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CCM | IACUC | IRB | ORD | ORI | ORIS | ORPFC | ORS | OSR | TTP |
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| Reference Documents | |||
|---|---|---|---|
| Document | Date | Description | |
FAQs - See answers to the frequently asked questions. |
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| 1. | Instructions, Additional Elements and Suggested Language Consent Forms |
08.24.2009 (Updated to include RIC's language subject compensation- see page 27) |
Includes special clauses, additional phrases and elements to be included in the consent form Definition of Financial and Significant Conflict of Interest |
| 2. | |||
| 3. | |||
| 4. | 10.6.2009 NEW!! |
Chart Review Protocol Instructions | |
| 5. |
Posted with Permission from the University of Michigan Medical School: |
01.20.1999 | A handy tool when revising the Risk Section of the Consent Form |
| 6. | 07.16.2008 | This document provides suggested language to be used when preparing your consent forms. |
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| 7. | 07.16.2008 | This document provides suggested language to be used when preparing your consent forms. |
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| NU Informed Consents | |||
This template is updated regularly. Investigators should check the site if they are writing a new consent form or submitting a periodic review to see what changes have been made. The consent form template for paper submissions has been removed from our website. If your project has not yet been converted into eIRB and you are still using the paper version consent form, simply remove the footer from the eIRB consent form and replace it with the version date and page numbers. |
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| Document | Date | Description | |
| 1. | 09.01.2009 (Updated to include the date line for the submission preparer) |
The template should only be used for project that was initiated within eIRB or was transitioned into eIRB | |
| 2. | eIRB Biomedical Consent Form and Authorization for Research Template | 09.16.2009 (If you plan to revoke your consent language) |
The template should only be used for project that was initiated within eIRB or was transitioned into eIRB |
| 3. | eIRB Biomedical Consent Form Template | 09.01.2009 (Updated to include the date line for the submission preparer) |
The template should only be used for project that was initiated within eIRB or was transitioned into eIRB |
| 4. | eIRB consent form footer | 04.23.2009 |
Consent form template to be used when converting your paper projects into eIRB |
| 5. | Verbal Consent Form Instructions | ||
| 6. | Sample Verbal consent template for for studies involving Questionnaires and interviews | A recruitment /introduction letter may be used when a waiver of written consent has been granted. This letter typically accompanies a questionnaire but may be an introductory letter to direct someone to a website to respond to a questionnaire; to call if they wish to participate in an interview, or receive a questionnaire in the mail. |
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| Assent Forms | |||
| Document | Date | Description | |
| 1. | Assent Form Template | 01.30.2007 | This template should be used for creating the assent for minors 7-12 years old. |
| 2. | Assent Form Template | 01.30.2007 | This template should be used for creating the assent for minors 13-15 years old. |
| 3. | Assent Verbal Script | 01.30.2007 | This template should be used for creating a script to obtain assent from minors less than 7 years old. |
| Recruiment Templates | |||
| Document | Date | Description | |
| 1. |
Recruitment Scenarios and FAQs |
11.12.2004 | A researcher can ask care providers to inform their patients of a research study. The researcher should create a simple referral form (Example) that the patient completes to give his permission for the researcher to contact him regarding the study. The care providers ask their patients if they would like to be contacted to learn more about the study, the patients complete the form if interested and the care provider then forward these notes of permission to the researcher. The researcher may contact anyone who has documented his or her approval. |
| Consent Templates for Special Situations | |||
| Document | Date | Description | |
| 1. | Template for Consent Form for Documentation of an Emergency Procedure | 12.06.2002 | |
| 2. | Clinical Consent Form for a Humanitarian Use Device | 12.06.2002 | |
| Revocation of Authorization Template | |||
| Document | Date | Description | |
| 1. | Revocation of Authorization Template | 11.01.2004 | It is not necessary to submit this form to the IRB. A Principal Investigator can use this form if one subject wants to revoke his/her HIPAA authorization. Note that the PI has to report the number of revocations on the periodic review form. |
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