New Project Submission Form for Biomedical Research (NPSF)

(The Radiation Dosimetry Form and the Expedited Review Application are to be downloaded separately from this form. They are listed below.)

This form should be used for new projects. Copies of the consent form, instruments to be used, grants, drug/device company protocols, and recruitment materials are needed. The original and two copies should be submitted. If an investigator is seeking funding, the IRB applications must be submitted to allow adequate time for review. Investigators and staff in need of assistance should contact OPRS. Projects may not start until IRB approval is completed.

Guidance for protocol: Click here for the list of key elements of a biomedical protocol

HIPAA: Click here for additional guidance prior to completing the HIPAA section of this form.

Project Submission Form for Grants (PSFG) (Umbrella projects)

This form is used for training grants and grants composed of individually approved project.

Please use this form for initial and continuing review of a grant submission.

For information on the change in federal policy, please see this letter from OPRR: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/aplrev.htm. Northwestern uses this procedure on any grants regardless of the funding source. See Guidelines for additional information.

Click here for additional guidance prior to completing the HIPAA section of this form.

Medical Records Review Form

This form is to be used only when retrospective medical records are used in a research study. If prospective patient contact is involved, please submit a New Project Submission Form. See Guidelines for additional information.

Click here for additional guidance prior to completing the HIPAA section of this form.

For studies involving radiation. See Guidelines on additional review and sign-off required.

Use this form if a study will be conducted at Evanston Northwestern Healthcare (ENH) or Childrens Memorial Hospital (CMH) as a site of primary contractual authority and procedures of the study are being done at a Northwestern University (NU). This form should be used both after the initial approval and after each approval of periodic review is obtained from the primary site.

Description of Limited Data Set and Activities

Use this form when you receive a limited data set from one of the following institutions: NMH, NMFF, RIC. A master data use agreement has been executed with these institutions to allow use and disclosure of limited data sets in connection with research. Please contact the Office of the Protection of Research Subjects prior to completion of this form.

Data Use Agreement

A data Use Agreement is to be used in conjunction with a request to use a Limited Data Set. Please contact the Office for the Protection of Research Subjects if you receive a Limited Data Set.

A revision is any change in the research study as described in the IRB submission form, protocol, and consent form. When approval is given, it is given for the materials that were presented at the time of approval. Any proposed changes must be reviewed by the IRB before they are implemented. Examples of revisions include: amendments from the sponsor, dosing changes, PI changes, new recruitment strategies and materials, addition of new subjects, reimbursements, changes in procedures, and changes in the protocol. If you are only revising media relation materials, use the Media Relations Submission Form instead of the Revision Submission Form.

See Guidelines for additional information.

(NEW) Media Relations Submission Form for Open Human Clinical Trials

NOTE: The Media Relations Form IS NOT for subject recruitment materials such as flyers, brochures, posters, letters or paid advertising in print or broadcast outlets. These must be submitted on an IRB Revision Form.

The Media Relations Form is only for open human clinical trials, as follows:

• Press releases being sent out by the Media Relations or Public Relations staff to newspapers, magazines, TV or radio outlets
• Communications articles appearing in NU or NMH publications or websites
• Principal investigators must sign the form, which NU media relations or NMH public relations staffs will submit with the press release to IRB for approval.

Please contact NU Media Relations, NMH Media Relations or NMH Communications for assistance before submitting media relations materials to the IRB.

(Form available only thru NUMR, NMHMR or NMH Communications)

Project Submission Form for Grants (PSFG) (Umbrella projects)

This form is used for training grants and grants composed of individually approved project.

Please use this form for initial and continuing review of a grant submission.

For information on the change in federal policy, please see this letter from OPRR: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/aplrev.htm Northwestern uses this procedure on any grants regardless of the funding source.
See Guidelines for additional information.

Click here for additional guidance prior to completing the HIPAA section of this form.

(NEW) Death Reporting for Continuing Review

Documentation of Emergency Use or Procedure

See Emergency Use Exemption for Drugs, Biologics and Devices for guidance. Also see the Consent Form for Documentation of Emergency Procedure template. The definition for emergency use procedures can be used within a very limited framework of FDA guidance.
See Guidelines for additional information.

Guidelines for Investigators conducting research at Jesse Brown VAMC

This document includes guidelines, IRB protocol submission checklist and information from the Jesse Brown VA Medical Center

VA Form #10-9012

This form should be included with each human subject application submission to the IRB if Investigational Drugs are being used at the VA. Failure to comply will result in your protocol being returned.

FDA 1571

For Investigator - held IND - "A Sponsor - Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed." See: http://www.fda.gov/cder/about/smallbiz/Forms.htm
www.fda.gov/cder/forms/1571-1572-help.html for the forms and for information.