Initial Submissions

National Jewish Health requires that investigators submit to the IRB all planned research activities involving bodily materials, residual diagnostic specimens, or private information originating from humans. For more information, review the NJH policy, Review of Research: Human/Non-Human Subject Research Determination (available only on the Spyderweb).

To facilitate this review, National Jewish Health IRB created two main application processes depending on whether there will be contact with human subjects. Please review descriptions of each application to ensure selection of the correct process.

Research on Data or Specimens (research on human data/specimens involving no contact with human subjects)
New Protocol Application (research on prospectively collected data/specimens OR direct contact with identifiable human subjects)

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Research on Data or Specimens

The following documents must be included in all applications involving existing data or specimens:

• Application Checklist - Data or Specimens (updated 14 Sep 2009)
• Application for Research on Data or Specimens (updated 14 Sep 2009)
• Protocol (or you may use the application form as a substitute)

The following documents must also be included when instructed in the application:

• Biobank Application (updated 08 Jun 2009)
• Child Research Assessment Form (updated 28 Sep 2009)
• Current (within 3 years) Certification of Human Research Protections for all research personnel (if not on file with the IRB). Click here for instructions to access the CITI program education.
• Conflict of Interest and Scientific Misconduct (updated 24 Jul 2009)
• Current (within 3 years) CVs for all investigators (if not on file with the IRB)
• Data/Specimen Access Template (updated 04 Jun 2009)
• Data Use Agreement (updated Apr 2009)
• Decedent Research Certification (updated Jan 2004)
• Fee Waiver (updated 24 Jun 2009)
• Grant Proposal
• ILD Application (updated 25 Sep 2009)
• Pregnant Women and Fetus Research Assessment (updated 30 Jun 2009)
• Waiver of HIPAA Authorization (updated July 2007)

Number of copies:

Submit the signed original and one (1) complete copy of all materials.

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New Protocol Application   

The following documents must be included in all applications (except for Requests for Exempt Review):

• Application Checklist - Contact (updated 14 Jul 2009)
• New Protocol Application (updated 25 Sep 2009)
• Informed Consent Document or Request for Waivers of Informed Consent/Authorization
  • Informed Consent Instructions and Guidelines
  • Request for Waiver of Informed Consent or Waiver of Documentation of Informed Consent (updated 23 Sep 2009)
    
  • Request for Waiver of HIPAA Authorization
• HIPAA Authorization (HIP-004) (updated 14 Sep 2009). Effective 07/14/09, the institutional HIPAA Authorization form must be submitted with all new applications.
• Protocol (Sponsor/Investigator)
• Conflict of Interest and Scientific Misconduct (updated 24 Jul 2009)
• Current (within 3 years) Certification of Human Research Protections for all research personnel (if not on file with the IRB). Click here for instructions to access the CITI program education.
• Current (within 3 years) CVs for all investigators (if not on file with the IRB)

The following documents must also be included for studies involving vulnerable populations (children, pregnant women, economically-disadvantaged persons, workers at off-site locations, developmentally-disabled persons, students or staff at National Jewish Health):

• Research Involving Vulnerable Populations (updated 30 Jun 2009)

      Include other forms appropriate to the vulnerable population

• Child Assent form
• Child Research Assessment (updated 28 Sep 2009)
• Pregnant Women and Fetus Research Assessment (updated 30 Jun 2009)

The following documents must be included when applicable:

• Advertising or recruiting materials
• Data and Safety Monitoring Plan (DSMP) Addendum (updated 24 Jun 2009)
• Fee Waiver (updated 24 Jun 2009)
• Genetics Addendum (updated 22 Sep 2009)
• Grant Proposal
• High Risk Addendum (updated 08 Jun 2008)
• Instruments (surveys, questionnaires)
• Investigational Device Exemption (IDE) Addendum (updated 27 Jun 2009)
• Investigational New Drug (IND) Addendum (updated 30 Jun 2009)
• Investigator's Brochure
• Recruitment Authorization to be Contacted about Research (HIP-001) (updated Jan 2010)
• Recruitment Authorization to be Contacted about Research (HIP-001) - Spanish (Updated Feb 2010)
• Supplemental Access to NJH Data/Specimen Repositories - for recruitment or medical history collection (updated 28 Sep 2009)

Number of copies:

If the study qualifies for expedited review, submit the signed original and one (1) copy of all materials.

If the study does not qualify for expedited review, submit the signed original and twenty (20) copies. All packets must be collated.