The following steps will chronologically describe the process of IRB review from making the first decision of whether to apply through explaining what to do after you obtain approval.

Step 1: Decide if you are conducting human subjects research.

For a project to require oversight, it must meet the regulatory definitions of research AND human subjects.

  • Research is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
  • A Human Subject is a living individual about whom an investigator (professional or student) conducting research obtains data or biospecimens through interaction with groups or individuals and analyzes the data.

If you are unsure whether your project requires approval, please review the definitions above or the Human Subject Regulations Decision Charts available through the Office of Human Research Protections. Investigators should not rely only on the decision charts for exemption determinations, expedited review, or continuing review. Individual state laws and institutional policies, which may not be taken into account within the decision charts, could affect the University's IRB review categories and applicability. If your project requires IRB approval, please submit your application through IRBNet.

Faculty who require students to do classroom-based research projects assume responsibility for the conduct of those projects. The IRB will not review student project submissions until a faculty member has first reviewed and signed off on it in IRBNet. If a project is intended just to contribute to generalizable knowledge and to be an educational experience for students, IRB approval is not required. However, neither the students nor the faculty member may publish or present any of the findings. Projects on sensitive topics or that involve vulnerable populations require IRB approval regardless of their research status.

Please note that projects will not be approved if the research has already started, data has been collected, and/or if the determination of IRB applicability was made incorrectly by the investigator.

Step 2: Prepare your IRB Application.

Investigators must submit ALL new projects electronically through IRBNet. Student PI's must work closely with a faculty sponsor. Before beginning your protocol submission, the following item might be helpful:

  • All students are required to submit their application with a faculty member as a Co-Investigator on the project. Usually, this person is the student’s advisor, committee chair, or mentor. This person must review the project in its entirety and sign the submission within IRBNet. The IRB will not review the project or grant approval without this signature or evidence of completion of the required CITI training modules.

Step 3: The Review Process.

Several steps take place during the review process of each project. These steps can vary depending on the review level of your project through the Exempt, Expedited, or Full Board review method.

Step 4: IRB Approval (Criteria, Review Level and Category).

Once the review process is complete, the IRB will notify the PI via IRBNet. The PI should address all comments meticulously and thoroughly. The IRB will include specific notes, points of clarifications, reminders or stipulations within the official approval letters.

The IRB reviews research involving human subjects through an assessment of the following basic but required criteria, as it relates to the investigation, the review level, and the proposed population:

  • Minimized risks to participants, or reasonable risks relative to the anticipated benefits to participants and the advancement of knowledge.
  • Selection of subjects is equitable in light of the research aims.
  • Collect informed consent from each participant or their legally authorized representative, and appropriately document. If you would like to collect data from children, please contact the IRB to discuss assent in addition to consent.
  • The research plan makes adequate provision for monitoring the data collected to ensure the privacy, confidentiality, and safety of subjects.
  • Three review levels with multiple categories allow the IRB to place projects in certain review levels.

Once an application is submitted, the IRB confirms the review level. A change in review level is common.

NOTE: The following descriptions have been truncated for ease of reference and quick comparison. Certain restrictions will likely apply to each category.

Exempt

Category

Description

1

Research conducted in established or commonly accepted educational settings involving standard instructional practices.

2

Research including the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior to obtain non-sensitive data. Certain exceptions apply to this category. Most notable, this category cannot include minors.

3

Research involving elected or appointed officials and all identifying information remain confidential for the life of the data.

4

Research involving the collection or study of EXISTING public and unidentifiable materials.

5

Research including the study of public benefit or service programs.

6

Research involving a taste and food quality or consumer acceptance study.

Expedited

Category

Description

1

Specific clinical studies of drugs and medical devices. (very limited situations can this category be used)

2

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.

3

Prospective collection of biological specimens for research purposes by noninvasive means.

4

Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.

5

Research involving materials (data, documents, records, or specimens) that have been collected, or will be obtained solely for non-research purposes (such as medical treatment or diagnosis).

6

Collection of data from voice, video, digital or image recordings made for research purposes.

7

Research on individual or group characteristics or behavior OR analysis employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies.

Full Board Review

Projects that do NOT “fit” within an Exempt or Expedited category(ies); OR

Projects that are greater than minimal risk; OR

Projects that Involve prisoners (with few exceptions based on retrospective secondary data analysis ONLY); OR

Projects that include vulnerable research participants, as applicable; OR

Any projects/forms that are referred to the Full Board by the IRB Chairperson or an Expedited reviewer

 

Step 5: Receive IRB Approval

After the project requirements have been met/confirmed during the review process, the IRB will issue approval via IRBNet through an official letter (PDF). Your approval from the IRB will expire on the date indicated on your official letter. If your employment with the University ends prior to the expiration date on your letter, your project approval will automatically expire.

Step 6: Understand the responsibilities after approval.

After IRB approval and throughout the life of the project, there are several responsibilities that the Investigator has concerning the IRB. All project changes, no matter how minimal, must be reported. If a situation arises that requires immediate notification to the IRB or you have “reportable new information,” it must be reported. The Investigator(s) must report annually to the IRB and must also report to the IRB when the project is completed. The following items will describe these requirements in more detail:

a. Modifications or Change Requests

A Change Request Form must be submitted when the Primary Investigator wishes to modify the currently approved protocol. Any proposed change in a protocol which affects the human participants must be reviewed and approved by the IRB before implementation except when an immediate change is necessary to eliminate a hazard to the participants as required under 45 CFR §46.103(b)(4).

b. Continuing Review

A Continuing Review Form must be submitted before the expiration of the approved project. All approved projects will require a continuing review of research at intervals appropriate to the degree of risk, but no less than once per year as required under 45 CFR §46.109(e).

For a study to continue without interruption, the IRB must re-review and approve the protocol before the IRB approval expiration date. Continuing Review must occur when:

  • The research remains active for long-term follow-up of subjects, even when the investigation is permanently closed to the enrollment of new participants, and all participants have completed all research-related interventions.
  • The remaining activities are limited to collection and analysis of private identifiable information.

If an investigator does not provide continuing review information to the IRB, or the IRB has not approved the protocol by the expiration date, the investigator must stop all research activities, including recruitment, enrollment, interventions, and interactions, and collection of private identifiable data, and to cease all interventions and communications until the protocol has been reapproved.

c. Final Reports

Final Report Forms are submitted to notify the IRB that the project has been completed. Final Reports are a requirement for Expedited and Full Board approved projects ONLY.

d. Reportable New Information

The Principal Investigator should report any adverse events or unanticipated problems within 48 hours of any of the research team members becoming aware of the incident. Submit Incident Reports to IRB Chair Dr. Al Bardi at irb@sewanee.edu. 

All policies referenced throughout the preceding steps are based on federal regulatory requirements found at 45 CFR §46 (i.e., the Common Rule).