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Types of IRB Review

The TCNJ Institutional Review Board (IRB) goals are to protect human subjects and support the design and conduct of sound research by reviewing for approval IRB submissions: new applications, amendments to approved studies, and continuing reviews.

All projects that meet the federal definition of research with human subjects (45 CFR 46.102 ) must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research.  The IRB staff initially screens submissions to determine the completeness and the appropriate type of review.  Submissions may be returned to the study team for changes before the review type is assigned.  The review type may be reassessed at any time during the review process.

Helpful Hints & Tips: What is the IRB Looking For?


Types of IRB Review

There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt.  The review path is determined by:

  • Level of risk to subjects associated with the project
  • The type of research being conducted (e.g., an educational intervention, a survey, an ethnograhpich observation, etc.)
  • The sensitivity of the research questions or complexity of the research design
  • The involvement of vulnerable populations as research subjects

Full Board Review

Federal regulations and institutional policy require an IRB Full Board Review for applications where the research involves more than minimal risk to human subjects or has been referred to the committee by an expedited reviewer or the Chair.  Regardless of risk level, TCNJ IRB may require full board review when the research involves:

  • Vulnerable populations, particularly prisoners
  • Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality (CoC) to protect subject data from compelled disclosure
  • Research involving genetic testing
  • A complex research design requiring the expertise of multiple board members to evaluate

Applications requiring full board review are accepted by the submission deadlines and reviewed by the full board on the scheduled IRB meeting dates.  The IRB Chair assigns submissions to a primary and secondary IRB reviewer for presentation at the full board meeting.  Investigators are welcome to attend the meeting to answer questions from the board.  At the conclusion of the meeting, the board votes and issues a determination.


IRB Full Board Determinations

Approved:  The application has been approved as submitted. For the research to be approved, it must receive the approval of a majority of those voting members present.  (Note that, in effect, an abstention counts as a negative vote.)The approval date is the date of the IRB review.

Action Deferred: The IRB needs additional information from the investigator before an accurate assessment or final approval of the application can be made. The principal investigator must submit the requested additional information regarding specified changes to the protocol, informed consent document(s) and/or other supporting materials before the IRB will consider the application for further review. Final approval status is granted when the IRB has reviewed and approved all requested changes.

Disapproved:  The protocol does not provide adequate protection to human subjects, and it is unlikely that it may be modified to provide such protection. The IRB notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision and providing the opportunity for the investigator to respond to the IRB in person or in writing.

Tabled:  The IRB full board did not have time to review the application at the convened board meeting. The application is placed on the agenda for the next convened meeting. Applications for full board review are due to the board 4 week prior to it’s scheduled board meeting.


Expedited Review

Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:

Applications qualifying for expedited review are accepted and reviewed on a continuing basis.  Expediting reviewers are experienced IRB members appointed to the role by the IRB Chair.  The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval.  Only the full board has the authority to disapprove a study.

IRB Expedited Review Determinations

In addition to the Approved and Action Deferred determinations (described above) a Changes Requested status may occur, where substantial changes to the application and/or materials are required before the expediting reviewer can approve the study.

For certain kinds of research involving no more than minimal risk, and for minor changes in approved research, the IRB Chair and/or a designated voting member(s) or group of voting members review the proposed research rather than the entire IRB. It cannot be assumed that research poses minimal risk because it involves only interview or survey data collection. Sensitive questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to participants, their relatives, and others.


Research Exemptions from IRB Review

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

  • Exempt projects are not subject to continuing review
  • Amendments are required only if changes to the project could alter the exempt determination
  • An exempt determination does not lessen the investigator’s ethical obligations, including the completion of human subjects protections training (NIH or CITI)
  • Review the Common Rule on exempt research:  45 CFR 46.104

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#1 – EDUCATIONAL EXEMPTION – TIP Sheet – Exemption 1

What’s New:  A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible “adverse effects” on student learning of the required education content and/or on the assessment of educators.

Review Path:  The Self-determination* review path is permitted unless the research involves the use of:

  • Student education records (FERPA regulated), which requires an IRB Determination
  • Protected health information (PHI) (HIPAA regulated), which requires an IRB Determination with (often) a  Privacy Board Review.

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#2 – SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR – TIP Sheet – Exemption 2

What’s New: The scope will be expanded to include the collection of sensitive and identifiable data.  However, the following is not allowed:

  • Interventions
  • The collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)

Review Path: The Self-determination* review path is permitted if the data collected is not sensitive or not identifiable; but Limited IRB Review is required if it is.

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# 3 – BENIGN BEHAVIORAL INTERVENTION (NEW)  – TIP Sheet- Exemption 3

A “benign intervention” is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact.

What’s New:  This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.  However, the following is not allowed:

  • Research with children
  • Deception, unless prior agreement obtained
  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBitTM; blood pressure monitors)
  • Linking to additional personally-identifiable data

Review Path:  The Self-determination* review path is permitted unless the research involves:

  • Undisclosed deception, which requires a Comprehensive IRB Review
  • The collection of sensitive and identifiable data, which requires a Limited IRB Review

A “benign intervention” is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact.

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#4 – SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS) 

What’s New: The scope of this exemption will be expanded to allow:

  • Prospective data review
  • Maintenance of identifiers, if all study data is protected health information (PHI)
  • Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities

Review Path:  An IRB Determination is required; however, if PHI is used then a Privacy Board Review (HIPAA) is conducted with the IRB Determination.

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#5 – PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS)

What’s New:  A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

Review Path:  An IRB Determination is required with validation from the IRB Chair.

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#6 – TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE

What’s New:  Unchanged

Review Path:  An IRB Determination is required.

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#7 – STORAGE / MAINTENANCE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH “BROAD CONSENT” (NEW)

What’s New:  This new exemption allows for the storage of data and/or specimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with “Broad Consent” for future secondary use research.  

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#8 – USE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH “BROAD CONSENT” (NEW)

What’s New:  This new exemption allows for secondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with “Broad Consent”.


Exemption review paths

Self-determination means that the Principal Investigator is permitted to issue a system-generated exemption determination letter based on responses to key questions within qualifying human subjects exemption categories.  The IRB does not review self-determined projects.  Investigators may choose not to apply self-determination but, instead, choose to submit a study for an IRB determination of exemption.  As this is a new process, TCNJ’s IRB has decided that all self-determination applications will receive IRB review/audit prior to approval for AY 2018-2019. At the end of AY 2018-2019, the IRB will review the results of the self-determination audit and determine whether complete self-determination can be implemented in AY 2019-2020. In the event that full self-determination is implemented, TCNJ will implement a post-determination validation process for self-determinations to ensure that the exemption criteria are being applied in accordance with regulatory requirements and that the potential risk to human subjects remains minimal.

 If the research conducted by TCNJ researchers involves access to PHI data for the purposes of identifying potential subjects, then self-determination is NOT permitted.

Limited IRB Review is a type of expedited review process required in the Common Rule.  Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection or use of sensitive, identifiable data (exemptions 2, 3 and 8) and, for exemption 7, that “broad consent” was obtained and (if appropriate) documented according to an approved protocol.  For exempt studies involving access to PHI (e.g., from medical records), the required Privacy Board review may be integrated with Limited IRB Review by the same assigned reviewer.


Termination Report

As Exempt studies do not require continued IRB review (i,.e. there will be no expiration date for approval) the Closure Submission Form in iMedris should be completed to close the study upon completion of the research.

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