303.398.1477

National Jewish Health (NJH) fosters a research environment that promotes respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the Organization. In support of this, NJH has established a Human Research Protection Program (HRPP). The NJH HRPP, in partnership with its research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted under NJH’s auspices.

SMART IRBAn Institutional Review Board (IRB) is an independent committee designated by National Jewish Health to review, to approve the initiation of, and to conduct periodic review of research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The IRB acts as an advocate for the research subject.

The National Jewish Health HRPP website is designed to assist investigators and research staff with information on the regulatory procedures and requirements for conducting human subject research.
 

Work in Progress

Please note that the NJH HRRP/IRB Staff is working hard on the new version of our website. If you need any guidance or assistance in the meantime please contact us.

Phone: 303.398.1477
Email: irb@njhealth.org

 

Common Rule Change & Other Changes

Common Rule Change

 

 Major Regulation Changes

  • Continuing Review - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.  Please refer to the revised NJH HRPP SOPs (January 2019) Section 12.13 for further guidance.

  • Exemptions - New categories and clarification of existing categories.  Some exemptions may require "limited IRB review" (similar to an expedited review process), while others may qualify for HRPP Office review.  Please refer to the revised NJH HRPP SOPs (January 2019) Section 5 for further guidance.

  • Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not.  For details, see the National Jewish Health revised consent form.

 

What to Expect

*The new regulations do not impact studies approved prior to the proposed implementation date of January 21, 2019, further guidance for studies which can be switched to the new common rule to minimize the burden for investigators will be evaluated by the NJH HRPP team in conjunction with the study teams.*

For new studies, expect to see:

  1. NJH IRB application changes ( Please see new submission templates to be used for submissions after 1/15/2019)
  2. Informed consent template revisions
  3. HRPP SOP updates
  4. NJH HRPP/IRB, in consultation with study team, will determine when NJH will serve as the sIRB (single IRB of record)

 

NJH Actions

The NJH HRPP/ IRB and Research Administration Offices have worked collectively to ensure successful implementation of the revised Common Rule elements including updated policies and business processes.

 

DETERMINATIONS/Decisions Made to Date

sIRB (single IRB) – NJH IRB/HRPP Staff will continue to assess its criteria for when NJH will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.

Broad Consent- NJH will not implement the new regulatory "Broad Consent" option as an informed consent process at this time. Exemptions 7 & 8, which rely on Broad Consent, also will not be implemented.

Electronic protocol management system – NJH HRPP/IRB staff are in the process of implementing a new electronic management system (IRB Manager) to accommodate the changes while maintaining a high-level of human subjects protection.

 

Useful Resources

CITI Final Rule Resources
OHRP Revised Common Rule Educational Resources

 

What You Can Do

  1. Check the NJH website periodically for new information.
  2. Look for educational sessions and opportunities offered by the HRPP Staff. Communication for these will occur on the NJH SpyderWeb, in newsletters, and in NJH email blasts.
  • HRPP/IRB Office Presentation on the New Common Rule Forms and Processes January 29th at 10:00 a.m., Heitler Hall

 

Initial Submissions

Initial Submission Form
Consent Authorization Template Common Rule
Request for Determination of Exempt Status
Request for Human Subjects Research Determination
Supplement Form C - Research Involving Children as Subjects
Supplement Form J - Research Involving Prisoners as Subjects
Supplement Form P - Research Involving Pregnant Women
Supplement Form I - Research Involving Subjects with Impaired Decision Making Capacity
Supplement Form W - Request for Waiver Alteration and or Documentation of Consent
Supplement Form H - Request for Waiver or Alteration of HIPAA
Supplement Form D - Research Involving Drugs or Biologics
Supplement Form M - Research Involving Medical Devices
Supplement Form F - Storing Data or Specimens for Future Research
Supplement Form S - Collaborative Research

 

Contact Information

Human Research Protection Program
National Jewish Health
1400 Jackson Street, Room M211
Denver, CO 80206
Phone: 303.398.1477
Email: IRB@NJHealth.org

 


Federalwide Assurance and IRB Registration

Federal-wide Assurance #: FWA00000778, expires August 1, 2019.
IRB Registration #: IORG0000018, expires January 26, 2021.

For information about National Jewish Health Federalwide Assurance, IRB Registration, and general organization, download our Letter of Assurance (PDF).

The IRB roster was last modified February 15, 2018. View a redacted roster (PDF).