IRB Approval

An institutional review board (IRB) is an organization that reviews and approves (or disapproves) any research study involving human subjects. A human subject is any individual about whom the research team collects data through an intervention, or interaction with the individual. Institutional review boards (or IRBs) can recommend changes in all aspects of an impact evaluation, including protocols, content, and data security. The research team must seek IRB approval to ensure that they are protecting the rights and welfare of human subjects. The Federal Policy for Protection of Human Subjects (or 'Common Rule') outlines the basic ethical principles for IRB review.

Read First

• Research ethics.
• Protecting human research subjects.
• DIME Analytics has compiled the DIME Research Ethics Standards to outline guidelines for ethical research.
• The research team must obtain IRB approval before starting an impact evaluation, as well as for any changes that they make during the study.

Overview

Institutional review boards (IRBs) review and monitor research studies to protect the rights of human subjects. The IRB can also request the research team for information on additional measures to protect the interests of vulnerable populations, such as pregnant women, prisoners, children, or economically or educationally disadvantaged people. In general, the research team must seek an IRB approval for all studies that interact with human subjects, and collect (or use) personally identifiable information about individuals.

The research team must prepare the applications for IRB approval in advance, since it can be a time-consuming process. Further, the research team must set aside enough time for obtaining all necessary approvals in the timeline for the entire study. The entire process of obtaining approvals also involves applying for the following approvals:

• Local approval. The research team will often need to obtain permissions from relevant government agencies and ministries in the area of the study.
• Budgetary approval. The research team must also seek approval for the study budget from the organization funding the study.

Timeline

Researchers must seek IRB approval at various stages:

• Initial protocol review: this review occurs at the beginning of the study, before any research activity involving human participants begins. Ideally, research teams should seek IRB approval after piloting and finalizing all survey instruments. The pre-IRB pilot should not collect nor store personally identifying information. In order to not be considered research, the pre-IRB pilot should not contribute to generalizable knowledge, but rather simply assess the feasibility of the study protocols.

• Amendment review: this review occurs prior to implementing any change in the study. The research team must submit an amendment application whenever it alters any study design, informed consent procedure, or investigation team within an IRB-approved research protocol. IRBs will typically review amendments involving minor changes that pose no more than minimal risk to subjects on an expedited basis. Other changes may need to be reviewed by the full Committee at the next available IRB meeting. As a principle, the IRB must prospectively review all proposed changes to approved research, except when the research team must make necessary changes to eliminate apparent immediate hazards to subjects.

• Continuing review: as risks to participants may evolve through time, the research team must submit a continuing review every year, even if no study protocol has changed. In the submitted material, the research team reports on the progress of the approved research in the format prescribed by the IRB.

When submitting a project for review, allow enough time to ensure the non-interruption of studies. Consider that IRBs can make decisions in 3-5 days (commercial IRBs), 1 month (typical for university IRBs) or up to 4 months (IRBs based in the countries where research is taking place). Finally, the IRB must be informed of any cases of unanticipated problems involving risks to participants or others, usually within 24 hours to 2 weeks, depending on the severity of the adverse events.

Content

When the research team submits an application for approval of a study that involves human subjects, they must include the following information:

• section labeled "Protection of Human Subjects" which describes the proposed involvement of human subjects, including an assessment of risk, the steps taken to protect the subjects from risk, potential benefits from the study to the subjects and others and the importance of the knowledge to be gained from these studes.

A plan must be provided describing the inclusion of women, children and minorities in the research project or adequate justification for why a particular category might be excluded (e.g., a study might propose to exclude children, given adequate justification). A Table indicating anticipated enrollment figures for the above categories (women, children and minorities) must be included.

Process

IRB applications can be quite demanding, especially those from institutions based in the countries where research is taking place. IRBs require submission of study design, study instruments, interview guides, data collection protocols, recruitment materials, and informed consent documents, among others. Note that retrieving this information and submitting it in the required format can consume substantial time and energy.

As the World Bank does not have an IRB, World Bank projects typically seek IRB approval from partner academic or research organizations (i.e. principal investigators’ universities, Innovations for Poverty Action, etc.). It is not uncommon to need more than one IRB approval, especially when researchers work in different institutions. Additional IRB approvals may be required based on the local regulations.

Exemptions

Very few circumstances exempt a research team from needing IRB approval for a study that interacts with human subjects. In practice, for IRB approval only apply to continuing review, as an initial review must be submitted to obtain exemption.

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This article is part of the topic Research Ethics

Additional Resources

• DIME Analytics’ Research Ethics & Data Security
• Berk Ozler's Research with adolescents: issues surrounding consent on the World Bank Development Impact blog
• Martin Ravallion's Taking Ethical Validity Seriously on the World Bank Development Impact blog and Berk Ozler's response
• NIMH, Human Subjects in Research: Things to Consider