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.

Research Ethics Committees are composed of a minimum of five members which include a lay person, a member from a different institution and at least another three members which should be versed in ethics. Legal and expert advisors can be sought by the committee. The REC will require a detailed protocol from the researcher including the curriculum of the principal investigator and all other researchers under him/her. The protocol should include all details of the research to be undertaken including a detailed description, the reasons for the research, literature pertaining to the research, a clear description of the target population, the actual consent form including what information is to be given to the participants, a declaration where necessary that things prohibited by the law (such as use of embryonic stem cells if this is the case in the country [2] will not be researchers, and a declaration that the relevant directives and rules and procedures which the REC falls under will be followed. The REC will also require a description of any risks and what actions are to be undertaken to eliminate hazards. The researchers must adhere only to the protocol given and any changes, minor or major, must be reported to the REC and approved.

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.