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
- English Informed Consent Template (new version dated February 2022)
- Concise Summary Example – Greater Than Minimal Risk Study
- Concise Summary Example – Minimal Risk Study
- Concise Summary Example – Repository
- Individual Patient Expanded Access Consent Template (only for use with protocols using the “Individual Patient Expanded Access” submission type in CHeRP).
- Humanitarian Use Device Consent Template for On Label Clinical Use (only for use with protocols using the "Humanitarian Use Device (HUD)" submission guide in CHeRP
- Humanitarian Use Device Consent Template for Off Label Clinical Use (only for use with protocols using the "Humanitarian Use Device (HUD)" submission guide in CHeRP AND after confirming use of HUD Off Label templet is appropriate with the IRB (contact irb@childrens.harvard.edu)
Informed Consent Library
The BCH Informed Consent Library (ICLibrary) provides investigators and their staff the ability to access the currently approved versions of their informed consent(s). The site is accessible to anyone with a Children's Hospital web 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.
Use of the Short Form Consent
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. There are specific regulatory requirements that need to be met in order to use this form. Please review IRB Policy 6.4 "Informed Consent with Non-English Speakers" before using a short form.
When a short form is used and the interpreter is present in the room with the subject we have provided a checklist to help you through this process.
Due to the increasing numbers of non-English speaking patients, interpreter services have contracted with remote interpreters to provide assistance as needed. This process is facilitated through the use of iPads dedicated for this purpose. If a short form is used and a REMOTE interpreter (VRI iPad Technology) is utilized there is a checklist that must be completed and filed with the short form to assure compliance.
- Short Form Checklist for use with Remote Interpreters, REQUIRED for both OPI (over the phone interpretation) and VRI (video remote interpreting)
Short Form Translations
Albanian
Amharic
Arabic
Bosnian
Bulgarian
Cape Verdean Creole
Chinese
Czech
Danish
Dutch
English Version (for reference)
Farsi
French
German
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Italian
Japanese
Khmer
Korean
Laotian
Maay Maay
Nepali
Polish
Portuguese
Russian
Somali
Spanish
Tamil
Thai
Tibetan
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.
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