Informed Consent

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  Subject Areas on Research

  • "How Much Time Do I Have?": Communicating Prognosis in the Era of Exceptional Responders. 
  • 1995 Public Policy Plenary Symposium: "the crisis in clinical research". 
  • A change in medical student attitudes of obstetrics-gynecology clerkships toward seeking consent for pelvic examinations on an anesthetized patient. 
  • A new design for randomized trials. 
  • A pilot study for a randomized controlled trial comparing the efficacy, safety and cost-effectiveness of surgical treatments of the prostate. 
  • A randomized controlled trial comparing quantitative informed consent formats. 
  • A review of consent practices and perspectives for pharmacogenetic testing. 
  • A rose by any other name: pain contracts/agreements. 
  • A stakeholder-driven approach to improve the informed consent process for palliative chemotherapy. 
  • A step toward solving some of the problems of cryopreservation. 
  • A trade secret model for genomic biobanking. 
  • AIDS testing and informed consent. 
  • Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). 
  • Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). 
  • Accidental communities: race, emergency medicine, and the problem of polyheme. 
  • Adolescent cancer patients: sperm storage, consent and emotion. 
  • Adult Spinal Deformity Patients Recall Fewer Than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period. 
  • Agency and communication challenges in discussions of informed consent in pediatric cancer research. 
  • Amendment to Clinical Research Project. Project 90-C-195. April 1, 1993. Treatment of severe combined immunodeficiency disease (SCID) due to adenosine deaminase deficiency with autologous lymphocytes transduced with a human ADA gene. 
  • An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management). 
  • An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial. 
  • An automated communication system in a contact registry for persons with rare diseases: scalable tools for identifying and recruiting clinical research participants. 
  • An effective strategy for decontamination, ex vivo expansion, and storage of human fetal liver hematopoietic stem cells. 
  • An informatics research agenda to support precision medicine: seven key areas. 
  • An intervention to improve cancer patients' understanding of early-phase clinical trials. 
  • An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting. 
  • An official American Thoracic Society/International Society for Heart and Lung Transplantation/Society of Critical Care Medicine/Association of Organ and Procurement Organizations/United Network of Organ Sharing Statement: ethical and policy considerations in organ donation after circulatory determination of death. 
  • Are Well-Informed Potential Trial Participants More Likely to Participate? 
  • Are patients willing to participate in medical education? 
  • Are patients with longer emergency department wait times less likely to consent to research? 
  • Are there adverse consequences of quizzing during informed consent for HIV research? 
  • Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia. 
  • Awareness and perceptions of electroconvulsive therapy among psychiatric patients: a cross-sectional survey from teaching hospitals in Karachi, Pakistan. 
  • Balancing disclosure of diagnosis and assent for research in children with HIV. 
  • Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants. 
  • Benefits of coronary revascularization: a failure to communicate. 
  • Biospecimen Sharing Among Hispanic Women in a Safety-Net Clinic: Implications for the Precision Medicine Initiative. 
  • Bone marrow transplantation for sickle cell disease. 
  • CT dose and risk estimates in children. 
  • CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes. 
  • Cardiac surgery in octogenarians: have we gone too far...or not far enough? 
  • Centralized biorepositories for genetic and genomic research. 
  • Certificates of confidentiality and informed consent: perspectives of IRB chairs and institutional legal counsel. 
  • Challenges faced by research ethics committees in El Salvador: results from a focus group study. 
  • Challenges in creating an opt-in biobank with a registrar-based consent process and a commercial EHR. 
  • Charting the course of clinical research: from an inspired past to a promising future. 
  • Children in research: new perspectives and practices for informed consent. 
  • Clinical trials and medical care: defining the therapeutic misconception. 
  • Clinical trials: to terminate or not to terminate. The VA Cooperative Studies Group on AIDS. 
  • Clinical trials:randomization before consent. 
  • Coagulopathy after cardiopulmonary bypass in Jehovah's Witness patients: management of two cases using fractionated components and factor VIIa. 
  • Comment regarding benefit in phase 1 oncology trials. 
  • Commentary on Vickers. 
  • Communicating and understanding the purpose of pediatric phase I cancer trials. 
  • Community engagement and informed consent in the International HapMap project. 
  • Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices. 
  • Concealed medicines for people with schizophrenia: a U.S. perspective. 
  • Conducting empirical research on informed consent: challenges and questions. 
  • Confronting real time ethical, legal, and social issues in the Electronic Medical Records and Genomics (eMERGE) Consortium. 
  • Consent (assent) for research with pediatric patients. 
  • Consent for a minor's abortion. 
  • Consent issues and pediatric regional anesthesia. 
  • Consent process for US-based family reference DNA samples. 
  • Consent: where research design meets reality. 
  • Considering the Benefits and Risks of Research Participants' Access to Sequence Data. 
  • Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings. 
  • Content and style of radiation risk communication for pediatric patients. 
  • Cord blood banking for potential future transplantation: subject review. American Academy of Pediatrics. Work Group on Cord Blood Banking. 
  • Deciding for Others 
  • Deficits and variations in patients' experience with making 9 common medical decisions: the DECISIONS survey. 
  • Depression and ischemic heart disease: what have we learned so far and what must we do in the future? 
  • Dermatologic surgery in geriatric patients: psychosocial considerations and perioperative decision-making. 
  • Design of clinical trials in AKI: a report from an NIDDK workshop. Trials of patients with sepsis and in selected hospital settings. 
  • Determinants of a subject's decision to participate in clinical anesthesia research. 
  • Determining when impairment constitutes incapacity for informed consent in schizophrenia research. 
  • Developing a simplified consent form for biobanking. 
  • Direct observation of prognosis communication in palliative care: a descriptive study. 
  • Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators. 
  • Does informed consent to research require comprehension? 
  • Don't ask, don't tell: a change in medical student attitudes after obstetrics/gynecology clerkships toward seeking consent for pelvic examinations on an anesthetized patient. 
  • Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study. 
  • Editorial position on publishing articles on human organ transplantation. 
  • Effects of disclosing financial interests on participation in medical research: a randomized vignette trial. 
  • Empirical research on informed consent. An annotated bibliography. 
  • Ensuring the safe use of genomic medicine in children. 
  • Epidemiology and screening for prostate cancer. 
  • Epilepsy patient-participants and genetic research results as "answers". 
  • Estimating the number of potential family members eligible for BRCA1 and BRCA2 mutation testing in a "Traceback" approach. 
  • Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval. 
  • Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems. 
  • Ethical aspects of banking placental blood for transplantation. 
  • Ethical dilemmas in continuing a zidovudine trial after early termination of similar trials. 
  • Ethical issues in identifying and recruiting participants for familial genetic research. 
  • Ethical issues in umbilical cord blood banking. Working Group on Ethical Issues in Umbilical Cord Blood Banking. 
  • Ethical ramifications of alternative means of recruiting research participants from cancer registries. 
  • Ethics and regulatory complexities for pragmatic clinical trials. 
  • Ethics in human subjects research: do incentives matter? 
  • Ethics of postmortem sperm retrieval: ethics of sperm retrieval after death or persistent vegetative state. 
  • Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research. 
  • Evidence-based community consultation for traumatic brain injury. 
  • Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. 
  • Facilitating Research in Physician Assistant Programs: Creating a Student-Level Longitudinal Database. 
  • Far beyond informed consent. US research institutions keep close watch on OPRR's suspensions. 
  • First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 4: pre-clinical efficacy and complication data required to justify a clinical trial. 
  • Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials. 
  • Fostering informed decisions: a randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer. 
  • Gender, age, and ethnicity in HIV vaccine-related research and clinical trials: report from a WHO-UNAIDS consultation, 26-28 August 2004. Lausanne, Switzerland. 
  • Gene therapy for cystic fibrosis using E1-deleted adenovirus: a phase I trial in the nasal cavity. The University of North Carolina at Chapel Hill. 
  • Genetic privacy needs a more nuanced approach. 
  • Genomics. Genomics, biobanks, and the trade-secret model. 
  • Getting meaningful informed consent from older adults: a structured literature review of empirical research. 
  • HIV testing in North Carolina. 
  • Healing prayer outcomes studies: consensus recommendations. 
  • How can we draw the line between clinical care and medical research. 
  • How preliminary data affect people's stated willingness to enter a hypothetical randomized controlled trial. 
  • How should we implement psychiatric advance directives? Views of consumers, caregivers, mental health providers and researchers. 
  • I perform more than 100 interventional procedures every year but have never seen radiation-induced skin injury: am I missing something? 
  • Impact of quality of life on patient expectations regarding phase I clinical trials. 
  • Impact of undergoing prostate carcinoma screening on prostate carcinoma-related knowledge and distress. 
  • Implementation of vascularized composite allografts in the United States: recommendations from the ASTS VCA Ad Hoc Committee and the Executive Committee. 
  • Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention. 
  • Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods. 
  • In Defense of "Denial": Difficulty Knowing When Beliefs Are Unrealistic and Whether Unrealistic Beliefs Are Bad. 
  • In situ monitoring of health in older adults: technologies and issues. 
  • Inability to Consent Does Not Diminish the Desirability of Stroke Thrombolysis 
  • Informed Consent for Electroconvulsive Therapy--Finding Balance. 
  • Informed Consent for Radiation Risk from CT Is Unjustified Based on the Current Scientific Evidence. 
  • Informed Decision Making: Assessment of the Quality of Physician Communication about Prostate Cancer Diagnosis and Treatment. 
  • Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. 
  • Informed consent and investigational new drug abuses in the U.S. military. 
  • Informed consent and the therapeutic misconception: clarifying the challenge. 
  • Informed consent for AIDS testing. Or: whose vein is it anyway? 
  • Informed consent for biobanking: consensus-based guidelines for adequate comprehension. 
  • Informed consent for biorepositories: assessing prospective participants' understanding and opinions. 
  • Informed consent for population-based research involving genetics. 
  • Informed consent for research in Borderline Personality Disorder. 
  • Informed consent for tissue research. 
  • Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. 
  • Informed consent in genomics and genetic research. 
  • Informed consent in human research: what to say and how to say it. 
  • Informed consent in pediatric clinical trials. 
  • Informed consent procedures: an experimental test using a virtual character in a dialog systems training application. 
  • Informed consent. 
  • Informed consent. From bodily invasion to the seemingly mundane. 
  • Informing the consent process. 
  • Integrating ethics and science in the International HapMap Project. 
  • Intensive insulin therapy in critically ill patients. 
  • Internet education of African American consumers on quality of care. 
  • Involving children in research. 
  • Is information always a good thing? Helping patients make "good" decisions. 
  • Is informed consent needed for fluorescein angiography? 
  • Issues in protection of human subjects in internet research. 
  • Judging the past. The case of the human radiation experiments. 
  • Let the punishment fit the crime: sensible consent in the management of human subjects research and standard-of-care interventions. 
  • Leveraging electronic health records for clinical research. 
  • Literacy and informed consent: a case for literacy screening in glaucoma research. 
  • Longitudinal consent-related abilities among research participants with schizophrenia: results from the CATIE study. 
  • Lost to Follow-up and Withdrawal of Consent in Contemporary Global Cardiovascular Randomized Clinical Trials. 
  • Low risk pragmatic trials do not always require participants' informed consent. 
  • Male circumcision and HIV prevention: ethical, medical and public health tradeoffs in low-income countries. 
  • Managing accrual in cooperative group clinical trials. 
  • Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents. 
  • Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings. 
  • Medical paternalism. 
  • Medicolegal aspects of foot and ankle surgery. 
  • Medicolegal aspects of sports medicine. 
  • Merging Electronic Health Record Data and Genomics for Cardiovascular Research: A Science Advisory From the American Heart Association. 
  • Okukkera Ng'omuzungu (lost in translation): understanding the social value of global health research for HIV/AIDS research participants in Uganda. 
  • Opt-Out HIV Testing of Inmates in North Carolina Prisons: Factors Associated with not Wanting a Test and not Knowing They Were Tested. 
  • Opt-out HIV testing in prison: informed and voluntary? 
  • Optimization of informed consent for umbilical cord blood banking. 
  • Outcomes of patients consented but not randomized in a trial of primary percutaneous coronary intervention in acute myocardial infarction (the CADILLAC registry). 
  • Overbilling and Informed Financial Consent--A Contractual Solution 
  • Oversight mechanisms for clinical research. 
  • Pancreas and liver resection in Jehovah's Witness patients: feasible and safe. 
  • Parents' and clinicians' attitudes toward the risks and benefits of child psychotherapy: a study of informed-consent content. 
  • Participant-centered adaptations in caregiver trials: strategies for managing confounds. 
  • Patient Anxiety Before and Immediately After Imaging-Guided Breast Biopsy Procedures: Impact of Radiologist-Patient Communication. 
  • Patient Decision Aids: A Case for Certification at the National Level in the United States. 
  • Patient Radiation Exposure During Fluoro-Assisted Direct Anterior Approach Total Hip Arthroplasty. 
  • Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. 
  • Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. 
  • Patients' Views Concerning Research on Medical Practices: Implications for Consent. 
  • Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research. 
  • Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants. 
  • Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study. 
  • Pharmacogenetic testing: not as simple as it seems. 
  • Pharmacogenetics: ethical issues and policy options. 
  • Predictors of consent to pharmacogenomics testing in the IDEAL study. 
  • Prenatal gene tranfer: scientific, medical, and ethical issues: a report of the Recombinant DNA Advisory Committee. 
  • Preparedness planning before mechanical circulatory support: a "how-to" guide for palliative medicine clinicians. 
  • Prisoners on death row should be accepted as organ donors. 
  • Privacy, families, and human subject protections: some lessons from pedigree research. 
  • Procedure-based complications to guide informed consent: analysis of society of thoracic surgeons-congenital heart surgery database. 
  • Promoting informed decision making: hormone replacement therapy. 
  • Protecting the vulnerable in brain research. 
  • Protocol of a randomized controlled trial of culturally sensitive interventions to improve African Americans' and non-African Americans' early, shared, and informed consideration of live kidney transplantation: the Talking About Live Kidney Donation (TALK) Study. 
  • Proxies and consent discussions for dementia research. 
  • Pruning the regulatory tree. 
  • Psychiatric advance directives and social workers: an integrative review. 
  • Psychometric evaluation of the Midlife Women's Symptom Index in multiethnic groups. 
  • Public attitudes to the storage of blood left over from routine general practice tests and its use in research. 
  • Publication policy, informed consent, and the randomized clinical trial. 
  • Quality Improvement Project to Increase Patients' Knowledge About Their Impending Procedures During the Consent Process. 
  • Randomized clinical trials--removing unnecessary obstacles. 
  • Randomized trial showed requesting medical records with a survey produced a more representative sample than requesting separately. 
  • Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) study. 
  • Redefining Genomic Privacy: Trust and Empowerment 
  • Reducing Consent Form Length: Stakeholder Support, Evidence-Based Strategies, and Regulatory Requirements. 
  • Reframing Consent for Clinical Research: A Function-Based Approach. 
  • Regarding Mohan, Kuplian, and Willoughby, IJROBP 2000;46:575-580. 
  • Regulatory and ethical considerations for linking clinical and administrative databases. 
  • Relationship of external influence to parental distress in decision making regarding children with a life-threatening illness. 
  • Reply: To PMID 22915409. 
  • Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question? 
  • Researching the world of children. 
  • Response. 
  • Responsible use of CT. 
  • Restoring balance: a consensus statement on the protection of vulnerable research participants. 
  • Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations. 
  • Sample size in obesity trials: patient perspective versus current practice. 
  • Scientific and ethical concerns in neural fetal tissue transplantation. 
  • Should we obtain informed consent for examinations that expose patients to radiation? 
  • Simplifying informed consent for biorepositories: stakeholder perspectives. 
  • Social moral epistemology. 
  • Special care unit research: ethical issues. 
  • Special care unit research: ethical issues. 
  • Sports medicine and ethics. 
  • Stakeholder views on returning research results. 
  • Start me up: ways to encourage sharing of genomic information with research participants. 
  • Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial. 
  • Surgical innovation, industry partnership, and the enemy within. 
  • Survival at the threshold of viability: a nationwide survey of the opinions and attitudes of physicians in a developing country. 
  • Suspended judgment. Clinical trials of informed consent. 
  • Systematic review and metasummary of attitudes toward research in emergency medical conditions. 
  • Testing the Presumption of Consent to Emergency Treatment for Acute Ischemic Stroke 
  • The Food and Drug Administration and pragmatic clinical trials of marketed medical products. 
  • The Image Gently Think A-Head Campaign: Keep Calm and Image Gently. 
  • The Legal Ethics of Pediatric Research 
  • The OHRP and SUPPORT. 
  • The appropriate and justified use of medical radiation in cardiovascular imaging: a position document of the ESC Associations of Cardiovascular Imaging, Percutaneous Cardiovascular Interventions and Electrophysiology. 
  • The concept of voluntary consent. 
  • The consent process and children. 
  • The correlation between patient characteristics and expectations of benefit from Phase I clinical trials. 
  • The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. 
  • The current status of living donor liver transplantation. 
  • The decision making control instrument to assess voluntary consent. 
  • The double-blind in danger: untoward consequences of informed consent. 
  • The ethics of experimenting with human brain tissue. 
  • The ethics of research on deep brain stimulation for depression: decisional capacity and therapeutic misconception. 
  • The experimental imperative. 
  • The immediately available physician standard. 
  • The impact of privacy and confidentiality laws on the conduct of clinical trials. 
  • The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry. 
  • The influence of relationships on children's and adolescents' participation in research. 
  • The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial. 
  • The psychiatric hospital and therapeutic jurisprudence: applying the law to promote mental health. 
  • The psychiatric use of electrically induced seizures. 
  • The role of decision analysis in informed consent: choosing between intuition and systematicity. 
  • The stability of DNR orders on hospital readmission. The SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. 
  • The views and outcomes of consenting and non-consenting patients receiving ECT. 
  • Therapeutic misconception in early phase gene transfer trials. 
  • Toward a national framework for the secondary use of health data: an American Medical Informatics Association White Paper. 
  • Toward elimination of perinatal HIV transmission: New Jersey hospital barriers to rapid HIV testing in labor and delivery, 2005. 
  • Trauma Surgery. 
  • Truth be told: not all nudging is bullshit. 
  • Understanding cognition in older patients with cancer. 
  • Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials. 
  • Unintended changes in cognition, mood, and behavior arising from cell-based interventions for neurological conditions: ethical challenges. 
  • Use of altered informed consent in pragmatic clinical research. 
  • Use of research biopsies in clinical trials: are risks and benefits adequately discussed? 
  • Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials. 
  • Using the PRACTICE mnemonic to apply cultural competency to genetics in medical education and patient care. 
  • Variability in IRBs regarding parental acceptance of passive consent. 
  • Varieties of uncertainty and the validity of informed consent. 
  • What Is Adequate Understanding? 
  • What constitutes a psychiatric emergency: clinical and legal dimensions. 
  • What is blood and what is not? Caring for the Jehovah's Witness patient undergoing cardiac surgery. 
  • Who refuses enrollment in cardiac clinical trials? 
  • iCONCUR: informed consent for clinical data and bio-sample use for research. 
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  Keywords of People

  • Granger, Christopher Bull, Professor of Medicine, School of Nursing
  • Muhlbaier, Lawrence H., Associate Professor Emeritus of Biostatistics and Bioinformatics, Biostatistics & Bioinformatics
  • O'Connor, Christopher Michael, Richard Sean Stack, M.D. / Guidant Foundation Professor of Cardiology, Medicine, Clinical Pharmacology
  • Richesson, Rachel L, Associate Professor in the School of Nursing, School of Nursing
  • Wu, Li-Tzy, Professor in Psychiatry and Behavioral Sciences, Medicine, General Internal Medicine