Full Committee Review
The IRB application process begins with the submission of the application form, consent forms and other required appendices/materials. For forms and detailed instructions, review the Submissions page.
All new submissions for full committee review are due on Tuesday, two weeks prior to the scheduled IRB meeting. Click here for the submission page. The IRB staff will examine the application to make sure all of the necessary materials are there for IRB review. The Principal Investigator and IRB Contact Person will receive an email indicating the date and time the protocol will be reviewed by the IRB Full Committee. It is requested that the PI or a representative be present during the meeting to present a summary of the project and answer questions from board members.
The full committee meets on the 2nd and 4th Thursday of each month. Approximately 5 - 7 days after the meeting, notification of the IRB decision will be forwarded to the PI and IRB Contact Person. If the stipulations request a re-review of the new protocol, please refer the re-review submission deadline schedule on the Submissions page.
Forms & Links
NJH IRB SOP: Review of Research: Full Committee Review for New Submissions (Available only on the NJH Spyderweb, updated 24 Mar 2009)
Expedited review is an option when the research activity will expose participants to no more than minimal risk and when the proposed study falls into a category described in the federal regulations. Review the Expedited Review Categories.
Because the risks of participating in the research are no more than minimal, the regulations allow the study to be reviewed by the IRB Chairperson or an experienced IRB member.
Expedited review may also be used for some requests to renew protocols and for minor amendments to approved protocols.
Procedure for Requesting an Expedited Review of a New Protocol
Investigators who wish to apply for expedited review should complete the appropriate submission requirements on the Initial Submissions page. There are no submission deadlines for expedited review.
If the application meets the criteria for expedited review, a Primary Reviewer will be assigned to the protocol. The Primary Reviewer will correspond directly with the PI or IRB contact person to request any clarifications. Once all stipulations have been adequately addressed, the protocol is approved and the PI is notified.
Generally, an expedited review requires 2-3 weeks, but it is dependent upon the availability of the Primary Reviewer. The length of the review process is also dependent upon the need for changes to the protocol.
Forms & Links
Expedited Review Categories
Research that poses minimal or no risk to subjects and falls under one or more of the categories of exempt research may be exempt from the need for ongoing IRB review. If it is determined that a proposal submitted for an exemption does not meet the exemption criteria, Investigators may be asked for additional information about the project. The IRB reserves the right to decline exemptions for any research proposal they believe needs another form of review.
Procedure for Requesting an Exempt Review of a New Protocol
Investigators who wish to submit a project for an exemption determination should complete the Exemption Application. Note that research eligible for Exempt Category 4 must be submitted using the Application for Research on Data and/or Specimens. There are no submission deadlines for exempt review.
A Primary Reviewer will be assigned to the protocol submission and will correspond directly with the PI or IRB Contact person to request any clarifications. Once all stipulations have been adequately addressed, the exemption is granted and the PI will be notified.
Generally, an exempt determination review will take place within two weeks, but it is dependent upon the availability of the Primary Reviewer. The length of the review process is also dependent upon the need for changes to the protocol.
Forms & Links
Exempt Review Categories
Exempt submission page
Non-Human Subjects Review
National Jewish Health requires that investigators submit to the IRB all research activities involving bodily materials, residual diagnostic specimens, or private information originating from humans. When an investigator receives data or specimens that cannot be linked (by the investigator) to human subjects, the IRB may make a non-human subjects determination.
Note: While the research may not fall under federal regulations for protections of human subjects, it may still be regulated by the HIPAA Privacy Rule. The IRB will help investigators ensure that all appropriate approvals are in place.
Procedure for Requesting a Non-Human Subjects Determination
Investigators who believe their research does not involve human subjects should complete the Application for Non-Human Subject Determination. The application asks questions that guide investigators through review steps and supplemental documents dependent on exposure to identifiable information.
The IRB requires the original set of documents plus one (1) complete copy of all materials. There are no submission deadlines for submissions. A Primary Reviewer will be assigned to the protocol. The Primary Reviewer will correspond directly with the PI or IRB contact person to request any clarifications. Once all stipulations have been adequately addressed, the PI will be provided a letter verifying that the research does not involve human subjects.
Generally, this level of review could be performed in 2-3 days, but it is dependent upon the availability of the Primary Reviewer. The length of the review process is also dependent upon the need for changes to the protocol.
Forms & Links
Application for Research on Data and/or Specimens
The National Jewish IRB has the authority to approve, require modifications or disapprove all research activities involving human subjects at National Jewish Health. The types of outcomes of IRB decisions regarding human research proposals are as follows:
The full IRB, IRB Chairperson, or IRB Chairperson's designee has approved the research proposal as written for a period not to exceed one year. An approval letter and all applicable attachments are sent to the investigator.
Minor modifications must be made to the research proposal before approval may be granted. Minor modifications may include such things as typographical errors and minor re-wording of the informed consent form. The research may not commence until the Investigator has made the required modifications to the satisfaction of the IRB Chair or IRB Chairperson's designee.
The Investigator is sent a letter indicating the required modifications. The Investigator must address the concerns of the IRB before Approval can be granted. These modifications must be submitted in writing to the IRB office. The IRB Chair or IRB Chairperson's designee may grant approval if the changes are satisfactory.
A deferral does not indicate that the submission doesn't have quality or merit. An IRB is required to defer approval of research if the research proposal does not meet one or more of the Criteria for IRB Approval.
The Investigator is sent a letter indicating the concern(s)/issue(s) being raised. The research proposal will be placed on the agenda for the next scheduled IRB meeting upon receipt of the Investigator's response.
The protocol, as submitted, cannot be approved in its current form and requires complete revision and resubmission as a new protocol. Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedures outweighs any benefit to be gained. The Investigator is sent a letter describing the reasons for disapproving the protocol.