Human research determination
All research applications must be submitted to the IRB through IRBNet, an externally-hosted software product. All IRB forms must be obtained from the IRBNet Forms and Templates library.
If you are unsure if the activities you are conducting are considered Human Subjects Research, please complete a Determination of human research form.
The Human Research Protection Program will provide a written determination which can be used to provide sponsors, collaborators, journal editors, and others with verification from an impartial source as to whether or not the proposed activities require IRB approval.
Determination submission
All determinations require the following:
- Complete and upload the Determination of human research form.
- Share your project with the NAU IRB Office, granting “Full” access.
- The PI must sign the package. Student projects must be signed by the faculty advisor as well as by the student PI.
- Submit the package by clicking the “Submit” button in IRBNet. Select “Other” from the “Submission Type” dropdown options.
Additional information about determinations:
This form is required if the proposed study involves any of the following activities and it is unclear whether these activities require IRB review:
Because research must be systematic and designed to be generalizable, it does not include:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, and historical scholarship) that focus directly on the specific individuals about whom the information is collected;
- Public health surveillance;
- Activities for criminal justices agencies as authorized by law;
- Homeland security and intelligence activities
Case report Accordion Closed
The proposed activity is a case report or case series of no more than three (3) cases describing an interesting treatment, presentation, or outcomes.
Program evaluation/quality improvement/quality assurance Accordion Closed
The proposed activity will assess, analyze, critique, and improve current processes of a program OR health care delivery in an institutional setting. These projects involve data-guided, systematic activities designed to bring about prompt improvements in a program or health care delivery.
Course-related activities Accordion Closed
The proposed activity is limited to course-related activities designed specifically for educational or teaching purposes.
Oral history Accordion Closed
The activity is limited to oral history activities, such as open ended interviews that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings.
Public use datasets Accordion Closed
The activity is limited to analyzing de-identified data contained within a publicly available dataset. NOTE: This does not include reviewing or analyzing information from social media.
Journalism/documentary activities Accordion Closed
The activities are limited to investigations and interviews that focus on specific events, views, etc., and that lead to publication in any medium (including electronic), documentary production, or are part of training that is explicitly linked to journalism. There is no intent to test a hypothesis.
Purchased cell lines Accordion Closed
The activity involves commercially available, de-identified non-human embryonic cell lines.
Database creation Accordion Closed
The primary reason for establishing this database is for clinical purposes or an improvement project (IRB approval of a new protocol must be obtained before any data from this database may be used for research purposes).
Native American/Alaskan Native Accordion Closed
The activity involves access to tribal resources (e.g. cultural artifacts, environmental samples, or people), but the activity is not intended to produce generalizable knowledge.
dbGap Accordion Closed
Receipt of data from the dbGap that requires IRB approval, but the data you will receive
- Is de-identified, but the Data Use Committee requires IRB approval
- The researcher did not submit any of the original data to dbGap
- The researcher will not collaborate with others on the project who submitted the original data to dbGap
If in the future, the intent of the project changes to meet the definition of research or human subject research, please note that an amendment to the original project needs to be submitted through IRBNet.