Informed Consent

Informed Consent Template

New Common Rule Key Information Examples:

To assist investigators in developing the key information section of the consent form we are posting a few examples. These examples would be placed at the beginning of the consent form document. Currently there is no federal guidance defining exactly what “key information” is required in the concise and focused introduction. This is due in part to the fact that the application of this new requirement will depend upon the nature of the specific research study.  The “key information” that a subject will need to decide whether to enroll in a Phase II Clinical Trial will be different from the “key information” needed to decide whether or not to enroll in a longitudinal or observational research study involving not greater than minimal risk. For some minimal risk studies, the concise introduction may require only a few paragraphs. For more complex research trials key information should never be longer than 2 pages and most should fit on one page. 

It is important to note that the concise and focused introduction should include a summary of why an individual may want to participate, but should also include information about why an individual may not want to participate in the research, such as the fact that participation involves significant time commitments or risks.  While the introductory section should not list every foreseeable risk of participation, it should describe those risks that occur with significant frequency or are of significant severity. The total time commitment may also be an important factor. Investigators know their participant population best; therefore they are in the best position to determine the key information that should  be provided at the start of the consent to meet this new requirement . Some key information examples are provided below

New English Informed Consent Template (New Common Rule version dated November 2018)

Concise Summary Example – Greater Than Minimal Risk Study

Concise Summary Example – Minimal Risk Study

Concise Summary Example – Repository

Individual Patient Expanded Access Consent Template

This template is only for use with protocols using the “Individual Patient Expanded Access” submission type in CHeRP.

Individual Patient Expanded Access Consent Template 

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. Study staff are 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.

Short Consent Translations

The IRB 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
Bosnian
Bulgarian
Chinese
Czech
Dutch
English Version (for reference)
Farsi
French
German
Greek
Haitian Creole
Hebrew
Hindi
Italian
Japanese
Khmer
Korean
Laotian
Maay Maay
Nepali
Polish
Portuguese
Russian
Somali
Spanish
Tamil
Telugu
Turkish
Urdu
Vietnamese

Informed Assent Template

All assent documents must be reviewed and approved by the IRB. 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 IRB. 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

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 plain language medical dictionary

Interpreter/Translation Services at Boston Children's Hospital

Interpreter Services and the IRB Office 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 Interpreter Services at (617) 355-7198 or visit Children's Hospital internal website at http://web2.tch.harvard.edu/interpreter_svc/ for more information.

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 IRB 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