Guidance

All research protocols that meet the federal definitions of research and human subject are required to meet criteria for approval before the research may begin. The criteria are based on federal regulations and the ethical principles discussed in the Belmont Report.

Learn More : Applying the 7 criteria for approval

Undergraduate class assignments and/or Capstone graduation projects generally do not require IRB review and oversight because the goal is to teach methods and prepare the student for future research. However, there are expectations to consider for class and capstone projects that do not require IRB review.

Learn More: Capstone Projects & Undergraduate Research

The federal regulations that govern human subject research require that researchers seek participants’ consent using procedures that minimize the possibility of coercion or undue influence (45 CFR 46.116). Research incentives may limit the ability of the subject to provide truly voluntary, informed consent. Subjects should be able to make informed decisions to participate based on the real risks and benefits of participation, not on compensation. Subject compensation should be equitable, and the confidentiality of information related to payments should be protected. When reviewing research protocols that include subject compensation, the IRB does so guided by these principles. In designing their research and preparing the protocols describing it, investigators should be aware of the related issues discussed below.

Learn More : Compensating human subjects for research

Informed consent is the process by which potential participants are provided important information about the research study. Obtaining written consent from individuals ensures investigators have provided the necessary and required information for one to make a fully informed choice to enroll as a research participant.

Learn More : Components of informed consent

The Institutional Review Board [IRB] must ensure that financial or other business interests do not compromise the protection of human subjects in research.

If an investigator on the study team has an actual, potential, or perceived conflict of interest, this information must be disclosed to the IRB.

Learn More : Conflict of interest & human subject research, 08.31.2023

Risk in human subject research is the probability of harm or injury (physical, psychological, social, legal, or economic) occurring because of participation in a research study. Both the probability and magnitude (severity) of a possible harm may vary from minimal to significant.

This guidance details types of research risks and strategies that may minimize the possibility of these risks.

Learn More: Criteria #1 & #2, Assessing research risks, 04.04.2024

Federally funded studies that meet the NIH definition of a clinical trial and any study (regardless of funding) that meets the FDA definition of an applicable clinical trial must be registered.

Learn More : Defining & Registering Clinical Trials 12.13.2023

The Human Research Protection Program (HRPP) supports research involving humans and works with investigators and students on conducting work appropriately, and the Institutional Review Boards (IRB) review and approve research as required. The HRPP and the IRB follow the federal definitions of regulated research and human subjects.

Undergraduate class projects and research methods classes may involve data collection activities for instructional purposes that do not require IRB review and oversight because the goal is to teach methods and prepare the student for future research, not to contribute to generalizable knowledge. This guidance provides definitions used in the regulations, examples of research, and the distinction between human and not human research.

Learn More : Defining human subjects research 09.01.2023

This document provides definitions for terms as they apply to human subject research.

Learn More : Definitions and terms used in human subject research

Regardless of whether research study meets the federal definitions of research and human subjects, measures must be taken to ensure research participants are treated with respect and that their rights and welfare are considered during every stage of the research. There are lots of areas to consider when developing a research study and this document can be used as a guide of items to consider when planning your project.

Learn More : Designing human subject research

While conducting self-assessments and reviewing study records, issues may be identified. The Department of Human Research (DHR) recognizes that even the most experienced and diligent research teams may deviate from the approved protocol or experience unexpected events. Research teams must identify, evaluate, and respond to these deviations and unexpected events to protect the rights, safety, and welfare of participants and others and the integrity of the research data. This guidance provides an overview on how to address an incident and how to develop a Corrective & Preventive Action (CAPA) Plan.

Learn More : Developing a CAPA plan, 03.07.2024 & Self-Assessment checklist, 03.07.2024

To help reduce the administrative burden with duplicative reviews and manage the complexity
of multi-site research, reliance agreements may be established. This guide provides information for Northeastern University (NU) researchers who are collaborating with co-investigators/research team members who are affiliated with other institutions or are independent investigators.

Learn More : Establishing reliance agreements

When exercise testing is used as part of a human subject research study, investigators should consider whether procedures may expose the participants to greater risk based on their physical fitness level and general health. In some circumstances, a safety plan should also be developed in the event of injury.

Learn More : Exercise testing in Human Subjects Research, 08.26.2023

Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from the Common Rule, 45 CFR, Part 46.Pursuant to Northeastern University (NU) po licy, investigators do not make their own determination as to whether a research study qualifies for an exemption. The NU HRPP provides oversight and communicates exempt determinations to the investigator(s). Exempt applications must receive the exempt determination before any research commences.

Learn More : Exemption Categories

This documents delves deeper into each category and provides examples and additional considerations.

Learn More : Exemption: Examples & additional considerations

Expedited review is a review category for protocols and modifications to approved protocols that qualify as minimal risk research or are considered minor changes to approved research. These submissions may be reviewed outside an IRB meeting allowing for an expeditious process that decreases turnaround time. Under expedited review the designated reviewer applies all applicable regulations (e.g., Common Rule, FDA, etc.) including the seven criteria for approval and the requirements for informed consent.

Learn More : Expedited categories

Submitting to the IRB, for a first timer or season investigator, can be confusing and at times overwhelming. Below are some helpful tips and considerations when submitting a human research protocol application.

Learn More : Helpful tips when submitting to the IRB 09.01.2023

Some sponsors, including NIH & NSF will accept new grant proposals with the understanding that the researcher will proceed with the IRB review process upon receiving notification of a score in the fundable range. This is sometimes referred to as the “Just-in-Time” [JIT] procedure.

Learn More : Just-in-Time, 07.13.2023

In the absence of documentation from an ethics committee at the site of recruitment or
research, a letter of support or other documentation of permission may be needed. The IRB may request that researchers provide this documentation to ensure that appropriate
safeguards are in place, that the study is feasible, or the research plan is culturally appropriate.

Learn More : Letters of support from external sites

After receiving the written approval from the NU IRB to begin a research project, investigators may follow the protocol procedures and use only the versions of the recruitment materials, consent and assent forms and study instruments as approved. However, if you need to make
changes to the study, you may do so by completing the modification form and providing all new
and revised documents. Depending on the requested modification and risk to study
participants, modifications may either be reviewed expeditedly or by a convened IRB.

Learn More : Modifications to protocols (exempt and non-exempt)

To assist investigators new to Northeastern, we have drafted guidance and provided resources and reference links. Our team is also happy to meet with you one on one to discuss your project and to guide you in preparing and submitting the materials for IRB review.

Learn More : New Investigators Conducting HSR

The mission of the Department of Human Research (DHR) Quality Assurance Program is to support the University’s research enterprise by ensuring the protection of research participants; monitoring compliance with all applicable federal, state, and local laws and regulations; fostering the ethical conduct of human subject’s research; and providing education and guidance to the University’s researchers regarding regulatory requirements. One way in which these goals are met is by conducting ongoing oversight of human research activities.

Learn More : Post Approval Monitoring Program, 03.07.2024

During a research study, unintentional mistakes in following the IRB-approved protocol or unexpected issues may occur.  The Principal Investigator (PI) is responsible for the accurate documentation, timely reporting, investigation, and follow-up of these events.

This guidance is intended to help the PI ensure that the reporting and review of these events occur in a timely, meaningful way so that research participants can be protected from avoidable harm.

Learn More: Reporting New Information & Incidences, 04.04.2024

School based research projects require special considerations beyond the federal regulations and University policy. This guidance provides an overview of the unique aspects of conducting research in K-12 schools.

Learn More : Research in k-12 schools

Presentation: IRB Presentation — Education and Dual Role research — 4.2.24

Research involving potentially vulnerable populations must include additional protections to minimize the possibility of coercion or undue influence. Federal regulations provide specific protections for pregnant women and fetuses, prisoners, and children; however, considerations may also be necessary for other potentially vulnerable groups, such as students and employees.

The purpose of this guidance is to outline additional protections that investigators and IRBs should consider for research involving employees.

Learn More : Research involving employees

Incarceration places prisoners under constraints that may affect their ability to make truly voluntary and un-coerced decisions about whether or not to participate as subjects in research. Prisoners, therefore, constitute a vulnerable population for which additional protections are warranted. This guidance details the additional protections

Learn More : Research with Prisoners

Northeastern University human research protection office (HRPO) has three primary roles: (i) protect human participants by ensuring applicable studies comply with the federal regulations; (ii) promote ethical and compliant research by providing education and training tools; and (iii) enhance research efforts in the development of resources, e.g., forms, templates, checklists, and guidance. This guidance details components on how the HRPO protect human participants by ensuring applicable studies comply with the federal regulations.

Learn More : Review types & processes

Secondary data analysis includes data that was collected previously for a different purpose. Some research projects involving existing data sets and archives may not meet the definition of “human subjects” research requiring IRB review; some may meet definitions of research that is exempt from the federal regulations at 45 CFR part 46; and some may require IRB review. This guidance details each of these situations and provides examples.

Learn More : Secondary data analysis

The FDA Regulations define an investigational device as a device, including a transitional device that is the object of an investigation. The regulations describe three types of device studies:

• Significant Risk (SR)
• Non-Significant Risk (NSR)
• Exempt

This guidance is a summary of two FDA documents: Frequently Asked Questions About Medical Devices and Significant Risk and Nonsignificant Risk Medical Device Studies – Information Sheet

Learn More: Significant Risk & Non-significant risk devices, 04.02.2024

Snowball sampling (or chain sampling, chain-referral sampling, referral sampling) is a non-probability sampling technique where existing study subjects recruit or refer future subjects from among their acquaintances. This recruitment approach may be approved by the IRB with justification to its use and how it relates to the study and subject population. The protocol should address how the risk of violating an individual’s privacy will be minimized and how snowball sampling may impact other study risks. Investigators are to provide this justification in the recruitment section of the protocol application form.

Learn More : Snowball Sampling, 02.28.2024

The Northeastern University IRB has the authority to suspend or terminate IRB approval of research that is not being conducted per IRB requirements, an approved IRB protocol or that may pose unexpected, serious harm to participants. The authority to suspend or terminate IRB approval is retained regardless of whether the research was approved by the convened IRB, through the expedited procedure, through limited IRB review, or is exempt. The IRB retains the ability to suspend or terminate research even when continuing IRB review is not required.

Learn More: Suspensions & Terminations, 03.20.2024

The IRB accepts the need for certain types of studies to employ strategies that include deception. However, employment of such strategies must be justified. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been fully informed of the true purpose of the research.

Learn More : Using deception in research

Northeastern University strongly recommends gender inclusive language and consciousness in all study materials including surveys. Sex, gender identity, and sexual orientation are specific terms and should not be used interchangeably. When researchers ask questions about sex, gender identity, and/or sexual orientation, there must be an understanding of what is being asked and what information is sought.

This guidance explains the rationale behind this recommendation, how to comply, and examples of respectful language. Gender inclusivity, in this context, refers to considering all possible options regarding sex, gender, and sexual orientation when collecting research data.

Learn More : Using gender inclusive language in research

Video and audio recordings can be extremely valuable in collecting study data as it often allows investigators to be engaged during data collection without having to simultaneously take notes. It also provides a means by which the investigator can ensure the information the participant shared is accurate. Researchers may either choose to transcribe the recordings manually or use an external transcription service. This guidance includes considerations when using an external transcription service as a sample confidentiality agreement.

Learn More : Using transcriptions for recorded interviews in Human Subjects Research

Under the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”), the IRB may approve an informed consent process that:

• Waives the requirement to obtain informed consent, or
• Alters some or all of the elements of informed consent, or
• Waives the requirement to document informed consent (i.e., to obtain a signature)

Learn More : Waivers or alterations of informed consent