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1.  Emergency Medical Service Providers' Attitudes and Experiences Regarding Enrolling Patients in Clinical Research Trials 
The purpose of this study was to evaluate Emergency Medical Services (EMS) providers' attitudes and experiences about enrolling patients in clinical research trials utilizing the federal rules for exception from informed consent. We hypothesized that Emergency Medical Technicians (EMTs) would have varied attitudes about research using an exception from informed consent which could have an impact on the research.
Methods and setting
Since January 2007, the EMS system has been participating in a randomized, multicenter interventional trial in which out-of-hospital providers enroll critically injured trauma patients using exception from informed consent. A voluntary, anonymous, written survey was administered to EMS providers during an in-service. The survey included demographics and Likert-type questions about their experiences with and attitudes towards research in general, and research using an exception from informed consent for an out-of-hospital clinical trial.
The response rate was 79.3% (844/1067). Most respondents, 93.3%, agreed that “research in EMS care is important.” However, 38.5% also agreed that individual EMTs/paramedics should maintain the personal right of refusal to enroll patients in EMS trials. Fifty-four percent of respondents agreed with the statement that “the right of research subjects to make their own choices is more important than the interests of the general community.” In response to statements about the current study, 11.3% agreed that “the study is unethical because the patient cannot consent” and 69.2% responded that they would personally be willing to be enrolled in the study before they were able to give consent if they were seriously injured. Those who had not enrolled a patient into the study (681 respondents) were asked their reasons: 76.8% had not encountered an eligible patient or did not work for an agency that carried the fluid; 4.3% did not have time; 4.1% forgot and 1.1% stated that they were opposed to enrolling patients in studies without their consent.
The majority of EMS personnel in one community support EMS research and this specific out-of-hospital clinical trial being conducted under an exception from informed consent. Potential barriers to enrollment were identified. Further study in other systems is warranted to better understand EMS provider perspectives about exception from informed consent research.
PMCID: PMC2924590  PMID: 19291551
paramedic attitudes; EMS research; research ethics; consent in research
2.  Consenting options for posthumous organ donation: presumed consent and incentives are not favored 
BMC Medical Ethics  2012;13:32.
Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries.
We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive.
Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and less preferred mandated choice with medical incentive option (7[4,9] vs. 5[2,7], p < 0.001). There was no association between consenting options ranking scores and age, health status, education level, or knowing an organ donor or recipient.
We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference.
PMCID: PMC3519501  PMID: 23173834
Organ donation; Islamic ethics; Preference; Norm perception; Mandated choice; Presumed consent; Informed consent; Medical incentives; Financial incentive; Gender difference
3.  Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study 
BMC Medical Ethics  2013;14(Suppl 1):S3.
Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent.
The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa.
The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001).
This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.
PMCID: PMC3878312  PMID: 24564932
Africa; Autonomy; Patients' rights; Informed consent; Doctors; Empirical ethics; Nurses; Laws; Regulations
4.  Associations between Mode of HIV Testing and Consent, Confidentiality, and Referral: A Comparative Analysis in Four African Countries 
PLoS Medicine  2012;9(10):e1001329.
A study carried out by Carla Obermeyer and colleagues examines whether practices regarding consent, confidentiality, and referral vary depending on whether HIV testing is provided through voluntary counseling and testing or provider-initiated testing.
Recommendations about scaling up HIV testing and counseling highlight the need to provide key services and to protect clients' rights, but it is unclear to what extent different modes of testing differ in this respect. This paper examines whether practices regarding consent, confidentiality, and referral vary depending on whether testing is provided through voluntary counseling and testing (VCT) or provider-initiated testing.
Methods and Findings
The MATCH (Multi-Country African Testing and Counseling for HIV) study was carried out in Burkina Faso, Kenya, Malawi, and Uganda. Surveys were conducted at selected facilities. We defined eight outcome measures related to pre- and post-test counseling, consent, confidentiality, satisfactory interactions with providers, and (for HIV-positive respondents) referral for care. These were compared across three types of facilities: integrated facilities, where testing is provided along with medical care; stand-alone VCT facilities; and prevention of mother-to-child transmission (PMTCT) facilities, where testing is part of PMTCT services. Tests of bivariate associations and modified Poisson regression were used to assess significance and estimate the unadjusted and adjusted associations between modes of testing and outcome measures. In total, 2,116 respondents tested in 2007 or later reported on their testing experience. High percentages of clients across countries and modes of testing reported receiving recommended services and being satisfied. In the unadjusted analyses, integrated testers were less likely to meet with a counselor before testing (83% compared with 95% of VCT testers; p<0.001), but those who had a pre-test meeting were more likely to have completed consent procedures (89% compared with 83% among VCT testers; p<0.001) and pre-test counseling (78% compared with 73% among VCT testers; p = 0.015). Both integrated and PMTCT testers were more likely to receive complete post-test counseling than were VCT testers (59% among both PMTCT and integrated testers compared with 36% among VCT testers; p<0.001). Adjusted analyses by country show few significant differences by mode of testing: only lower satisfaction among integrated testers in Burkina Faso and Uganda, and lower frequency of referral among PMTCT testers in Malawi. Adjusted analyses of pooled data across countries show a higher likelihood of pre-test meeting for those testing at VCT facilities (adjusted prevalence ratio: 1.22, 95% CI: 1.07–1.38) and higher satisfaction for stand-alone VCT facilities (adjusted prevalence ratio: 1.15; 95% CI: 1.06–1.25), compared to integrated testing, but no other associations were statistically significant.
Overall, in this study most respondents reported favorable outcomes for consent, confidentiality, and referral. Provider-initiated ways of delivering testing and counseling do not appear to be associated with less favorable outcomes for clients than traditional, client-initiated VCT, suggesting that testing can be scaled up through multiple modes without detriment to clients' rights.
Please see later in the article for the Editors' Summary
Editors' Summary
In 2007, World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) issued a joint guidance document on “provider-initiated” HIV testing and counseling. They noted that previous testing strategies that relied on “client-initiated” testing (also referred to as VCT, for voluntary counseling and testing) had failed to reach enough people, both in high-income and resource-constrained countries—in Africa, for example, at that time, just 12% of men and 10% of women had ever been tested. They argued that many opportunities to diagnose and counsel people that visit health facilities for other reasons are being missed, and that provider-initiated HIV testing and counseling can help expand access to HIV treatment, care, and support. They made it clear, however, that mandatory testing is not acceptable. All provider-initiated testing must therefore give individuals the option to not be tested. In addition, the guidelines stressed that all testing must continue to observe “the three Cs” (informed consent, counseling, and confidentiality) and be accompanied by an “enabling environment” including the availability of antiretroviral therapy, prevention and support services, and a supportive social, policy, and legal framework. A number of advocates have subsequently criticized the guidelines for failing to recognize that health-care services and staff in some countries do not always observe the three Cs. Critics have also questioned the appropriateness of the strategy for settings where antiretroviral therapy is not always available or where stigma and discrimination remain widespread.
Why Was This Study Done?
To inform the debate surrounding scale-up of HIV testing in general and provider-initiated testing in particular with data on “real-life” testing, researchers have since carried out a number of studies. One of them, called MATCH (for Multi-Country African Testing and Counseling for HIV), was designed to allow systematic comparisons across African countries of different ways of HIV testing. Its goal was to investigate the uptake of testing, to analyze differences in the experience of testing across countries and modes of testing, and to use the results to devise better strategies to increase knowledge of HIV status and referral to care. MATCH used different means to collect information, including surveys and interviews. People from Burkina Faso, Kenya, Malawi, and Uganda participated. Some had undergone HIV testing, others had not. This study used a subset of the survey data collected for the MATCH study and asked whether there were systematic differences depending on the type of testing people had experienced.
What Did the Researchers Do and Find?
The data the researchers used were from 2,116 people who had undergone testing in the two previous years at different facilities in the four countries. The different facilities were grouped into three “modes” of testing: VCT-only testing, integrated testing (which included hospitals and other medical facilities where provider-initiated and client-initiated testing were both available, along with other medical services), and prevention of mother-to-child transmission (PMTCT) testing at medical facilities offering services to pregnant women. Analyzing the survey responses, the researchers categorized them as related to eight different “outcomes”: pre-test meeting, pre-test counseling, consent, confidentiality, satisfaction with the person-to-person interactions, post-test meeting to receive results, post-test counseling, and referral to care.
They found that across countries and different facilities, the majority of participants reported having received most of the testing-related services. More than 90% reported having a pre-test meeting, and around 80% were satisfied with the personal interactions, with the consent process, and with confidentiality. About 50% of participants reported receiving all post-test services, and 71% of those who had tested positive for HIV reported appropriate referral to care.
When they looked for differences between different modes of testing, the researchers found that while they existed, they did not consistently favor one mode over another. Some outcomes scored higher in VCT facilities, some in PMTCT facilities, and some in integrated facilities.
What Do These Findings Mean?
While there is room for improvement in HIV testing services (especially post-test services) across the countries and facilities included, the study did not reveal major problems with consent or confidentiality. The results also suggest that services at PMTCT and integrated facilities are not any worse than those at VCT-only sites. It seems therefore reasonable to continue expanding access to HIV testing and to include all facilities in the scale-up. That said, this is only one of a number of studies examining issues surrounding HIV testing, and decisions should be based on all available evidence. The results here are consistent with some of the other studies, but there are also reports that counseling might become neglected as testing is scaled up, and that offering testing routinely at every doctor's visit makes it seem mandatory even if there is the possibility to “opt out.” Other analyses of the MATCH study use in-depth interviews to understand in more detail the feelings, experiences, and attitudes of participants who have been tested as well as those who have not been tested. It will be important to see whether their results are consistent with the ones here, which are based on a survey of people who have been tested.
Additional Information
Please access these websites via the online version of this summary at
WHO has published a toolkit for scaling up HIV testing and counseling services in resource-limited settings, as well as the report Service Delivery Approaches to HIV Testing and Counselling (HSC): A Strategic HTC Programme Framework
In response to reactions to the 2007 joint WHO/UNAIDS guidelines Guidance on Provider-Initiated HIV Testing and Counselling in Health Facilities, the UNAIDS Reference Group on HIV and Human Rights issued a Statement and Recommendations on Scaling up HIV Testing and Counselling
The NAM/aidsmap website has a section on HIV testing policies and guidelines.
PMCID: PMC3479110  PMID: 23109914
5.  Surgeons’ opinions and practice of informed consent in Nigeria 
Journal of Medical Ethics  2010;36(12):741-745.
Informed consent is perhaps more relevant to surgical specialties than to other clinical disciplines. Fundamental to this concept is the provision of relevant information for the patient to make an informed choice about a surgical intervention. The opinions of surgeons in Nigeria about informed consent in their practice were surveyed.
A cross-sectional survey of surgeons in Nigeria was undertaken in 2004/5 using self-administered semistructured questionnaires.
There were 102 respondents, 85.3% of whom were men and 58.8% were aged 31–40 years. 43.1% were consultants and 54.0% were surgical trainees. 27.4% were in surgical subspecialties, 26.5% in general surgery and 21.6% were obstetricians and gynaecologists. 54.9% agreed that sufficient information is not provided to patients while obtaining their consent for surgical procedures. They listed medicolegal reasons (70.6%), informing patients about benefits, risks and alternatives (64.7%) and hospital policy (50.0%) as some reasons for obtaining consent for surgical procedures. When patients decline to give consent for surgery, 84.3% of them thought that poor communication between surgeons and patients may be contributory. They identified taking a course in bioethics during surgical training and compulsory communication skills course as some ways to improve communication between surgeons and patients.
Most Nigerian surgeons seemed to have a good knowledge of the informed consent requirements and process but fall short in practice. There is a need to improve the surgeon–patient relationship in line with modern exigencies to provide interactive environments for fruitful patient communication and involvement.
PMCID: PMC3332031  PMID: 20940174
6.  Quality of informed consent for invasive procedures in central Saudi Arabia 
Informed consent is considered the most important step in clinical interventions. The aims of this study were (1) to assess the quality of informed consent for invasive procedures with regard to consent process and information given about risks and alternative treatments, and (2) to determine patients’ attitude toward informed consent at King Abdulaziz Medical City, Riyadh, Saudi Arabia.
A cross-sectional study was conducted of 162 adult patients in different wards after undergoing surgery or invasive procedures within 1–2 days of signing the informed consent, using a previously validated interview questionnaire. Data on patients’ characteristics, type of invasive procedure, and some informed consent-related issues were collected. Multiple linear regression analysis was used to identify the predictors of the percentage mean score of quality of informed consent, and significance was considered at P ≤ 0.05.
The quality of informed consent was generally poor (% mean score = 50.98 ± 17.49). About two-thirds of patients were told during the informed consent process that they have to sign merely as routine, 48% thought that if they refused the treatment plan they would lose the interest of the treating physician to help them, 42% thought that by saying no they would lose the good relationship with their physician, and 42.6% were not interested in having a copy of the informed consent document. Significantly higher quality was predicted when the physicians were the ones who explained the informed consent (t = 4.15, P < 0.001) and when informed consent was explained to younger patients (t = 2.754, P = 0.007). The overall attitude of the patients toward the process of informed consent was satisfactory (% mean score = 76.31 ± 7.63).
The results suggest either that patients are not aware of their rights or that physician paternalism is practiced in Saudi Arabia. Cultural barriers should not be an argument to diminish the role of informed consent. Further studies should focus on how the value of autonomy can be appreciated in the Saudi culture.
PMCID: PMC3325015  PMID: 22505825
informed consent; quality; invasive procedure; Saudi Arabia
7.  Knowledge & attitudes of mental health professionals regarding psychiatric research 
Background & objectives:
Mental health professionals have varied attitudes and views regarding informed consent and confidentiality protections in psychiatric research and clinical care. The present study was designed to understand the knowledge and views of mental health professionals (MHPs) regarding informed consent and confidentiality protection practices.
Mental health professionals (n=121) who were members of the Delhi Psychiatric Society, were invited to participate in this questionnaire-based study of their knowledge and attitudes regarding informed consent and confidentiality. Half of them expressed willingness to discuss participation and gave initial oral consent (n=62); of these, 31 gave written informed consent to participate and completed the questionnaires. The questionnaires included both forced choice (yes / no / do not know) and open-ended questions. Questionnaires content reflected prominent guidelines on informed consent and confidentiality protection.
Attitudes of the majority of the participants towards informed consent and confidentiality were in line with ethical principles and guidelines. All expressed the opinion that confidentiality should generally be respected and that if confidentiality was breached, there could be mistrust of the professional by the patient/participant. The mean knowledge scores regarding informed consent and confidentiality were 8.55 ± 1.46 and 8.16 ± 1.29, respectively.
Interpretation & conclusions:
The participating mental health professionals appeared to have adequate knowledge of basic ethical guidelines concerning informed consent and confidentiality. Most respondents were aware of ethical issues in research. Given the small sample size and low response rate, the significance of the quantitative analysis must be regarded with modesty, and qualitative analysis of open-ended questions may be more valuable for development of future research. Increased efforts to involve mental health professionals in research on ethical concerns pertinent to their work must be made, and the actual practices of these professionals with regard to ethical guidelines need to be studied.
PMCID: PMC4001336  PMID: 24718399
Confidentiality; ethical guidelines; informed consent; mental health professionals; mental health research
8.  Malpractice awareness among surgeons at a teaching hospital in Pakistan 
The duty of a doctor to take care presumes the person who offers medical advice and treatment to unequivocally possess the skills and knowledge to do so. However, a sense of responsibility cannot be guaranteed in the absence of accountability, which in turn requires a comprehensive medical law system to be in place. Such a system is almost non-existent in Pakistan. Keeping the above in mind, we designed this study to assess the knowledge, attitudes and practices of surgeons regarding malpractice at a tertiary care center in Pakistan.
This was an observational, cross-sectional, questionnaire-based study conducted during a three month period from 31st March, 2012 to 30th June, 2012 at Civil Hospital, Karachi. Surgeons who were available during the period of our study and had been working in the hospital for at least 6 months were included. Self-administered questionnaires were distributed after seeking informed, written consent. The specialties included were general surgery, cardiothoracic surgery, neurosurgery, ophthalmology, otolaryngology, plastic surgery, pediatric surgery, orthopedic surgery, oral and maxillofacial surgery and gynecology and obstetrics. The study questionnaire comprised of four sections. The first section was concerned with the demographics of the surgeons. The second section analyzed the knowledge of the respondents regarding professional negligence and malpractice. The third section assessed the attitudes surgeons with regard to malpractice. The last section dealt with the general and specific practices and experiences of surgeons regarding malpractice.
Of the 319 surgeons interviewed, 68.7% were oblivious of the complete definition of malpractice. Leaving foreign objects inside the patient (79.6%) was the most commonly agreed upon form of malpractice, whereas failure to break news in entirety (43.9%) was most frequently disagreed. In the event of a medical error, majority (67.7%) were ready to disclose their error to the patient. The most common perceived reason for not disclosing the error was threat of a claim or assault (90.9%). Majority (68.3%) believed that malpractice had a negative effect on reputation. Only 13(4.1%) had received at least one legal claim for damages. Only about three-fourths (75.5%) had the habit of frequently obtaining informed consent from the patients. 83(26.0%) expressed reluctance in accepting a case that was deemed to be difficult. Financial gains and liabilities were responsible for biased approach in 8.5% and 12.2% of the respondents respectively.
There is a dire need of programs aimed at increasing awareness among practicing surgeons in our setup. Proactive measures are required for the formulation of an efficient system of litigation. Physician accountability will not only arouse a greater sense of responsibility in them, but will also augment the confidence placed by patients on the healthcare system.
PMCID: PMC3503777  PMID: 23126456
Malpractice; Negligence; Knowledge; Attitudes; Practices; Teaching hospital; Pakistan
9.  Informed consent in patients undergoing eye surgery: A qualitative study assessing their attitude, knowledge and anxiety level in a community based hospital of Nepal 
Journal of Optometry  2013;6(3):147-153.
Introduction and purpose
Informed consent means the process whereby patients are informed of all the necessary information about health care and subsequent treatment plans. In socioeconomically developing semi-urban setting, where most of the patients are illiterate, we wanted to assess knowledge, attitude and anxiety of patients towards informed consent.
Patients were recruited from the waiting list for ophthalmic surgery at the department of Ophthalmology, Dhulikhel Hospital. A detail optometric and ophthalmologic evaluation was carried out. Data were collected through a 12-item questionnaire and an 8-item Likert scale. Statistics included regression analysis, chi-square test as well as frequency and percentages.
Of 42 questionnaire responders, female participation was high (64.3%). Sixty two percent of patients wanted the physician to decide for or against the surgery. Most of (69%) patients thought that by signing the consent they were agreeing for surgery and few (16.7%) thought that the consent was a legal document. Twenty two patients (52.4%) gave importance to the surgical intervention even though there were chances of serious complications. The preoperative anxiety was affected by surgical outcome (81%), complication (40.5%) and anaesthesia (9.5%). The patients prioritized the preoperative information on nature of illness, need for operation and the chances of vision improvement after surgery.
Most of patients wanted the doctor to decide their treatment. Many patients wanted to know about the disease, treatment and the success rate of surgery. The success of the operation, the anaesthesia and the long list of complications tended to provoke anxiety.
PMCID: PMC3880498
Consent; Eye disease; Eye surgery; Ocular complications; Patient anxiety; Consentimiento; Enfermedad ocular; Cirugía ocular; Complicaciones oculares; Ansiedad del paciente
10.  Offering patients entry in clinical trials: preliminary study of the views of prospective participants. 
Journal of Medical Ethics  1996;22(4):227-231.
OBJECTIVE: To ascertain attitudes to different methods of obtaining informed consent for randomised clinical trials (RCTs). DESIGN: Structured interviews with members of the public, medical secretaries and medical students. SETTING: The public were approached in a variety of public places. Medical secretaries and students were approached in their place of work. SUBJECTS: Fifty members of the public, 25 secretaries and 25 students. MAIN OUTCOME MEASURES: Views on RCTs were elicited, with particular emphasis on how subjects thought the concept of randomisation should be explained. Each participant was presented with descriptions of proposed clinical trials and asked to select his or her preference from a range of options. RESULTS: Written information was preferred over verbal information in 91% of replies. Most respondents (86%) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour of explanations that were less explicit about the play of chance (ANOVA; p = 0.0004). Eighty-three per cent of participants thought that randomised trials were morally acceptable when there was no prior medical preference between treatments. However, over half (55%) thought they would find it upsetting to be offered entry in such a trial and a quarter thought the outcome of treatment might be adversely affected. CONCLUSIONS: Our results offer some support for the idea that "economy with truth" is less unsettling than a frank description of the stark reality of what randomisation means. It is a matter of debate as to whether, if we are correct, autonomy should have precedence over beneficence. The offer of entry in a clinical trial is likely to affect the experience of care for many people, especially if the process of randomisation is described explicitly. Potential participants should be given a detailed written explanation of the rationale for the trial and be asked to sign a consent form if they agree to take part.
PMCID: PMC1377002  PMID: 8863148
11.  Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review 
PLoS Medicine  2010;7(11):e1000368.
Patrina Caldwell and colleagues performed a systematic review of randomized studies that compared methods of recruiting individual study participants into trials, and found that strategies that focus on increasing potential participants' awareness of the specific health problem, and that engaged them, appeared to increase recruitment.
Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs.
Methods and Findings
A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00–2.18], attendance at an education session [RR 1.14, 95% CI 1.01–1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14–1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11–2.74), and also monetary incentives (RR1.39, 95% CI 1.13–1.64 to RR 1.53, 95% CI 1.28–1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007.
Recruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis.
Please see later in the article for the Editors' Summary
Editors' Summary
Before any health care intervention—a treatment for a disease or a measure such as vaccination that is designed to prevent an illness—is adopted by the medical community, it undergoes exhaustive laboratory-based and clinical research. In the laboratory, scientists investigate the causes of diseases, identify potential new treatments or preventive methods, and test these interventions in animals. New interventions that look hopeful are then investigated in clinical trials—studies that test these interventions in people by following a strict trial protocol or action plan. Phase I trials test interventions in a few healthy volunteers or patients to evaluate their safety and to identify possible side effects. In phase II trials, a larger group of patients receives an intervention to evaluate its safety further and to get an initial idea of its effectiveness. In phase III trials, very large groups of patients (sometimes in excess of a thousand people) are randomly assigned to receive the new intervention or an established intervention or placebo (dummy intervention). These “randomized controlled trials” or “RCTs” provide the most reliable information about the effectiveness and safety of health care interventions.
Why Was This Study Done?
Patients who participate in clinical trials must fulfill the inclusion criteria laid down in the trial protocol and must be given information about the trial, its risks, and potential benefits before agreeing to participate (informed consent). Unfortunately, many RCTs struggle to enroll the number of patients specified in their trial protocol, which can reduce a trial's ability to measure the effect of a new intervention. Inadequate recruitment can also increase costs and, in the worst cases, prevent trial completion. Several strategies have been developed to improve recruitment but it is not clear which strategy works best. In this study, the researchers undertake a systematic review (a study that uses predefined criteria to identify all the research on a given topic) of “recruitment trials”—studies that have randomly divided potential RCT participants into groups, applied different strategies for recruitment to each group, and compared recruitment rates in the groups.
What Did the Researchers Do and Find?
The researchers identified 37 randomized trials of recruitment strategies into real and mock RCTs (where no actual trial occurred). In all, 18,812 people agreed to participate in an RCT in these recruitment trials out of at least 59,354 people approached. Some of these trials investigated novel strategies for recruitment, such as changes in how patients are randomized. Others looked at the effect of recruiter differences (for example, increased contact between the health care professionals doing the recruiting and the trial investigators), the effect of offering monetary incentives to participants, and the effect of giving more information about the trial to potential participants. Recruitment strategies that improved people's awareness of the health problem being studied—provision of an interactive computer program or a video about the health condition, attendance at an educational session, or inclusion of a health questionnaire in the recruitment process—improved recruitment rates, as did monetary incentives. Increasing patients' understanding about the trial process itself, recruiter differences, and alterations in consent design and randomization generally had no effect on recruitment rates although consent rates were higher when patients knew the treatment to which they had been randomly allocated before consenting. However, differential losses among the patients in different treatment groups in such nonblinded trials may jeopardize study findings.
What Do These Findings Mean?
These findings suggest that trial recruitment strategies that focus on increasing the awareness of potential participants of the health problem being studied and its possible effects on their health, and that engage potential participants in the trial process are likely to increase recruitment to RCTs. The accuracy of these findings depends on whether the researchers identified all the published research on recruitment strategies and on whether other research on recruitment strategies has been undertaken and not published that could alter these findings. Furthermore, because about half of the recruitment trials identified by the researchers were undertaken in the US, the successful strategies identified here might not be generalizable to other countries. Nevertheless, these recruitment strategies should now be investigated further to ensure that the future evaluation of new health care interventions is not hampered by poor recruitment into RCTs.
Additional Information
Please access these Web sites via the online version of this summary at
The Web site is a searchable register of federally and privately supported clinical trials in the US and around the world, providing information about all aspects of clinical trials
The US National Institutes of Health provides information about clinical trials
The UK National Health Service Choices Web site has information for patients about clinical trials and medical research
The UK Medical Research Council Clinical Trials Units also provides information for patients about clinical trials and links to information on clinical trials provided by other organizations
MedlinePlus has links to further resources on clinical trials (in English and Spanish)
The Australian Government's National Health and Medical Research Council has information about clinical trials
WHO International Clinical Trials Registry Platform aims to ensure that all trials are publicly accessible to those making health care decisions
The Star Child Health International Forum of Standards for Research is a resource center for pediatric clinical trial design, conduct, and reporting
PMCID: PMC2976724  PMID: 21085696
12.  An audit of the knowledge and attitudes of doctors towards Surgical Informed Consent (SIC) 
Background: The Surgical Informed Consent (SIC) is a comprehensive process that establishes an information-based agreement between the patient and his doctor to undertake a clearly outlined medical or surgical intervention. It is neither a casual formality nor a casually signed piece of paper. The present study was designed to audit the current knowledge and attitudes of doctors towards SIC at a tertiary care teaching hospital in Pakistan.
Methods: This cross-sectional qualitative investigation was conducted under the auspices of the Department of Medical Education (DME), Pakistan Institute of Medical Sciences (PIMS), Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU), Islamabad over three months period. A 19-item questionnaire was employed for data collection. The participants were selected at random from the list of the surgeons maintained in the hospital and approached face-to-face with the help of a team of junior doctors detailed for questionnaire distribution among them. The target was to cover over 50% of these doctors by convenience sampling.
Results: Out of 231 respondents, there were 32 seniors while 199 junior doctors, constituting a ratio of 1:6.22. The respondents variably responded to the questions regarding various attributes of the process of SIC. Overall, the junior doctors performed poorer compared to the seniors.
Conclusion: The knowledge and attitudes of our doctors particularly the junior ones, towards the SIC are less than ideal. This results in their failure to avail this golden opportunity of doctor-patient communication to guide their patients through a solidly informative and legally valid SIC. They are often unaware of the essential preconditions of the SIC; provide incomplete information to their patients; and quite often do not ensure direct involvement of their patients in the process. Additionally they lack an understanding of using interactive computer-based programs as well as the concept of nocebo effect of informed consent.
PMCID: PMC4226621  PMID: 25396207
Surgical Informed Consent (SIC); Consent; Nocebo Effect of Informed Consent; Surgery
13.  Theory and practice of informed consent in the Czech Republic 
Journal of Medical Ethics  2007;33(5):273-277.
The large‐scale change of Czech society since 1989 has involved the democratic transformation of the health system. To empower the patient was one important goal of the healthcare reform launched immediately after the Velvet Revolution. The process has been enhanced by the accession of the Czech Republic to the European Union and the adoption of important European conventions regulating the area. The concept of informed consent and a culture of negotiation are being inserted into a traditionally paternalistic culture. Our article describes the current situation on the issue of the communication of information on state of health and treatment, and on the question of the participation of the patient in decisions on treatment. We present empirical results of a public opinion survey on this issue. The results show a still prevailing submissive attitude towards the physicians, despite the fact that the concept of informed consent has become more and more publicly familiar (42% of respondents gave the completely correct answer regarding informed consent). The impact of age, education and sex on answers to the questionnaire was analysed. Men, younger and more educated respondents were more likely to show the autonomous attitude, whereas women, older and less educated people tended to show the traditional submissive attitude. Further, our article raises the question of the cultural and historical background within which the current ethically and legally binding norms (products of western democracies, in fact) are interpreted. The question is how far cultural modifications are tolerable in the practical implementation of universal ethical constructs (informed consent).
PMCID: PMC2598120  PMID: 17470503
14.  A Population-Based Evaluation of a Publicly Funded, School-Based HPV Vaccine Program in British Columbia, Canada: Parental Factors Associated with HPV Vaccine Receipt 
PLoS Medicine  2010;7(5):e1000270.
Analysis of a telephone survey by Gina Ogilvie and colleagues identifies the parental factors associated with HPV vaccine uptake in a school-based program in Canada.
Information on factors that influence parental decisions for actual human papillomavirus (HPV) vaccine receipt in publicly funded, school-based HPV vaccine programs for girls is limited. We report on the level of uptake of the first dose of the HPV vaccine, and determine parental factors associated with receipt of the HPV vaccine, in a publicly funded school-based HPV vaccine program in British Columbia, Canada.
Methods and Findings
All parents of girls enrolled in grade 6 during the academic year of September 2008–June 2009 in the province of British Columbia were eligible to participate. Eligible households identified through the provincial public health information system were randomly selected and those who consented completed a validated survey exploring factors associated with HPV vaccine uptake. Bivariate and multivariate analyses were conducted to calculate adjusted odds ratios to identify the factors that were associated with parents' decision to vaccinate their daughter(s) against HPV. 2,025 parents agreed to complete the survey, and 65.1% (95% confidence interval [CI] 63.1–67.1) of parents in the survey reported that their daughters received the first dose of the HPV vaccine. In the same school-based vaccine program, 88.4% (95% CI 87.1–89.7) consented to the hepatitis B vaccine, and 86.5% (95% CI 85.1–87.9) consented to the meningococcal C vaccine. The main reasons for having a daughter receive the HPV vaccine were the effectiveness of the vaccine (47.9%), advice from a physician (8.7%), and concerns about daughter's health (8.4%). The main reasons for not having a daughter receive the HPV vaccine were concerns about HPV vaccine safety (29.2%), preference to wait until the daughter is older (15.6%), and not enough information to make an informed decision (12.6%). In multivariate analysis, overall attitudes to vaccines, the impact of the HPV vaccine on sexual practices, and childhood vaccine history were predictive of parents having a daughter receive the HPV vaccine in a publicly funded school-based HPV vaccine program. By contrast, having a family with two parents, having three or more children, and having more education was associated with a decreased likelihood of having a daughter receive the HPV vaccine.
This study is, to our knowledge, one of the first population-based assessments of factors associated with HPV vaccine uptake in a publicly funded school-based program worldwide. Policy makers need to consider that even with the removal of financial and health care barriers, parents, who are key decision makers in the uptake of this vaccine, are still hesitant to have their daughters receive the HPV vaccine, and strategies to ensure optimal HPV vaccine uptake need to be employed.
Please see later in the article for the Editors' Summary
Editors' Summary
About 10% of cancers in women occur in the cervix, the structure that connects the womb to the vagina. Every year, globally, more than a quarter of a million women die because of cervical cancer, which only occurs after the cervix has been infected with a human papillomavirus (HPV) through sexual intercourse. There are many types of HPV, a virus that infects the skin and the mucosa (the moist membranes that line various parts of the body, including the cervix). Although most people become infected with HPV at some time in their life, most never know they are infected. However, some HPV types cause harmless warts on the skin or around the genital area and several—in particular, HPV 16 and HPV 18, so-called high-risk HPVs—can cause cervical cancer. HPV infections are usually cleared by the immune system, but about 10% of women infected with a high-risk HPV develop a long-term infection that puts them at risk of developing cervical cancer.
Why Was This Study Done?
Screening programs have greatly reduced cervical cancer deaths in developed countries in recent decades by detecting the cancer early when it can be treated; but it would be better to prevent cervical cancer ever developing. Because HPV is necessary for the development of cervical cancer, vaccination of girls against HPV infection before the onset of sexual activity might be one way to do this. Scientists recently developed a vaccine that prevents infection with HPV 16 and HPV 18 (and with two HPVs that cause genital warts) and that should, therefore, reduce the incidence of cervical cancer. Publicly funded HPV vaccination programs are now planned or underway in several countries; but before girls can receive the HPV vaccine, parental consent is usually needed, so it is important to know what influences parental decisions about HPV vaccination. In this study, the researchers undertake a telephone survey to determine the uptake of the HPV vaccine by 11-year-old girls (grade 6) in British Columbia, Canada, and to determine the parental factors associated with vaccine uptake; British Columbia started a voluntary school-based HPV vaccine program in September 2008.
What Did the Researchers Do and Find?
In early 2009, the researchers contacted randomly selected parents of girls enrolled in grade 6 during the 2008–2009 academic year and asked them to complete a telephone survey that explored factors associated with HPV vaccine uptake. 65.1% of the 2,025 parents who completed the survey had consented to their daughter receiving the first dose of HPV vaccine. By contrast, more than 85% of the parents had consented to hepatitis B and meningitis C vaccination of their daughters. Nearly half of the parents surveyed said their main reason for consenting to HPV vaccination was the effectiveness of the vaccine. Conversely, nearly a third of the parents said concern about the vaccine's safety was their main reason for not consenting to vaccination and one in eight said they had been given insufficient information to make an informed decision. In a statistical analysis of the survey data, the researchers found that a positive parental attitude towards vaccination, a parental belief that HPV vaccination had limited impact on sexual practices, and completed childhood vaccination increased the likelihood of a daughter receiving the HPV vaccine. Having a family with two parents or three or more children and having well-educated parents decreased the likelihood of a daughter receiving the vaccine.
What Do These Findings Mean?
These findings provide one of the first population-based assessments of the factors that affect HPV vaccine uptake in a setting where there are no financial or health care barriers to vaccination. By identifying the factors associated with parental reluctance to agree to HPV vaccination for their daughters, these findings should help public-health officials design strategies to ensure optimal HPV vaccine uptake, although further studies are needed to discover why, for example, parents with more education are less likely to agree to vaccination than parents with less education. Importantly, the findings of this study, which are likely to be generalizable to other high-income countries, indicate that there is a continued need to ensure that the public receives credible, clear information about both the benefits and long-term safety of HPV vaccination.
Additional Information
Please access these Web sites via the online version of this summary at
The US National Cancer Institute provides information about cervical cancer for patients and for health professionals, including information on HPV vaccines (in English and Spanish)
The US Centers for Disease Control and Prevention also has information about cervical cancer and about HPV
The UK National Health Service Choices website has pages on cervical cancer and on HPV vaccination
More information about cervical cancer and HPV vaccination is available from the Macmillan cancer charity
ImmunizeBC provides general information about vaccination and information about HPV vaccination in British Columbia
MedlinePlus provides links to additional resources about cervical cancer (in English and Spanish)
PMCID: PMC2864299  PMID: 20454567
15.  Beliefs and attitudes towards participating in genetic research – a population based cross-sectional study 
BMC Public Health  2013;13:114.
Biobanks have the potential to offer a venue for chronic disease biomarker discovery, which would allow for disease early detection and for identification of carriers of a certain predictor biomarker. To assess the general attitudes towards genetic research and participation in biobanks in the Long Island/Queens area of New York, and what factors would predict a positive view of such research, participants from the NSLIJ hospital system were surveyed.
Participants were recruited at six hospital centers in the NSLIJ system during the summers of 2009 and again in 2011 (n = 1,041). Those who opted to participate were given a questionnaire containing 22 questions assessing demographics, lifestyle and attitudes towards genetic research. These questions addressed individual participant’s beliefs about the importance of genetic research, willingness to participate in genetic research themselves, and their views on informed consent issues.
Respondents took a generally positive view of genetic research in general, as well as their own participation in such research. Those with reservations were most likely to cite concerns over the privacy of their medical and genetic information. Those who were married tended to view genetic research as important, while those in the younger age group viewed it as less important. Prior blood donation of respondents was found to be a predictor of their approval for genetic research. Demographic factors were not found to be predictive of personal willingness to participate in genetic research, or of approval for the opt-out approach to consent.
While respondents were generally inclined to approve of genetic research, and those who disapproved did not do so based on an underlying moral objection to such research, there is a disconnect between the belief in the importance of genetic research and the willingness of individuals to participate themselves. This indicates a continued concern for the ways in which genetic materials are safeguarded once they are collected. Also indicated was a general lack of understanding about the various consent processes that go along with genetic research, which should be addressed further to ensure the successful continuation of biobanks.
PMCID: PMC3568732  PMID: 23388465
Biological specimen banks; Genetic research; Public opinion
16.  Attitudes Towards Informed Consent: A Comparison Between Surgeons Working in Saudi Arabia and the United Kingdom 
Oman Medical Journal  2011;26(1):29-33.
Changes in legal standing and new guidelines for consent have generated changes in medical culture that doctors must adhere to. This study aims to highlight the differences in the way the surgeons in the two cultures view the informed consent for surgery processes.
The attitudes towards informed consent of a group of surgeons working in Saudi Arabia (KSA) were compared with those of a similar group working in the United Kingdom (UK), a country with a longer medical history and a more established medico-legal system.
The study shows that KSA surgeons tend to view informed consent not only as an ethical and legal obligation but also as a benefit to patients. In addition, KSA surgeons are more likely to adopt a paternalistic attitude during informed consent. They believe that information about harmful risks may dissuade their patients from undergoing the operation and they admit that the amount of information they provide to their patients is significantly influenced by a number of patient and non-patient related factors.
It is concluded that surgeons in KSA should be more aware of the informed consent guidelines and they should adhere to them. In addition, there is room for the introduction of formal training on informed consent in both countries and for making written information more widely available particularly in KSA.
PMCID: PMC3191608  PMID: 22043376
Informed consent; medical ethics; surgical risk; Saudi Arabia; United Kingdom.
17.  Patients’ perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial 
Heart  2004;90(10):1124-1128.
Objective: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial.
Design: A questionnaire based follow up survey including patients who gave informed consent as well as patients who did not consent to the trial.
Patients: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardial infarction trial (DANAMI-2).
Results: 76% of the trial participants and 63% of the non-participants agreed or mostly agreed that they felt able to make a decision about whether or not to participate in the trial; 50% of the trial participants and 34% of the non-participants found it acceptable that patients in their situation have to make such a decision. Only 28% of the trial participants and 7% of the non-participants read the information sheet before they made the decision.
Conclusions: Informed consent should be sought in acute myocardial infarction trials despite the emergency situation and the medical condition of the patients. Patients’ self assessed ability to make a decision should be explicitly addressed during the informed consent process and patients should not be pressurised into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.
PMCID: PMC1768493  PMID: 15367504
informed consent; ethics; acute myocardial infarction; clinical trial
18.  Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico 
BMC Medical Ethics  2006;7:13.
A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important.
To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale.
Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade.
The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.
PMCID: PMC1764745  PMID: 17166274
19.  A Rural Community's Involvement in the Design and Usability Testing of a Computer-Based Informed Consent Process for the Personalized Medicine Research Project 
Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants’ understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, such as genetic clinical trials consents. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time.
PMCID: PMC4145717  PMID: 24273095
Decision making; focus groups; genetic research; computer-based informed consent; usability
20.  Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes 
Trials  2008;9:45.
During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. There is little published information regarding patients' opinions and competence to provide informed consent, nor on physicians' attitudes towards the process. We have investigated the problem of obtaining consent from patients in emergency-setting clinical trials (such as acute coronary syndromes (ACS) and stroke) from a physicians' perspective.
A standardised anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres.
Two hundred and fourteen informative investigator responses were received. Of these investigators, 73.8% had experience with ACS and 25.2% had experience with acute stroke trials (and 1% with both fields). The complete model of informed consent (embracing all aspects required by Good Clinical Practice (GCP) and law) was used in 53.3% of cases in emergency settings, whereas the legal option of proxy consent was not used at all. While less than 15% of respondents considered written information to have been fully read by patients, 80.4% thought that the amount of information being given to emergency patients is too lengthy. Although there is no legal obligation, more than half of the investigators sought parallel consent (assent) from patients' relatives. Most investigators confirmed that they would adopt the model proposed by the GCP guidelines: abbreviated verbal and written consent in emergency conditions with obligatory "all-embracing" deferred consent to continue the trial once the patient is able to provide it. However, this model would not follow current Polish and European legislation.
An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines.
PMCID: PMC2517587  PMID: 18644120
21.  Informed consent for abdominal aortic aneurysm repair: Assessing variations in surgeon opinion through a national survey 
Informed consent discussions for elective abdominal aortic aneurysm (AAA) repair should reflect appropriate risks of the open or endovascular repair (EVAR), but few guidelines exist describing what surgeons should discuss. This study examines expert opinion regarding what constitutes informed consent.
We conducted an anonymous, web-based, national survey of vascular surgeons. Associations between surgeon characteristics and opinions regarding informed consent were measured using bivariate statistics; multivariable logistic regression was performed to estimate effects adjusted for covariates.
Academic and private practice surgeons were surveyed.
United States members of the International Society for Vascular Surgery membership. Main Outcome Measure. Surgeons' self-reported opinions regarding the content of informed consent for AAA repair.
A total of 199 surgeons completed the survey (response rate 51%). More than 90% of respondents reported that it was essential to discuss mortality risk for both procedures. However, only 60% and 30% of respondents reported that it was essential to discuss the risk of myocardial infarction and stroke, respectively. Opinions varied by procedure regarding the risks of impotence (32% vs 62%; EVAR vs open repair), reintervention (78% vs 17%), and rupture during long-term follow-up (57% vs 17%). Younger and private practice surgeons were more likely to discuss complications compared with older surgeons and those in academic practice. Surgeons who perform predominantly EVAR were more likely to quote higher mortality rates for open repair (odds ration [OR] = 3.1, 95% confidence interval [CI] = 1.4-6.4) and lower reintervention rates for EVAR (OR = 0.3, 95% CI = 0.1-0.7) compared with other surgeons.
This is the first study of the practice of informed consent for AAA repair. The only risk that the vast majority of surgeons agreed should be included in informed consent for AAA repair was mortality. Significant variation exists regarding whether other complications should be discussed and what complication rates should be quoted. surgeon characteristics may influence how risks are presented to patients. Further efforts are needed to develop guidelines to ensure consistent communication of appropriate risk during informed consent for AAA repair.
PMCID: PMC2659171  PMID: 18241751
22.  Surrogate consent for critical care research: exploratory study on public perception and influences on recruitment 
Critical Care  2013;17(1):R5.
Critical Care research involves an increasing level of technical and clinical interventions for the unconscious patient. If the general public has a negative (unfavourable) view of surrogate consent, low recruitment rates are likely. Results bias will be introduced if study populations are small, hindering knowledge generation and transfer through research. In the rapidly expanding healthcare industry of South East Asia, opportunities for critical care research will grow given a positive willingness (favourability) by the general public to act as a surrogate in the consent process when the (unconscious) patient cannot consent for him/herself.
To determine public willingness for surrogate consent, a quantitative cross-sectional study was undertaken at a University Teaching Hospital in South East Asia during a three month interval. Four hypothetical critical care research scenarios were presented and responses from the public were analysed using a three-part questionnaire.
Three hundred and five members of the public were recruited. In general, participants had a positive view of research. The level of education was significantly associated with a person's views about research especially in studies regarded as high risk. For low risk studies, a person's perception of research and willingness to be recruited to a study in the event that they were the (unconscious) patient, was the same whether they were the study subject or the person (legally acceptable representative) giving surrogate consent' on behalf of another (spouse, parent, child). Across all study scenarios, 60-80% of the public preferred to be approached by doctors to discuss the surrogate consent process.
Given the hypothetical scenarios presented in this study, the odds of a person having a positive view and willingness to be consented to a critical care research study on the advice of another (surrogate consent) was greater than for those who had a negative or unfavourable view. Nurses may be disadvantaged in leading on the recruitment process due to a preference for information to be delivered by medically qualified clinicians. In the setting of South East Asia, cultural attitudes to nurse-led research in critical care must be taken in to consideration in the multidisciplinary approaches to building the research team.
PMCID: PMC4057109  PMID: 23320945
23.  Attitudes to drug trials among relatives of unconscious intensive care patients 
BMC Anesthesiology  2010;10:6.
In many countries relatives are asked to consent on behalf of ICU patients prior to inclusion in clinical trials. However, the attitudes to drug trials among relatives of unconscious ICU patients are largely unknown.
We performed a prospective questionnaire survey at two university hospital ICUs of the next-of-kin to 50 unconscious adult patients. They were asked to complete a questionnaire within 48 hours of the patients' acute ICU admission.
Forty-two relatives returned the questionnaire of which 41 were completed by direct family members and in one case by a friend to the patient.
The majority of relatives (36/42) were positive/positive with some scepticism towards performing drug trials in unconscious ICU patients and 30/42 would most likely accept trial-participation by their relative. The majority (30/42) agreed that they should decide if their relative was to participate in a drug trial and 24 of these found that the treating clinician/ICU consultant should also consent. The majority (27/42) found that deferred consent would be acceptable if there was a limited time frame for initiation of treatment, however 8 respondents found this unacceptable when the intervention was a new drug.
The majority of relatives stipulated that adherence to legislation, treatment benefit for the study patient and for future patients, no patient-risk or -discomfort and development of new drugs were important factors if their relative was to participate in an ICU drug trial. When questioned about doctors' motives for performing drug trials the wish for drug development and better patient care were highly rated among relatives.
In general, relatives to unconscious ICU patients expressed positive attitudes to drug trials in the ICU and the inclusion of their relative in drug trials. Consent by next-of-kin and deferred consent was acceptable to the majority of relatives.
PMCID: PMC2890661  PMID: 20504325
24.  Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting 
BMC Medical Ethics  2014;15:40.
Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching Hospitals in a low resource setting.
A cross-sectional study conducted at three university teaching hospitals in Uganda. Self-guided questionnaires were left at a central location in each of the surgical departments after verbally communicating to the surgeons of the intention of the study. Filled questionnaires were returned at the same location by the respondents for collection by the research team. In addition, 20 in-depth interviews were held with surgeons and a review of 384 patients’ record files for informed consent documentation was done.
A total of 132 (62.1%) out of 214 questionnaires were completed and returned. Respondents were intern doctors, residents and specialists from General surgery, Orthopedic surgery, Ear, Nose and Throat, Ophthalmology, Dentistry, Obstetrics and Gynaecology departments. The average working experience of respondents was 4.8 years (SD 4.454, range 0–39 years). 48.8% of the respondents said they obtained consent all the time surgery is done while 51.2% did not obtain consent all the time. Many of the respondents indicated that informed consent was not obtained by the surgeon who operated the patient but was obtained either at admission or by nurses in the surgical units. The consent forms used in the hospitals were found to be inadequate and many times signed at admission before diagnosing the patient’s disease.
Informed consent administration and documentation for surgical health care is still inadequate at University teaching hospitals in Uganda.
PMCID: PMC4068318  PMID: 24885609
Informed consent practices; Surgery; Uganda
25.  Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue 
BMC Medical Ethics  2008;9:18.
The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.
We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.
Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.
Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.
PMCID: PMC2601042  PMID: 19019239

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