scholarly journals Negotiating informed consent: A students-as-partners perspective

2020 ◽  
Vol 4 (2) ◽  
pp. 132-137
Author(s):  
J. Michael Rifenburg ◽  
Emily Pridgen
Keyword(s):  
Informed Consent ◽  
Research Process ◽  
Central Place ◽  
Lead Author ◽  
Willingness To Participate ◽  
College Level ◽  
Research Participants ◽  
Consent Document ◽  
English Major ◽  
The University

Building on our 2019 ISSOTL poster presentation, we (Michael: a tenured English Department faculty member; and Emily: an undergraduate English major) are developing a reflective essay about our in-progress SaP project designed to assess the effectiveness of recent university system mandated curricular changes to multiple sections of an introductory college-level writing course at our home institution, the University of North Georgia, USA. Even though we received the necessary institutional and federal government permissions to conduct this research, and even though the research participants signed the necessary informed consent document, as we continue our data collection we wonder how we might better listen and watch for what Bivens (2018) calls “microwithdrawals of consent.” Bivens describes this phenomenon as the “implied or partial halt of a person’s willingness to participate in one or more aspects of the research process and the researcher’s awareness of that withdrawal.” Bivens calls on researchers to stay attuned to the participant’s body language and vocal tone to notice when participants may want to withdraw consent but not explicitly say so. When undergraduate researchers conduct interviews with other undergraduates, they are well-positioned to perceive these microwithdrawals of consent. With Emily as the lead author for this proposed piece, we wonder: How can students working in partnership with faculty help faculty better understand how informed consent is an on-going and negotiated process that does not end when research participants sign a consent document? Pondering this question emphasizes the “messy, ‘work in progress’ nature of SaP” (Matthews, 2017, p. 4), which, we argue should hold a central place in our SaP publications.

Reflexivity in Research Practice: Informed Consent with Children at School and at Home

2008 ◽  
Vol 13 (4) ◽  
pp. 17-30 ◽  
Author(s):  
Hayley Davies
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Research Process ◽  
Research Practice ◽  
Ethical Practices ◽  
Research Participants ◽  
Ethical Approach ◽  
Ethics Guidelines ◽  
Research Ethics Guidelines

Informed consent is a key consideration in ethical research, particularly research conducted with children. Devising an approach to and obtaining informed consent is a complex task involving multiple considerations. The examples used in this paper are derived from a study investigating how children constitute family members and close relationships. The paper is divided into two sections. The first section suggests that researchers should take a reflexive approach to their professional research practice and addresses how a researcher's professional location determines their particular ethical approach. Consideration is given to how the researcher's particular ethical approach can be achieved in consultation with academic thought and research ethics guidelines, which often offer contradictory advice on important ethical issues. The second section of the paper addresses how researchers negotiate their approach to informed consent in particular research contexts which offer challenges to the researcher's thinking about research participants or chosen procedures for obtaining and maintaining that informed consent is upheld. The paper concludes by arguing that the researcher can incorporate academic thought and aspects of the research ethics guidelines in an approach to informed consent that simultaneously values the research participants and the ethical practices operating in the research setting. Such an approach involves careful negotiation and consideration of the interests of all stakeholders in the research process.

scholarly journals Views of university students in Jordan towards Biobanking

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Faisal Khatib ◽  
Dayana Jibrin ◽  
Joud Al-Majali ◽  
Mira Elhussieni ◽  
Sharifeh Almasaid ◽  
...  
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Willingness To Participate ◽  
Online Questionnaire ◽  
Research Results ◽  
Factors Associated ◽  
Majority Students ◽  
Primary Means ◽  
The University ◽  
Negative Connotation

Abstract Background Biobanks are considered primary means+ of supporting contemporary research, in order to deliver personalized and precise diagnostics with public acceptance and participation as a cornerstone for their success. Aims This study aims to assess knowledge, perception, and attitudes towards biomedical research and biobanking among students at the University of Jordan. Methodology An online questionnaire was designed, developed, and piloted. It was divided into 5 sections that included questions related to issues of biomedical research and biobanking as well as factors influencing the decision to participate. Results Responses from 435 students revealed that 52.9% previously heard of biobanks. There was an overwhelming acceptance for participation in biomedical, genetic, and biobanking research. A blood sample was the most preferred for donation. Protection of privacy, informed consent prior to donation, approval of an ethics committee, and trust towards researchers were the most important factors associated with willingness to participate. On the other hand, the vagueness of the type of research performed on the biospecimens and the unavailability of general research results to the donor had a negative connotation. There was no clear agreement on the type of informed consent preferred by students, but to be contacted and informed of research results was preferred by the majority. Students also preferred the disposal of biospecimens and information when deciding to withdraw from participation. Conclusion There is strong enthusiasm among students to participate in biomedical research and biobanking with all rights reserved thus providing hope for a very promising future in Jordan.

scholarly journals Informed Consent

2015 ◽  
Vol 06 (03) ◽  
pp. 466-477 ◽  
Author(s):  
F. Manion ◽  
K. Hsieh ◽  
M. Harris ◽  
S. H. Fenton
Keyword(s):  
Informed Consent ◽  
Medical Record ◽  
Health Systems ◽  
Research Process ◽  
Institutional Review ◽  
Consent Document ◽  
Information Governance ◽  
Informed Consent Document ◽  
Computer Based ◽  
Investigative Team

Summary Background: Despite efforts to provide standard definitions of terms such as “medical record”, “computer-based patient record”, “electronic medical record” and “electronic health record”, the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process — patients, information technology and regulatory staff, and the investigative team — fully understand what data and information they are asking to obtain and agreeing to share. Objectives: This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question “Does the use of the term “medical record” in the context of a research informed consent document accurately represent the scope of the data involved?” Methods: Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine’s (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. Discussion: The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. Conclusions: “Medical record”, a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context of contemporary information management and governance. Citation: Fenton SH, Manion F, Hsieh K, Harris M. Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record? Appl Clin Inform 2015; 6: 466–477http://dx.doi.org/10.4338/ACI-2014-09-SOA-0081

scholarly journals 3412 Informed Consent: Refining the Process

2019 ◽  
Vol 3 (s1) ◽  
pp. 123-123
Author(s):  
Courtney Perry ◽  
Terrence Barrett
Keyword(s):  
Ulcerative Colitis ◽  
Informed Consent ◽  
Retention Rate ◽  
Standard Of Care ◽  
Research Process ◽  
Informed Consent Process ◽  
Consent Process ◽  
Willingness To Participate ◽  
Study Protocols ◽  
The One

OBJECTIVES/SPECIFIC AIMS: -This study aims to evaluate our retention rate into our prospective clinical trial. We will be comparing the rate of withdrawal both before and after our revamped informed consent process. -We aim to assess patient satisfaction with our study and u METHODS/STUDY POPULATION: -The informed consent process for an observational prospective study at our institution has been modified to lengthen the recruitment and consenting process. -In brief, the research protocol for this observational prospective aims to evaluate the role of steroids on ulcer healing in patients with ulcerative colitis. This study involves an initial standard of care colonoscopy with biopsies and photos. The areas biopsied are marked with a tattoo. The patients are started on steroids for management of their Ulcerative Colitis, and must return for two research colonoscopies at one week post- initial diagnostic visit, and at one month. Additional study biopsies are obtained at the one week visit and photo documentation is obtained. At the one month visit, only photos are obtained to document healing. -In addition to patients with active ulcerative colitis, this study recruits control groups of patients with UC in remission, as well as two groups of normal control patients (one group on steroids for non-IBD reasons, and one group not on steroids. -Prior to our informed consent intervention, patients were screened for eligibility on the day of their standard of care endoscopy. The study was explained to the patient prior to their endoscopy, often in the “pre-op” endoscopy suite. -Our intervention seeks to draw out the consent and recruitment process. All patients scheduled for upcoming endoscopies will be mailed a generic flyer announcing research studies occurring in the endoscopy suite. Patients will be pre-screened at least a week prior to endoscopy with the aid of the endoscopy scheduler. Patients interested in hearing about research will be contacted via phone by study personnel, and a copy of the consent as well as a brief summary will be mailed to the patient. -Patients potentially interested in study participation will be asked to arrive 30 minutes earlier than they typically would for their procedure, and they will be consented in a quiet and private consultation room. They will be given ample time to ask clarifying questions regarding the study. -At the conclusion of their participation, patients will receive an anonymous post-participation survey that seeks to assess their feelings regarding the study and their understanding of the research process. RESULTS/ANTICIPATED RESULTS: DISCUSSION/SIGNIFICANCE OF IMPACT: This study adds to the ongoing body of evidence suggesting that the informed consent process is more than the three key elements initially described by the Belmont Report 40 years ago. Several factors can impact patient’s willingness to participate in research, and the amount of time it takes for patients to achieve all three elements of consent can vary from person to person. The traditional method of consent just prior to study entrance is one that needs to be revisited, and we propose that prolonging the consenting process will positively impact not only patients, but also the overall research process by ensuring that those who decide to participate remain adherent to study protocols.

scholarly journals Seven Snags of Research Ethics on the Qualitative Research Voyage

2019 ◽  
Vol 12 (6) ◽  
pp. 1
Author(s):  
MacDonald Kanyangale
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Research Process ◽  
Qualitative Inquiry ◽  
Ethical Guidelines ◽  
Ethical Approval ◽  
Conceptual Paper ◽  
Research Students ◽  
The University

Responsible researchers with ethically sound research skills are fundamental to success in an ever-changing business and social world. Embedding ethics into research by students seems to be intuitively easy given tight, standardized ethical guidelines and rigorous ethical approval process in the university. In reality, there are Masters and PhD research students who feel ill-prepared when they encounter ethical ambiguities and complexities in the field which are unique, beyond what they had foreseen at the outset of a qualitative inquiry or were prescribed, advised and forewarned by a research ethics committee (REC). The aim of this conceptual paper is to discuss seven pitfalls of research ethics in a qualitative research voyage in order to educate and sensitize current and prospective research students. The seven pitfalls are: (1) complexity and ambiguity of informed consent; (2) embedding informed consent as a process rather than an event; (3) navigating the moral conundrum of unintentional disclosure; (4) dealing with deductive disclosure; (5) dialectic between participant`s desire for recognition and greater confidentiality; (6) researcher role conflict and (7) difficulty of embedding researcher reflexivity. The paper concludes that only research students who are ethically literate and actively reflexive in the entire research process are more likely to know whenever they encounter ethical pitfalls, deal with them properly; and ultimately entrench relevant skills to conduct ethically sound research. Highlighted are implications for research educators to develop research competence of current and future researchers. Responsible researchers with ethically sound research skills are fundamental to success in an ever-changing business and social world. Embedding ethics into research by students seems to be intuitively easy given tight, standardized ethical guidelines and rigorous ethical approval process in the university. In reality, there are Masters and PhD research students who feel ill-prepared when they encounter ethical ambiguities and complexities in the field which are unique, beyond what they had foreseen at the outset of a qualitative inquiry or were prescribed, advised and forewarned by a research ethics committee (REC). The aim of this conceptual paper is to discuss seven pitfalls of research ethics in a qualitative research voyage in order to educate and sensitize current and prospective research students. The seven pitfalls are: (1) complexity and ambiguity of informed consent; (2) embedding informed consent as a process rather than an event; (3) navigating the moral conundrum of unintentional disclosure; (4) dealing with deductive disclosure; (5) dialectic between participant`s desire for recognition and greater confidentiality; (6) researcher role conflict and (7) difficulty of embedding researcher reflexivity. The paper concludes that only research students who are ethically literate and actively reflexive in the entire research process are more likely to know whenever they encounter ethical pitfalls, deal with them properly; and ultimately entrench relevant skills to conduct ethically sound research. Highlighted are implications for research educators to develop research competence of current and future researchers.

Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 23-23
Author(s):  
Andrew Schumacher ◽  
Carolyn Bartley ◽  
Anne Kaplan ◽  
Benjamin Murphy ◽  
Howard Safran ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Research Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Participants ◽  
Oncology Research ◽  
Consent Document ◽  
Oncology Clinical Trials ◽  
Informed Consent Document

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.

Readability of Pediatric Biomedical Research Informed Consent Forms

PEDIATRICS ◽  
1990 ◽  
Vol 85 (1) ◽  
pp. 58-62 ◽  
Author(s):  
Kenneth J. Tarnowski ◽  
Denise M. Allen ◽  
Christine Mayhall ◽  
Patricia A. Kelly
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Human Subjects ◽  
Linear Increase ◽  
Willingness To Participate ◽  
Consent Forms ◽  
Flesch Reading Ease ◽  
Informed Consent Form ◽  
Consent Document ◽  
Protection Of Human Subjects

Informed consent forms are used in biomedical research as a mechanism to convey study information to potential subjects so that they may arrive at a decision concerning their willingness to participate. Although the Department of Health and Human Services Regulations for the Protection of Human Subjects require the presentation of specific study information at a level that is easily understood, according to research concerning adult biomedical consent forms, the typical form is not readily comprehensible. Unfortunately, no data exist concerning the readability of informed consent forms that are used in the context of pediatric biomedical research. In the present study, readability analyses were conducted on a large sample (N = 238) of pediatric biomedical informed consent forms obtained during a 10-year period from a large midwestern children's hospital. For the entire sample, results derived from two readability estimates (Fry grade equivalent and Flesch Reading Ease methods) indicated that the consent forms were written at the college graduate level. Although there was a linear increase in the length of the consent document during the 10-year period evaluated, expanded length was not associated with improved readability. According to analyses, a differential pattern of reading difficulty was associated with specific sections of the informed consent document. Findings are highly consistent with those from studies of adult biomedical consent forms and document that the purpose of the informed consent form is being compromised, in part, by a readability factor. Suggestions for solving this critical problem are advanced.

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

2021 ◽  
pp. 155626462110201
Author(s):  
Caitlin Geier ◽  
Robyn B. Adams ◽  
Katharine M. Mitchell ◽  
Bree E. Holtz
Keyword(s):  
Individual Differences ◽  
Informed Consent ◽  
Research Process ◽  
The Other ◽  
Consent Form ◽  
Online Research ◽  
Consent Forms ◽  
Potential Benefits

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

Zeitzeuge der Zeitschrift für Evangelische Ethik von 1970 bis 2003

2008 ◽  
Vol 52 (5) ◽  
pp. 29-35
Author(s):  
Theodor Strohm
Keyword(s):  
Social Order ◽  
World Wide ◽  
Central Place ◽  
Reform Process ◽  
Evangelical Church ◽  
Scientific Debate ◽  
The Social ◽  
Willy Brandt ◽  
The University ◽  
The Welfare State

Abstract This article shows clearly the experiences of the author concerning the social restart of Germany after 1945. The ZEE was and is a place for reflection and reorientation. Personal encounters with personalities of the »first hour« constitute the opening. This is followed by five central situations which were witnessed and devised by the author. They had a direct effect on the ZEE. 1. The participation in the senior staff of Willy Brandt had an effect on the contemplation of an »ethos of inner reforms«. 2. The reform process in South Africa with its »peaceful revolution« brought the author there, having intense working relations to the leaders of the »black majority«. These experiences found their way into the ZEE. 3. As chairman of the chamber for social order of the EKD (Evangelical Church in Germany) the author worked nearly 20 years intensively on memoranda concerning the reorientation of the welfare state in many dimensions. The ZEE was a central place of scientific debate. 4. and 5. As head of the Diakoniewissenschaftliches Institut (I. for Christian social work) of the University of Heidelberg basic questions of deaconry theologically and at the same time world wide aspects were at the centre of interest also at the ZEE

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