IRB Review

Does my project or proposal need IRB Review?

Federal regulations require that any project or proposal involving research ("a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge") with living individuals about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information, must be reviewed by the Pacific University IRB. The Pacific University IRB reviews all proposals by investigators associated with Pacific University that require human subjects, as well as research conducted by investigators external to Pacific University using data from Pacific University students.

Use the decision tree to help you decide which template you need to use.

Download the IRB Study Proposal and Informed Consent Templates

Types of IRB Review

There are three types of IRB reviews: (1) full board review, (2) expedited review, and (3) exemption from full review. Regardless of the review type, the submission requirements remain the same. Each section below details the criteria and the process for the type of review.

Full Board Review

Proposals requiring full committee review may fall under one or more of the following criteria:

Involve data collected from protected populations (e.g., children or adolescents, inmates, pregnant women) or other socially or politically vulnerable groups
Involve some form of manipulation of research participants
Participants could potentially be identified
Assesses issues of a sensitive nature (e.g., sexual behavior, mental illness) or illicit/illegal activities (e.g., drug abuse, binge drinking)

The IRB meets monthly to review all proposals falling in this category. A majority vote of the IRB members present at the meeting is required for proposal approval. If modifications to the proposal are required, which is quite common, investigators will be notified of the changes to be made. A final approval letter will be sent out once the proposal has been updated and reviewed by an appointed IRB member.

Exemption from Full Review

Federal regulations stipulate that you do not need to go through the full review process if:

You are using existing data that is publicly available, or if you are using existing data from which the investigator records data in such a way that subjects cannot be identified.
Youare conducting research using educational tests, survey procedures, interview procedures or observation of public behavior
You are collecting data only from public officials or political candidates regarding their office

UNLESS (1) subjects are identified in, or identifiable from, the data collected; AND (2) any disclosure of subjects' responses could place subjects at risk of criminal or civil liability or be damaging to subjects' financial standing, employability or reputation.

If you are not sure if your research is exempt, ask the IRB representative for your College/School.

Note : Protocols that have been granted exemption from Pacific University IRB Review may still be subjected to review mandated by study sites, schools, or collaborating institutions.

Because certain categories of individuals, such as children and inmates, are viewed as more vulnerable to harm by research, and less able to give fully-informed consent, extra safeguards are included for these groups. Federal regulations require that all research with children, including adolescents, must be reviewed, except: observations of children's public behavior with no interaction with the children; research conducted in education settings of normal educational practices (e.g., on instructional strategies or curricula); research using existing records or data, if these sources are publicly available or if the information is recorded in such a way that the child cannot be identified. When in doubt, consult the IRB chair.

If you believe your proposal qualifies for exempt review, submit a cover letter with your proposal stating that you are requesting exempt review and the specific reasons for the request. Please be aware that the IRB determines whether or not your proposal qualifies for exempt status, not the investigator(s).

If your proposal is considered as exempt, it will still be reviewed by two appointed members of the IRB, but not the full committee. If modifications to the proposal are required, you will be notified of those changes. A final approval letter will be sent out once the proposal has been updated and reviewed by an appointed IRB member.

Expedited Review

Research that does not meet the criteria for exempt status, but involves some, though minimal, risk to the subject may receive "expedited review" by the IRB. "Risk" is defined as the probability of physical, psychological, social or economic harm or injury as a result of participation in a research study. "Minimal risks" are those where the probability of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily experienced in daily life or during the performance of routine psychological or physical examinations or tests.

Expedited reviews are quicker. All PIs are encouraged to request an expedited review if the circumstances warrant and your source of funding does not require a full committee review. However, the IRB may still require a full, convened review of an eligible research study, if they consider it useful or appropriate.

PIs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

If a PI wishes to apply for an expedited review, please include why you feel your proposal qualifies for expedited review in your cover letter to the IRB.

IRB Training Certification

As of February 15, 2007, all investigators (both faculty and students) and faculty advisors listed on submitted proposals are required to have completed an online training regarding the protection of human subjects in research. At present, research assistants do not need to complete the training. The training requires approximately 2 hours total to complete, but does not have to be done all in one session. Once you have completed the training, please submit either an electronic version or hard copy of your certification to the administrative assistant at irb@pacificu.edu or via regular mail at the Office of Academic Affairs, c/o IRB.

Once we have your name on file, you do not need to resubmit the documentation each time you submit a proposal. However, please note that your proposal will NOT be reviewed until ALL investigators listed on the proposal have completed the training.

The instructional course and assessment is sponsored by the National Institute of Health and is widely used by many IRBs for training purposes. The link to the training can be found at: http://phrp.nihtraining.com/users/login.php