The impact of obtaining explicit informed consent for medical student participation in the pelvic examination under anesthesia: A qualitative interview study
Hannah C. MiladKatie WatsonPatrick EucalittoRicky HillAlithia ZamantakisMarlise Jeanne Pierre‐WrightAdaeze A. EmekaSusan TsaiSusan GoldsmithMagdy P. Milad
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Pelvic examination
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—The purpose of our article was not to advance the debate about informed consent for the use of stored DNA. Our goal was to outline what should be done prospectively when obtaining informed consent for nonanonymous cancer susceptibility tests when the results will be disclosed to individual patients. Drs Page and Jensen overlook 2 important distinctions: one between existing samples and those being obtained in new projects, and the other between identifiable and "anonymized" samples. Are Page and Jensen suggesting that genetic testing on identifiable samples be permitted without specific consent? The authors support institutional review board review of protocols as an alternative to the guidelines emerging from multidisciplinary panels. However, the Office of Protection From Research Risks 1993 guidelines for institutional review boards states in the "Human Genetic Research" section: "Particular attention should be paid to protecting the confidentiality of the data and obtaining consent from the participants forInstitutional review board
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This chapter contains sections titled: Background to Working with People's Feelings Common Kinds of Difficulties with Feelings Skills and Techniques to Enable People to Change their Feelings Specific Techniques to Help People Change their Feelings The Application of Working with Feelings
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Introductory 420 I. Quantitative Results......... 422 Percentage of Localised Feelings 422 Distribution of Localised Feelings 422 Relation of Localised Feelings to Mixed Feelings 422 Conclusions 424 II. Analytical 424 Qualitative Differences of Feeling 424 Types of Localisation 426 Characterisation of Object-feeling 427 III. D iscussion 428 Dependence of Qualitative Differences of Feeling upon Sensory Com ponents 428 Dependence of Localisation of Feeling upon Sensory Components 429 Conclusions 430
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Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials.The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.
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Life is more than cat pictures. There are tough days, heartbreak, and hugs. Under what contexts do people share these feelings online, and how do their friends respond? Using millions of de-identified Facebook status updates with poster-annotated feelings (e.g., "feeling thankful" or "feeling worried"), we examine the magnitude and circumstances in which people share positive or negative feelings and characterize the nature of the responses they receive. We find that people share greater proportions of both positive and negative emotions when their friend networks are smaller and denser. Consistent with social sharing theory, hearing about a friend's troubles on Facebook causes friends to reply with more emotional and supportive comments. Friends' comments are also more numerous and longer. Posts with positive feelings, on the other hand, receive more likes, and their comments have more positive language. Feelings that relate to the poster's self worth, such as "feeling defeated," "feeling unloved," or "feeling accomplished" amplify these effects.
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Informed consent in research requires investigators to explain to potential participants the procedures, risks, benefits, and alternatives of a study through either oral or written consent. This article discusses cases when oral consent may be more appropriate to use than written consent. A proposal is presented for writing Institutional Review Board (IRB) protocols that incorporate both types of consent to protect the interests of participants and investigators.
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Background: Questions have been raised by researchers and ethics committees about whether human research subjects comprehend study participation when signing a research consent form. Methods: To determine existing beliefs about the informed consent review process, impediments to shorter consent, and augmented/alternative consent methods, a survey of institutional review board (IRB) chairpersons was conducted. Results: IRB chairs expressed concern with (but do not often assess) the length, complexity, and reading level of the consent form or participant comprehension. IRB chairs reported varied (but generally low) familiarity, acceptance, and use of possible solutions and alternatives. Conclusions: Best practice standards should be developed for (1) assessing consent form reading level; (2) measuring and monitoring participant comprehension; (3) alternative consent methods and enhancements; and (4) electronic signatures.
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Background: Patient participation in clinical research is low, in part because of the length and complexity of the informed consent process. Video informed consent may enhance the appeal of research and help break down barriers to participation. Methods and Results: The PALM study (Patient and Provider Assessment of Lipid Management) enrolled 7904 patients at cardiology, endocrinology, and primary care clinics across the United States to evaluate cholesterol management practices. Of 153 participating clinics, 67 (43.8%) secured institutional review board approval to use a tablet-based video informed consent tool that patients could select to navigate through the informed consent process instead of traditional text-based informed consent. At sites without institutional review board approval of video consent, all patients read a text-based informed consent document. Site activation times and enrollment volumes, as well as characteristics of enrolled patients, were compared between sites with and without video consent capability. Sites with video consent capability more often used a central institutional review board (89.6% versus 73.3%), were more often rural (16.7% versus 3.8%), and tended to have fewer providers. Compared with sites without video consent capability, sites with video consent capability had shorter times from site approach to first patient enrollment (median 178 versus 207 days; P =0.02). Sites with video consent capability enrolled similar numbers of patients as sites without video consent capability ( P =0.48) but enrolled a greater proportion of patients who were ≥75 years old (27.5% versus 23.6%; P <0.001) and nonwhite (17.7% versus 14.2%; P <0.001). Conclusions: In this observational study of recruitment in a multicenter registry, sites approved for video consent use enrolled the same number of patients as sites with only traditional text-based informed consent but had faster speed to first patient enrolled and more often enrolled older and nonwhite patients. Future randomized trials are needed to assess the impact of video consent on enrollment mechanics and demographics. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02341664
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