Elements Of Informed Consent Research Articles

PI-REAL: A study of informed consent (IC) communication in real-time during phase I clinical trial encounters.

22 Background: Advanced cancer patients (ACP) in phase I clinical trials are unable to recall significant elements of IC, yet the actual verbal and non-verbal content of trial discussion between oncology fellows and ACP consenting in real time to such trials has not been well described. Methods: Phase I Communication in Real Time Fellow-ACP Encounters (PI-REAL) study is an evidence-based intervention designed to improve communication about phase I clinical trial IC. ACP completed follow-up questionnaires after new patient visits to assess understanding of IC elements, such as research purpose. Video recordings were analyzed using CanCode for verbal and non-verbal skills associated with IC elements. Results: To date, 61 ACP-fellow clinical encounter video recordings were available for analysis. Average length of encounters: 45.4 min (range: 5.7-87.8 min). ACP demographics included: median age 60y (33-83); 55% male; 89% Caucasian; 55% median income > $60,000. Fellows were coded as verbally disclosing: 1. Purpose of phase I trial as dose-determining in 49% of encounters; 2. Physical risks of trial in 75% of encounters; 3. Potential benefits (e.g. improved QOL) gained by ACP participation in trial in 70% of encounters; 4. Alternatives to trial entry (e.g. other trials, palliative/supportive care) in 55% of encounters. A significant association existedbetween coded fellow empathic statements and ACP subsequently recalling the purpose of the trial as dose-determining, with 72% of subjects who heard empathic statements identifying “dosage” compared to 10% of subjects who did not (72% v. 10%, p < 0.05). Regarding non-verbal skills, fellows: leaned toward ACP in 64% of encounters; observed ACP face directly in 72% of encounters; had relaxed body posture in 55% of encounters; and displayed responsive facial expressions in 77% of encounters. Conclusions: Empathic statements by fellows appear to be associated with improved ACP understanding of Phase I trial research purpose as dose-determining. Additional encounters continue to undergo video recording and analysis.

Parental and youth understanding of the informed consent process for pediatric endoscopy.

Informed consent (IC) is an essential communication between patient/representative and physician that acknowledges patient autonomy; assent is the equivalent process performed between youth and physician. For clinical procedures involving youth, only the IC process between guardian/parent and physician is required to be performed. Nevertheless, experts recommend that youth undergo assent whenever possible. In the present study, we explored both parental and youth understanding of required IC elements in IC discussions before pediatric endoscopy. Following signing of IC documents on the day of endoscopy at a tertiary care academic medical center, youth and their parents underwent structured interviews to assess comprehension of key elements of the IC process. A total of 88 children and adolescents and their parents were evaluated. Two youth and 12 parents demonstrated comprehensive understanding of key IC elements for pediatric endoscopy. Suboptimal youth understanding was demonstrated for nature of the procedure (25% with adequate understanding) and related risks (17%), and alternatives (14%) to the procedure. Suboptimal parental understanding was demonstrated for procedure alternatives (24%). Youth overall understanding of IC varied by age, whereas parental global understanding of IC varied by physician. Understanding of IC performed for pediatric endoscopy could be improved in both parents and youth. Our findings suggest that interventions targeting parents, youth, and physicians may be helpful. Further study is needed to determine whether our findings are representative of IC understanding at other pediatric endoscopy centers.

Informed Consent of Living Kidney Donors: Pitfalls and Best Practice

Informed consent is clearly considered the ethical bedrock fundamental to living organ donation, a procedure lacking medical benefits for its participants. Recent guidelines have focused on strengthening content components of living kidney donor informed consent, including Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) policies that prescribe key components, and integration of the Independent Living Donor Advocate (ILDA), as mandated by Centers for Medicare and Medicaid Services (CMS) and the OPTN/UNOS. The European Union member states’ Working Group on Living Donation provided recommendations for care standardization in the “Toolbox Living Kidney Donation,” including integration of an independent clinician advocate. However, even with these changes, studies suggest inconsistency in informed consent elements across transplant programs, and retrospective studies show that although the vast majority of living donors (LDs) reflect back positively on the experience of donation, some describe lacking complete knowledge of risks (or process) before donation. Processes to assure achievement of informed consent remain in the purview of individual transplant centers to implement and measure. Herein, methods to assess prospective LD intentionality, voluntariness, and understanding of risks/benefits are described, with promising techniques highlighted and recommendations for best practice outlined. Specific clinical challenges are addressed, including ambivalence, risk of secondary gain, and difficulty integrating understanding of risks. Finally, additional content elements are proposed to improve validity of informed consent in specific clinical circumstances.

Informed consent training for medical oncology fellows: Checklist-based simulation exercise.

e20671 Background: Discussing informed consent (IC) is essential for quality cancer care. While essential elements of IC are clearly defined, there is little data to guide how best to teach IC to medical oncology fellows’ (MOF). A PI project was conducted using a simulation (SIM) exercise to assess the MOF skills in obtaining IC to enhance our teaching of the subject. Methods: Program directors from 2 training sites in San Antonio, TX created a 30-minute SIM lab using standardized patients (SP) and the use of checklists (CKL) for obtaining IC. MOF from both institutions were asked to obtain IC for chemotherapy in a patient with Stage III seminoma. Half the MOF were given an IC checklist prior to their SIM encounter that included 18 side effects (SE) for discussion recommended by ASCO along with 12 essential elements (EE) for IC. All encounters were videotaped and data recorded by 2 faculty. Results: 17 MOF (6 PGY-4s, 6 PGY-5s, and 5 PGY-6s) participated. Video review was available for 15 MOF, and 8/15 wer...

Informed consent documentation for lumbar puncture in the emergency department.

Introduction: Informed consent is a required process for procedures performed in the emergency department (ED), though it is not clear how often or adequately it is obtained by emergency physicians. Incomplete performance and documentation of informed consent can lead to patient complaints, medico-legal risk, and inadequate education for the patient/guardian about the procedure. We undertook this study to quantify the incidence of informed consent documentation in the ED setting for lumbar puncture (LP) and to compare rates between pediatric (<18 years) and adult patients.Methods: In this retrospective cohort study, we reviewed the ED electronic health records (EHR) for all patients who underwent successful LPs in 3 EDs between April 2010 and June 2012. Specific elements of informed consent documentation were reviewed. These elements included the presence of general ED and LP-specific consent forms, signatures of patient/guardian, witness, and physician, documentation of purpose, risks, benefits, alternatives, and explanation of the LP. We also reviewed the use of educational material about the LP and LP-specific discharge information.Results: Our cohort included 937 patients; 179 (19.1%) were pediatric. A signed general ED consent form was present in the EHR for 809 (86%) patients. A consent form for the LP was present for 524 (56%) patients, with signatures from 519 (99%) patients/guardians, 327 (62%) witnesses, and 349 (67%) physicians. Documentation rates in the EHR were as follows: purpose (698; 74%), risks (742; 79%), benefits (605; 65%), alternatives (635; 68%), and explanation for the LP (57; 6%). Educational material about the LP was not documented as having been given to any of the patients and LP-specific discharge information was documented as given to 21 (2%) patients. No significant differences were observed in the documentation of informed consent elements between pediatric and adult patients.Conclusion: General ED consent was obtained in the vast majority of patients, but use of a specific LP consent form and documentation of the elements of informed consent for LP in the ED were suboptimal, though comparable between pediatric and adult patients. There is significant opportunity for improvement in many aspects of documenting informed consent for LP in the ED. [West J Emerg Med. 2014;15(3):318–324.]

Sponsor/research ethics boards (REB) communications about informed consent (IC) and time to local activation (LA): An NCIC CTG pilot study.

6131 Background: Communications between sponsors, investigators and REBs about IC details may affect a centre’s LA time. We evaluated factors associated with these communications and LA times for a series of NCIC CTG trials. Methods: A sample of NCIC CTG sponsored phase III trials (P3T) was selected based on mandatory compliance with regulatory requirements and NCIC CTG central ethics review (initiated in 2003). Two independent and trained reviewers systematically extracted data. We assessed LA times, number of IC communications between NCIC CTG and centre/REB, and IC elements leading to communication. Results: Between Apr 2003-Dec 2008, 63 P3Ts were activated by NCIC CTG; 16 (25.4%) were selected for inclusion, including 15 requiring Health Canada (HC) approval. A mean of 4.5 trials/centre (TC) were activated among 15 centres (range 1-10), resulting in 72 data sets. Median LA time was 11.3 mos with variation by centre (interquartile range [IR] = 0.66–21.78 mos) and trial (IR= 0.36–21.62 mos) and was 19.2 mos in 2003-05 and 10.1 mos in 2006-08 (p=0.006). Median LA times were 11.9, 9.2, 12.1, 14.6 and 21.5 mos for number of communications = 1, 2, 3, 4 and 5 (p-trend = 0.007). The number of IC elements requiring communication per TC trended towards longer LA time (0.3 mo/additional element; p=0.06). The top 5 IC elements leading to at least one communication per TC were: tissue banking language (39), confidentiality terms (25), risk frequency categorization (24), description of trial details (18), and risks to the subject (13); 3 of these are HC regulatory requirements. An exploratory analysis assessing all 65 elements found only communication about “subject responsibilities” (e.g., questionnaires) to be associated with longer LA time (7.5 mos; p=0.04 [corrected for multiple comparisons]). Conclusions: For NCIC CTG trials, LA times are longer than desired, may have reduced over time and are associated with more frequent communications between NCIC CTG and REB and possibly with more IC elements needing review. Systematic evaluations may assist in identifying elements associated with sponsor/REB interactions. Processes to standardize consent language may help reduce LA times.

The Gettier Problem in informed consent

The duty to procure informed consent (IC) from patients before any significant intervention is among the pillars of medical and research ethics. The provision by the doctor of relevant information...

Communication of the essential elements of informed consent (IC) for research: A RIAS analysis of phase I clinical trial encounters.

6045 Background: Advanced cancer patients (ACP) in phase I clinical trials are unable to recall many important elements of IC, yet the content of discussion between physician-investigators (PI) and ACP consenting to such trials has not been well described. Methods: Clinical encounters were recorded between 131 ACP entering phase I trials and 25 PIs at three institutions (University of Chicago; Johns Hopkins; and Duke University). ACP completed follow-up questionnaires 1 week later to assess understanding of IC elements, e.g., research purpose of phase I trials. Recordings were analyzed using the Roter Interaction Analysis System (RIAS), and coding for terms associated with IC elements. Results: To date, 87 ACP-PI encounters have been analyzed. Average length of encounters: 30.4 min (range: 5.7-77.8 min). ACP demographics include: median age 60y (33-83); 55% female; 88% Ca; 55% < $60,000. PIs were coded as stating: 1) The purpose of a phase I trial as determining dosage/toxicity in 40% of encounters; 2) Physical risk of a trial in 70% of the encounters; 3) Life-threatening risks in 10% of the encounters; 4) Potential benefits gained by subject participation in the trial related to improvement in quality of life or stabilization of disease in 63% of encounters; and 5) Trial alternatives in 58% of the encounters. Within follow-up interviews, 26% of ACP described the purpose of a phase I trial as determining drug safety; 67% described alternatives to trial participation. An association existedbetween coding for PI statements re: the purpose of a phase I trial as dosage/toxicity and ACP correctly recalling the purpose of the trial (86% vs. 14%, p < 0.05). Conclusions: PI communication and subsequent ACP understanding of important elements of IC remain inadequate in the phase I trial setting. No significant financial relationships to disclose.

A study of physician investigator (PI) disclosure of alternatives of care and prognostic information to advanced cancer patients (ACP) enrolling in phase I trials

6508 Background: ACP in phase I trials have been described as having an inadequate understanding of several elements of informed consent. However, actual PI disclosure of alternatives to trial participation and prognostic information, and subsequent ACP understanding of these elements, have not been described. Methods: Clinical encounters between 131 ACP entering phase I trials and 25 oncologists at three institutions (University of Chicago; Johns Hopkins; and Duke University) were audio-taped. ACP completed follow-up questionnaires one week later to assess understanding of informed consent elements. Audiotapes were analyzed using the Roter Interaction Analysis System (RIAS) and specifically coded for terms associated with trial alternatives and patient prognosis. Results: To date, 85 encounters have been analyzed. Average encounters length: 30.4 min (range: 5.7–77.8 min). For ACP: median age 60y (33–83); 55% female; 88% Ca; 55% &lt;college educ; 52% income &lt;$60,000. The PI was recorded as discussing options other than anticancer treatment in 47% of encounters. The terms “palliative” or “hospice” were used in 1% and 2.3% of encounters respectively. In 29% of encounters the PI described the option of “doing nothing”. The PI used the terms “death” or “terminal” in 5.8% encounters. The PI was never recorded using the term “dying”. Within these encounters, no ACP was recorded as using any of the following terms: “palliative,” “hospice,” “terminal,” “death,” “dying.” Within follow-up interviews, 30% reported no alternatives to trial participation were discussed; 1% reported that palliative care/hospice was discussed. Based on coding of qualitative responses, 53% of ACP said that either their prognosis was excellent or they didn't know their prognosis. An association was found between recorded physician statements regarding general prognosis and ACP subsequently reporting having discussion regarding life expectancy (59% v. 33%, p = 0.04). Conclusions: PI communication and subsequent measured understanding regarding alternatives to trial participation and prognosis remain inadequate in the setting of phase I trial enrollment. [Table: see text]

Evaluating Living Kidney Donors: Relationship Types, Psychosocial Criteria, and Consent Processes at US Transplant Programs

We conducted a survey of 132 US kidney transplant programs to examine how they evaluate and select potential living kidney donors, focusing on donor-recipient relationships, psychosocial criteria, and consent processes. There is heterogeneity in donor-recipient relationships that are considered acceptable, although most programs (70%) will not consider publicly solicited donors. Most programs (75%) require a psychosocial evaluation for all potential living donors. Most programs agree that knowledge of financial reward (90%), active substance abuse (86%), and active mental health problems (76%) are absolute contraindications to donation. However, there is greater variability in how other psychosocial issues are considered in the selection process. Consent processes are highly variable across programs: donor and recipient consent for the donor evaluation is presumed in 57% and 76% of programs, respectively. The use of 13 different informed consent elements varied from 65% (alternative donation procedures) to 86% (description of evaluation, surgery and recuperative period) of programs. Forty-three percent use a 'cooling off' period. Findings demonstrate high variability in current practice regarding acceptable donor-recipient relationships, psychosocial criteria, and consent processes. Whether greater consensus should be reached on these donor evaluation practices, especially in the context of more expansive use of living donor kidney transplantation, is discussed.

Handbook for health care ethics committees

Preface Acknowledgments I. Curriculum for Ethics Committees 1. Ethical Foundations of Clinical Practice The Role of Ethics in Clinical Medicine Ethics Committees in the Health Care Setting Fundamental Ethical Principles Principlism and Alternative Approaches The Role of Culture, Race, and Ethnicity in Health Care Conflicting Obligations and Ethical Dilemmas 2. Decision Making and Decisional Capacity in Adults Health Care Decisions and Decision Making Decision-Making Capacity Assessment and Determination of Capacity Deciding for Patients without Capacity 3. Informed Consent and Refusal Evolution of the Doctrine of Informed Consent Elements of Informed Consent and Refusal The Nature of Informed Consent Exceptions to the Consent Requirement 4. Truth Telling Justifications Disclosure Disclosure of Adverse Outcomes and Medical Error Privacy and Confidentiality Genomic Testing and Control of Information 5. Special Decision-Making Concerns of Minors Decisional Capacity and Minors Consent for and by Minors Confidentiality and Disclosure Special Problems of Functionally Alone Adolescents 6. Ethical Issues in Reproduction The Ethics and Politics of Reproductive Choice Assisted Reproductive Technologies Surrogacy and Gestational Carriers Termination of Pregnancy Maternal-Fetal Issues Prenatal/Newborn Genetic Testing and Genomic Newborn Screening Special Decision-Making Concerns of the Elderly The Other Side of the Mountain Diminishing Autonomy and Decisional Capacity Promise that you won't ever put me in a nursing home Independence, Dependence, and Role Reversals Prior Wishes and Current Needs Intimacy and Security Transition from Hospital to Home or Nursing Home 8. Ethical Issues in the Care of Disabled Persons Disability and Its Place in Bioethics Defining Disability The Medical and Social Models of Disability The Disability Rights Critique of Prenatal Genetic Testing Special Challenges in the Care of Persons with Severe Cognitive Impairment Medical Decision Making and the Disabled 9. End-of-Life Issues Decision Making at the End of Life Defining Death Organ Donation Advance Health Care Planning Honoring Patients' End-of-Life Decisions Goals of Care at the End of Life Forgoing Life-Sustaining Treatment Protecting Patients from Treatment Rejection of Recommended Treatment and Requests to Do Everything Medical Futility 10. Palliation From Caring to Curing and Back Again The Experience of and Response to Pain The Moral Imperative to Relieve Pain Assisted and Permitted Dying Pediatric Palliative Care Palliative Care and Hospice Palliative Care 11. Justice, Health, and Access to Health Care Access to Health Care in the United States Justice and Health Disparities Health Care as a Requirement of Justice Health Care and Health Theories of Justice Rationing Health Care Reform 12. Organizational Ethics From Bioethics to Health Care Organizational Ethics Moral Responsibilities of Health Care Organizations Organizational Ethics and Compliance Ethics and the Allocation of Resources Ethics Committees and Organizational Issues Developing an Organizational Ethics Service II. The Creation, Nature, and Functioning of Ethics Committees 13. Profile of Ethics Committees Origins Committee Functions Membership Expertise in Ethics Leadership Securing a Foothold Clinical Ethics Consultation Overview of Ethics Consultation Three Models of Clinical Ethics Consultation Services Building an Ethics Consultation Service Credentialing and Privileging Clinical Ethics Consultants Analytic Approaches to Clinical Ethics Consultation Selecting the Best Clinical Ethics Consultation Service Model for Your Institution Access to Clinical Ethics Consultation Policies 15. Ethics Education Brown Bag Lunches Journal Clubs Case Conferences Ethics Grand Rounds Ethics Modules in Residency Training and Medical School Programs Ethics Symposia White Papers, Memoranda, Guidelines, and Protocols Additional Education Opportunities 16. Sample Clinical Cases Adolescent Decision Making Advance Directives Autonomy in Tension with Best Interest Confidentiality Decisional Capacity Disclosure and Truth Telling End-of-Life Care Forgoing Life-Sustaining Treatment Goals of Care Informed Consent and Refusal Medical Futility Parental Decision Making Surrogate Decision Making 17. Sample Policies and Procedures III. Organizational Codes of Ethics Regional Medical Center Code of Conduct Metropolitan Medical Center Code of Ethics University Health Network Code of Ethics IV. Key Legal Cases Informed Consent Privacy Confidentiality Health Care Decision Making Medical Decision Making for Minors Reproductive Rights State Action to Protect Public Health State Action to Control What Practitioners Must or Must Not Discuss with Their Patients Health Care Reimbursement V. An Ethics Committee Meeting Index

A study of informed consent (IC), age, and cognitive function (CF) among advanced cancer patients (acp) in phase I trials

6548 Background: Ethical concerns exist about acps’ ability to provide adequate informed consent (IC) for phase I trials. While cognitive impairment (CI) among acp is well-recognized due to multiple factors, e.g., previous effects of chemotherapy, age, psychological status, the prevalence of CI among acp in phase I trials has never been described. Methods: Acp CF was assessed using a neuropsychological battery of instruments: Hopkins Verbal Learning (HVLT); Verbal Fluency; Mini-Cognitive Assessment; Trail-making (Parts A&amp; B); Boston Naming (short); WAIS subtests (Comprehension and Digit Span). Acp underwent semi-structured interviews to evaluate elements of IC, and completed the FACT-COG and the Hospital Anxiety and Depression Scale (HADS). Results: To date, a total of 34 acp enrolling in Phase I trials have been studied. Median age: 63y (range: 38–81y); 77% male; 77% Caucasian; 67% &gt; HS education. Regarding IC understanding: Only 20% of responding acp correctly identified the purpose of Phase I trials; all subjects could recall risks of side effects, correctly stated they could refuse trial participation, and stated they could withdraw at anytime; 53% believed the trial was their only option. Older acp (&gt;age 55y) were less likely to correctly describe the research purpose of the trial (29% v. 71% p=0.02). Older acp had measurable deficits in CF: Boston Naming (14±0.9 v.15±0.3, p=0.09); HVLT Total Recall (14±2 v.26±6, p&lt;0.00) and Discrimination Index (7.5±3 v.11±1, p=0.03); Digit Span-Backwards (4±2 v.7±2, p&lt;0.00); Trail-making B (244±64 v.188±51, p=0.04). While there were no differences in perceived CI (95±18 v.101±19, p=0.5) or impact on quality of life (25±7 v. 27±5, p=0.5), both groups had scores well below prior reported means. Older acp tended to report depressive symptoms more than younger acp (8±2 v.6±1, p=0.07). Conclusions: Our data suggest that CF may play a role in acp understanding of IC for clinical trials, especially among the elderly. Further research is needed, given ethical concerns regarding elderly acp in clinical trials of experimental agents who may have CI. No significant financial relationships to disclose.

General aspects and specific issues of informed consent on breast cancer treatments

Informed consent (IC) is the process by which a patient can make choices about his/her health care; therefore it is considered to be a voluntary authorization given by the patient to the physician. To ensure the patient's right to self-determination, what can the physicians do? When treating breast cancer, there are several specific issues that must be clarified by the IC. We have selected and evaluated the basic elements of IC and mentioned the basic concepts of IC in details. First of all, complete information must be disclosed to the patient (physician's responsibility for medical accountability). The information to be disclosed is summarized in the following three elements: 1) The nature of the treatment/procedure, 2) The relevant risks/benefits, and 3) Reasonable alternatives to the proposed intervention (alternative treatments/procedures). However, the physician is not obliged to persuade the patient to accept the proposed intervention. IC information should be documented in detail on the patient's chart without delay. These issues include IC regarding surgical procedures (mastectomy or breast conservation treatment), IC regarding clinical studies (description of randomized controlled trials), IC regarding genetic diagnosis (ethical issues), and the like. IC means informed decision-making, close relationships between physicians and patients are needed.

Using Our Best Judgment in Conducting Human Research

The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board (IRB) could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical research to discover the most effective way to act on their moral sense (e.g., to discover how best to approach potential research participants and explain the nature and purpose of the research participation for which they are being recruited, to ensure comprehension and competent decision making). On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment.