Although the category is called "exempt," this type of research does require IRB review and registration. To qualify, research must fall into one of 8 (eight) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects. At DU, only 6 (six) exempt categories are allowed in total. Specifically, exempt categories 7 & 8 are not allowed at DU (no Broad Consent). The interpretation for these two categories is that it is for the research storage and maintenance institution-wide of samples and / or data. Currently there is no current infrastructure in place at DU to ensure that participants are not (re)approached should they decline an initial broad consent and to track which specimens or data a participant has allowed (and has not allowed) for research use.
Some examples of Exempt research are:
Anonymous or identifiable surveys or interviews
Passive observation of public behavior with or without the collection of identifiers
Retrospective and prospective medical chart reviews (allowable under specific criteria)
Analysis of specimens that are publicly available or if not publicly available, where the identities of the subjects cannot be readily ascertain
To qualify for an expedited review, research must fall into one or more of the nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
studies involving collection of hair, saliva or dental plaque samples,
studies of blood samples from healthy volunteers,
analyses of voice recordings
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a reviewer cannot approve the research under expedited review, the study is referred to the Full Committee for review.
Applicability of Expedited Review
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the federally-defined expedited categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The expedited categories apply regardless of the age of subjects, except as noted.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
The expedited review procedure may not be used for classified research involving human subjects.
The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review utilized by the IRB (i.e., expedited or full committee review).
Revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s). All applicable revisions must be checked on the project revision form and must be incorporated into the relevant study documents using track changes.
The federal regulations allow for expedited review of minor changes to studies previously approved by the full board. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:
The level of risks to subjects
The research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)
The number of subjects enrolled in the research (no greater than 10% of the total requested)
The qualifications of the research team (change in PI is not considered minor)
The facilities available to support safe conduct of the research, or
Any other actor which would warrant review of the proposed changes by the convened IRB or was used to initially evaluate the risk/benefit ratio and any other criteria for approval
The IRB Office will make a determination regarding the appropriate review process upon receipt of the form.
All amendment requests must be submitted electronically through IRBNet. To submit an Amendment Application please follow these steps:
Log into IRBNet, and then select your project by clicking on the project title.
On the left-hand side, select "Create New Package."
Then you will be able to "Attach New Document."
Next, upload the Amendment Request form and any other necessary documents (e.g., updated consent forms, recruitment materials, etc.). Please refer to the Amendment/Modification Checklist for more details.
Finally, please Sign the Package, and then click "Submit this Package."
The "Next Report Due" Date
For research projects that have undergone an expedited review or have been granted exempt status, the IRB will issue a “Next Report Due” (NRD) date within the IRBNet system. When the NRD date is upcoming, the investigator will receive automated emails from IRBNet (30 Day Notice and Review Period Expiration Notice) requiring the investigator to notify the IRB via IRBNet about the status of the study:
If the exempt or expedited study is still active, a faculty or staff investigator can request a 2-year administrative extension of the next report due date. For all student investigators, a 1-year administrative extension of the next report due date may be requested.
If the study has been completed, the investigator must submit a Final Report Form to close the study in IRBNet.
In the event the PI has not communicated to the IRB on the status of the study prior to the NRD date, the IRB will administratively close the project in IRBNet.
All project extension requests must be submitted electronically through IRBNet. To submit an Extension Request in response to your NExt Report Due notice, please follow these steps:
Log into IRBNet, and then select your project by clicking on the project title.
On the left-hand side, select "Create New Package."
Then you will be able to "Attach New Document."
Next, upload the completed Next Report Due/Project Extension form and any other necessary documents (e.g., updated consent forms, recruitment materials, etc.).
Finally, please Sign the Package, and then click "Submit this Package."
Study Expiration for More than Minimal Risk Studies
It is the responsibility of each investigator to be aware of when their study expires and submit a Continuing Review Form (or final report) to the IRB Office, via IRBNet, at least 30 days prior to that date. In the event that a study expires prior to the submission of the renewal application, the study will be administratively closed. No research activities, including data analysis, may be conducted in the absence of a current IRB approval.
Final reports should be submitted by the study expiration date or sooner if all study activities, including data analysis, are complete. If a project expires or Investigators are responsible to notify the IRB if they left the University or graduate.
NOTE: If a student investigator graduates or leaves the University without submitting a Final Report, the Faculty Sponsor is responsible for closing the research project.
