Tonic Arousal During Field Polygraph Tests in Guilty vs. Innocent Suspects in Japan

Eighty four sets of GKT field data (52 guilty and 32 innocent persons) were analyzed for tonic level of heart rate and respiration rate during polygraph interrogation. The innocent persons in our sample showed consistently lower heart rate than guilty persons and revealed significant decrease over the course of interrogation, whereas guilty persons did not. Respiration rate was not significantly different between these two groups. Although it is popularly believed that a naïve person tends to show and maintain higher cardiovascular and respiratory activity during polygraphy, and that this makes polygraph interrogation ineffective, such is not the case at least in the GKT polygraph.     

The P300-Based, Complex Trial Protocol for Concealed Information Detection Resists Any Number of Sequential Countermeasures Against Up to Five Irrelevant Stimuli

We previously tested the P300-based Complex Trial protocol for deception detection against 2 and 4 countered of 4 irrelevant stimuli. The protocol detected 90-100% of these subjects with <10% false positives. We have also shown that Reaction Time (RT) to the first trial stimulus is increased (group effect) with countermeasure use. We also reported a new P900 component associated with countermeasure use when 2 of 4 irrelevants are countered. In the present study we report data from 4 new groups and re-present for comparison previously collected data to have 7 groups: an innocent control, a guilty group not using countermeasures, and 5 guilty/countermeasure groups who counter from 1 to all 5 stimuli presented (4 irrelevants plus a probe). Subjects were detected at rates varying from 92 to 100% in the 6 guilty groups (n = 12 or 13 per group). There was 1 false positive in 13 innocent subjects. Additionally, 41 of 60 CM users were identified with RT as using countermeasures. P900 appeared in the 2 groups using 2 and 3 countermeasures.     

Autonomous Judges: African Ordeals as Dramas of Power

Judicial ordeals subject accused persons to fire, poison etc. and mark or kill those whom they divine as guilty, while the innocent are unscathed. They presume a person-directed universe, may share features with non-divinatory processes and can be used politically, but they are trusted as autonomous, unlike fallible human judgments. African examples are comparable in form and often in context to those of medieval Europe. The article focuses on sasswood poison ordeals in Southeastern Liberia. It is argued that they change over time and may convince individual participants differently. They are also considered as persuasive dramaturgical events.     

The probability of matching genetic markers in different samples

Hypervariable DNA polymorphisms in humans have been introduced in forensic science for the exclusion of innocent persons, and possibily for the identification of guilty ones, through mismatches and matches of DNA patterns in incriminating samples. Under the assumption of random mating and linkage equilibrium, it is observed that the probability of mismatch, then of exclusion of innocent persons, is very high. The probability of a match on the contrary may be very low, particularly when several hypervariable DNA polymorphisms are used for the DNA pattern. When a match is observed, and the probability of match is calculated, and it is lower than one in five billions, this might be considered incriminating by a judge. It is concluded that an innocent person has all advantages in submitting to the DNA fingerprinting test.     

Does Exonerating an Accused Researcher Restore the Researcher’s Credibility?

Scientific misconduct appears to be on the rise. However, an accused researcher may later be exonerated. The present research examines to what extent participants adhere to their attitude toward a researcher who allegedly committed academic misconduct after learning that the researcher is innocent. In two studies, participants in an exoneration and an uncorrected accusation condition learned that the ethics committee of a researcher’s university demanded the retraction of one of the researcher’s articles, whereas participants in a control condition did not receive this information. As intended, this manipulation led to a more favorable attitude toward the researcher in the control compared to the exoneration and the uncorrected accusation conditions (pre-exoneration attitude). Then, participants in the exoneration condition learned that the researcher was exonerated and that the article was not retracted. Participants in the uncorrected accusation and the control condition were not informed about the exoneration. Results revealed that the exoneration effectively worked, in that participants in the exoneration condition had a more favorable attitude (post-exoneration attitude) toward the researcher than did participants in the uncorrected accusation condition. Moreover, the post-exoneration attitude toward the researcher was similar in the exoneration and the control conditions. Finally, in the exoneration condition only, participants’ post-exoneration attitude was more favorable than their pre-exoneration attitude. These findings suggest that an exoneration of an accused researcher restores the researcher’s credibility.     

Participant informed consent in cluster randomized trials: review

Background

The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information.

Methods and Findings

We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%). In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization) was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias.

Conclusions

For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully described (namely, whether participants were informed of the allocation group before being recruited) for a better appraisal of the risk of selection bias.     

PROCESS FOR OBTAINING INFORMED CONSENT: WOMEN’S OPINIONS

In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96. 1 Consent must be obtained through a specific structured process. Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women’s health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. Results: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long‐term effects. The use of audiovisual aids to provide information was suggested. Conclusion: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided.     

Evaluation of two communication tools,slideshow and theater,to improve participants’ understanding of a clinical trial in the informed consent procedure on Pemba Island,Tanzania

BackgroundClinical trial participants are required to sign an informed consent form (ICF). However, information is lacking on the most effective methods to convey trial relevant information prior to inviting participants to sign the ICF, being particularly pertinent in low-income countries. A previous study on Pemba Island, Tanzania, found that a verbal information session (IS) was significantly better than providing an ICF alone. However, knowledge gaps remained. Building on these findings, we investigated the effect of adding a slideshow or a theater to the IS in the informed consent procedure of an anthelminthic clinical trial.Methodology/principal findingsA total of 604 caregivers were randomized into the control group that only received an ICF (n = 150) or an ICF plus one of three intervention strategies: (i) verbal IS (n = 135), (ii) verbal IS with a slideshow (n = 174) or (iii) verbal IS followed by a theater (n = 145). All modes of information covered the same key messages. Participants’ understanding was assessed using a semi-structured questionnaire. The mean score of caregivers in the control group (ICF only) was 4.41 (standard deviation = 1.47). Caregivers attending the IS alone were more knowledgeable than those in the control group (estimated difference in mean scores: 2.40, 95% confidence interval (CI) 1.95 to 2.86, p < 0.01). However, there was no evidence of an improvement compared to the IS only when participants attended a slideshow (0.09, 95% CI -0.53 to 0.35, p = 0.68) or a theater (0.28, 95% CI -0.27 to 0.82, p = 0.32). Three out of 10 key messages remained largely misunderstood, regardless of the mode of information group.Conclusions/significanceOur study confirmed that, in this setting, an ICF alone was not sufficient to convey clinical trial-related information. An IS was beneficial, however, additional theater and slideshows did not further improve understanding. Future research should explore methods to improve communication between study teams and participants for different key messages, study types and settings.     

Information that should be given to HIV cohort participants during ongoing research: the viewpoints of patient representatives and research professionals

While investigators have a duty to provide research participants with summary findings at the end of a study, providing general information during the course of research is rarely considered. However, this raises an important ethical issue in the context of long-term studies such as cohorts or biobanks. We investigated this issue in the context of two ANRS cohorts of HIV-infected patients, AQUITAINE and COPILOTE. Face-to-face interviews were conducted with HIV patient representatives and research professionals concerning the delivery of information in the course of the research. Respondents stated that participants wish to be informed of research results (both aggregate and individual) but also expect general information about the cohort itself, research progression, and what their participation may provide. It was concluded that information provided during the course of the research may help participants to distinguish between care and research. The essential role of clinicians-investigators in providing information was emphasized.     

A multimedia tool for the informed consent of patients prior to gastric banding

Objective: Severe obesity is a clear indication for appropriate, effective weight loss therapy. One option is operative intervention, e.g., gastric banding. Risks of the operation and therapeutic alternatives need to be comprehensibly presented to the patient. The literature has shown that better informed consent is obtained using information presented in a multimedia/video‐based format. The current study developed and evaluated a multimedia program aimed at obtaining informed consent from obese patients before gastric banding. Research Methods and Procedure: An interactive multimedia program was developed with information about preoperative examinations, the operation itself, hospital stay, operative risks, alternative therapies, and the pathophysiology and health risks of obesity. Two groups (Group 1, n = 20, mean age 38 years, informed consent attained with conventional document information; Group 2, n = 20, mean age 37 years, informed consent attained with additional multimedia information) were interviewed regarding comprehensibility of the information presented, personal satisfaction, and anxiety levels during the informed consent process. Results: Group 2 showed significantly better (p < 0.05) understanding of the presented information and higher levels of satisfaction with the informed consent process. Anxiety levels did not significantly differ between the two groups. Discussion: Because patient satisfaction with the informed consent process and understanding of the presented information significantly improved, the multimedia program clearly benefits both surgeons and patients. Personal contact from the surgeon remains essential. High volumes of information presented in multimedia format do not alleviate patient anxiety, and personal contact may be beneficial.     

A Novel Approach for Lie Detection Based on F-Score and Extreme Learning Machine

A new machine learning method referred to as F-score_ELM was proposed to classify the lying and truth-telling using the electroencephalogram (EEG) signals from 28 guilty and innocent subjects. Thirty-one features were extracted from the probe responses from these subjects. Then, a recently-developed classifier called extreme learning machine (ELM) was combined with F-score, a simple but effective feature selection method, to jointly optimize the number of the hidden nodes of ELM and the feature subset by a grid-searching training procedure. The method was compared to two classification models combining principal component analysis with back-propagation network and support vector machine classifiers. We thoroughly assessed the performance of these classification models including the training and testing time, sensitivity and specificity from the training and testing sets, as well as network size. The experimental results showed that the number of the hidden nodes can be effectively optimized by the proposed method. Also, F-score_ELM obtained the best classification accuracy and required the shortest training and testing time.     

Countering Countermeasures in the Concealed Information Test Using Covert Respiration Measures

The effects of physical and mental countermeasures on the accuracy of the concealed information test (CIT) were examined in a mock crime experiment with 64 participants. To combat countermeasures, two covert respiration measures, hidden in the seat and back of the examination chair, were used in addition to the standard physiological measures (SCR, FPWL, RLL). Some guilty participants were trained to use either physical or mental countermeasures and apply them to distort the outcomes of the CIT. In the second phase of the experiment participants were detached from the standard polygraph devices and examined solely with the two covert measures. Results indicated that physical countermeasures lowered SCR accuracy but had a relatively small effect on the other standard measures. On the other hand, SCR was relatively resistant to mental countermeasures. Both covert measures were resistant to physical countermeasures in the polygraph phase. When the standard devices were removed, the covert seat measure was effective in the no countermeasure and in the mental countermeasure conditions but not when physical countermeasures were applied. The back measure was entirely ineffective.

WHAT SHOULD RESEARCH PARTICIPANTS UNDERSTAND TO UNDERSTAND THEY ARE PARTICIPANTS IN RESEARCH?

To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution : those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship : the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact : the extent to which participating in the study will alter what participants do and what happens to them.     

To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka,Zambia

We conducted a study to review the consenting process in a vaginal Microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not attained from most of the participants since 77% (n = 154) of the participants had numerous questions about the study and 34% (n = 68) did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations.     

Informing participants of allocation to placebo at trial closure: postal survey

ObjectivesTo assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback.DesignPostal survey with a semistructured questionnaire.ParticipantsAll investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database.Results45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%).ConclusionFurther research is required to examine sensitive ways to communicate treatment information to trial participants.

What is already known on this topic

Information is poor on the nature, extent, and effect of informing participants of placebo controlled randomised trials about their treatment allocation at trial closureLess than 50% of participants receiving placebo are informed about their treatment allocation

What this study adds

No standard procedure is available for informing patients of their treatment arm or of study results at the end of a trialEffective and sensitive ways of communicating treatment allocation to participants are required, as is information on the effects on placebo responders     

The Definition of Placebo in the Informed Consent Forms of Clinical Trials

Aim

Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee.

Methods

All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety.

Results

Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all.

Conclusions

Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate.     

Development and First Phase Evaluation of a Maternity Leave Educational Tool for Pregnant,Working Women in California

Background

Despite the provision of maternity leave offered to mothers, many American women fail to take leave.

Methods

We developed an evidence-based maternity leave educational tool for working women in California using participatory design. We tested its short-term efficacy with a randomized controlled trial of pregnant English-speakers (n=155).

Results

Among intervention participants exposed to the tool, 65% reported that they learned something new; 38% were motivated to seek more information; and 49% said it helped them plan their maternity leave. Among participants who delivered at ≥ 37 weeks gestation and said the tool helped them plan their leave, 89% took more than one week of prenatal leave, a significantly higher proportion than among controls who did not receive the tool (64%, p=0.049). Other findings favored trial participants, but were not statistically significant in this small sample. More intervention participants took some prenatal leave (80%) vs. controls (74%, p=0.44). Among participants who had returned to work when surveyed (n=50), mean postnatal leave uptake was on average 1 week longer for intervention participants vs. controls (13.3 vs. 12.2 weeks, p=0.54).

Conclusions

The first-phase evaluation of this tool shows that it successfully informed women about maternity leave options, clarified complex regulations, encouraged women to seek further information and helped plan maternity leave. Compared to controls, trial participants who used the tool to plan their leave were far more likely to take prenatal leave close to term. Future evaluation of the tool when mediated by a health provider or employer is warranted.     

What research participants want to know about genetic research results: the impact of "genetic exceptionalism"

The disclosure of individual genetic results has generated an ongoing debate about which rules should be followed. We aimed to identify factors related to research participants' preferences about learning the results of genomic studies using their donated tissue samples. We conducted a cross-sectional survey of 279 patients from the United States and Spain who had volunteered to donate a sample for genomic research. Our results show that 48% of research participants would like to be informed about all individual results from future genomic studies using their donated tissue, especially those from the U.S. (71.4%) and those believing that genetic information poses special risks (69.7%). In addition, 16% of research participants considered genetic information to be riskier than other types of personal medical data. In conclusion, our study demonstrates that a high proportion of participants prefer to be informed about their individual results and that there is a higher preference among those research subjects who perceive their genetic information as riskier than other types of personal medical data.     

Patients' Perception of Quality of Pre-Operative Informed Consent in Athens,Greece: A Pilot Study

Background

We sought to perform a study to record and evaluate patients'' views of the way surgeons communicate informed consent (IC) in Greece.

Methodology/Principal Findings

A prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males) volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD) was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3%) achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD) was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman''s rank-order correlation coefficient was 0.4 and p<0.001). Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001), and among participants who were given information regarding other possible therapeutic options (p = 0.001). 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC.

Conclusions

Despite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as the patient-physician relationship, the time spent by the physician to inform the patient, a participant''s comprehension of the right to IC and the provision of information regarding other possible therapeutic options.     

Cardiovascular evaluation,including resting and exercise electrocardiography,before participation in competitive sports: cross sectional study

Objective To evaluate the clinical usefulness of complete preparticipation cardiovascular screening in a large cohort of sports participants.Design Cross sectional study of data over a five year period.Setting Institute of Sports Medicine in Florence, Italy.Participants 30 065 (23 570 men) people seeking to obtain clinical eligibility for competitive sports.Main outcome measures Results of resting and exercise 12 lead electrocardiography.Results Resting 12 lead ECG patterns showed abnormalities in 1812 (6%) participants, with the most common abnormalities (>80%) concerning innocent ECG changes. Exercise ECG showed an abnormal pattern in 1459 (4.9%) participants. Exercise ECG showed cardiac anomalies in 1227 athletes with normal findings on resting ECG. At the end of screening, 196 (0.6%) participants were considered ineligible for competitive sports. Among the 159 participants who were disqualified at the end of the screening for cardiac reasons, a consistent proportion (n=126, 79.2%) had shown innocent or negative findings on resting 12 lead ECG but clear pathological alterations during the exercise test. After adjustment for possible confounders, logistic regression analysis showed that age >30 years was significantly associated with an increased risk of being disqualified for cardiac findings during exercise testing.Conclusions Among people seeking to take part in competitive sports, exercise ECG can identify those with cardiac abnormalities. Follow-up studies would show if disqualification of such people would reduce the incidence of CV events among athletes.