When Is IRB Approval Required?
If you plan to conduct research involving human subjects, you will likely need IRB oversight. IRB stands for Institutional Review Board, an independent ethics committee that reviews and monitors research projects to protect the rights and welfare of human participants.
Navigating the IRB approval process can be complex, especially if you're new to research or unfamiliar with human subjects research regulations and guidelines. It's essential to understand when IRB approval is required and what steps to take to ensure your study is ethically sound and compliant with institutional and federal standards.
This article provides an overview of the IRB approval process, including what it is, when it's required, and how to determine if your study needs IRB review. We also discuss the consequences of conducting research without IRB approval and offer guidance on obtaining approval for your study.
Key Takeaways
IRB approval ensures ethical standards in research involving human subjects to safeguard participants' rights and welfare.
Approval is required for research involving human subjects, systematic investigation, and generalizable knowledge, with specific exemptions for activities like journalism and public health surveillance.
The IRB process involves training, a detailed application, and review, with timelines varying based on the study’s risk and complexity.
Compliance is critical, as IRB approval is often required for publication and funding.
What Is IRB Approval?
IRB approval is a review process that evaluates research involving human subjects to ensure it is ethical and protects participants' rights and welfare. The IRB assesses the study's design, procedures, and materials to determine if the benefits outweigh the risks and if appropriate safeguards are in place to minimize potential harm to subjects.
Federal regulations mandate the IRB review process, specifically the Common Rule (45 CFR 46), which applies to research conducted or supported by the U.S. Department of Health and Human Services (HHS). Institutions that receive federal funding for research must have an IRB to oversee human subjects research.
The IRB comprises scientists, non-scientists, and community members who are experts in research ethics and human subjects protection. Its primary responsibility is to review and approve research protocols, informed consent documents, and recruitment materials to ensure they meet ethical and regulatory standards.
When Is IRB Approval Required?
IRB approval is necessary when your research project meets specific criteria related to human subjects involvement, systematic investigation, and the intent to contribute to generalizable knowledge. Here are three situations that typically require IRB review and approval:
1. Research Involving Human Subjects
Studies involving human participants, either through intervention or interaction, generally require IRB approval. This includes projects that:
Collect data through surveys, interviews, focus groups, or observations where the researcher interacts with the subjects
Conduct physical procedures, such as blood draws or medical exams, or manipulate the subjects' environment for research purposes
Use identifiable private information, such as medical records or educational data, even if the researcher does not directly interact with the individuals
2. Systematic Investigations
IRB review is necessary for projects that follow a systematic data collection and analysis approach. This encompasses a wide range of research activities, including:
Studies that adhere to a predefined protocol or methodology to ensure consistent data collection across participants
Pilot studies and feasibility studies designed to assess the viability of a larger research project or to refine data collection procedures
Research that involves testing a hypothesis, evaluating outcomes, or comparing different interventions or conditions
3. Generalizable Knowledge
Studies that aim to contribute to generalizable knowledge, meaning the findings have implications beyond the specific individuals or settings studied, typically require IRB approval. This includes research that:
Seeks to draw conclusions or make statements that apply to a broader population or context
Contributes to theoretical frameworks, scientific evidence, or the understanding of a particular phenomenon
Intends to publish or present the results in academic journals, conferences, or other public forums to disseminate the findings to the scientific community and general public
It's important to note that quality improvement projects, program evaluations, and journalistic activities focusing on specific individuals or organizations may not require IRB approval if they do not meet the criteria for research involving human subjects or the intent to generate generalizable knowledge.
However, if you are unsure whether your project requires IRB review, it is best to consult your institution's IRB office for guidance.
Activities Exempt from IRB Review
While most research involving human subjects requires IRB approval, certain activities are exempt from IRB review. These exemptions are outlined in the federal regulations and include:
Scholarly and journalistic activities that focus directly on specific individuals, such as oral history, journalism, biography, literary criticism, legal research, and historical scholarship. These activities are not considered research as long as they do not extend beyond the studied individuals.
Public health surveillance activities conducted, supported, requested, ordered, required, or authorized by a public health authority. These activities are limited to regulations necessary for the authority to identify, monitor, assess, or investigate potential public health signals, disease outbreaks, or conditions of public health importance.
Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized operational activities, as determined by each agency, in support of intelligence, homeland security, defense, or other national security missions.
However, even if these exemptions apply to your study, you may still need to obtain IRB approval or a determination of exemption from your institution's IRB office. Some institutions require researchers to submit an exemption application to ensure the study meets the exempt criteria and to maintain oversight of all research activities.
Additionally, research that involves vulnerable populations, such as children, prisoners, or individuals with impaired decision-making capacity, may not be eligible for exemption and may require full IRB review and approval.
How to Determine if Your Study Needs IRB Approval
Navigating the IRB approval process can be complex, especially if you're new to research or unsure about the specific requirements for your study. To help you determine if your project requires IRB review:
1. Assess if the Project Meets the Definition of Research
First, evaluate whether your project qualifies as research according to the federal regulations. Ask yourself if your study is a systematic investigation designed to develop or contribute to generalizable knowledge.
If your project involves a systematic approach to data collection and analysis, intending to draw conclusions or make statements that apply beyond the specific individuals or settings studied, it likely meets the definition of research.
2. Evaluate if Human Subjects are Involved
Next, assess if your research involves human subjects. Consider whether you will obtain data through intervention or interaction with living individuals, such as conducting surveys, interviews, or physical procedures.
Additionally, determine if your study uses identifiable private information or biospecimens, such as medical records or biological samples that can be linked to specific individuals. If your project involves either of these elements, it likely involves human subjects and may require IRB approval.
3. Submit a Human Subjects Research Determination Form
If you're unsure whether your project meets the criteria for research involving human subjects or needs an official determination for funding or publication purposes, you can submit a Human Subjects Research Determination Form to your institution's IRB office.
This form typically requires briefly describing the project, including the purpose, methodology, and data collection procedures. The IRB will review your submission and provide an official determination of whether your study requires IRB approval or qualifies for an exemption.
It's important to seek IRB guidance early in the research planning process to ensure your study is ethically sound and compliant with institutional and federal regulations. If your project requires IRB approval, you must submit a complete application, including a detailed protocol, informed consent documents, and recruitment materials.
The IRB will review your application and may request additional information or modifications before granting approval.
Consequences of Conducting Research Without IRB Approval
Failing to obtain IRB approval for human subjects research can have profound implications for the participants and the researchers involved.
Conducting a study without IRB oversight risks exposing participants to unethical practices, such as coercion, deception, or unnecessary harm. This can result in physical, psychological, or social damage to the individuals involved, undermining the fundamental principles of research ethics.
In addition, conducting research without IRB approval can have significant professional and legal ramifications for researchers. Many peer-reviewed journals require evidence of IRB approval before publishing research findings.
If you fail to obtain IRB approval, you may be unable to disseminate your results through reputable scientific channels, limiting the impact and credibility of your work.
Furthermore, institutions that receive federal funding for research must ensure that all human subjects research undergoes IRB review.
If you conduct a study without IRB approval, you may face institutional sanctions, such as losing funding, suspension of research privileges, or disciplinary action. In some cases, researchers who violate IRB regulations may be subject to legal consequences, including fines or criminal charges.
Conducting research without IRB approval can also damage your reputation as a researcher. Ethical violations can erode trust in the scientific community and the public, making securing future funding or collaborations difficult.
To avoid these consequences and ensure compliance with ethical and regulatory standards, consider partnering with a company specializing in clinical trials. These services help streamline the IRB approval process and provide oversight to protect participants and researchers.
How to Obtain IRB Approval for Your Study
Once you've determined that your research requires IRB approval, you must navigate the application process to ensure your study meets ethical and regulatory standards. Here's a step-by-step guide to help you obtain IRB approval for your research:
1. Complete Required Training
Before submitting your IRB application, you and your research team must complete training on human subjects protection and research ethics.
Many institutions offer online courses, such as the Collaborative Institutional Training Initiative (CITI) program, which covers topics like informed consent, privacy and confidentiality, and risk assessment.
Completing this training demonstrates your commitment to ethical research practices and helps you design a study that prioritizes participant welfare.
2. Prepare IRB Application
The next step is to prepare a comprehensive IRB application that details your study's purpose, methodology, and safeguards for human subjects. Your application should include:
A detailed protocol outlining the research question, study design, data collection procedures, and analysis plan
Informed consent documents that clearly explain the study's purpose, procedures, risks, benefits, and confidentiality measures to potential participants
Recruitment materials, such as flyers, emails, or social media posts that you'll use to invite individuals to participate in your study
Your IRB application should be thorough, well-organized, and easy to understand. If necessary, consult your institution's IRB office or a research mentor to ensure your application meets all requirements.
3. Submit an Application for Review
Once your IRB application is complete, submit it to your institution's IRB office for review. The IRB will assess your study's risk level and assign it to one of three review categories:
Exempt review: For studies that pose minimal risk to participants and fall under one of the exemption categories outlined in the federal regulations
Expedited review: For studies that involve no more than minimal risk and fit one of the expedited review categories, such as minor changes to approved research or research on individual or group characteristics or behavior
Full board review: For studies that involve more than minimal risk, vulnerable populations, or complex ethical considerations, requiring review by the full IRB committee at a convened meeting
The review process can take several weeks to a few months, depending on the complexity of your study and the IRB's workload. During this time, the IRB may request additional information or clarifications about your application.
4. Respond to IRB Feedback and Revisions
After reviewing your application, the IRB may require revisions or additional safeguards to ensure your study meets ethical and regulatory standards. Common feedback includes clarifying recruitment procedures, revising informed consent documents, or modifying data collection methods to minimize participant risks.
Address any concerns or requested changes promptly and resubmit your application for further review. Maintain open communication with the IRB throughout the revision process for a smooth and efficient approval.
5. Obtain IRB Approval Before Initiating Research
Once your IRB application is approved, you'll receive an official approval letter outlining the conditions of your study. Obtaining this approval is vital before beginning any research activities, including recruiting subjects or collecting data.
Remember that IRB approval is an ongoing process. If you need to make changes to your study after initial approval, you must submit an amendment to the IRB for review and approval before implementing those changes. Additionally, you must submit continuing review applications annually to maintain IRB oversight throughout the study.
How Long Does the IRB Approval Process Take?
The IRB approval process timeline can vary depending on your study's complexity and risk level. Exempt and expedited reviews, which involve minimal risk to participants, typically take 2-4 weeks from submission to approval.
However, full board reviews, required for studies with more than minimal risk or complex ethical considerations, may take 4-8 weeks or longer.
Several factors can impact the IRB approval timeline. IRB meeting schedules, particularly for full board reviews, can affect how quickly your application is reviewed.
If your study requires revisions or additional information, the time needed to address these concerns and resubmit your application can extend the approval process. Your responsiveness to IRB feedback and the thoroughness of your revisions can also influence the timeline.
To ensure a smooth IRB approval process, plan ahead and allow sufficient time for review and potential revisions. Consult your institution's IRB office early in the research planning stages to understand their specific requirements and timelines.
If you're interested in participating in research, joining an IRB-approved study is a great way to advance scientific knowledge while ensuring your rights and welfare are protected. Participating in research that has undergone IRB review provides peace of mind, knowing that the study has been carefully evaluated for ethical and scientific merit.
Understanding the necessity of IRB approval ensures ethical and compliant research involving human subjects. Reputable Health offers expertise and guidance to streamline the IRB process, helping you conduct research confidently.
Book a call with Reputable Health to fast-track your IRB approval process.
