What Does IRB Stand For?

An IRB stands for Institutional Review Board.

What is an IRB (Institutional Review Board)?

Institutional Review Boards are independent committees composed of experts in diverse fields, including medicine, ethics, law, and social sciences, who evaluate research proposals to safeguard participants’ rights, welfare, and privacy.

What Types of Research Protocols Are Most Likely to Require IRB Review?

While all research involving human subjects should undergo IRB review, certain types of research protocols are more likely to raise concerns and require closer scrutiny. These include:
  • Studies involving invasive procedures or interventions
  • Studies with vulnerable populations
  • Studies involving deception or the withholding of information
  • Studies with long-term follow-up or longitudinal data collection
  • Studies involving genetic or biological materials
  • Studies with the potential for financial or other incentives

How Does an IRB Ensure Ethical and Safe Conduct in Research Trials?

Institutional Review Boards:
  1. Carefully review informed consent documents to ensure they are clear and concise, providing participants with adequate information about the study, risks, benefits, and alternatives.
  2. Assess the potential risks and benefits of the research, ensuring that the risks are minimized and justified by the potential benefits to society.
  3. Establish additional safeguards for studies involving vulnerable populations, such as children, pregnant women, and prisoners, to protect their interests and minimize undue risks.
  4. Protect participants’ personal information from being revealed to unauthorized individuals.
  5. Monitor data collection and analysis procedures to ensure the quality and integrity of the research data and prevent manipulation or falsification.
  6. Employ mechanisms to monitor adverse events that may occur during the research, ensuring timely and appropriate reporting and management of any potential harm to participants.
  7. Conduct regular reviews of research protocols and audits to ensure compliance with approved protocols and ethical guidelines.

When Must Investigators Update the IRB about the Progress of a Trial?

The frequency of progress reports to the IRB depends on the specific research protocol and the requirements of the funding agency or regulatory body. However, most IRBs require investigators to submit progress reports at least annually. In some cases, more frequent reporting may be necessary, such as when there are significant changes to the research protocol, unexpected adverse events occur, or the study is nearing completion. In addition to these general guidelines, it is important for investigators to carefully review the specific requirements of their IRB and funding agency. These requirements may specify the frequency of progress reports, their format, and any additional information that must be included.

What Are the Essential Components of an IRB Application?

The application must thoroughly outline the research proposal, including the study’s objectives, methods, risks, benefits, and plans for participant protection and data management. Its essential components are:
  • Title
  • Principal Investigator (PI)
  • Institutional Affiliation
  • Study Abstract
  • Introduction
  • Specific Aims
  • Research Methods
  • Risks and Benefits
  • Informed Consent Document
  • Recruitment and Selection
  • Data Management and Confidentiality
  • Data Analysis and Dissemination
  • Compliance with Regulatory Requirements
  • Timeline
  • Contact Information
  • Attachments

What is Involved in Obtaining IRB Certification for a Research Study?

The IRB approval process typically involves the following steps:
  1. Submission of a Research Proposal
  2. Initial Review
  3. Full Review
  4. Approval (or Disapproval)
  5. Ongoing Review
The IRB may also review potential conflicts of interest among the research team members or any financial relationships that could influence the conduct of the study. This helps maintain objectivity and ethical integrity throughout the research process. Once the study is complete, the investigators must submit a final report to the IRB. This report should summarize the study’s findings, address any ethical considerations that arose during the study, and describe any actions taken to address concerns or adverse events.

Which Types of Studies Typically Need IRB Approval?

Institutional Review Boards are responsible for evaluating research proposals to ensure the ethical and safe conduct of research involving human subjects. In general, IRB review is required for any research that involves human subjects, regardless of the type of research or the institution conducting the research. Some specific types of studies that typically require IRB approval include:
  • Clinical trials
  • Observational studies
  • Surveys
  • Qualitative studies
  • Research involving vulnerable populations
In addition to the type of research, the following factors can also influence whether IRB approval is required:
  • The level of risk to participants
  • The sensitivity of the research data
  • The involvement of human subjects in data interpretation or analysis
It is important to note that not all research involving human subjects requires IRB approval. Some types of research, such as studies that use publicly available data or do not involve any interaction with human subjects, may be exempt from IRB review. If you are unsure whether your research mandates IRB approval, contact your institution’s IRB or a qualified research ethics expert for guidance.