***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: BACKGROUND The informed consent of participants is ethically and legally required for most research involving human subjects . However , st and ardized methods for assessing the adequacy of informed consent to research are lacking . METHODS AND RESULTS We design ed a brief question naire , the  Quality of Informed Consent ( QuIC ) , to measure subjects ' actual ( objective ) and perceived ( subjective ) underst and ing of cancer clinical trials . The QuIC incorporates the basic elements of informed consent specified in federal regulations , assesses the therapeutic misconception ( the belief that all aspects of a clinical trial are design ed to directly benefit the subject ) , and employs the language and structure of the new National Cancer Institute template for informed consent documents . We modified the QuIC after receiving feedback from pilot tests with cancer research subjects , as well as validation from two independent expert panels . We then sent the QuIC to 287 adult cancer patients enrolled on phase I , II , or III clinical trials . Two hundred seven subjects ( 72 % ) completed the QuIC . To assess test-retest reliability , a r and om sample of 32 respondents was selected , of whom 17 ( 53 % ) completed the question naire a second time . The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective underst and ing and .77 for tests of subjective underst and ing . The current version of the QuIC , which consists of 20 questions for objective underst and ing and 14 questions for subjective underst and ing , was tested for time and ease of administration in a sample of nine adult cancer patients . The QuIC required an average of 7.2 minutes to complete . CONCLUSIONS The QuIC is a brief , reliable , and valid question naire that holds promise as a st and ardized way to assess the outcome of the informed consent process in cancer clinical trials Objective . Health professionals must enable patients to make informed decisions about health care choices through unbiased presentation of all options . This study examined whether presenting the decision as “ opportunity ” rather than “ choice ” biased individuals ’ preferences in the context of trial participation for cancer treatment . Methods . Self- selecting healthy women ( N = 124 ) were r and omly assigned to the following decision frames : opportunity to take part in the trial ( opt-in ) , opportunity to be removed from the trial ( opt-out ) , and choice to have st and ard treatment or take part in the trial ( choice ) . The computer-based task required women to make a hypothetical choice about a real-world cancer treatment trial . The software presented the framed scenario , recorded initial preference , presented comprehensive and balanced information , traced participants ’ use of information during decision making , and recorded final decision . A posttask paper question naire assessed perceived risk , attitudes , subjective norm , perceived behavioral control , and satisfaction with decision . Results . Framing influenced women ’s immediate preferences . Opportunity frames , whether opt-in or opt-out , introduced a bias as they discouraged women from choosing st and ard treatment . Using the choice frame avoided this bias . The opt-out opportunity frame also affected women ’s perceived social norm ; women felt that others endorsed the trial option . The framing bias was not present once participants had had the opportunity to view detailed information on the options within a patient decision aid format . There were no group differences in information acquisition and final decisions . Sixteen percent changed their initial preference after receiving full information . Conclusions . A “ choice ” frame , where all treatment options are explicit , is less likely to bias preferences . Presentation of full information in parallel , option-by-attribute format is likely to “ de-bias ” the decision frame . Tailoring of information to initial preferences would be ill-advised as preferences may change following detailed information Purpose : To determine the individual and combined effects of a simplified form and a review /retest intervention on  biobanking consent comprehension . Methods : We conducted a national online survey in which participants were r and omized within four educational strata to review a simplified or traditional consent form . Participants then completed a comprehension quiz ; for each item answered incorrectly , they review ed the corresponding consent form section and answered another quiz item on that topic . Results : Consistent with our first hypothesis , comprehension among those who received the simplified form was not inferior to that among those who received the traditional form . Contrary to expectations , receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group . The review /retest procedure significantly improved quiz scores in every combination of consent form and education level . Although improved , comprehension remained a challenge in the lowest-education group . Higher quiz scores were significantly associated with willingness to participate . Conclusion : Ensuring consent comprehension remains a challenge , but simplified forms have virtues independent of their impact on underst and ing . A review /retest intervention may have a significant effect , but assessing comprehension raises complex questions about setting thresholds for underst and ing and consequences of not meeting them . Genet Med advance online publication 13 October Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long , there is little research on whether longer informed consent documents actually result in ( 1 ) better informed research subjects or ( 2 ) higher consent rates . We therefore conducted an add-on r and omized controlled trial to the Takashima Study , a prospect i ve Japanese population -based genetic cohort study , to test the hypothesis that a shorter informed consent form would satisfy both of the above goals . Methods St and ard ( 10 459 words , 11 pages ) and short ( 3602 words , 5 pages ) consent forms in Japanese were developed and distributed using cluster-r and omization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units , respectively . Results Few differences were found between the 2 groups with regard to outcome measures , including participants ’ self-perceived underst and ing , recall of information , concerns , voluntariness , trust , satisfaction , sense of duty , and consent rates . Conclusions A short informed consent form was no less valid than a st and ard form with regard to fulfilling ethical requirements and securing the scientific validity of research Purpose : The potential of interactive multimedia to improve biobank  informed consent has yet to be investigated . The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant underst and ing and confidence in underst and ing of informed consent compared with a st and ard , face-to-face ( F2F ) biobank consent process . Methods : A 2 ( face-to-face versus multimedia ) × 2 ( st and ard versus enhanced interactivity ) experimental design was used with 200 patients r and omly assigned to receive informed consent . All patients received the same information provided in the biobank ’s nine-page consent document . Results : Interactivity ( F(1,196 ) = 7.56 , P = 0.007 , partial η2 = 0.037 ) and media ( F(1,196 ) = 4.27 , P = 0.04 , partial η2 = 0.021 ) independently improved participants ’ underst and ing of the biobank consent . Interactivity ( F(1,196 ) = 6.793 , P = 0.01 , partial η2 = 0.033 ) , but not media ( F(1,196 ) = 0.455 , not significant ) , result ed in increased participant confidence in their underst and ing of the biobank ’s consent material s. Patients took more time to complete the multimedia condition ( mean = 18.2 min ) than the face-to-face condition ( mean = 12.6 min ) . Conclusion : This study demonstrated that interactivity and multimedia each can be effective at promoting an individual ’s underst and ing and confidence in their underst and ing of a biobank consent , albeit with additional time investment . Research ers should not assume that multimedia is inherently interactive , but rather should separate the two constructs when study ing electronic consent . Genet Med 18 1 , 57–64 Purpose : Federal regulations and best practice guidelines identify categories of information that should be communicated to prospect i ve biobank participants during the informed consent process . However , uncertainty remains about which of this information participants must underst and to provide valid consent . Methods : We conducted a Delphi process to define “ adequate comprehension ” in the context of biobanking consent . The process involved an iterative series of three online surveys of a diverse panel of 51 experts , including genome scientists , biobank managers , ethics and policy experts , and community and participant representatives . We sought consensus ( > 70 % agreement ) concerning what specific details participants should know about 16 biobank consent topics . Results : Consensus was achieved for 15 of the 16 consent topics . The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act . Conclusion : Our Delphi process was successful in identifying a concise set of key points that prospect i ve participants must grasp to provide valid consent for biobanking . Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes , as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension . Genet Med 17 3 , 226–233 OBJECTIVE Patients are commonly presented with complex documents that they have difficulty underst and ing . The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants . METHODS Subjects were invited to participate in a simulated consent process for a study involving a genetic repository . Explanation of the research consent form by the computer agent was compared to explanation by a human and a self- study condition in a r and omized trial . Responses were compared according to level of health literacy . RESULTS Participants were most satisfied with the consent process and most likely to sign the consent form when it was explained by the computer agent , regardless of health literacy level . Participants with adequate health literacy demonstrated the highest level of comprehension with the computer agent-based explanation compared to the other two conditions . However , participants with limited health literacy showed poor comprehension levels in all three conditions . Participants with limited health literacy reported several reasons , such as lack of time constraints , ability to re-ask questions , and lack of bias , for preferring the computer agent-based explanation over a human-based one . CONCLUSION Animated computer agents can perform as well as or better than humans in the administration of informed consent . PRACTICE IMPLICATION S Animated computer agents represent a viable method for explaining health documents to patients Using examples from psychiatric research , the authors explore the ethical dilemma of the " therapeutic misconception , " where , despite explanation , patient-subjects believe that research protocol s are design ed to benefit them directly rather than to test or compare treatment methods . Even potential subjects who demonstrate an underst and ing of r and omization , double-blinded studies , and the use of placebos frequently persist in a belief that they purpose ly will receive the treatment most likely to benefit them . They expect the st and ards of personal care that characterize the therapeutic relationship to carry over to the clinical trial , failing to underst and that the need for valid research results makes this impossible . Appelbaum et al. suggest ways in which patients can be made to underst and the differences between treatment and research , and the disadvantages and advantages of participation in the latter As genomic research ers are urged to openly share generated sequence data with other research ers , it is important to examine the utility of informed consent documents and processes , particularly as these relate to participants ' engagement with and recall of the information presented to them , their objective or subjective underst and ing of the key elements of genomic research ( e.g. , data sharing ) , as well as how these factors influence or mediate the decisions they make . We conducted a r and omized trial of three experimental informed consent documents ( ICDs ) with participants ( n = 229 ) being recruited to genomic research studies ; each document afforded varying control over breadth of release of genetic information . Recall and underst and ing , their impact on data sharing decisions , and comfort in decision making were assessed in a follow-up structured interview . Over 25 % did not remember signing an ICD to participate in a genomic study , and the majority ( 54 % ) could not correctly identify with whom they had agreed to share their genomic data . However , participants felt that they understood enough to make an informed decision , and lack of recall did not impact final data sharing decisions or satisfaction with participation . These findings raise questions about the types of information participants need in order to provide valid informed consent , and whether subjective underst and ing and comfort with decision making are sufficient to satisfy the ethical principle of respect for persons BACKGROUND Many research studies conducted today in critical care have a genomics component . Patients ' surrogates asked to authorize participation in  genomics research  for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient 's participation in the research . OBJECTIVES To examine the effectiveness of a new , computer-based education module on surrogates ' underst and ing of the process of informed consent for genomics research . METHODS A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center . Visitors were r and omly assigned to the experimental ( education module plus a sample genomics consent form ; n = 65 ) or the control ( sample genomics consent form only ; n = 69 ) group . Participants later completed a test on  informed genomics consent .  RESULTS Underst and ing the process of informed consent was greater ( P = .001 ) in the experimental group than in the control group . Specifically , compared with the control group , the experimental group had a greater underst and ing of 8 of 13 elements of informed consent : intended benefits of research ( P = .02 ) , definition of surrogate consenter ( P= .001 ) , withdrawal from the study ( P = .001 ) , explanation of risk ( P = .002 ) , purpose of the institutional review board ( P = .001 ) , definition of substituted judgment ( P = .03 ) , compensation for harm ( P = .001 ) , and alternative treatments ( P = .004 ) . CONCLUSIONS Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit . Preparing patients ' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care 
    Output:
    
Results indicated that elements of informed consent unique to biobanking were poorly understood .
Increased disclosures , values-clarification , and presenting information via multiple modalities may facilitate underst and ing .