What is the role and authority of gatekeepers in cluster randomized trials in health research? Effect of the Informed Consent Process on Anxiety and Comprehension of Patients Undergoing Esophageal and Gastrointestinal Surgery Improving Informed Consent of Surgical Patients Using a Multimedia-Based Program?: Results of a Prospective Randomized Multicenter Study of Patients Before Cholecystectomy Informed consent for cataract surgery: Patient understanding of verbal, written, and videotaped information Educational intervention for women undergoing image-guided breast biopsy: results of a randomized clinical trial. Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study). “I don’t like that, it’s tricking people too much…”: acute informed consent to participation in a trial of thrombolysis for stroke The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. Enhancement of Surgical Informed Consent by Addition of Repeat Back: A Multicenter, Randomized Controlled Clinical Trial Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent? When is informed consent required in cluster randomized trials in health research? Informed consent, parental awareness, and reasons for participating in a randomised controlled study The quality of informed consent in a clinical research study in Thailand. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Informed consent and participant perceptions of influenza vaccine trials in South Africa Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy Long term clinical trials: how much information do participants retain from the informed consent process? Specific barriers to the conduct of randomized trials Seeking informed consent to cancer clinical trials: describing current practice. THE EFFECTIVENESS OF PATIENT VERBALIZATION ON INFORMED CONSENT
This article is part of a series of papers examining ethical issues in  cluster r and omized trials ( CRTs )  in health research . In the introductory paper in this series , we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation . This paper addresses the sixth of the questions posed , namely , what is the role and authority of gatekeepers in CRTs in health research ? ‘ Gatekeepers ’ are individuals or bodies that represent the interests of cluster members , clusters , or organizations . The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster r and omization , cluster-level interventions , and cluster size . In this paper , we call for a more restrictive underst and ing of the role and authority of gatekeepers . Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers . We considered that consent to r and omization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data - collection procedures have started . Further , when cluster-level interventions or cluster size means that obtaining informed consent is not possible , a waiver of consent may be appropriate . In this paper , we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited . Generally , gatekeepers do not have the authority to provide proxy consent for cluster members . When a municipality or other community has a legitimate political authority that is empowered to make such decisions , cluster permission may be appropriate ; however , gatekeepers may usefully protect cluster interests in other ways . Cluster consultation may ensure that the CRT addresses local health needs , and is conducted in accord with local values and customs . Gatekeepers may also play an important role in protecting the interests of organizations , such as hospitals , nursing homes , general practice s , and schools . In these setting s , permission to access the organization relies on re source implication s and adherence to institutional policies Objective This study seeks to evaluate the level of anxiety , recall , and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery . Methods Sixty-one patients without cognitive disorders entered a prospect i ve study design ed to assess the effect of a surgical informed consent process . The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation . The  State Trait Anxiety Inventory test  was used to assess state anxiety and tract anxiety . The test was repeated after the informed consent process . A disease-specific feedback question naire was subsequently administered to assess the actual comprehension of the provided information . Results A significant decrease of the state anxiety scores was documented in most patients ( p < 0.001 ) . This effect was more evident in the elderly ( p = 0.021 ) and in those who used Internet as a previous source of information ( p = 0.032 ) . The mean correct exact answer rate on the disease-specific question naire was 76 % ( IQ range 66.7–85 % ) . No statistically significant relationship was found between the rate of correct answers and the state anxiety scores . Conclusions An exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are c and i date s to minimally invasive esophageal and gastrointestinal surgical procedures Objective : The term “ informed consent ” explains the process by which a patient , before treatment , is provided comprehensive and impartial information regarding a planned operative procedure so that he/she underst and s the implication s of the procedure before consenting . The goal of the current study was to investigate whether st and ard methods of consenting can be improved using a multimedia-based information program ( MM-IP ) . Patients and Methods : In a prospect i ve multicenter study , 80 patients undergoing laparoscopic cholecystectomy went through the st and ard informed consent process . One group of patients was also given access to a MM-IP . Question naires were completed before surgery . These evaluated how patients perceived their own underst and ing of important aspects of their illness ( ie , disease , therapeutic alternatives , operation , risks ) and satisfaction with the consenting process . Patients ’ anxiety levels were also assessed . These question naires were used to evaluate the effectiveness of the MM-IP for improving the consent process . Results : Seventy-six patients ( 47 women , 29 men , median age 54 years ) were included . There was no significant age or gender variation between the groups ( st and ard n = 41 and MM-IP n = 35 ) . Eighty-two percent of all respondents were satisfied with the st and ard informed consent process . However , perceived underst and ing of the material was significantly improved in the MM-IP group ( P < 0.001 ) . Patients with less formal education profited particularly from the MM-IP .  Preoperative anxiety did not vary between the groups . Conclusion : Use of the multimedia-based program was positively evaluated by patients , and significantly improved patients ’ perceived underst and ing of their disease and its treatment . It is , therefore , valuable in the informed consent process PURPOSE : To determine the effectiveness of verbal , written , and videotaped descriptions of cataract surgery on patients ’ underst and ing of the risks , benefits , and treatment alternatives . SETTING : Veterans Affairs Boston Healthcare System , Boston , Massachusetts , USA . DESIGN : R and omized prospect i ve study . METHODS : Patients eligible for cataract surgery were r and omized into 1 of 4 arms of the informed consent process as follows : Group 1 , conventional verbal information ; Group 2 , conventional verbal information plus second‐ grade reading level brochure ; Group 3 , conventional verbal information plus eighth‐ grade reading level brochure ; Group 4 , conventional verbal information plus American Academy of Ophthalmology DVD Underst and ing Cataract Surgery : Patient Education DVD Featuring an Aid to Informed Consent . After the informed consent process , patients in each group completed a 12‐ question question naire discussing the surgical procedure , its benefits , its foreseeable and unforeseeable risks , and the alternatives to cataract surgery . Scores in each group were calculated as the number of correct responses out of 12 questions . RESULTS : Patients in Group 2 ( mean score 10.8 ± 1.29 [ SD ] ) and Group 4 ( mean score 10.56 ± 1.44 ) scored significantly higher than patients in Group 1 ( mean score 7.68 ± 2.80 ) or Group 3 ( mean score 9.08 ± 1.60 ) . Previous cataract surgery and education level had no significant influence on recall of the informed‐consent process . CONCLUSIONS : Concise informed consent information sheets at lower reading grade levels and videotape presentation optimized patient underst and ing of the risks , benefits , and treatment alternatives to cataract surgery . The cost – benefit of these results is important because better patient underst and ing has the potential to decrease the risk for indemnity payments awarded because of inadequate informed consent . Financial Disclosure : No author has a financial or proprietary interest in any material or method mentioned BACKGROUND The process of informed consent has been examined for patients undergoing various procedures but not breast biopsy . Our study was a r and omized trial that examined the effect of an educational flip chart as part of the informed consent . METHODS A total of 122 patients referred for stereotactic or ultrasound-guided core breast biopsy  were r and omly assigned to receive an informed consent discussion with or without an illustrated flip chart . The chart included information about breast anatomy , pathology , and diagnostic procedures . Outcome measures included objective knowledge , subjective knowledge , anxiety , and satisfaction . RESULTS Analysis showed few significant main effects of the intervention . However , results showed interactions between experimental condition and race/ethnicity , indicating that the intervention was effective in enhancing objective and subjective knowledge for African American but not Caucasian patients . Anxiety after consultation was higher among patients assigned to the flip chart condition , possibly because they were better informed about the risks of the procedure . Patients who underwent biopsy sooner after learning they needed one were more satisfied with their care . CONCLUSIONS The usual care consent process is effective for many but not all patients . Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients BACKGROUND : Consent for participation in clinical research is considered valid if it is informed , understood , and voluntary . In the case of minors , parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision . Although informed consent is a vital component of clinical research , there is little information evaluating its validity in neonatal intensive-care population s. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter r and omized research study , neurologic outcomes and pre-emptive analgesia in the neonate ( NEOPAIN ) . DESIGN / METHODS : Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of underst and ing about the NEOPAIN study . The NEOPAIN consent form , which had been approved by the University of Kentucky Medical Institutional Review Board ( IRB ) , was used to formulate these questions . Questions addressed the timing of consent , parental underst and ing of the purpose , benefits , and risks of the study , the voluntary nature of the project , and their willingness to enroll in future studies if the opportunity presented . Answers were scored on a Likert scale , with 1 for no underst and ing and 5 for complete underst and ing . RESULTS : Five of 64 parents ( 7.8 % ) had no re collection of the NEOPAIN study or of signing consent . Of those who remembered the study , only 67.8 % understood the purpose of the study , with a higher proportion of the mothers than fathers knowing the purpose of the study ( 73.3 % vs 57.1 % ) , ( p=0.029 ) . Of those who understood the purpose of the study 95 % were able to verbalize the benefits , but only 5 % understood any potential risks . No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked . CONCLUSIONS : Valid consent in the antenatal/perinatal population is difficult , if not impossible , to obtain . To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process . Additional attention during the consent process should be given to possible risks of the study Cluster r and omized trials are increasingly common . Obtaining informed patient consent to participation in these trials raises practical challenges and ethical issues . The aims of this paper were to 1 ) develop a typology of interventions employed in cluster r and omized trials in primary care ; 2 ) assess whether the likelihood of seeking  individual consent to participation  varies by intervension type ; 3 ) assess whether this likelihood has increased over time ; 4 ) assess evidence for under reporting of consent procedures ; 5 ) articulate reasons for not obtaining consent ; and 6 ) make recommendations for future trial investigators . We collected data on trial interventions and consent procedures from reports of 152 recently published trials , and 47 unpublished trials . We develop a typology of interventions based on reasons for adopting a clustered design . We examine proportions seeking individual consent  to participation among trials involving different types of intervention , in different periods , and among published and unpublished trials . Two-thirds of the trials had multifaceted interventions . Trials involving different types of intervention had different propensities to seek consent , largely because of practical obstacles to obtaining consent . Obtaining consent can compromise internal validity . More recent trials are no more likely to obtain consent than past trials . There was no evidence of under-reporting of consent procedures in publications . In conclusion , future trial investigators should consider both practical reasons and scientific arguments for not obtaining individual patient consent for all interventions in their trials . Where feasible , they should allow patients to opt out of the trial . Lay individuals should represent trial participants as part of the process of cluster consent to participation , and lay individuals could also be involved in considering ethical issues during trial planning . A more public debate may clarify the general acceptability of not obtaining consent in certain situations OBJECTIVES To ascertain the acceptability of a r and omised controlled trial comparing arthroscopic lavage with a placebo-surgical procedure for the management of  osteoarthritis of the knee ; and to assess the practical feasibility of mounting such a multicentre placebo-controlled trial . DESIGN Mixed methods study including : focus groups with surgeons and anaesthetists ; focus groups and interviews with potential participants ; interviews with chairpersons of UK Multicentre Research Ethics Committees ( MRECs ) ; surveys of surgeons and anaesthetists ; and a two-centre , three-arm pilot . SETTING UK secondary care . PARTICIPANTS Members of the British Association of Surgeons of the Knee and members of the British Society of Orthopaedic Anaesthetists took part in the focus groups and surveys . Surgeons and anaesthetists from two regional centres in the UK also contributed to focus groups , as did patients from consultant lists in two UK regional centres , and members of Arthritis Care . Chairpersons of six UK MRECs were interviewed . Participants were eligible for the pilot if they were adults ( 18 years or older ) with radiological evidence of osteoarthritis of the knee who might be considered for arthroscopic lavage , and were fit for general anaesthetic ( defined by the American Society of Anaesthesiologists grade s 1 and 2 ) , and able to give informed consent . INTERVENTIONS Participants in the pilot study were r and omised to arthrosocopic lavage  ( with or without debridement at the clinical discretion of the surgeon ) ; placebo surgery ; or non-operative management with specialist re assessment . MAIN OUTCOME MEASURES The acceptability and feasibility of mounting a  placebo-controlled trial for the evaluation of knee  arthroscopic lavage .  RESULTS There was broad acceptance across all stakeholder groups of the need to find out more about the effectiveness of arthroscopic lavage . Despite this there was variation in opinion within all the groups about how research ers should approach this and whether or not it would be acceptable to investigate using placebo surgery . Within the health professional groups , there tended to be a split between those who were strongly opposed to the inclusion of a placebo surgery arm and those who were more in favour . For prospect i ve trial participants who had osteoarthritis of the knee , the acceptability of the trial was discussed from a more individual perspective - reflecting on their personal reasons for or against participating . The majority of this group said they would consider taking part . The pilot study showed that , in principle , a placebo-controlled trial could be conducted . It showed that patients were willing to participate in a trial which would involve a placebo-surgical arm and that it was possible to undertake placebo surgery successfully and to blind patients to their allocation - although once patients knew their allocation , some patients allocated to surgery became more concerned about the possibility of undergoing placebo surgery , and withdrew . The experience of the pilot , however , showed that , despite full MREC approval , the study required major discussion and negotiation before local clinical approvals could be obtained . The fact that ethics approval had been granted did not mean that clinicians would automatically accept that the process was ethical . CONCLUSIONS The study showed that , in principle , a placebo-controlled trial of arthroscopic lavage could be conducted in the UK , albeit with difficulty . Against the background of falling use of arthroscopic lavage the decision was , therefore , taken not to proceed to full-scale trial for this procedure . The study showed that for some health professionals the use of placebo surgery can never be justified . It highlighted the importance of the surgeon-anaesthetist relationship in this context and how acceptance of the trial design by both parties is essential to successful participation . It also highlighted the importance of informed consent for trial participants and the strength and influence of individuals ' ethical perspectives in addition to collective ethics provided by MRECs . TRIAL REGISTRATION Current Controlled Trials IS RCT N02328576 Background : Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure , underst and ing , voluntariness and consent . The validity of informed consent for critically ill patients has been question ed . Little is known about how these patients experience the process of consent . Objective : The aim of this study was to explore critically ill patients ’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent . Design : 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews .  Results : None of the patients had any clear underst and ing of the purpose of the trial . Neither did they underst and the principles of r and omisation and voluntariness . Reasons for giving or not giving consent were trust , conceptions of benefits and risks and altruism . Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors ’ responsibility . Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity . A majority of the patients found the consent process vague and ambiguous . Conclusions : The results indicate that the principle of informed consent from critically ill patients can not be seen as a contract between equal and autonomous parties . Further studies are needed to explore critically ill patients ’ experiences with the process of informed consent BACKGROUND Obtaining informed consent before performing invasive procedures and operations has become a st and ard practice at all medical institutions in the United States . All agree that patients should be both conscious of and in agreement with their medical care . Though patients routinely sign consent forms with numerous risks and complications detailed , there are only a limited amount of reports that study if these patients have a thorough underst and ing of those risks and complications . Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English . To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy  understood the complications associated with this procedure . METHODS We conducted a r and omized prospect i ve study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy . Fifty patients agreed to participate in our study . Participants were split into two groups . In the first group ( the control group ) surgical benefits , risks and complications were explained in the usual fashion . In the second group , after hearing the st and ard explanation of surgical risks , complications and benefits , patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy . Patients from both groups then took a ten question assessment based on the presentations that they encountered . Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment . The patients ' age , education level , income , and birth country were also studied . RESULTS Fifty-two percent of the patients in the study were born outside of the United States . All of the non-US born patients were Hispanic and their primary language was Spanish . The average age of the studied patients was 38 . Sixty-eight percent of the patients reported an education level no higher than high school . The majority of the studied patients noted an  income of less than $ 40,000 . Differences were seen between patient native to the US and those born outside the United States . US born patients had an 80 % correct response rate versus non-US born patients who had only a 63 % correct response . Differences were seen between US born patient and non-US born patients concerning the topics of the severity of a common bile duct injury , gastrointestinal changes after cholecystectomy and the safety concerning conversion from laparoscopic to open cholecystectomy . No difference was appreciated in the PowerPoint group versus the non-PowerPoint group . CONCLUSION The addition of a PowerPoint presentation did not increase underst and ing of the risks and benefits associated with a laparoscopic cholecystectomy . This study did however highlight the problem of obtaining consent from foreign born patients . Patients who were not US natives showed a decreased underst and ing of the surgical procedure and the severity of the complications in both the control group and the PowerPoint group . Better methods of educating foreign patients should be investigated to truly obtain informed consents from this patient population Objective : In this r and omized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussion s. Summary Background Data : RB has been suggested as a method to improve patient comprehension when obtaining informed consent . In this technique , patients are asked to recount what they have been told in the informed consent discussion . Despite preliminary data , this practice has not been evaluated in any large scale study . Methods : This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform . Patients scheduled for elective surgeries were r and omized to RB ( a module added to the iMedConsent package ) or st and ard iMedConsent ( no RB ) .  Comprehension was tested after the informed consent using procedure-specific question naires . Time stamps in the iMedConsent program estimated the time spent completing the informed consent process . Provider and patient satisfaction were measured using 5-point Likert scales . Statistical comparisons of groups were performed using t-tests and & khgr;2 tests . Results : A total of 575 patients were enrolled . In the RB group , providers spent 2.6 minutes longer ( P < 0.0001 ) obtaining informed consent . The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) . Quality of decision making was rated similarly . Providers were neutral to slightly favorable regarding RB . Conclusions : RB implemented within an electronic informed consent system improved patient comprehension . The additional time required was acceptable to providers . RB should be considered as an enhancement to surgical informed consent . This clinical trial was registered at http://www . clinical trials.gov ( Identifier NCT00288899 ) Due to possible method ological and practical problems , many research ers refrain from using a r and omized controlled trial design to evaluate procedures already embedded in routine health care . We performed a r and omized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians . The trial started after 4 years of feedback and lasted for 2.5 years . With some adaptations a r and omized trial proved to be possible . In evaluating health-care procedures that can not be blinded in a traditional way , asking full and study -specific informed consent may conflict with the validity of the design . In such studies , an alternative procedure is to be considered . Our trial , with doctors as study subjects , was held on an already accepted routine procedure ( feedback ) . This made it possible to refrain from obtaining study -specific informed consent . Consequently , a Hawthorne effect and contamination of the trial arms through information leakage could be avoided . Justification and general criteria for not obtaining full and study -specific informed consent are worked out . In health-care research on the performance of doctors or on interventions into the quality of care , obtaining a general informed consent in advance is an acceptable alternative approach This article is part of a series of papers examining ethical issues in  cluster r and omized trials ( CRTs ) in health research . In the introductory paper in this series , we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation . This paper addresses the second of the questions posed , namely , from whom , when , and how must informed consent be obtained in CRTs in health research ? The ethical principle of respect for persons implies that research ers are generally obligated to obtain the informed consent of research subjects . Aspects of CRT design , including cluster r and omization , cluster level interventions , and cluster size , present challenges to obtaining informed consent . Here we address five questions related to consent and CRTs : How can a study proceed if informed consent is not possible ? Is consent to r and omization always required ? What information must be disclosed to potential subjects if their cluster has already been r and omized ? Is passive consent a valid substitute for informed consent ? Do health professionals have a moral obligation to participate as subjects in CRTs design ed to improve professional practice ? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions . First , when informed consent is not possible , a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied . Second , informed consent to r and omization may not be required if it is not possible to approach subjects at the time of r and omization . Third , when potential subjects are approached after cluster r and omization , they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been r and omized ; detailed information on interventions in other trial arms need not be provided . Fourth , while passive consent may serve a variety of practical ends , it is not a substitute for valid informed consent . Fifth , while health professionals may have a moral obligation to participate as subjects in research , this does not diminish the necessity of informed consent to study participation BACKGROUND The informed consent procedure plays a central role in r and omised controlled trials but has only been explored in a few studies on children . AIM To assess the quality of the informed consent process  in a paediatric setting . METHODS A question naire was sent to parents who volunteered their child ( 230 children ) for a r and omised , double blind , placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures . RESULTS 181 ( 79 % ) parents responded . On average , 73 % of parents were aware of the major study characteristics . A few had difficulty underst and ing the information provided . Major factors in parents granting approval were the contribution to clinical science ( 51 % ) and benefit to the child ( 32 % ) . Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials . 89 % of participants felt positive about the informed consent procedure ; however , 25 % stated that they felt obliged to participate . Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ , relatively more were hesitant about participating in future . Parents appreciated the investigator being on call 24 hours a day ( 38 % ) and the extra medical care and information provided ( 37 % ) as advantages of participation . Disadvantages were mainly the time consuming aspects and the work involved ( 23 % ) . CONCLUSIONS Parents ’ underst and ing of trial characteristics might be improved by design ing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents . Adequate measures should be taken to avoid parents feeling obliged to participate , rather than giving true informed consent btaining the informed consent of participants in clinical studies is a fundamental requirement for ethical research . ' Based on the principle of respect for persons , potential research subjects are provided with relevant information about a study so that they can make an informed and voluntary decision about participation . Skepticism and controversy exists , however , about informed consent from research participants in developing countries . In addition to concepts about research and individual choice that might be unfamiliar , developing country participants may be plagued by poverty , illiteracy , and limited access to health care services that make it difficult for them to give valid informed consent.2 Most agree that following the provision of adequate and accurate information about a study , valid informed consent requires at least some knowledge of the study details and a voluntary decision to enroll.3 Evaluation of the quality of informed consent therefore should attempt to measure what participants underst and and how freely they made the enrollment decision . A small yet increasing number of studies using quantitative or qualitative methods to evaluate participants ' informed consent or to test informed consent interventions have been reported . Yet , only a few published studies from Thail and , 4 South Africa , s The Gambia,6 Bangladesh,7 and Haiti,8 have used quantitative methods to survey research participants in developing countries about the informed consent process . Although the results of these studies show mixed comprehension , the paucity and small size of these studies make it difficult to say much about the quality of informed consent in developing countries or to compare it to the quality of informed consent in developed countries . This difficulty is compounded by method ological limitations in the studies that have been conducted in both setting s. For example , in some studies the time period between the informed consent process and the administration of the informed consent question naire varied from respondent to respondent , even extending to several months.9 In other studies , crucial domains , such as the degree to which subjects felt pressured to participate in the clinical research , were excluded . 10 To assess the quality of informed consent in a developing country while avoiding some of these method ological limitations , we interviewed 141 individuals immediately after they consented to participate in a r and omized HIV study in Bangkok , Thail and . In Thai culture , individuals often defer to the authority of the health care professional . However , because there has been a considerable volume of clinical research in Thail and including HIV research , Thai citizens may be more familiar with and experienced in research overall than people in other re source poor countries . Very little is known , however , about the quality of informed consent given by Thai subjects in HIV studies . In this study , individuals were surveyed about their experience with the  informed consent process  , their underst and ing of the information they were given about the trial , and the voluntary nature of their decision to join PURPOSE Here we report the results of a r and omized study undertaken to test the efficacy of a supplementary , telephone-based nursing intervention in increasing patients ' awareness and underst and ing of the clinical trials in which they are asked to participate . METHODS During a 12-month period , 180 cancer patients who were approached to participate in a phase II or III clinical trial were r and omized to undergo either of the following : ( 1 ) st and ard informed consent procedures based on verbal explanations from the treating physician plus written information ( controls ) ; or ( 2 ) st and ard informed consent procedures plus a supplementary , telephone-based contact with an oncology nurse ( intervention ) . For purpose s of evaluation , face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed . RESULTS The two groups were comparable with regard to sociodemographic and clinical variables . Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments . The intervention group was significantly ( P < .01 ) better informed about the following : ( 1 ) the risks and side effects of treatment ; ( 2 ) the clinical trial context of the treatment ; ( 3 ) the objectives of the clinical trial ; ( 4 ) where relevant , the use of r and omization in allocating treatment ; ( 5 ) the availability of alternative treatments ; ( 6 ) the voluntary nature of participation ; and ( 7 ) the right to withdraw from the clinical trial . The intervention did not have any significant effect on patients ' anxiety levels or on rates of clinical trial participation . Patients reported high levels of satisfaction with the intervention . CONCLUSION The use of a supplementary , telephone-based nursing intervention is a feasible and effective means to increase cancer patients ' awareness and underst and ing of the salient issues that surround the clinical trials in which they are asked to participate Background and objectives : There are few insights from sub-Saharan Africa on research participants ’ experiences of the informed consent process , particularly in the context of r and omised controlled trials , where issues of r and omisation and the use of placebos may be confusing concepts for participants . This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa . Method : Four to 12 months after completion of the trials , participants were contacted to return to participate in the informed consent study . The semistructured question naire administered to assess recall of trial procedures and the informed consent process covered key issues including : purpose of the study ; awareness that the study was not part of routine treatment ; voluntary nature of participation and freedom to withdraw ; r and omisation ; placebos ; and remuneration . Results : A total of 334 participants ( 93 % of the original vaccine trial sample ; mean age 68 years , median level of education grade 8 , 69 % women ) completed the question naire . Only 21 % were able to recall that they were allocated r and omly to the different treatment arms . Only 19 % of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication . Conclusion : Although a good general recall of trial concepts was demonstrated , only a small proportion of the participants correctly interpreted and recalled the concepts of r and omisation and placebos . Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve underst and ing of the research process should be explored BACKGROUND Patients who undergo cardiac catheterization or percutaneous coronary intervention ( PCI ) often have a poor underst and ing of their disease and of related therapeutic risks , benefits , and alternatives . This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients ' knowledge of st and ard consent elements . METHODS Patients undergoing first-time elective , outpatient cardiac catheterization and possible PCI  were r and omly assigned to a scripted verbal or written consent process ( group I ) or a web-based , audiovisual presentation ( group II ) . Preconsent and postconsent question naires were administered to evaluate changes in patients ' self-reported underst and ing of st and ard consent elements . RESULTS One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys ( group I=48 ; group II=54 ) . Changes in patient comprehension rates were similar between groups for risk and benefit consent elements , but group II had significantly greater improvement in the identification of treatment alternatives than group I ( p=0.028 ) . Independent of intervention , correct identification of all risks and alternatives increased significantly after consent ( p<0.05 ) ; 4 of 5 queried risks were correctly identified by greater than 90 % of respondents . However , misperceptions of benefits persisted after consent ; increased survival and prevention of future myocardial infa rct ion were identified as PCI-related benefits by 83 % and 46 % of respondents , respectively . CONCLUSIONS Although both scripted verbal and audiovisual informed consent improved patient comprehension , important patient misperceptions regarding PCI-related outcomes and alternatives persist , independent of informed consent approach , and considerable challenges still exist in educating patients about contemplated medical procedures . Future research appears warranted to improve patient comprehension Objectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy . Methods The Consent-20 instrument was developed and piloted on 47 subjects . Subsequently , parents of 101 children undergoing first-time , diagnostic upper endoscopy performed under moderate IV sedation were prospect ively and consecutively , blinded , r and omised and enrolled into two groups that received either st and ard form-based informed consent or st and ard form-based informed consent plus a commercial ( Emmi Solutions , Inc , Chicago , Il ) , sixth grade level , interactive learning module ( electronic assisted consent ) . Anonymously and electronically , the subjects ' anxiety ( State Trait Anxiety Inventory ) , satisfaction ( Modified Group Health Association of America ) , number of questions asked , and attainment of informed consent were assessed ( Consent-20 ) . Statistics were calculated using t test , paired t test , and Mann Whitney tests . Results The ability to achieve informed consent , as measured by the new instrument , was 10 % in the control form-based consent group and 33 % in the electronic assisted consent group ( p<0.0001 ) . Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction , anxiety or number of questions asked in a paediatric endoscopy unit . Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy . It also shows that even when necessary information was repeated electronically in a comprehensive and st and ardised video , informed consent as measured by our instrument was incompletely achieved . The supplemental information did , however , significantly improve underst and ing in a manner that did not negatively impact workflow , subject anxiety or subject satisfaction . Additional study of informed consent is required . Clinical trial registration number Clinical Trials.gov Identifier NCT00899392 Previous studies report mixed results about how much information study participants actually can read , underst and and retain after completing the informed consent process ; fewer studies have examined disparities in the retention and recall of information by patient factors , such as age , education , and race . Not retaining or being able to recall information from the informed consent process has potentially important ethical and legal implication s and consequences for research quality and integrity , especially when found in population s that commonly are underserved or underrepresented in clinical trials . To determine how much basic knowledge participants finishing a five-year , multi-center , double-blinded r and omized , placebo-controlled clinical trial had about the study , participants ( n=1,789 ) were asked at their final follow-up visit three multiple-choice questions : ( 1 ) the study 's purpose ; ( 2 ) the name of the medication under investigation ; ( 3 ) the main side effect of the medication . The associations between knowledge of these fundamental details and participant social and demographic factors were investigated . A majority of participants correctly recalled the study 's purpose ( 64.7 % ) and medication ( 79.6 % ) , but few correctly reported the main side effect ( 31.1 % ) . In spite of relatively high recall for study purpose and medication , disparities by age , education and race exist . Increasing age was significantly associated with higher odds of incorrectly recalling both the study purpose and the name of the study medication . Likewise those with less than a high school education were more likely to incorrectly identify the study 's purpose and the name of the study medication . Black and other non-white race or ethnic groups were more than two and a half times as likely to incorrectly identify the study 's purpose . These findings suggest that even the most basic information may not be understood or retained by important subgroups of patients enrolled in clinical trials . Implementing effective strategies , such as additional time and effort for consent or repetition of study information , may be necessary in order to assure ethical and valid consent Large r and omized trials are required to provide reliable evidence of the typically moderate benefit of most interventions . To be affordable , such trials need to be simple ; to be widely applicable , they need to be close to normal clinical practice . However , current regulations and guidelines have hugely increased trial complexity , effectively becoming barriers to their design and conduct . Key barriers include inadequate funding , overly complex regulations producing needlessly complex trial procedures , excessive monitoring , over restrictive interpretation of privacy laws without evidence of subject benefit , and inadequate underst and ing of methodology . Complex regulations result in multiple ethics approvals for a multi-center study , unnecessary complexity in the study protocol , delays in securing regulatory approval , and cumbersome regulatory procedures , even for drugs widely used in clinical practice . The type of detailed safety monitoring currently needed in trials of new drugs is being applied indiscriminately to all studies including a simpler and basic level of monitoring that constitutes good practice in most trials could be agreed on , with that level being exceeded only in specific instances . More evidence about the pros and cons of alternative approaches to data quality monitoring would help inform this process . Complex procedures in the form of multiple-page consent forms , overzealous monitoring of side effects and adverse events , source data verification , and over-restrictive approaches to protocol amendments , can impede , rather than facilitate , trial objectives . Finally , further education on the nuances and functions of r and omisation would facilitate trial conduct , and reduce the need for burdensome complexity . A radical re-evaluation of existing trial guidelines is needed , based on a clear underst and ing of the important principles of r and omized trials , with the objective of eliminating unnecessary documentation and reporting without sacrificing validity or safety . Research ers should encourage public debate about how best to strike the balance between regulation and cost . Clinical Trials 2008 ; 5 : 40—48 . Clinical trials have come to be regarded as the gold st and ard for treatment evaluation . However , many doctors and their patients experience difficulties when discussing trials , leading to poor accrual to trials and question able quality of informed consent . We have previously developed a typology for ethical communication about Phase II and III clinical trials within four domains : ( a ) shared decision making , ( b ) sequencing information , ( c ) type and clarity of information , and ( d ) disclosure/coercion . The aim of this study was to compare current clinical practice when seeking informed consent with this typology . Fifty-nine consultations in which 10 participating oncologists sought informed consent were audiotaped . Verbatim transcripts were analysed using a coding system to ( a ) identify the presence or absence of aspects of the four domains and ( b ) rate the quality of aspects of two domains : ( i ) shared decision-making and ( ii ) type and clarity of information .  Oncologists rarely addressed aspects of shared decision-making , other than offering to delay a treatment decision ( 78 % ) . Moreover , many of these discussion s scored poorly with respect to ideal content . The oncologists were rarely consistent with the sequence of information provision . A general rationale for r and omising was only described in 46 % of consultations . In almost one third of the consultations ( 28.8 % ) doctors made implicit statements favouring one option over another , either st and ard or clinical trial treatment . Doctors complied with some but not other aspects of a st and ard procedure for discussing clinical trials . This reflects the difficulty inherent in seeking ethical informed consent and the need for communication skills training for oncologists OBJECTIVE To determine if preoperative patient verbalization of the risks and benefits of  anterior cruciate ligament ( ACL ) reconstruction  enhances underst and ing of the risks and benefits of that procedure . DESIGN A r and omized clinical trial . SETTING A referral-based outpatient sport medicine clinic . SUBJECTS Twenty patients from the general population with clinical ly diagnosed ACL tears requiring elective reconstruction surgery were r and omly assigned to 2 groups . Twelve patients who made up a control group received a st and ard surgical consultation , consisting of knee models , diagrams , open dialogue and informed consent to surgery . Eight patients in the experimental group were exposed to the same surgical consultation and were required to accurately verbalize the associated risks and benefits before operation . One month after informed consent was obtained , patients answered 3 questions about the risks and benefits of ACL reconstruction . INTERVENTION ACL reconstruction . MAIN OUTCOME MEASURES A 3- question question naire , addressing 2 risks and 1 benefit of ACL reconstruction . MAIN RESULTS Patients in the experimental group were able to answer all 3 questions correctly . In the control group , 4 patients answered all 3 questions correctly , but 1 patient answered all 3 questions incorrectly , and 7 patients answered 1 question incorrectly . There was a statistically significant difference ( p = 0.03 ) between the control group and the experimental group . CONCLUSION Patients who verbalized the risks and benefits during their surgical consultation demonstrated a significantly greater underst and ing of the risks and benefits of an ACL reconstruction procedure
We have identified efforts by research ers to investigate interventions which seek to improve information delivery and consideration of information to enhance  informed consent .
The interventions used consistently improve patient knowledge , an important prerequisite for informed consent .
This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable .
Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions .
BACKGROUND Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken .
However , it is a complex process which requires patients be provided with information which they can underst and and retain , opportunity to consider their options , and to be able to express their opinions and ask questions .
There is evidence that at present some patients undergo procedures without informed consent being achieved .
OBJECTIVES To assess the effects on patients , clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures .
AUTHORS ' CONCLUSIONS Informed consent is an important ethical and practical part of patient care .