Informed Consent Language and Parents' Willingness to Enroll Their Children in Research (Report) by IRB: Ethics & Human Research

Informed Consent Language and Parents' Willingness to Enroll Their Children in Research (Report)

By IRB: Ethics & Human Research

  • Publication Date: 2011-03-01
  • Genre: Health & Fitness

Book Summary

Federal regulations governing research with humans require that specific information be provided to potential research participants in the informed consent process: 1) that the study involves research, with a description of its purpose, duration, and the procedures, including those that are experimental; 2) the study's potential risks to participants; 3) the study's potential benefits to participants or others; 4) the alternatives to participating in the study; 5) the policies for protecting the confidentiality of participant information; 6) whether compensation for research-related injuries will be provided; 7) information about whom to contact if injuries occur or questions arise; and 8) notification that participation is voluntary and that individuals can withdraw from the study at any time. (1) Yet it has become increasingly clear that securing an individual's signature on a consent document is not sufficient to satisfy the regulatory and ethical requirement for information exchange in the consent process. (2) A key concern is whether individuals comprehend the information presented to them. Comprehension of informed consent information requires not only that potential research participants (or their legally authorized representatives) understand the words that are used in consent forms, but also that the semantic content of the words is similar, if not identical, for all parties. (3) However, in informed consent documents and in the oral consent process, different words are often used to describe the same study. (4) For instance, during our long tenure on the University of Pittsburgh's pediatric institutional review board (IRB) and the IRB at the Children's Hospital of Pittsburgh (known as the Human Rights Committee), we have seen a variety of different words used synonymously and thus interchangeably within and across protocols, irrespective of differences in the risk/benefit ratio of the studies. One concern this raises is whether descriptions about a particular study have value-laden connotations (either good or bad) that might bias parents' willingness to enroll their children in the study.5

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