Informed Consent Library(ICLibrary) provides investigators and their staff the ability to access the currently approved version of the informed consent(s). The site is accessible to anyone with a Children's Hospital account. The Committee on Clinical Investigation will no longer provide separate electronic copies of consents with approval letters rather investigators and their staff will be instructed to obtain their consent forms directly from the ICLibrary website.
This ICLibrary is available through internal access only and may be found through the Committee on Clinical Investigation website or from CH Internal Home page in Research section. To access the website, please click on:
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Informed Consent Library
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Frequently Asked Questions
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All informed consent documents submitted to the Committee must be in the CCI template. Please use the templates below when developing informed consent documents.
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English Informed Consent Template
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Spanish Header/Footer and HIPAA
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All assent documents must be reviewed and approved by the Committee. The assent template below was developed to provide guidance to investigators as to what information to include in an assent form. Please feel free to use this sample in the development of assent documents. The language and information in the template should be modified as appropriate for each protocol depending on the age and cognitive level of the subject population.
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Informed Assent Template
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This template only applies to investigators who indicate that informed consent/assent/authorization will be obtained through a method other than a written document in Part C and plan to develop an information sheet. All information sheet documents must be reviewed by the Committee. The information sheet template below was developed to provide guidance to investigators as to what information to include in an information sheet. Please feel free to use this sample in the development of information sheet documents. The language and information in the template should be modified as appropriate for each protocol depending on the age and cognitive level of the subject population. Information sheets will not be uploaded to the ICLibrary website.
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Information Sheet Template
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This application is designed to help create informed consent documents. The ICA inserts template language that has been approved by the Committee on Clinical Investigations. The text must then be placed into the approved Children's Hospital Template (above).
This application is only available through CH internal website. To access ICA, please click on:
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Informed Consent Assistant(ICA)
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Informed consent documents should be written at a 6th grade reading level and should avoid the use of complex medical terminology. Please consult the links below for lay descriptions of common medical terms.
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Stanford University's Glossary of Lay Terms
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University of Michigan's IRB Simplification Guide to Medical Terms
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Interpreter Services and the Office of Clinical Investigation are working together to ensure that patients of all languages are given the opportunity to participate in the research opportunities available at Children's Hospital. Research participants must be provided with adequate information in order to decide whether to participate in a research study; therefore, it is imperative that consent forms are available in a patient's native language. Interpreter Services is committed to providing translation services to the research community, and are available to provide information about the types and costs of translation/interpretation services available.
Please contact Dorys Alarcon at (617) 355-4176 or visit Children's Hospital internal website at http://web2.tch.harvard.edu/interpreter_svc/ for more information. In addition, the Office of Clinical Investigation has funds to translate informed consent documents, if there are no sources of funding available. If you require funding in order to translate consent documents please complete the Translation of Informed Consent Request Form and return it to the Clinical Investigation Office.
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IMPROVING THE INFORMED CONSENT PROCESS AT CHILDREN'S HOSPITAL
Two projects that focused on improving the informed consent process for clinical research were recently completed as a result of a grant from the National Institutes of Health. The first project is a report " The Process of Informed Consent, What's at Stake?" Dr. Arlene Katz prepared this ethnographic report after she spent a year at Children's interviewing and observing investigators, subjects, family members research staff and Committee on Clinical Investigation members during informed consent discussions. The report summarizes her observations and provides recommendations for improving the informed consent process. The report includes many direct quotes from those interviewed and is powerful and provocative. We recommend all staff review the report.
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Click here to view the report.
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The second project is an interactive website aimed at helping parents make an educated decision about whether or not to enroll their child for participation in a clinical trial. The website,
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www.bostonchild.vitalconsent.com
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is intended for use by anyone considering clinical trials for their child and was designed to help parents answer questions about medical research. Parents who visit the site will be able to find out what medical research is, who participates in medical research, and why children participate in medical research, as well as a glossary of terms that are commonly used with medical research and clinical trials.
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