***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Summary Objective Several reports have shown that despite the informed consent process , enrolled patients misunderst and the modalities and goals of r and omized clinical trials ( RCTs ) . We believe that this may be linked to a priori misconceptions in the main population . The purpose of this study is to compare the knowledge about cancer RCTs in enrolled participants ( cases ) versus patients treated under cancer st and ard care who have never taken part in RCTs ( controls ) . Methods We su bmi tted a vali date d question naire ( ICEC-R ) to both population s to explore their knowledge about RCTs . A total of 75 cases and 107 controls were included . Results Globally , the cases ’ knowledge was significantly better , especially about ( i ) the r and omization process , ( ii ) the uncertain potential benefits , and ( iii ) the right to withdraw consent . Both population s presented the lowest scores for items exploring the r and omization process and uncertain treatment benefits . Conclusion Enrolled patients ’ comprehension of the goals and means of RCTs is actually better than controls ’ . Nevertheless , additional efforts should be made to enhance information about clinical research to patients as well as to the main population . Practice Implication s Having better knowledge about patients ’ difficulties in underst and ing RCTs would allow physicians to adjust the information they give and then to enhance patients ’ well-being We attempted to characterize the motivation , comprehension and expectations of patients who had given informed consent to participate in phase I trials of anti-cancer agents at the National Cancer Center of Japan . Thirty-three patients were given a simple multiple-choice question naire  and asked to return it at a later date . The completed survey was returned by 32 patients . The patients were surveyed before they had received any investigational phase I agents . Nineteen per cent of patients were motivated to participate in the phase I trials by the possibility of therapeutic benefit , 9 % because participation seemed a better choice than no treatment and only 6 % for altruistic reasons . Most patients comprehended the major features of a phase I trial , namely its investigational nature , the unknown effects of the agent investigated and the unclear benefit to the patients themselves . Fifty-nine per cent of the patients anticipated that they might suffer severe or life-threatening side-effects if they participated in the phase I trial , and 43 % were able to indicate accurately the purpose of the phase I trial as a dose determination study . Although only a minority of the patients indicated that their motivation to participate was possible treatment benefit to themselves , when answering questions regarding expectations , more than half indicated that there might be personal benefits of varying degrees by participation Background and aim : As non-r and omised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infa rct ion , r and omisation may be considered unethical in controlled trials testing this treatment strategy . We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infa rct ion with Life-threatening Edema Trial ( HAMLET ) and representatives of patients participating in the r and omised trial of Paracetamol ( Acetaminophen ) In Stroke ( PAIS ) . Methods : 1 year after study inclusion , we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET , and 30 for PAIS .  Recall of trial details and appreciation of the informed consent procedure were investigated using st and ardised question naires and compared between the two groups . Results : All 30 PAIS representatives and 28 HAMLET representatives were interviewed . Participation of their relative in a clinical trial was remembered by 86 % of HAMLET and 40 % of PAIS representatives ( p<0.001 ) . HAMLET representatives remembered more trial details ( effect of the treatment under study ( 61 % vs 3 % , p<0.001 ) ; r and omised treatment allocation ( 71 % vs 0 % , p<0.001 ) ) . With respect to appreciation of the informed consent procedure , we found no differences between the groups : in each trial , four representatives ( 14 % vs 13 % ) had considered the question of r and omisation unacceptable . Conclusions : Participation of patients in a r and omised controlled trial of surgical decompression for space occupying infa rct ion is generally considered acceptable by their representatives , and recall of trial details is better than in a trial in which less vital issues are at stake Background : R and omised controlled trials of interventions in critical situations are necessary to establish safety and evaluate outcomes .  Pregnant women have been identified as a potentially vulnerable population . Objective : To explore women ’s experiences of being recruited to ORACLE , a r and omised controlled trial of antibiotics in pre-term labour . Methods : Twenty qualitative interviews were conducted with women who had participated in ORACLE . Analysis was based on the constant comparative method . Results : Women gave prominence to the socioemotional aspects of their interactions with healthcare professionals in making decisions on trial participation . Comments on the quality of written and spoken information were generally favourable , but women ’s accounts suggest that the stressful nature of the situation affected their ability to absorb the information . Women generally had poor underst and ing of trial design and practice s. The main motivation for trial participation was the possibility of an improved outcome for the baby . The second and less prominent motivation was the opportunity to help others , but this was conditional on there being no risks associated with trial participation . In judging the risks of participation , women seemed to draw on “ common sense ” underst and ings including a perception that antibiotics were risk free . Discussion : Recruitment to trials in critical situations raises important questions . Future studies should explore how rigorous governance arrangements for trials , particularly in critical situations , can protect participants rather than relying on ideals of informed consent that may be impossible to achieve . Future research should include a focus on interactions between research c and i date s and professionals involved in recruitment 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 Background  Informed consent ( IC ) has been an international st and ard for decades for the ethical conduct of clinical trials . Yet frequently study participants have incomplete underst and ing of key issues , a problem exacerbated by language barriers or lack of familiarity with research concepts . Few investigators measure participant comprehension of IC , while even fewer conduct interim assessment s once a trial is underway . Methods and Findings We assessed comprehension of IC using a 20- question true/false quiz administered in 6-month intervals in the context of a placebo-controlled , r and omized trial for the prevention of tuberculosis among HIV-infected adults in Botswana ( 2004–2009 ) .  Quizzes were offered in both Setswana and English . To enroll in the TB trial , participants were required to have ≥16/20 correct responses  . We examined concepts understood and the degree to which underst and ing changed over three-years . We analyzed 5,555 quizzes from 1,835 participants . The participants ' highest education levels were : 28 % primary , 59 % secondary , 9 % tertiary and 7 % no formal education . Eighty percent of participants passed the enrollment quiz  ( Quiz1 ) on their first attempt and the remainder passed on their second attempt . Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt ( adjusted odds ratios and 95 % confidence intervals , 3.1 ( 2.4–4.0 ) and 1.5 ( 1.2 , 1.9 ) , respectively ) . The trial 's purpose or procedures were understood by 90–100 % of participants , while 44–77 % understood r and omization , placebos , or risks . Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial . Pass rates improved with quiz re-administration in subsequent years . Conclusions Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large , international collaboration and efficiently determined IC comprehension by trial participants . Strategies to improve underst and ing of concepts like placebos and r and omization are needed . Comprehension assessment s throughout a study may reinforce key concepts In the Beta-blocker Heart Attack Trial ( BHAT ) a number of strategies were implemented to increase the probability of informed voluntary consent among survivors of an acute myocardial infa rct ion . To evaluate the subjects ' comprehension of the study , a bioethicist conducted in-depth home interviews with a r and om sample of 64 participants from 11 geographic areas . The great majority of respondents proved to be well informed about the study design , its scientific logic , and possible risks of the experimental drug . However , five subjects ( 8 % of the sample ) appeared to believe they were involved in a therapeutic program rather than a research project . The analysis of predictor variables indicates that education , race , and age were associated with the degree of respondent awareness of fundamental aspects of the trial Background : In patients with acute life threatening diseases , and in their relatives , the ability to make a balanced decision on participation in a clinical trial may be impaired . Objectives : To assess what relevant information could be recalled by patients who were living independently after a subarachnoid haemorrhage , and by their relatives ; and to determine how these patients and relatives had reacted to the informed consent encounter . Methods : Twenty months ( range 7 to 31 ) after treatment for subarachnoid haemorrhage , 49 patients and 47 relatives who had participated in one of two r and omised trials on medical management were interviewed . The interview consisted of items on : spontaneous recall and knowledge of trial design ; underst and ing of the trial design and the informed consent procedure ; the amount and clarity of the information given ; and reasons for participating . Finally patients and relatives were asked whether they would participate again in similar circumstances . Results : One third of the patients recalled having participated in a clinical trial . Thirteen per cent of the patients and 20 % of the relatives felt that the information supplied had not been sufficient . Nine per cent of the patients and half the relatives had read the written information . None of the patients and one relative thought that participation had been obligatory . Twenty eight per cent of the patients and 94 % of the relatives felt in retrospect that they had been capable of making an adequate decision . Virtually all patients and relatives would participate again in similar circumstances . Conclusions : Many patients and their relatives have little recall of the informed consent procedure and the essentials of acute subarachnoid haemorrhage trials . However , most were satisfied with the overall procedure and would participate again 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 
    Output:
    
Investigators could do more to help participants achieve a complete underst and ing