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:

• Local approvals. 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

Institutional review boards (IRBs) can take between 1 day to 4 months to approve a study. When submitting a project for review, the research team should allow enough time to ensure that the study is not interrupted. Further, the research team may need to obtain new approvals from the IRB at various stages of a study, so it is important to allocate sufficient time for this in the study timeline.

• Initial protocol review: The first review occurs at the beginning of the study, before any research activity begins. Ideally, the research team should seek IRB approval after conducting the pre-pilot and finalizing survey protocols. Since the pre-pilot is conducted before obtaining IRB approval, it should not collect or store personally identifying information. The pre-pilot should only be used to assess the feasibility of the survey protocols, and to make sure all members of the research team have clearly understood the purpose of the study.

• Amendment review: The research team must submit an amendment application to an IRB whenever it makes changes to the following aspects of a study:
  • General study design. This covers changes to location of study, method of sampling, and changes to the primary hypothesis of the study (or theory of change).
  • Method of data collection. This covers changes in the method of data collection. For example, the research team might decide to transition from a field survey to a remote survey.
  • Survey instrument. This covers changes to the content, translations, and programmed version of the questionnaire.
  • Training. This covers changes in the methods, and medium of conducting enumerator training. For example, the research team decide to conduct the training virtually, instead of in-person.
  • Protocols. This covers changes to survey protocols. For example, if the research team decides to transition to a phone survey, then they will need to update the protocols to include audio audits.
  • Informed consent procedures. This covers changes to the manner in which the research team obtains informed consent from participants of a study.

Note: In the above cases, the full committee of the IRB may need to review and discuss suggested changes in detail, and approval can take more than a month. However, in other cases where the changes are minor, and do not pose any risk to human subjects, the IRB can provide speedy approval.

• Continuing review: Finally, since risks to the human subjects are constantly changing over time, the research team must submit the study for a continuing review. As part of this, the research team must reports on the progress of the approved research every year, even if no aspect of the study has changed. Every IRB clearly lays out the format of the application for annual approval, which the research team must follow.

Content

As a general rule, 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.

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. See [sample table from NIMH.

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.

Procedure

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