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Institutional Review Board (IRB) is a group designated by an institution to review, approve, disapprove, or require changes in research involving human subjects. IRBs ensure that researchers take appropriate steps to [[Protecting Human Research Subjects | protect the rights]] and welfare of human subjects. Researchers should seek IRB approval at the beginning of a study , prior to implementing any change to the study, and every year of the study, even if no study protocol has changed. This page outlines IRB requirements and where, when, and how to seek IRB approval.
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An IRB approval is required for any study involving human subjects.
*Researchers must acquire IRB approval at initial protocol review and continuing review; if any changes are made in the study , researchers must also acquire IRB approval at amendment review.
*Prepare IRB applications with anticipation, as compiling materials can consume substantial time and energy.
IRB review is a process through which an IRB reviews, approves, disapproves, or requires changes in research involving human subjects. IRB approval is required for all studies that:
* Interact with human subjects for the purposes of research
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* Collect data on individuals including [[ Personally Identifying Information (PII) | personally identifying information]]
Use data collected from individuals that includes personally identifying information
An IRB will request researchers about additional measures taken for studies that include vulnerable populations , such as pregnant women, prisoners, children, or economically or educationally disadvantaged people.
Where to seek IRB approval==
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.
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==How to seek IRB approval ==
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, [[Survey Protocols | data collection protocols]], recruitment materials, and [[Informed Consent | informed consent]] documents, among others. Note that retrieving this information and submitting it in the required format can consume substantial time and energy.
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==When to seek IRB approval==
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 [[ Survey Pilot | 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.
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*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.
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:* 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.
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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.
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Very few circumstances [ https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101%28b%29%281%29/ 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.
few circumstances [research teamfrom needing IRB approvalfor a study that interacts with human subjects. In practice, for continuing , an initial review exemption.
Back to Parent ==
This article is part of the topic [[ Research Ethics]]
== Additional Resources ==
== Additional Resources ==
DIME Analytics’ [ https:// github. com/ worldbank/ DIME- Resources/blob/master/survey-ethics .pdf Research Ethics & Data Security]
* [://.//--ethics ]
Ozler's [https://blogs.worldbank.org/impactevaluations/research-adolescents-issues-surrounding-consent Research with adolescents: issues surrounding consent] on the World Bank Development Impact blog
* Berk [https://blogs.worldbank.org/impactevaluations/research-adolescents-issues-surrounding-consent Research with adolescents: surrounding consent]
's [https://blogs.worldbank.org/impactevaluations/taking-ethical-validity-seriously Taking Ethical Validity Seriously] on the World Bank Development Impact blog and Berk Ozler's [ http:// blogs. worldbank. org/ impactevaluations/ taking- ethics- seriously- response- 1 response]
[[Category: Research Ethics]]
* Martin Ravallion [https://blogs.worldbank.org/impactevaluations/taking-ethical-validity-seriously Taking ]
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.
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 local approvals with government agencies, and budgetary approvals from the organization funding the study.
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. The three broad stages of approval are as follows:
- Initial protocol review
- Amendment review
- Continuing review
Initial protocol review
The first review occurs at the beginning of the study, before starting with data collection. Ideally, the research team should seek IRB approval after conducting the pre-pilot, and finalizing survey protocols and instruments. Since the pre-pilot is conducted before obtaining IRB approval, it should not collect or store personally identifiable information (PII). 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.
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).
- 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.
- Informed consent procedures. This covers changes to the manner in which the research team obtains informed consent from participants of a study.
Finally, since risks to the human subjects are constantly changing over time, the research team must submit the study for a yearly 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 the yearly review, which the research team must follow.
Applications for approval from an IRB can be quite demanding, especially in cases where research is taking place outside the borders of the United States. IRBs require the research team to submit details about various aspects, including study design, instruments, training guidelines, data collection protocols, and documents for Preparing for Field Data Collection#Procurement. In addition to these documents, the research team must also submit the following information for approval of a study involving human subjects:
- Informed consent
- Protecting human subjects and certification
- Vulnerable populations and expected enrollment
Before involving a human subject in a research study, the research team must obtain informed consent from each individual. This means that the research team must clearly mention all possible risks and benefits from participating in a study, either for the survey pilot or as a respondent in the actual study. The research team must clearly lay out the procedure for obtaining informed consent, and clearly state that human subjects can take back this consent at any point during the study. DIME Analytics has created templates for obtaining oral, as well as written consent.
Protecting human subjects and certification
The application should contain a separate section that deals with protecting human subjects. This section should specifically mention that human subjects are a part of the study. It should also include an assessment of possible risks and benefits to human subjects, steps taken to protect the human subjects from these risks, and the key insights that the research team hopes to gain from conducting the study.
Finally, every member of the research team who handles personally identifiable information must obtain a human research subjects certification before the research team submits an application for approval. Two organizations that provide the human research subjects certification are:
Vulnerable populations and expected enrollment
The proposal should also include a plan detailing how it will protect the interests of vulnerable members of the population. These may include women, children, or minority communities in the area of the study.
The proposal should also include a table which lists indicating expected enrollment figures, especially for vulnerable categories, like women, children and minorities. Enrollment rate (or take-up rate) is the number of individuals who actually participated in a study, out of the total number of individuals who were eligible to participate in a study. The National Institute of Mental Health (NIMH) has created a template that research teams can use to create such a table.
Often, experimental and quasi-experimental methods exclude certain sections of the population from the study. In such cases, the proposal must provide a justification for excluding a particular section of the population, especially if participating in the study can provide certain financial, or health benefits. For example, a study designed to provide cash transfers to farmers might propose to exclude farmers who cultivate more than 10 hectares of land. In this case, the research team must provide strong reasoning for excluding this group.
Institutional review boards (IRBs) follow the basic principles for IRB approval that are outlined in the Federal Policy for Protection of Human Subjects, or the 'Common Rule'. Research teams often submit applications to institutional review boards (IRBs) that are based in partner academic institutions, or research organizations. Some examples of these IRBs are given below:
Since the World Bank does not have its own IRB, World Bank projects typically seek IRB approval from one of these above IRBs. In many cases, the research team may also need multiple IRB approvals, especially when different members of the research team are associated with different institutions. Sometimes, additional approvals are needed based on the requirements in the country in which the study is being conducted.
- Additional IRB approval. In some cases, a particular country will require the research team to obtain approval from local IRBs as well.
- Local approvals. The research team may also need to obtain other permissions from relevant government agencies and ministries in the area of the study. These can include permissions to access administrative, or geospatial data. These approvals can allow the research team to work smoothly in the location of the study.
- Budgetary approval. The research team must also seek approval for the study budget from the organization funding the study. This includes obtaining approval for various expenses, including administrative costs like salaries, costs for purchasing physical equipment like tablets, as well as country-specific costs like taxes.
There are very few circumstances under which a research team can be exempted from needing an IRB approval for a study that interacts with human subjects. In practice, exemptions can only be obtained for continuing reviews, since the research team must submit an initial application to an institutional review board (IRB) for future exemption.
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