BackgroundThe use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.MethodsThis multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).ResultsOf the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).ConclusionsResearch participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0318-x) contains supplementary material, which is available to authorized users.
Bowel obstruction is one of the most common surgical emergencies and a major cause of morbidity and mortality. Standard supportive measures must be instituted as soon as the diagnosis is confirmed. Anastomotic strictures are a benign etiology of intestinal obstruction, occurring in up to 22 % of patients following colorectal resection. Traditionally, endoscopic balloon dilation (EBD) has been the intervention of choice in such cases; however, it may not be feasible in all settings. We report a novel application of the AXIOS stent and electrocautery-enhanced delivery system (Boston Scientific, Marlborough, Massachusetts, United States) to create a colo-colostomy to bypass a sigmoid colon stricture in a 51-year-old woman who presented with acute intestinal obstruction. Despite stent dislodgment during the procedure, the preexisting tract allowed us to improvise our technique with a second LAMS placement. The patient was discharged well 48 hours after the procedure. However, 4 months later, she required a session of EBD following a presentation for fecal impaction. She is currently asymptomatic and being followed up regularly as an outpatient.
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