New application:

Research activities involving human participants in which there is more than minimal risk (which therefore does not fall within one or more of the exemption categories or expedited review categories ), or involves certain vulnerable populations (e.g., prisoners) must undergo a full IRB review.  The IRB college representative will recommend to the IRB Chairperson that a full Board review is warranted.  The PI is invited and encouraged to attend the meeting in which the application will be reviewed.  If the PI is a student, the faculty sponsor and student must attend. 

The PI is responsible for submitting the required materials to the IRB for a full Board review 10 working days prior to a scheduled meeting.  Submission of materials by the deadline does not guarantee the full review will be conducted at the next meeting. Reasons for delaying review until the next meeting may include an already full agenda or the protocol requires revisions prior to review. Therefore, the IRB recommends that the PI submit the materials as early as possible.  If a majority of the IRB members deem it appropriate, they may waive this time period.

Under the full review process, the IRB will discuss issues pertinent to the wellbeing of potential research participants, including issues of adequate informed consent, research designs and procedures adequate to provide safety and confidentiality, and risk/benefit ratios.  The IRB may take one of the following three actions:

• Approve the research application and decide on the length of time the study is approved (one year or less from the date of the convened meeting at which the IRB reviewed and approved the proposal).  The PI is sent a letter of approval.
• Require additional information or modifications.  During the IRB meeting, the IRB members may ask the PI for additional information.  If the PI does not have the additional information available at the meeting, the PI will forward this information, in writing, to the IRB Chairperson or designee, as soon as possible.  Additionally, the IRB may require that modifications be made.  At the conclusion of the review, the IRB will decide whether:
  • The IRB Chairperson or designee may review the additional information or modifications to ensure that they meet the IRB requirements and approve the application, if appropriate.  If the additional information or modifications are not sufficient, the IRB Chairperson or designee may continue to work individually with the PI until the IRB requirements are met. The IRB may require that the additional information or modifications be reviewed at the next IRB meeting.  The PI would again need to be present at the meeting.
• Disapprove the research application.  The PI is sent a letter describing the reasons the research application was not approved.  The PI may revise the research application in accordance with IRB recommendations; discuss the reasons for disapproval with the IRB Chairperson or a designee; or withdraw the research application.

Projects that require full Board review that are approved shall provide the IRB quarterly reports about the progress of the project and about adherence to the approved project protocol.  Additional information may be required by the Board at the time the project is reviewed and approved, and shall be specified at that time.

Modification Request:

The PI must request approval for any proposed modifications to the research project’s protocol or informed consent or assent forms.  The modifications must be approved by the IRB prior to implementation. 

Continuation Request:

Research projects are approved for a period of one year, unless a shorter interval is specified by the IRB.  All projects that continue beyond the maximine shall submit (a) an IRB application cover sheet indicating the PI, the project title, and that a continuation is requested, and (b) a brief statement about any changes or modifications to the protocol since originally approved.  This should be sighed by the PI and his/her department head, and submitted directly to the IRB Chairperson (or designee) for review.  The IRB Chairperson, or designee, may approve the continuation.  If modifications have been made since the original approval that either significantly change the project or significantly increase participant risk, then the IRB Chairperson (or designee) may inform the PI that submission of a completely new application is required.  This application will then be reviewed as a new application (see section F1.1.1, F1.2.1, or F1.3.1).  If modifications are approved, then the IRB Chairperson (or designee) will notify the PI of the approval.

If the PI fails to request a continuation or submit requested information, IRB approval will be terminated on the expiration date.  All research activities, including data analysis, must cease unless the IRB finds it is in the best interest of the individual research participants to continue participating in the research interventions or interactions.  A notification letter will be sent to the PI and, if appropriate, the funding agency.

Length of IRB Approval:

Typically, the IRB approves a research study or continuation request for up to one year.  However, approval may be granted for less than one year in some circumstances, which may include, but are not limited to, high-risk protocols, projects involving unusual types of risk to participants, projects involving vulnerable participants (e.g., prisoners), and projects conducted by a PI who has previously failed to comply with IRB requirements.

Verification of Sources other than the PI:

Some projects may require verification from sources other than from the PI that no material changes have occurred since previous IRB review.  The criteria for determining which studies may need outside verification include, but are not limited to complex projects involving unusual levels or types of risk to participants; projects conducted by PIs who previously failed to comply with 45 CFR 46 or the requirements of the IRB; and projects where concern about possible material changes occurring without IRB approval have been raised based on information provided in continuing review reports or from other sources.

Preparation of Public Use Data Files:

Many funding agencies require or recommend that projects produce public use data files. If the PI knows that a public use data file will be created, he or she must indicate this in the initial application form. Once the project is completed, the PI shall submit the proposed public use data file to the IRB for inspection. The funding agency may provide guidance in creation of public use files. The PI should provide this information to the IRB when submitting the protocol to prepare a public use data file. If the PI does not initially plan to develop a public use data file, once the determination to develop a public use data file is made, he or she will need to submit a modification request to the IRB.

For the IRB to classify the file as a public use data file, one of the two following situations must apply:

• The data is anonymous when originally collected or when collected from unknown persons.
• The data is collected from identified persons, but the file has been stripped of individual identifiers and any other information that may risk disclosure of any subject’s identity.

When data have been collected from identified persons, the PI must consider the following elements in determining whether he or she has properly addressed the risk of disclosure of participants’ identity:

• All individual identifiers of each human research subject or any person named by any human research subject must be removed
• All variables that can be surrogates for individual identifiers (e.g., street address of subject) must be removed.
• To remove the possibility of identification when a human research subject is in a small subgroup within the sample, it may be necessary to collapse or combine categories of a variable. For example, detailed breakdowns of religious denomination in a survey question, or medical procedure codes may need to be collapsed into fewer categories.
• Delete or mask, as described above, any variable that a secondary user may employ to identify any research subject. For example, the PI may need to assign a new subject ID to each individual if the original subject ID contained identifying information, such as letters from the last name or part of the date of birth.
• Use statistical methods to add random variation to variables that cannot otherwise be masked. For example, a data file may contain a combination of public and private information on a relatively small sample, perhaps demographic characteristics and salary of a public official, along with attitudinal information. The income variable may need to be altered so that it cannot be combined with the demographic characteristics to enable identifying the individual and thereby risking disclosure of private information. This option should be used only if other techniques do not work, because it may compromise the integrity of the data.