Research

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Informed Consent

Informed Consent Library
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 CHeRP IRB website. To access the website, please click on:
Click here to login to CHeRP IRB and access the Informed Consent Library

Short Consent Translations
The Committee on Clinical Investigation provides short consent document translations in several commonly understood languages. This abbreviated translation or "short form" (which attests that the elements of consent have been presented orally) may be used to document informed consent in writing for individuals who do not speak English in limited situations. Please review the "Policy and Instruction" and "Question and Answer" documents before using a short form. There are specific regulatory requirements that need to be met in order to use this form.
Policy
Questions and Answers

The witness signature section of the BCH informed consent has been recently revised to include a specific section for interpreters to serve witnesses during the process of obtaining consent with the use of a short form. Since it will take time to revise all consents we have developed a witness signature addendum that may be attached to any consent document that has not been revised. This should be used and attached to the consent document if you are using the short form. The signature section of the actual short forms have not changed and may continue to be used as provided below.
Witness Signature Page 

Short Form Translations
Albanian
Amharic
Arabic
Bulgarian
Chinese
Dutch
English Version (for reference)
Farsi
French
German
Greek
Haitian Creole
Hebrew
Italian
Japanese
Khmer
Korean
Laotian
Nepali
Polish
Portguese
Russian
Somali
Spanish
Turkish
Urdu
Vietnamese

Informed Consent Template
All informed consent documents submitted to the Committee must be in the CCI template. Please use the templates below when developing informed consent documents.
English Informed Consent Template
Spanish Informed Consent Template

Informed Assent Template
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.
Informed Assent Template

Information Sheet Template
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.
Information Sheet Template

Informed Consent Assistant (ICA) -  is temporarily unavailable.
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.

Simplifying Medical Terms
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.
Stanford University Glossary of Lay Terms
University of Michigan IRB Simplification Guide to Medical Terms

Interpreter/Translation Services at Boston Children's Hospital
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.

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.
Click here to view the report

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, www.bostonchild.vitalconsent.comis 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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