Investigator Manual: 4. IRB Review Processes

There are 7 criteria that a non-exempt protocol, expedited or full board, must meet:

Regulations and institutional policy require a review by the convened IRB in any of the following circumstances: (i) the research involves more than minimal risk to human subjects; (ii) does not meet the criteria for one of the expedited categories; (iii) or, regardless of risk level a single IRB member (via expedited review), Chair, or the DHR request committee review.

The following two criteria must be met before a protocol may be considered for an expedited review process:

1. The activity must present no more than minimal risk to subjects. The regulatory definition of “minimal risk” is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests; and
2. The protocol procedures must be listed as one of the categories in the regulations’ list of procedures that qualify for an expedited review process.

The following documents are to be submitted for new IRB applications, both exempt and non-exempt:

• Exempt or non-exempt application form
• PI assurance signed by both the PI and student investigator, if applicable
• Research team form, when the research team includes more than the PI and student investigator.

Additional documents:

• Participant information sheet
• Consent & assent forms and scripts
• Online consent scripts
• Data collection instruments: surveys, focus group/interview questions, etc.
• Recruitment material

Submit all material to [email protected]

Expedited studies: If a study is deemed to have minimal risk the expedited review process may be applied. These submissions require review by only one IRB member and do not require board discussion. Minimal risk protocols are reviewed in the order in which they are received.

Full board reviews: Items are placed on an IRB agenda when it is determined to be complete, and all protocol documents are provided. The DHR staff assigns a primary and secondary presenter from the members of the IRB for all protocols requiring initial full review, continuing full review, and for all protocols requiring full review of modifications to previously approved research.

When making reviewer assignments, the DHR staff takes into consideration: the subject population targeted, especially when they include a vulnerable group; procedures the subjects will undergo; and the appropriate scientific or scholarly expertise. If the DHR staff cannot identify a primary reviewer with appropriate expertise, the IRB Chair, or the Executive Director of the DHR will solicit consultants from the university or the community with competence in special areas.

The convened IRB can make any of the following determinations:

• Approved – The submission is approved with no revisions requested by the IRB.
• Pending Stipulations – The submission and/or supporting documents require minor revisions, with suggestions or direct actions recommended by the board member or convened board. The DHR staff, listed on the OHRP roster, may approve the study upon receipt and approval of the revisions without further action or review required. Approval of the submission will not be granted until all required changes are addressed, and documents revised accordingly.
• Deferred – The protocol and/or supporting documents require major revisions and the IRB was unable to vote on all 7 criteria for approval due to the need for additional information, revisions, or clarification. Revised material and responses to the IRB questions will return to the next appropriate IRB when determined.
• Disapproved – Questions are significant such that one or more of the 7 criteria for approval cannot be met, and the IRB is unsure how the protocol could be approved or determines the risk level far outweighs the research benefits. Disapprovals are communicated to the PI and the reason(s) for the disapproved action. If an expedited reviewer believes a protocol should be disapproved, it will be placed on the next appropriate IRB agenda.

 Note – for expedited reviews: The designated expedited reviewer may approve, request modifications, or request a review of a protocol by the full board. A designated reviewer does not have the authority to disapprove an application.

The IRB, HSR Executive Director, Institutional Official/Organizational Official, or designee of the Institutional Official/Organizational Official can temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review.

The IRB, HSR IRB Executive Director, Institutional Official/Organizational Official, or designee of the Institutional Official/Organizational Official has the ability to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review.

The PI will be notified of IRB approval in writing and receive an approval packet noting the date of approval. This packet will include:

1. IRB approval letter.
2. Protocol application detailing all protocols in the document table.
3. Written consent and assent forms with signatory lines.

The Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from the Common Rule, 45 CFR, Part 46. Exempt research is the lowest level of review, available for research that falls into one of 6 categories. At Northeastern, the exempt determination must be made by an authorized or appointed member of the IRB.

Modifications do not need to be submitted for exempt studies so long as the research remains at minimal risk and stays within the boundaries of the exemption categories that the IRB found applied to the research.

There are also instances where modifications will not impact risks to participants or impact exempt determination, however, must still be reported to the office. Examples of these include:

• Change of Principal Investigator
• New data collection sites where a letter of support is required.
• Addition of external funding source

Human subject research cannot begin until the PI receives an exempt determination letter. Note: No additional documents will be provided to the PI.

To help reduce the administrative burden of duplicative reviews and manage the complexity of multi-site research, reliance agreements may be established. The Establishing reliance agreement guidance was developed for Northeastern researchers who are collaborating with investigators affiliated with other institutions or are independent investigators.

Northeastern applies the same principles detailed in the federal regulations, CFR Title 45, Part 46 regardless of funding source. Therefore, the reliance agreement processes extend to research studies with no external funding.

There are two different types of reliance agreements:

Institutional Authorization Agreement (IAA): a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution. Agreements are generally used to cover a single research study, categories of research studies, or all human subjects research under an organization’s FWA.

Individual Investigator Agreement (IIA): an agreement when one institution agrees to serve as the IRB of record for a non-NU investigator who’s collaborating on the research study and is not affiliated with an institution with its own IRB.

Yes. Northeastern does not cede review for exempt research. Northeastern researchers must submit an exempt application and obtain an official exemption determination from Northeastern.

No. External collaborators will need to complete whatever review is required by their respective organizations/institutions.

Case Report: The project consists of a case report or series (1-3 patients) that describes an interesting treatment, presentation, or outcome and is not subject to the jurisdiction of the FDA. A critical component is that nothing was done to the patient(s) with prior “research” intent. Note that HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.

Course-Related Activity: The project is limited to one or more course-related activities designed specifically for educational or teaching purposes where data are collected from and about students as part of routine class exercises or assignments and otherwise do not meet either of the definitions of human research in Section II of this manual. Note that some course-related activities, even those conducted by students, may yield information suggesting additional investigation or analysis. If an additional activity entails human research, then it must be submitted to the IRB for review.

Journalistic or Documentary Activity (including Oral History): The activity is limited to investigations or interviews (structured or open-ended) that focus on specific events (current or historical), views, etc. Such investigations or interviews may be reported or published in any medium, e.g., print newspaper, documentary video, or online magazine.

Program Evaluation| Quality Assurance Review| Quality Improvement Projects: The activity is limited to program evaluation, quality assurance, or quality improvement activities designed specifically to evaluate, assure, or improve performance within a department, classroom, or hospital setting. There is no intent to alter or control the evaluation for research purposes

Research not subject to the jurisdiction of the FDA, Using Public or Non-Identifiable Private Information about Living Individuals: The activity is limited to analyzing data about living individuals (1) where the data have been retrieved by the investigator from public, non-restricted data sets or (2) where the private data have been provided to the investigator without any accompanying information by which the investigator could identify the individuals.

Research Using Health Information from Deceased Individuals: This activity is limited to analyzing data (identifiable or not) about deceased individuals and the activities are not subject to the jurisdiction of the FDA. Note that deceased individuals cannot be Human Subjects according to DHHS, but may be subject to FDA jurisdiction, requiring IRB review.

Just-in-Time grants: Requesting the IRB’s acknowledgment of receipt and “proof of concept.” These types of submissions do not include all elements required to obtain full IRB approval. Refer to the Just-in-Time guidance and submit a Just-in-Time request form.

No, retroactive approval will not be granted. The OHRSP & the IRB will not review applications if any human subject research has already been conducted.

The consequences of conducting human subjects research without prior IRB approval are significant and could include some or all of the following:

• Required destruction of any data collected without IRB approval.
• Journals may not publish or you may be prohibited from presenting research findings.
• Retraction of any published research findings.
• Consequences with funding.
• Other academic disciplinary actions initiated by your department, college, or the University.

If you are concerned that the research you have conducted may have required IRB review, please email the IRB at [email protected].