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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 [[Impact Evaluation Team|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 [[Survey Protocols|protocols]], [[Questionnaire Design|content]], and [[Data Security|data security]]. The '''research team''' must seek '''IRB approval''' to ensure that they are [[Protecting Human Research Subjects|protecting the rights and welfare]] of '''human subjects'''. The '''Federal Policy for Protection of Human Subjects''' (or [https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html 'Common Rule']) outlines the basic ethical principles for IRB review.
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 [[Impact Evaluation Team|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 [[Survey Protocols|protocols]], [[Questionnaire Design|content]], and [[Data Security|data security]]. The '''research team''' must seek '''IRB approval''' to ensure that they are [[Protecting Human Research Subjects|protecting the rights and welfare]] of '''human subjects'''.  
==Read First==
==Read First==
* [[Research Ethics|Research ethics]].
* [[Research Ethics|Research ethics]].
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'''Institutional review boards (IRBs)''' review and monitor research studies  to [[Protecting Human Research Subjects|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 [[Impact Evaluation Team|research team]] must seek an '''IRB approval''' for all studies that interact with '''human subjects''', and collect (or use) [[Personally Identifiable Information (PII) | personally identifiable information]] about individuals.
'''Institutional review boards (IRBs)''' review and monitor research studies  to [[Protecting Human Research Subjects|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 [[Impact Evaluation Team|research team]] must seek an '''IRB approval''' for all studies that interact with '''human subjects''', and collect (or use) [[Personally Identifiable Information (PII) | 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 of Survey Pilot|timeline]] for the entire study. The entire process of obtaining approvals also involves applying for the following:
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 of Survey Pilot|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.
* '''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 [[Survey Budget|study budget]] from the organization funding the study.


== Timeline ==
== Timeline ==
Researchers must seek IRB approval at various stages:
'''Institutional review boards (IRBs)''' can take between 1 day to 4 months to approve a study.  When submitting a project for review, the [[Impact Evaluation Team|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 [[Survey Pilot#Timeline|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 [[Primary Data Collection|data collection]]. Ideally, the research team should seek '''IRB approval''' after conducting the [[Survey Pilot#Stages of a Survey Pilot|pre-pilot]], and finalizing [[Survey Protocols|survey protocols]] and [[Questionnaire Design|instruments]]. Since the '''pre-pilot''' is conducted before obtaining '''IRB approval''', it should not collect or store [[Personally Identifiable Information (PII)|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.
=== 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|sampling]], and changes to the primary hypothesis of the study (or [[Theory of Change|theory of change]]).


*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.
* '''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 Surveys|field survey]] to a [[Remote Surveys|remote survey]].
* '''Survey instrument.''' This covers changes to the [[Questionnaire Design|content]], [[Questionnaire Translation|translations]], and [[Questionnaire Programming|programmed version]] of the questionnaire.


*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.
* '''Training.''' This covers changes in the methods, and medium of conducting [[Enumerator Training|enumerator training]]. For example, the research team decide to conduct the training virtually, instead of in-person.


*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.  
* '''Protocols.''' This covers changes to [[Survey Protocols|survey protocols]]. For example, if the research team decides to transition to a [[Remote Surveys#Phone Surveys (CATI)|phone survey]], then they will need to update the '''protocols''' to include [[Monitoring_Data_Quality#Random_audio_audits|audio audits]].


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.
* '''Informed consent procedures.''' This covers changes to the manner in which the research team obtains [[Informed Consent|informed consent]] from '''participants''' of a study.
 
=== Continuing review ===
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.


== Content ==  
== Content ==  
When the [[Impact Evaluation Team|research team]] submits an application for approval of a study that involves '''human subjects''', they must include the following information:
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 [[Impact Evaluation Team|research team]] to submit details about various aspects, including study design, [[Questionnaire Design|instruments]], [[Training Guidelines: Content and Structure|training guidelines]], [[Survey Protocols|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''':
* 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.
* '''Informed consent'''
* 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).
* '''Protecting human subjects and certification'''
* A Table indicating anticipated enrollment figures for the above categories (women, children and minorities) must be included. See [[https://grants.nih.gov/grants/funding/phs398/enrollment.pdf sample table] from NIMH.
* '''Vulnerable populations and expected enrollment'''
* '''Exclusions'''


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.
=== Informed consent ===
Before involving a '''human subject''' in a research study, the research team must obtain [[Informed Consent|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|survey pilot]] or as a [[Survey Pilot Participants|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. [https://www.worldbank.org/en/research/dime/data-and-analytics DIME Analytics] has created templates for obtaining [https://github.com/worldbank/dime-standards/blob/master/dime-research-standards/pillar-1-research-ethics/research-ethics-resources/informed-consent-templates/informed-consent-template-verbal.md oral], as well as [https://github.com/worldbank/dime-standards/blob/master/dime-research-standards/pillar-1-research-ethics/research-ethics-resources/informed-consent-templates/informed-consent-template-written.md written] consent.
 
=== Protecting human subjects and certification ===
The application should contain a separate section that deals with [[Protecting Human Research Subjects|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 (PII)|personally identifiable information]] must obtain a [[Research Ethics#Before Data Collection|human research subjects certification]] before the research team submits an application for approval. Two organizations that provide the '''human research subjects certification''' are:
* [https://phrp.nihtraining.com/users/login.php Protecting Human Research Participants (PHRP)]
* [https://about.citiprogram.org/en/series/human-subjects-research-hsr/ Collaborative Institutional Training Initiative (CITI)]
 
=== 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 [https://grants.nih.gov/grants/funding/phs398/enrollment.pdf template] that research teams can use to create such a table.
 
=== Exclusions ===
Often, [[Experimental Methods|experimental]] and [[Quasi-Experimental Methods|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.


== Procedure ==
== 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.
'''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 [https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html 'Common Rule']. [[Impact Evaluation Team|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:
* MIT has its own '''IRB''', called [https://couhes.mit.edu/ Committee on the Use of Humans as Experimental Subjects (COUHES)].
* Innovations for Poverty Action (IPA) has its own '''IRB''', the [https://www.poverty-action.org/researchers/working-with-ipa/irb IPA IRB].
* There are also several certified independent '''IRBs''', like [http://wirb.com/Pages/IRBServices.aspx Western IRB].
 
Since the [https://www.worldbank.org/ 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 and Monitoring Data|administrative]], or [[Geo Spatial Data|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 [[Survey Budget|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.


==Exemptions==
==Exemptions==
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.  
There are very few circumstances under which a [[Impact Evaluation Team|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.


== Back to Parent ==
== Related Pages ==
This article is part of the topic [[Research Ethics]]
[[Special:WhatLinksHere/IRB_Approval|Click here for pages that link to this topic.]]


== Additional Resources ==
== Additional Resources ==
*DIME Analytics’ [https://github.com/worldbank/DIME-Resources/blob/master/survey-ethics.pdf Research Ethics & Data Security]
* DIME Analytics (World Bank), [https://osf.io/6fcvk Research Ethics]
*Berk 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 Özler (World Bank), [http://blogs.worldbank.org/impactevaluations/taking-ethics-seriously-response-1 Taking ethics seriously: Response #1]
*Martin Ravallion'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]
* Berk Özler (World Bank), [https://blogs.worldbank.org/impactevaluations/research-adolescents-issues-surrounding-consent Research with adolescents: Issues surrounding consent]
[[Category: Research Ethics]]
* J-PAL, [https://www.povertyactionlab.org/ethics Ethics]
* NIMH, [https://www.nimh.nih.gov/funding/managing-your-grant/human-subjects-in-research-things-to-consider.shtml Human Subjects in Research: Things to Consider]
* Martin Ravallion (World Bank), [https://blogs.worldbank.org/impactevaluations/taking-ethical-validity-seriously Taking ethical validity seriously]  
* National Institute of Mental Health, [https://www.nimh.nih.gov/funding/managing-your-grant/human-subjects-in-research-things-to-consider.shtml Human Subjects in Research: Things to Consider]

Latest revision as of 20:25, 16 August 2023

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.

Read First

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 local approvals with government agencies, and budgetary approvals 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. 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.

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).
  • 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.

Continuing review

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.

Content

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
  • Exclusions

Informed consent

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.

Exclusions

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.

Procedure

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.

Exemptions

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.

Related Pages

Click here for pages that link to this topic.

Additional Resources

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