BACKGROUND: Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a \'trusting relationship\' with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients\' and healthcare professionals\' perspectives.
METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding.
RESULTS: The \'Trusting relationship\' with healthcare professionals underpinned patient motivation to participate, with many patients \'feeling lucky\' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of \'What the doctor thinks is best\' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to \'please\' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, \'Is it possible to provide balanced information?\'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process.
CONCLUSIONS: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the \'experts\'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient\'s life is limited.

Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.

UNASSIGNED: Obtaining informed consents from older adults is surrounded by many ethical and practical challenges. The objective of this study was to evaluate ethical issues and strategies in consenting older adults in Jordan as perceived by academic researchers and older adults.
UNASSIGNED: An anonymous questionnaire was distributed to academic researchers in the Jordanian health sciences colleges, and a sample of older adults. The study survey included items eliciting demographics, professional characteristics, and perceptions regarding the consenting process in older adults, consent-related skills in elderly, and strategies to improve the consenting process in older adults. The survey was then modified to assess the consent-related ethical issues and challenges as viewed by a sample of older adults after explaining the concept of the consenting process to them.
UNASSIGNED: A total of 250 academic researchers and 233 older adults participated in the study. Both researchers and older adults reported that having to sign the written forms and the impact of age-related physical impairments were the most challenging obstacles when consenting older adults. Lack of consistency and repeating questions were the most frequently encountered obstacles by researchers in consenting older adults. Ensuring privacy (anonymity/confidentiality), dedicating more time for the consenting process, treating older adults as autonomous individuals and respecting their cultural beliefs were the most helpful strategies recommended by both academic researchers and older adults.
UNASSIGNED: Obtaining informed consents from older adults is a challenging process. Researchers should be aware of the special needs and strategies to achieve realistic and ethical informed consents from older adults.

Rapid Ethical Assessment (REA) is an approach used to design context tailored consent process for voluntary participation of participants in research including human subjects. There is, however, limited evidence on the design of ethical assessment in studies targeting cancer patients in Ethiopia. REA was conducted to explore factors that influence the informed consent process among female cancer patients recruited for longitudinal research from Addis Ababa Population-based Cancer Registry.
Qualitative study employing rapid ethnographic approach was conducted from May-July, 2017, at the Tikur Anbessa Specialized Referral Hospital. In-depth and key informants\' interviews were conducted among purposively selected 16 participants. Regular de-briefings among the study team helped to identify emerging themes and ensure saturation. Interviews and debriefings were tape recorded in Amharic, and transcribed and translated to English. Coding of the transcripts was facilitated by use of NVivo software. Thematic analysis was employed to respond to the initial questions and interpret findings.
Perceived barriers to voluntary study participation included lack of reporting back study results of previous studies, the decision making status of women, hopelessness or fatigue in the patients, shyness of the women, data collectors approach to the patient, and patient\'s time constraints. Most of the patients preferred oral over written consent and face-to-face interview over telephone interview. Provision of detail information about the study, using short and understandable tool, competent, compassionate and respectful enumerators of the same gender were suggested to assure participation. Due to the perceived severity, the use of the term \"cancer\" was associated with fear and anxiety. Alternatively, uses of phrases like \"breast or cervical illness/disease\" were suggested during patient interviews.
Voluntary participation is not straight forward but affected by different factors. Using competent, compassionate and respectful enumerators, short and precise questioning tools to limit the time of the interview could improve voluntary participation. Moreover, careful consideration of the patients and families concept of the disease such as wording and information has to be taken into account. This assessment helped in improving the consent process of the ongoing project on breast and cervical cancer patients.

OBJECTIVE: To compare patient\'s perception of consent quality, clinical and quality-of-life outcomes after laser vision correction (LVC) and refractive lens exchange (RLE) between patients who met their treating surgeon prior to the day of surgery (PDOS) or on the day of surgery (DOS).
METHODS: Retrospective, comparative case series.
METHODS: Optical Express, Glasgow, UK.
METHODS: Patients treated between October 2015 and June 2016 (3972 LVC and 979 RLE patients) who attended 1-day and 1-month postoperative aftercare and answered a questionnaire were included in this study. All patients had a thorough preoperative discussion with an optometrist, watched a video consent, and were provided with written information. Patients then had a verbal discussion with their treating surgeon either PDOS or on the DOS, according to patient preference. Preoperative and 1-month postoperative visual acuity, refraction, preoperative, 1-day and 1-month postoperative questionnaire were compared between DOS and PDOS patients. Multivariate regression model was developed to find factors associated with patient\'s perception of consent quality.
RESULTS: Preoperatively, 8.0% of LVC and 17.1% of RLE patients elected to meet their surgeon ahead of the surgery day. In the LVC group, 97.5% of DOS and 97.2% of PDOS patients indicated they were properly consented for surgery (P=0.77). In the RLE group, 97.0% of DOS and 97.0% of PDOS patients stated their consent process for surgery was adequate (P=0.98). There was no statistically significant difference between DOS and PDOS patients in most of the postoperative clinical or questionnaire outcomes. Factors predictive of patient\'s satisfaction with consent quality were postoperative satisfaction with vision (46.7% of explained variance), difficulties with night driving, close-up vision or outdoor/sports activities (25.4%), visual phenomena (12.2%), dry eyes (7.5%), and patient\'s satisfaction with surgeon\'s care (8.2%).
CONCLUSIONS: Perception of quality of consent was comparable between patients that elected to meet the surgeon PDOS, and those who did not.

OBJECTIVE: When considering repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, clinicians often face a lack of detailed information on potential interactions between rTMS and pharmacotherapy. This is particularly relevant to patients receiving bupropion, a commonly prescribed antidepressant with lower risk of sexual side effects or weight increase, which has been associated with increased risk of seizure in particular populations. Our aim was to systematically review the information on seizures occurred with rTMS to identify the potential risk factors with attention to concurrent medications, particularly bupropion.
METHODS: We conducted a systematic review through the databases PubMed, PsycINFO, and EMBASE between 1980 and June 2015. Additional articles were found using reference lists of relevant articles. Reporting of data follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.
METHODS: Two reviewers independently screened articles reporting the occurrence of seizures during rTMS. Articles reporting seizures in epilepsy during rTMS were excluded. A total of 25 rTMS-induced seizures were included in the final review.
METHODS: Data were systematically extracted, and the authors of the applicable studies were contacted when appropriate to provide more detail about the seizure incidents.
RESULTS: Twenty-five seizures were identified. Potential risk factors emerged such as sleep deprivation, polypharmacy, and neurological insult. High-frequency-rTMS was involved in a percentage of the seizures. None of these seizures reported had patients taking bupropion in the literature review. One rTMS-induced seizure was reported from the Food and Drug Administration in a sleep-deprived patient who was concurrently taking bupropion, sertraline, and amphetamine.
CONCLUSIONS: During the consent process, potential risk factors for an rTMS-induced seizure should be carefully screened for and discussed. Data do not support considering concurrent bupropion treatment as contraindication to undergo rTMS.

OBJECTIVE: In clinical trials where participants are likely to be able to distinguish between true and sham interventions, informing participants that they may receive a sham intervention increases the likelihood of participants \'breaking the blind\' and invalidating trial findings. The present study explored participants\' perceptions of the consent process in a sham controlled acupressure trial which did not explicitly indicate participants may receive a sham intervention.
METHODS: Nested qualitative study within a randomised sham controlled trial of acupressure wristbands for chemotherapy-related nausea. Convenience sample of 26 patients participated in semi-structured interviews. Interviews were audio-recorded and transcribed verbatim. Transcripts analysed thematically using framework analysis.
METHODS: Study conducted within three geographical sites in the UK: Manchester, Liverpool, and Plymouth.
RESULTS: All participants indicated that they believed they were fully informed when providing written consent to participate in the trial. Participants\' perceived it was acceptable to employ a sham intervention within the trial of acupressure wristbands without informing potential participants that they may receive a sham treatment. Despite the fact that participants were not informed that one of the treatment arms was a sham intervention the majority indicated they assumed one of the treatment arms would be placebo.
CONCLUSIONS: Many trials of acupuncture and acupressure do not inform participants they may receive a sham intervention. The current study indicates patients\' perceive this approach to the consent process as acceptable. However, the fact participants assume one treatment may be placebo threatens the methodological basis for utilising this approach to the consent process.

OBJECTIVE: Evidence indicates that research participants often do not fully understand the studies for which they have volunteered. The aim of this systematic review was to examine the relationship between the process of obtaining informed consent for research and participant comprehension and satisfaction with the research.
METHODS: Systematic review of published research on informed consent and participant comprehension of research for which they volunteer using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement as a guide.
METHODS: PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trails, and Cochrane Database of Systematic Reviews were used to search the literature for studies meeting the following inclusion criteria: (a) published between January 1, 2006, and December 31, 2013, (b) interventional or descriptive quantitative design, (c) published in a peer-reviewed journal, (d) written in English, and (e) assessed participant comprehension or satisfaction with the research process. Studies were assessed for quality using seven indicators: sampling method, use of controls or comparison groups, response rate, description of intervention, description of outcome, statistical method, and health literacy assessment.
RESULTS: Of 176 studies identified, 27 met inclusion criteria: 13 (48%) were randomized interventional designs and 14 (52%) were descriptive. Three categories of studies included projects assessing (a) enhanced consent process or form, (b) multimedia methods, and (c) education to improve participant understanding. Most (78%) used investigator-developed tools to assess participant comprehension, did not assess participant health literacy (74%), or did not assess the readability level of the consent form (89%). Researchers found participants lacked basic understanding of research elements: randomization, placebo, risks, and therapeutic misconception.
CONCLUSIONS: Findings indicate (a) inconsistent assessment of participant reading or health literacy level, (b) measurement variation associated with use of nonstandardized tools, and (c) continued therapeutic misconception and lack of understanding among research participants of randomization, placebo, benefit, and risk. While the Agency for Healthcare and Quality and National Quality Forum have published informed consent and authorization toolkits, previously published validated tools are underutilized.
CONCLUSIONS: Informed consent requires the assessment of health literacy, reading level, and comprehension of research participants using validated assessment tools and methods.