Initial Submissions

National Jewish Health IRB features four distinct application processes customized to common types of study designs.

1. Research on data and/or specimens that does not involve contact with human subjects 
2. Research involving contact with human subjects for intervention or collection of health information 
3. Exempt research that typically does not involve collection of health information (surveys, educational testing, etc.)
4. Research at National Jewish Health when COMIRB serves as the IRB of record

If unsure which application process to follow, please contact the IRB office for guidance.

Research on Data or Specimens

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

• Application for Research on Data and/or Specimens (updated 29 Nov 2012)
• 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 26 Jul 2011)
• Certification of research-specific HIPAA training for all research personnel (if not on file with the IRB). Click here for instructions to access the CITI program education. (effective 01 Jul 2010)
• 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 Dec 2012)
  • National Jewish Health 2012 Conflict of Interest Declaration for individuals not employed by NJH or UCD who are reporting a COI.
  • Updates for National Jewish Health 2012 Conflict of Interest Declaration
• Current (within 3 years) CVs for all investigators (if not on file with the IRB)
• Data/Specimen Access Template (updated 14 Jun 2010)
• Data Use Agreement (updated Apr 2009)
• Decedent Research Certification (updated Jan 2004)
• Fee Waiver (updated 11 Jun 2010)
• Grant Proposal
• ILD Application (updated 14 Jun 2010)
• Waiver of HIPAA Authorization (updated Aug 2010)

Number of copies:

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

New Protocol Application   

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

• New Protocol Application (updated 29 Nov 2011)
• Informed Consent Document
  • Informed Consent Instructions and Templates
• HIPAA Research Authorization (HIP-004) or HIPAA elements included in the consent form (HIP-004 updated 14 Sep 2009)
• HIPAA Research Authorization (HIP-005) - Spanish (updated Nov 2009)
• Protocol (Sponsor/Investigator)
• Conflict of Interest and Scientific Misconduct(updated 24 Dec 2012)
  • National Jewish Health 2012 Conflict of Interest Declaration for individuals not employed by NJH or UCD who are reporting a COI.
  • Updates for National Jewish Health 2012 Conflict of Interest Declaration
• Certification of research-specific HIPAA training for all research personnel (if not on file with the IRB). Click here for instructions to access the CITI program education. (effective 01 Jul 2010)
• 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 as directed 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):

• Child Assent form
• Child Research Assessment (updated 17 Apr 2013)
• Pregnant Women and Fetus Research Assessment (updated 21 Jun 2010)
• Research Involving Vulnerable Populations (updated 10 Aug 2011)

The following documents must be included when applicable:

• Advertising or recruiting materials
• Data and Safety Monitoring Plan (DSMP) Addendum (updated 07 Jun 2010)
• Fee Waiver (updated 11 Jun 2010)
• Genetics Addendum (updated 21 Jun 2010)
• Grant Proposal
• Instruments (surveys, questionnaires)
• Investigational Device Exemption (IDE) Addendum (updated 26 May 2010)
• Investigational New Drug (IND) Addendum (updated 07 Jun 2010)
• Investigator's Brochure
• NJH Clinical Trials Listing (posted 07 Nov 2011)
• Recruitment Authorization to be Contacted about Research (HIP-001) (updated Jan 2010)
• Recruitment Authorization to be Contacted about Research (HIP-001) - Spanish (Updated 3 Feb 2010)
• Supplemental Access to NJH Data/Specimen Repositories (National Jewish Health Research Database, ILD repository) (updated 10 Aug 2011)
• Waiver of Informed Consent (created 08 Nov 2012)
• Waiver of Documentation of Informed Consent (created 08 Nov 2012)
• Waiver of HIPAA Authorization (updated Aug 2010)

Number of copies:

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

If the study does not qualify for expedited review, submit the signed original and two (2) copies. All packets must be collated.

Research at National Jewish Health when COMIRB serves as the IRB of Record 

The following documents must be included in all applications for Secondary IRB Review:

• Application to Conduct Research at National Jewish Health when COMIRB is the IRB of Record (updated 10 Aug 2011) 
• COMIRB approval letter(s)
• All documents reviewed and stamped by COMIRB in the original approval notice
• Grant proposal if National Jewish Health is a grant recipient (This requirement does not apply when NJH serves only as a sub-contractor.)

If the study is ongoing, also provide:

• The most recently approved protocol, consent form, recruitment approvals, etc.
• The most recently approved notice of COMIRB Continuing Review approval

The following documents must be included, as appropriate, when collecting health information from subjects seen at National Jewish Health or from National Jewish Health records.

• Recruitment Authorization to be Contacted about Research (HIP-001) (updated Jan 2010)
• Recruitment Authorization to be Contacted about Research (HIP-001) - Spanish (Updated 3 Feb 2010)
• HIPAA Research Authorization (HIP-004) or HIPAA elements included in the consent form (HIP-004 updated 14 Sep 2009)
• HIPAA Research Authorization (HIP-005) - Spanish (updated Nov 2009)
• Waiver of HIPAA Authorization (updated Aug 2010)

The following document must be submitted if accessing the National Jewish Health Research Database, Biobank, or ILD Repository.

• Supplemental Access to National Jewish Health Data/Specimen Repositories - for recruitment or medical history collection (updated 10 Aug 2011)

Number of copies:

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