Review, Approval and Post-Approval Requirements

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The following steps will chronologically describe the process of IRB review from making the first decision of whether to apply for IRB approval to describing what to do after you have obtained approval.

Any Human Research Protection Program (HRPP) policies referenced throughout the following steps are based on federal regulatory requirements found at 45 CFR §46 (i.e., the Common Rule). 

Step 1: Decide if you are conducting human subjects research

Step 2: Prepare your IRB application through NUgrant

Step 3: Begin the “Routing” process to submit the IRB form

Step 4: The Review Process

Step 5: IRB Approval (Criteria, Review Level and Category)

Step 6: Receive IRB Approval

Step 7: Organize the research documents

Step 8: Understand the responsibilities after approval

Step 1: Decide if you are conducting human subjects research

In order for a project to require oversight it must meet the regulatory definitions of research AND human subjects. Policy #3.001, “Investigational Activities Requiring IRB Review and Approval” defines activities that must be reviewed and approved by the IRB before the project begins (including recruitment).

Pre-2018 Requirements
  • Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
  • Human subject is “a living individual 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 (including data or tissues)”

Notice

The effective date and general compliance date of the revisions to the Common Rule has been delayed until July 19, 2018. The 2018 requirements and policies are not currently in use. Implementation will be communicated to the campus as we near the July 19th deadline

2018 Requirements
  • Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
  • Human Subject is “a living individual about whom an investigator (whether professional or student) conducting research, (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens service programs may include research activities.

The decision of whether or not you are conducting human subjects research and whether or not an application for IRB review must be submitted can be made by the Principal Investigator. Policy #3.001, “Investigational Activities Requiring IRB Review and Approval” specifies that, “Any individual who is unsure whether or not a proposed activity constitutes research involving human subjects should contact the HRPP office for guidance.”

If you are unsure whether your project requires approval, you can:

  • Submit a Determination Form via NUgrant for official review
  • Review the definitions above or the Human Subject Regulations Decision Charts available through the Office of Human Research Protections.
    • The decision charts may not be used for exemption determinations, expedited review, or continuing review. Certain state laws and institutional policies, which may not be taken into account within the decision charts, could affect UNL IRB review categories and applicability.
  • Contact Research Research Compliance Services to discuss the project

If your project requires IRB approval, please begin your application in NUgrant.

If your project does NOT require IRB approval, you are not required to submit an application for determination. However, please be aware, IRB approval may not be granted if the research has already started or been conducted and the determination of IRB applicability was made incorrectly by the investigator.

Step 2: Prepare your IRB application through NUgrant

(NUgrant URL: https://nugrant.unl.edu)

All new projects are required to be submitted for review through UNL’s electronic research/grant administration system, NUgrant.  All UNL faculty, staff and students have access to NUgrant.  Before beginning your application, the following items might be helpful:

    • All forms specific to human subjects research are found in the Institutional Review Board module.
    • All undergraduate, graduate and post-doctoral trainees 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 as a post-doctoral trainee.
    • The IRB Guidebook provides helpful tips and insight on certain sections of the application that might create the most delay in receiving an approval.
    • The IRB templates/forms webpage provides several Word documents that can be revised to be specific to your project including documents that are specific for use with Exempt research.

HINT:  Take a moment to re-read the application before you officially submit for review.  One of the most common delays experienced during the review process is due to inconsistent information.

Step 3: Begin the “Routing” process to submit the IRB form

Once the form has been written and all applicable supporting documents have been uploaded, the form must be submitted through a “routing” process via NUgrant.  The routing process triggers the IRB review process to officially begin.  The routing process must be initiated via NUgrant by electronically signing the form and can be done so by either the Principal Investigator, the Secondary Investigator, or an administrative personnel member.  The routing process accomplishes multiple requirements such as:

  • Certifications and attestations by the investigator(s) specifying sound research design has been used to achieve the aims of the study with the least amount of risk possible.
  • If applicable, the second person in the routing process submitting the form for official review has the option of “requesting revisions” prior to official submission. This is completed on the routing signature page and is one of two options available (i.e., approval vs. request revisions).

Step 4: 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.  Generally speaking, each project will undergo a pre-review process, an official review process, and revisions completed, if required, by the research team. Once all regulatory requirements are met, the project will be approved.

  • Pre-review step
    Upon submission, the designated IRB Coordinator will review the form submitted to ensure clarity of information within the application, submission of all supporting documents, and confirmation of review level.
  • Official Review Step
    Once the form meets the minimum criteria to be submitted for Exempt, Exempt with Limited Review, Expedited or Full Board review, the IRB coordinator will submit the form to the appropriate reviewer/Board.   The IRB Coordinator also ensures the IRB reviewer and/or Board composition has the appropriate expertise based on background, training and familiarity with the research and/or procedures.

    • Exempt review is conducted by IRB Coordinator
    • Exempt with limited review is conducted either by the IRB Coordinator or a designated member of the IRB for certain categories. For more information about Limited Review, review step 5 below.
    • Expedited review is conducted by a designated member of the IRB who may also be the IRB Coordinator.
    • Full Board review is conducted by the convened IRB.
  • Revisions step
    Revisions are requested by the IRB Coordinator through the NUgrant system based on required elements of review and comments received from the designated Expedited reviewer or the Full Board.  All revisions are required to be completed via NUgrant within the specific form and are submitted by clicking on the “Submit Revisions” button via NUgrant.

The quality, consistency, and complexity of the project information submitted may directly impact the number of revisions and overall length of review time.

Step 5: IRB Approval (Criteria, Review Level and Category)

Once the review process is complete, the IRB Coordinator will process approval via NUgrant and you will be notified via email. Be aware that ALL information from the IRB Coordinator is important and should be read carefully. Even though the IRB coordinators use similar language for each approval, they do include specific notes, points of clarifications, reminders or stipulations within the email notification and/or the official approval letters.

The IRB reviews all non-exempt research involving human subjects through an assessment of the following basic but required criteria, as it relates to the research, the review level and the proposed population per Policy #3.004., titled “Criteria for IRB Approval of Research.”

  • Risks to subjects are minimized
  • Risks to subjects are reasonable in relation to the anticipated benefits to subjects and the advancement of knowledge
  • Selection of subjects is equitable in light of the research aims
  • Informed consent is sought from each prospective participant or legally authorized representative, and properly documented
  • The research plan makes adequate provision for monitoring the data collected to ensure safety of subjects
  • Adequate safeguards are in place to protect the privacy and confidentiality of subjects
  • Adequate provisions are made for the ongoing monitoring of the subjects’ welfare.

Three review levels with multiple categories allow the IRB to place projects in certain review levels.

It is important to note, the investigator will preliminarily select their review level or category upon new project form submission.

Upon submission, the IRB staff  assign the Coordinator who then officially confirms the review level.  It is not uncommon for the IRB Coordinator to change the review level based on the pre-review or consultation with HRPP staff, including the IRB Chairperson.

NOTE:  The following descriptions have been truncated for ease of reference and quick comparison.  Certain restrictions will likely apply to each category. For full category descriptions and limitations please review the Exempt and Expedited policies, 4.001 & 4.002, respectively.

Pre-2018 Requirements

Exempt (submission deadlines do not apply)

Notice

The effective date and general compliance date of the revisions to the Common Rule has been delayed until July 19, 2018. The 2018 requirements and policies are not currently in use. Implementation will be communicated to the campus as we near the July 19th deadline

2018 Requirements

Exempt (submission deadlines do not apply)

Category Description  Category Description

1

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

 1

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

2

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

 2

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

a) no identifiers are collected
b) identifiers are collected, but the participant cannot be at risk
c) identifiers are collected, and the IRB conducts a limited review to review privacy and confidentiality protocols

NOTE:  Certain exceptions apply to this category including the inclusion of minors.

3

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

 3

Research involving benign behavioral interventions in conjunction with other data collection from an adult only.

NOTE: Certain restrictions apply to this category including the inclusion of minors, interventions short in duration and authorized deception.

4

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

 4

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria are met:

a) The identifiable private information or identifiable biospecimens are publicly available
b) information, including information about biospecimens, is recorded without identifiers
c) HIPAA regulated information is analyzed
d) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities

NOTE: There is no requirement that the information or biospecimens are pre-existing at the time of the IRB application; however, certain requirements in addition to IRB Exemption may be necessary such as a waiver of authorization if the data is regulated by HIPAA.

5

Research involving the study of public benefit or service programs.

 5

Research involving the study of public benefit or service programs

6

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

 6

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

7

Storage or maintenance for secondary research using identifiable private information or identifiable biospecimens for which broad consent is required

 

 8

Use of identifiable private information or identifiable biospecimens for which broad consent is required for secondary research purposes

Certain Exempt categories also require the IRB to conduct a Limited Review. Exempt with limited review is conducted either by the IRB Coordinator or a designated member of the IRB for certain categories. The limited review process requires the review of certain criteria such as privacy and confidentiality as it applies to categories 2 and 3 above. Categories 7 and 8, above, require additional criteria as it applies to broad consent.

Expedited (submission deadlines do not apply)

Category Description

1

Certain clinical studies of drugs and/or 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 collected 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 research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies.

Step 6: Receive IRB Approval

After all requirements have been met or confirmed during the review process, the IRB could issue various forms of approval or a certification of exemption.  Your approval will depend on the review level in which your project met the criteria discussed above.

  • A project is “Approved by the IRB” if reviewed under the Expedited or Full Board categories.
  • A project is provided a “Certification of Exemption” if the project is reviewed under the Exempt categories.

An IRB Coordinator will notify the Investigator(s), upon each form’s approval via email.  The official IRB approval letter (with letterhead and regulatory references) is later available via NUgrant as a downloadable PDF.

Be sure to read both the unofficial and official email/letter very carefully as your coordinator may have provided you with suggestions, specifications, conditional approval stipulations, final notes, etc.  

Step 7:  Organize the research documents

After receiving approval, please be sure to take a moment and double-check that you understand how things are organized and available prior to starting your project.  The following list of items are available via NUgrant:

  • The “unofficial” email notification from your IRB Coordinator saying that your form has been approved. The official letter (with IRB letterhead) will come at a later time.
  • The consent form/letter/script that includes the official IRB stamp, as applicable to your study. We will always stamp the document in which consent information is included to ensure that the IRB has a final record of which document contains the consent information. If this is not stamped or you cannot find it, please contact your IRB Coordinator.
  • A stamped recruitment flier. Recruitment fliers are stamped to make it easier for others to recognize an approved project. If this is not stamped or you cannot find it, please contact your IRB Coordinator.

Step 8: Understand the responsibilities after approval

Protection of human subjects does not end with receiving IRB approval.  After receiving approval and throughout the life of the project, there are several responsibilities that the Investigator(s) have in relation to the IRB.  If things change within your project, they must be reported.  If a situation arises that requires immediate notification to the IRB or you have “reportable new information,” it must be reported.  If you are approved through an Expedited or Full Board method, 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.

Modifications or Change Requests

Beginning January 19, 2018, certain changes may or may not be required to be submitted for review prior to implementation depending on the review level of a project.

  • Expedited and Full Board: Any change in protocol must be reviewed and approved by the IRB prior to implementation except when an immediate change is necessary to eliminate a hazard to the participants as required under 45 CFR §46.108(a)(3)(iii).
  • Exempt: Only the following changes must be submitted for review prior to implementation:
    • A change in the scope of the project
    • A change that would increase risk to participants
    • A change that may alter the category of the original exemption determination
    • The project’s exemption falls under an exempt category requiring limited review
    • The addition or removal of a performance site
    • Change in Principal or Secondary Investigator

Exempt project only:  All other changes not specified above and within a project that is active and has been Certified as Exempt do not require review and approval prior to implementation.

More information about changes and how they are reviewed can be found in Policy #12.001, titled, “Request for Change.”

Continuing Review

Notice

The effective date and general compliance date of the revisions to the Common Rule has been delayed until July 19, 2018. The 2018 requirements and policies are not currently in use. Implementation will be communicated to the campus as we near the July 19th deadline

Pre-2018 Requirements

 

Continuing review forms are still required to be submitted per the usual process under the Pre-2018 Requirements for all ongoing research.

A Continuing Review Form must be submitted prior to expiration of the approved project. All approved Expedited and Full Board 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).

In order for a study to continue without interruption, the IRB must re-review and approve the protocol prior to the IRB approval expiration date. Continuing Review has to occur when:

  • The research remains active for long-term follow-up of subjects, even when the research 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/or 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 will be instructed to stop all research activities, including recruitment, enrollment, interventions, and interactions, and collection of private identifiable data, and to stop all interventions and interactions on current participants. However, exceptions are possible if the IRB finds an over-riding safety concern or ethical issue involved and it is in the best interests of individual participants to continue participating; [however, this must be approved by the Board before this is allowed.] New enrollment of participants is not allowed after the expiration of IRB approval.

More information about continuing review and how they are reviewed can be found in Policy #11.001, titled, “Continuing Review.”

2018 Requirements

 

NEW – Full Board projects: A Continuing Review Form must be submitted prior to expiration of the approved project for certain projects.

NEW – Expedited projects: A continuing review form is not required for Expedited projects initially approved on or after July 19, 2018.

  • A continuing review form may be required for approved Full Board projects approved on or after July 19, 2018. The continuing review requirement is based on the final decision by the IRB to provide annual review under the Expedited method or to remain at the Full Board level. Your project may 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).

In order for a study to continue without interruption, the IRB must re-review and approve the protocol prior to the IRB approval expiration date. Continuing Review has to occur if required under Full Board review unless the Research has:

  • progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
    • Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
    • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Annual Update Form

Notice

The effective date and general compliance date of the revisions to the Common Rule has been delayed until July 19, 2018. The 2018 requirements and policies are not currently in use. Implementation will be communicated to the campus as we near the July 19th deadline

Pre-2018 Requirements

Annual update forms are not required unless an ongoing research study has transitioned to the 2018 Requirements under the revised Common Rule.

2018 Requirements

An annual update form is required to be submitted for all Expedited and Full Board projects which are not required to submit a continuing review form. The annual update form provides the status of the project to the IRB and provides a few key reminders to Principal Investigators.  The annual update form should be submitted prior to the requested date.

More information about the annual update form and how they are reviewed can be found in Human Research Protection Program policy #11.001 titled, “Continuing Review.”

Final Reports

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

More information about Final Reports Forms can be found in Policy #11.001, section 2.10 titled, “Continuing Review.”

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.  A comprehensive list of examples and definitions can be found in Policy #13.001 titled, “Unanticipated Problems Involving Risk and Adverse Events.”  The incident report form must be submitted to the IRB within 48 hours of the research team and ultimately the PI becoming aware of the situation.