators from an independent bureau collected data from the patient charts and study forms during 3 clinic visits in the period 2000-2003. Whether various quality criteria had been fulfilled was assessed on the basis of these data. RESULTS: In all 4 participating clinics, approval of the medical ethics assessment committees had been obtained. The trial protocol corresponded to the consent form. A proper informed consent was obtained from 63/98 patients (64%). The last (third) follow-up was missed in 23/98 patients (23%). During the trial, the patients who had missed this follow-up were contacted by telephone, which succeeded in 98%. The status and trial forms had been filled out completely and correctly with regard to the peroperative randomisation forms in 90% of the cases and with regard to the follow-up in 75% of the cases. The trial protocol was adhered to on almost every point. CONCLUSION: The data collection in the studied, not financed trial was adequate, probably as a result of the relatively simple questions posed, the easily determinable outcome measure and the efforts expended above and beyond the protocol.

Antibiotic Prophylaxis↗

PubMed2001

Informed consent procedures: responsibilities of researchers in developing countries.

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision-making process enhances women's ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process.

Altruism↗

PubMed1990

The HIV-testing policies of US hospitals.

To determine the human immunodeficiency virus-testing policies adopted by US hospitals, we surveyed a stratified random sample of all nonfederal general acute care hospitals, drawn from the American Hospital Association's 1987 database. Interviews were completed with the chief administrator in 561 hospitals (response rate, 78.4%). Two thirds of hospitals have admitted at least one patient with the acquired immunodeficiency syndrome, and over 83% have formal written policies about human immunodeficiency virus testing. Most contain provisions protecting patients' rights; eg, 78% require pretest informed consent, 66% require a special human immunodeficiency virus-testing consent form, and 75% require that patients who test seropositive be so informed. Many policies also contain provisions that protect providers; eg, 56% require that test results appear in patients' records, 38% require review of treatment plans when a patient tests seropositive, and 3% require transferring such patients. Hospital characteristics are not strongly associated with the adoption of testing policies.

Acquired Immunodeficiency Syndrome↗

PubMed1990

Are we getting informed consent from patients with cancer?

We developed a consent form for a hypothetical trial and asked patients to underline information that was pertinent to their decision to accept or refuse to participate in the proposed trial. We also investigated whether patients correctly interpreted statements describing the probability of certain events occurring. Of the 50 patients, 74% did not indicate that both risks and benefits were pertinent. Of the 20 patients who would not enter the trial, 70% focused on risks of therapy only. In contrast, of the 30 who agreed to enter, only 33% focused entirely on risks, while 10% did not note potential for either benefit or risk. For each of four probability statements, patients chose one of four possible interpretations, only one of which was correct. Depending on the statement, between 26 and 54% of the interpretations were incorrect. It appears that many decisions regarding trial entry may be based upon incomplete or incorrect information.

Adult↗

PubMed2003

The doctor's duty to the elderly patient in clinical trials.

The ethical principles of beneficence (or non-maleficence), respect for persons and justice apply to both good medical practice and clinical research. Doctors have a duty to offer to their patients, of all ages, the opportunity to take part in clinical trials and to ensure that research is appropriately designed and conducted. Barriers to participation of elderly patients in clinical trials include complex protocols with onerous outcome measures, a research focus on aggressive therapies with substantial toxicity, restrictive entry criteria unnecessarily excluding concurrent conditions and medication, patients' and families' limited expectations of benefits and lack of financial, logistic and social support.Participation is encouraged when attitudes of care staff towards research are positive, altruistic motives are acknowledged, approval of family members is gained and protocols are designed for patient rather than staff convenience. Special consideration should be given to ensuring that patient consent is fully informed and freely given. Elderly patients may have more difficulty comprehending consent information and particular attention should be given to compensating for communication and sensory deficits, improving readability of information sheets and consent forms, and considering the use of innovative consent procedures. Those with cognitive impairment and the institutionalised are vulnerable to exploitation and require special consideration and management.

Aged↗