Informed Consent and the Protection of Human Subjects in Genomic Research with Children and Families

2010 ◽  
pp. 457-483 ◽  
Author(s):  
John G. Twomey
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Genomic Research ◽  
Children And Families ◽  
Research With Children ◽  
Protection Of Human Subjects

scholarly journals Improving readability of informed consents for research at an academic medical institution

2017 ◽  
Vol 1 (6) ◽  
pp. 361-365 ◽  
Author(s):  
Kristie B. Hadden ◽  
Latrina Y. Prince ◽  
Tina D. Moore ◽  
Laura P. James ◽  
Jennifer R. Holland ◽  
...  
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Plain Language ◽  
Post Intervention ◽  
Consent Forms ◽  
Institutional Review ◽  
Final Rule ◽  
The Mean ◽  
Protection Of Human Subjects

IntroductionThe final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Research Involving Children: Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

PEDIATRICS ◽  
1978 ◽  
Vol 62 (2) ◽  
pp. 131-136
Author(s):  
Albert R. Jonsen
Keyword(s):  
Medical Profession ◽  
Human Subjects ◽  
Mentally Retarded ◽  
Codes Of Ethics ◽  
The Body ◽  
National Commission ◽  
Proxy Consent ◽  
Public Controversy ◽  
Research With Children ◽  
Protection Of Human Subjects

Throughout history, children have been subjects of research. A legendary Persian prince is said to have isolated newborn babies from all human speech in hopes of discovering whether language was natural and spontaneous. Queen Caroline of England recruited children from a foundling hospital in order to test Jenner's vaccination on them before it was applied to her own royal progeny. The modern controversy over research with children and the retarded can be traced to events at Willowbrook State Hospital for the Mentally Retarded where, during the 1950s and 1960s, healthy mentally retarded children were infected with mild hepatitis in order to study the natural history of the disease. That research aroused great public controversy and its merits and faults are debated even today. It initiated a discussion within and without the medical profession over whether any invasion or manipulation of the body or person of a nonconsenting subject could ever be ethically justified, apart from expectation of benefit to that subjct.1 The prevailing codes of ethics governing the use of human subjects for experimentation are curiously ambivalent about children. The progenitor of these codes, The Code of Nuremberg, if taken literally, would exclude children as subjects, for it requires the voluntary consent of the subject "as absolutely essential," without any provision for proxy consent.1 The World Medical Association's Declaration of Helsinki, on the other hand, states that for nontherapeutic research involving legally incompetent subjects, "the consent of the legal guardian should be procured."3(p277) This position has been adopted by the American Medical Association:

scholarly journals The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection

2002 ◽  
Vol 30 (3) ◽  
pp. 411-419 ◽  
Author(s):  
Arlene M. Davis ◽  
Sara Chandros Hull ◽  
Christine Grady ◽  
Benjamin S. Wilfond ◽  
Gail E. Henderson
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Critical Role ◽  
Invisible Hand ◽  
Community Settings ◽  
Institutional Review ◽  
Research Organizations ◽  
Study Staff ◽  
Protection Of Human Subjects

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.

Informed consent: Timely issues from the past. Factors motivating patients with advanced cancer to participate in phase II trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20669-e20669
Author(s):  
C. G. Kardinal ◽  
J. B. Sanders ◽  
H. T. Cupper
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Advanced Cancer ◽  
Phase Ii ◽  
Human Subjects ◽  
Treatment Options ◽  
Disease Status ◽  
Research Subjects ◽  
Phase Ii Trials ◽  
Protection Of Human Subjects

e20669 Background: The current regulatory burden is well intentioned, but hampers both the conduct and recruitment to clinical trials. What factors actually motivate patients to become research subjects? After “informed consent” is obtained, what is the subject's understanding of the study, and its risks and benefits? Methods: In 1973 data were collected on the factors motivating 50 consecutive patients with advanced cancer to participate in Phase II trials. The data had not been previously analyzed. Now, 35 years later, the data obtained seem surprisingly current. These patients were interviewed a few days after obtaining “informed consent”. The 60 minute interviews were semi-structured, and included the factors motivating participation, the purpose of the trial, potential side effects, and treatment options. Results: Patients seldom expressed a single reason for participation. The motivating factors fell into 5 categories. (1) Hope that the new treatment would help control their disease; expressed by all 50. (2) Avoidance of regret; i.e, if they declined they would regret not having participated (19 of 50). (3) Altruism was expressed by 29 of the 50. (4) Trust that a physician-investigator would not have suggested the trial unless he thought it might help (10 of 50). (5) Being trapped by a lack of therapeutic alternatives (14 of the 50). Potential risks and side effects were minimized or forgotten. Many developed a sense of commitment to a cause; their morale improved even if their disease did not. Conclusions: The factors motivating patients with advanced cancer to participate in Phase II trials are complex, but evolve primarily around their personal disease status rather than their understanding of the trial. Truly informed consent in this vulnerable patient population may not be possible. The ultimate responsibility for the protection of human subjects lies not with the IRB, but with the physician investigator. No significant financial relationships to disclose.

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.

Disclosure of HIV Status on Informed Consent Forms Presents an Ethical Dilemma for Protection of Human Subjects

2006 ◽  
Vol 41 (2) ◽  
pp. 246-248 ◽  
Author(s):  
Ronald H Gray ◽  
Nelson K Sewankambo ◽  
Maria J Wawer ◽  
David Serwadda ◽  
Noah Kiwanuka ◽  
...  
Keyword(s):  
Informed Consent ◽  
Ethical Dilemma ◽  
Human Subjects ◽  
Hiv Status ◽  
Consent Forms ◽  
Protection Of Human Subjects

Research with Children

1998 ◽  
Vol 24 (2-3) ◽  
pp. 213-244 ◽  
Author(s):  
Leonard H. Glantz
Keyword(s):  
Human Subjects ◽  
A Priori ◽  
The United States ◽  
Human Experimentation ◽  
Nuremberg Code ◽  
Moral Principles ◽  
Research With Children ◽  
Mixed Feelings ◽  
Protection Of Human Subjects ◽  
Nazi Doctors

In the United States we have very mixed feelings about research with human subjects. The Nuremberg Code (the Code), which provides a foundation for the protection of human subjects, was written by American judges in the context of trying Nazi doctors who committed atrocious acts of human experimentation on concentration camp inmates. The Code provides ten common-sense guidelines controlling research. For example, a researcher may not conduct research on human subjects without that subject's informed consent, or if there is an a priori reason to believe that the research will cause death or disabling injury to the subject. What is remarkable about the creation of the Code is that it was thought to be necessary to document and impose the most fundamental moral principles on researchers. The Code demonstrates a remarkable suspicion of research with human subjects and those who perform such research.

Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Communities with Limited or Low Literacy

2016 ◽  
Author(s):  
Miraida Morales ◽  
Sarah Barriage
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Measurement Tool ◽  
Low Literacy ◽  
Consent Forms ◽  
Early Readers ◽  
Research With Children ◽  
Consentement Éclairé

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

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