Since the establishment of the IPA Institutional Review Board (IRB), the IRB team has been compiling a list of frequently asked questions (FAQ) on IRB procedures to better support our country programs in adhering to the highest international ethical standards when conducting research involving human subjects. This document will change overtime. If you do not see an answer to your question here, please reach out to humansubjects@poverty-action.org.

Why do I need to apply for an IRB review?
When do I need to apply for an IRB review?

About IPA IRB
What types of research must be reviewed by IPA IRB?
Who needs to apply to IPA IRB for review?
Does IPA IRB review studies not funded or implemented by IPA?
Does IPA IRB review cost money?
Can IPA IRB exempt some research from review?
Do I need IPA IRB review if an international institution outside the U.S. and outside the host country (e.g. Canada or the U.K.) is already providing a reviewin?
What is a reliance (authorization) agreement?

Local IRB Review
When do I need to seek IRB review from within the country of the study?

Human Subjects Training
Am I required to take the human subjects training course?
How do I take the human subjects training course?
What types of human subjects training does IPA IRB recognize?
How often am I required to take the human subjects training course?

IPA IRB Application Process
Is there a deadline for submitting applications to IPA IRB?
How do I submit an application to IPA IRB?
Which application form do I use when applying to IPA IRB?
What documents are required with my application?

Minimal Risk vs. Non Minimal Risk Review Process
What is a minimal risk study?
What is expedited review?
What if my protocol is determined as minimal risk?
What if my protocol is determined as non-minimal risk?
How often does IPA IRB meet?
What happens if I want to start my research before the next IRB meeting?

Continuing Review
How long is my study approval valid?
Is my study subject to continuing review?
What happens if I miss the continuing review deadline?

Collaboration with other Institutions
What if I am collaborating with other institutions?

Changes to Staff, Timelines, and Study Protocol
What happens if I go on leave or on sabbatical?
What if the study implementation is on hold?
What if I need to modify my study after it has been approved?

Consent
Am I required to obtain written informed consent from all study subjects?
In preparing informed consent forms, must I use the IPA IRB template?
What is a child assent and when do I need it?

Unexpected and Adverse Events
What do I do if a study subject suffers an adverse event?

Vulnerable Populations
What are vulnerable populations?
Can I use students as subjects?
What if I am studying children/ minors?

Gifts
Can I offer subjects a gift for participating in a survey?

 

Why do I need to apply for an IRB review?
An IRB review is an important part of IPA’s research quality protocols. IPA research protocols require that all IPA projects must be reviewed by a U.S. or a similar IRB institution and a nationally recognized (or equal) IRB prior to commencement of any human research activity. This process is required by the U.S. federal regulations (45 CFR pt. 46). When no other U.S. or similar institutions are reviewing the study or if a funder/partner requires it, IPA IRB will provide the review.

When do I need to apply for an IRB review?
The questions below are specific to IPA IRB ONLY. If you are seeking a review with another institution (i.e. an academic institution), please consult the respective IRB as protocols vary across IRB institutions).

 

About IPA IRB

What types of research must be reviewed by IPA IRB?
ALL TYPES of IPA research involving human subjects are reviewed by IPA IRB that meet the criteria from the “Who needs to apply to IPA IRB?” question.

 

Who needs to apply to IPA IRB for review?
IPA-affiliated researchers conducting research involving human subjects in ANY one of the following situations need to apply for IPA IRB review:

  1. Where another international institution (i.e. the researcher’s primary affiliated institution such as Yale, MIT, Harvard, etc.) is not providing review. If the institution is outside the U.S., see the question “Do I need IPA IRB review if an international institution, outside the U.S. is already providing the review?”
  2. Where another institution defers to IPA IRB as a primary reviewer and approver (the institution will need to send IPA IRB an IRB Authorization Agreement on their institutional letterhead).
  3. Where the collaborating principal investigator’s (PI) university, donor, or partner organization requires IPA IRB’s approval (in this instance, IPA IRB will review the study as secondary approver pending the primary institution’s approval).

If your project already has approval from another OHRP-recognized institution and that institution has agreed to cover all IPA staff and research activities, the project does not require IPA IRB review and approval. In such cases, IPA can prepare a Reliance Agreement to formally cede coverage of the research to the reviewing institution.

It is important for country programs to communicate the above scenarios to our partners (donors, PIs, implementers). It is also the role of Country Programs to understand their donor requirements for IRB, as well as for our collaborating researchers to know their academic institution's IRB requirements, as some donors and IRBs require that projects receive IRB review and approval from the implementing organization (in this case IPA). If you have questions, please consult with your primary IRB, donor, lead Principal Investigator, and Country Program management staff. As always, you can also reach out to humansubjects@poverty-action.org with questions.

Does IPA IRB review studies not funded or implemented by IPA?
Under the fee schedule implemented on August 1, 2020, IPA IRB can review studies not funded or implemented by IPA for an additional administrative fee of $500 on top of initial review fees.

Does IPA IRB review cost money?
Yes. As of August 1, 2020, any study seeking IPA IRB review will be charged according to the fee schedule that can be found here.

These fees are based on (i) staff time and training, including processing submissions, executing reliance agreements, advising projects and responding to questions, preparing templates and customized guidance on consent forms, and recruiting and working with Board members; (ii) Board member honoraria; (iii) annual CITI organizational subscription for human subjects training; and (iv) comparison research to identify fees charged by other IRBs completed in 2020.

IRB fees should be included in every research project’s budget. We advise that you discuss IRB during the project development stage together with your donors, PIs, and implementing partners so that you have adequately budgeted for the appropriate IRB costs.

Can IPA IRB exempt some research from review?
Yes. U.S. federal regulations may allow exemption of certain types of research from institutional review board review. An Original Application and an Exemption Application is required to evaluate qualifications from exemption.

Do I need IPA IRB review if an international institution outside the U.S. and outside the host country (e.g. Canada or the U.K.) is already providing a review?
You MAY NOT need IPA IRB review if an international institution outside the U.S. is already providing a review. Please email humansubjects@poverty-action.org to determine whether the other institution’s review is valid. IPA IRB will check to ensure the reviewing institution follows regulations that are compatible with U.S. IRB regulations. If this is the case, IPA IRB will enter into a reliance agreement to formally recognize the other institution’s review.

What is a reliance (authorization) agreement?
A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an IRB of another institution. Institutions may use different descriptive terms, e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s FederalWide Assurance (FWA). MOUs are generally used when covering an entire research program; reliance agreements are generally used to cover a designated protocol or protocols.

 

Local IRB Review

When do I need to seek IRB review from within the country of the study?
IPA IRB Guidelines require that if the location of the country where you are conducting research is outside of the U.S., you need to apply for local IRB review if a local research review body exists. In countries where local IRB reviews are legally required, or grants require that local IRBs provide a review, the projects must follow all externally imposed review obligations.


Additionally, IPA requires that if the location of the country where you are conducting research is outside of the U.S., some sort of local objective institution must review and approve the study before it proceeds. This can be fulfilled EITHER by a local IRB/REC, OR a local, objective institution that meets all the required elements. The PI is responsible for ensuring that local IRB review is acquired. Country-level IPA team members can support your project team to identify and acquire local IRB review. Please note that all IPA IRB approval is conditional upon local IRB review. A conditional IRB approval may be granted if the local IRB review is in process.

 

Human Subjects Training

Am I required to take the human subjects training course?
Yes. U.S. federal regulations require that any study personnel involved in human subjects research take and pass the training course. This requirement extends to principal investigators, associate investigators, student investigators, research coordinators and research associates, and anyone handling or viewing data with more than 10 percent of Personally Identifiable Information (PII). This includes direct and indirect contact with respondents and analysis of data. All IPA research staff members (RAs, RCs, RMs, DCDs, and CDs) are required to take and pass this course.
 

How do I take the human subjects training course?
The Collaborative Institutional Training Initiative (CITI) at University of Miami course can be taken here. Protecting Human Research Participants (PHRP) courses can be taken here.

What types of human subjects training does IPA IRB recognize?
IPA IRB recognizes both Collaborative Institutional Training Initiative (CITI) at University of Miami and Protecting Human Research Participants (PHRP). Additional Human Subjects Trainings may be valid on a case-by-case basis by contacting IPA Human Subjects at humansubjects@poverty-action.org.

How often am I required to take the human subjects training course?
You must take the human subjects training course when you first become involved in human subjects research. You must subsequently take and pass the course every 3 years from the date you first took the course. Some certificates are issued with no expiration date, however IPA’s policy remains that a new certificate must be obtained every 3 years from the date you took your last course.

 

IPA IRB Application Process

Is there a deadline for submitting applications to IPA IRB?
IPA IRB reviews applications on a rolling basis. For minimal risk studies, IPA IRB on average takes 2 weeks and up to 35 days to process after a complete application has been received. However, non-minimal risk applications that may need full board review should allow for 60 days to process.
 

How do I submit an application to IPA IRB?
Principal Investigators who seek IPA IRB review are required to use IPA’s standard application forms available on the IPA IRB page. Additional communications may be sent to humansubjects@poverty-action.org. This requirement can only be waived by the Human Subjects Coordinator, the Board’s Chair, or the Board (with a majority vote of those present and allowed to vote).

Which application form do I use when applying to IPA IRB?
All forms can be found on the IPA IRB page. Below is a list of different types of forms of the IRB application process and their purposes:

  • Original Application Form
    • Use this form to apply for review of a new research study
    • Use this form to apply for a review of a replication study of an existing study in a new country
  • Amendment Form
    • Use this form for any changes to the study protocol (subject population, design, sampling method, data security), questionnaire, or other factors that impact the comfort or risk level for respondents.
    • Also use this form to notify the IRB of changes to study personnel, or changes to privacy policies or grants agreement(s) that impact confidentiality of the participants.
  • Renewal Form
    • Use this form to apply for a study renewal without any changes to already-approved protocol.
    • Use this form to apply for a study renewal. If changes to the to the previously approved protocol coincide with renewal. Please ensure that you document the changes in the progress report.
  • Unexpected Event Form
    • Use this form to report any adverse events. The IRB will use this form to evaluate the risk to the study's human subjects and provide mitigating steps.
  • Exemption Form
  • Closure Form
    • Use this form to apply for a study closure. When there is no longer ongoing interaction or intervention with the subjects, data collection, or active analysis of identified data, your project can be closed. If you have identified information on file that is properly protected and is no longer being used for data analysis, you can still close out your study.

What documents are required with my application?

Original Application

  • IPA Application Form
  • MOU or letter of support from partner organization(s)
  • Survey(s) in English including:
    • Embedded consent(s) must also be submitted as a separate document. Please adhere closely to the consent template verbiage and consent checklist (found on the IPA IRB page) when drafting your consent. Note special considerations when surveying children.
    • If paper-based surveys are being used, identifying information/pages must be removable from survey.
  • Marketing materials being used to recruit subjects if IPA or IPA employees are doing the marketing.
  • If not already on file with IPA, certificate of Human Subjects training for all research personnel with influence over the study’s design, or with access to Personally Identifiable Information (PII) of more than 10 percent of a study’s participants. If applicable, documentation of equivalent training for all remaining research personnel that interacts with study participants or has access to participants’ PII. Human Subjects training certification must be renewed every 3 years to be considered valid for approval.
  • IRB approvals from other institutions, if applicable
  • Any other supporting documents

For studies that were originally approved expedited review before January 2019, and for ALL studies that originally received full board review and approval, the following documents are required:

Renewal Application

  • IPA Renewal Form
  • Last approved consent form(s) showing all changes (in "track changes") needed to create the current consent
  • Clean copy of the updated, current consent form(s)
  • Copy of the protocol revised (in "track changes") to update with all approved amendments (Word document)
  • Clean copy of the updated protocol
  • IRB approvals from other institutions, if applicable
  • Brief progress report
  • Any other supporting documents

For studies that were approved expedited review after January 2019, only a brief progress report on the study’s activities from the past year is required. Any exempt study is not under continuous review, and is not required to submit a renewal.

Study Amendment

  • IPA Amendment Form
  • Revised protocol and/or consent (highlighting all revisions)
  • Any other supporting documents

Report of Unexpected Events

  • IPA unexpected event report
  • Any other supporting documents

Study’s Exemption

  • IPA exemption form
  • Any other supporting documents

Closure Application

  • IPA Closure form
  • Clean copy of the protocol
  • Clean copy of the consent
  • Brief progress report
  • Any other supporting documents

 

Minimal Risk vs. Non Minimal Risk Review Process

What is a minimal risk study?
Upon receipt of an IRB application for review, the research study is evaluated to determine whether it involves no more than minimal risk to the subjects. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Pregnant women, children, and prisoners are considered vulnerable populations by IPA IRB. Additional populations may also be considered vulnerable based on local context. If a study is deemed to be no more than minimal risk, it will be reviewed via an expedited review process.
 

What is expedited review?
Under an Expedited Review process, a designated reviewer will make a determination of eligibility under a two-part test. First, the Reviewer must determine whether the research protocol involves no more than “minimal risk.” Under the second prong, the Reviewer must determine whether the research protocol fits within one of seven designated U.S. Department of Health and Human Services (DHHS) approved categories. If it is determined that a research proposal is eligible for expedited review, the protocol does not need full Board review, and will be reviewed on a rolling basis by the IRB Coordinator or person(s) designated by the IRB Chair.

It generally takes 2 weeks (10 business days) for the IRB to conduct an initial review. If your application is complete and satisfactory, a decision will be issued. If the application is incomplete, the IRB will request additional information. After receiving materials, it will again take 2 weeks to review and will offer additional feedback or issue a decision.

What if my protocol is determined as minimal risk?
If the protocol is deemed to be minimal risk, it will be reviewed on a rolling basis by an IRB Coordinator or (a) person(s) designated by the IRB Chair via an expedited review process. It generally takes 2 weeks (10 business days) for the IRB to conduct an initial review. If your application is complete and satisfactory, a decision will be issued. If the application is incomplete, the IRB will request additional information. After receiving materials, it will again take 2 weeks to review and will offer additional feedback or issue a decision.

What if my protocol is determined as non-minimal risk?
The Board Chair will refer the study to be reviewed by the full IRB board if a protocol is determined as non-minimal risk, or when necessary. The full board will review the study at the monthly meeting, propose changes, or grant a decision.

How often does IPA IRB meet?
The IPA IRB board meets once a month, usually on a Thursday towards the end of the month. Meeting dates are posted online to the IPA IRB Meeting Dates webpage. Please also note the deadlines for submission of materials are on the same page.


A project may not begin human subjects research prior to IRB approval.

If you believe your project falls under non-minimal risk, IPA IRB recommends that you submit all documents at minimum one month prior to the date of the IRB meeting you wish your project to receive review. It can take up to two weeks for the IRB coordinator to review your application for completeness, if your materials require edits. Once all the materials are ready, the IRB Coordinator will submit all documents to the IRB one week in advance of each meeting.

If you believe your project falls under minimal risk category, please allow yourself at least two weeks for initial review of materials for completion. See “What if my protocol is determined as minimal risk?” for more information.

 

Continuing Review

How long is my study approval valid?
Approval is valid for no more than one year for research involving minimal risk. For research involving non-minimal risk, IPA IRB will exercise its discretion to determine the duration of approval, which may be for less than one year.
 

Is my study subject to continuing review?
All non-exempt studies approved by IPA IRB before the implementation of the Revised Common Rule in January 2019 require continuing review. If changes are being submitted at the time of the renewal, a Renewal Application must be used and all the amendments must be clearly noted in the progress report, noticeable with track changes, as well as the supplementing materials. Please note that only studies whose original applications were approved before August 1, 2020 are able to submit amendments with renewals. All other studies are required to fill out a separate amendment form.

Studies approved after the implementation of the Revised Common Rule in January 2019 must submit only a brief progress report for their renewal.

What happens if I miss the continuing review deadline?
You must submit a renewal application as soon as possible after you realize you have missed the deadline. In the progress report, you must list the project’s progress since the last review, indicate why the deadline was missed, what activities have taken place during the lapsed time, and what steps will be taken by the PI to avoid missing deadlines in the future.

All studies who fail to submit a renewal 60 days after the project’s expiration date will be administratively closed out and will be subject to a $1,000 late fee. If you miss this deadline, but wish to re-open the study, you will additionally be subject to the standard $500 renewal fee.

 

Collaboration with other institutions

What if I am collaborating with other institutions?
If you are seeking IPA IRB review, clearly indicate in the application any close collaborators and list them in the consent form. If applicable, submit any Memorandum of Agreements that are in place.


Also, if you are seeking IRB review from a collaborating institution based in the US, you do not need to seek IPA IRB review unless that institution does not cover IPA staff and fieldwork activities. See "What is a reliance (authorization) agreement?" for more information.

 

Changes to Staff, Timelines, and Study Protocol

What happens if I go on leave or on sabbatical?
If you are a principal investigator and are away from the campus for an extended period of time, such as during a sabbatical or a formal leave of absence, then you must either suspend your human subjects studies or name a co-principal investigator or another qualified researcher to assume responsibility for direct supervision of the protocol. IPA IRB must approve the designated co-principal investigator.


If you are the primary project staff, update the project’s Salesforce record to indicate the role.

What if the study implementation is on hold?
You must inform the IRB of the changes. Additionally, you must continually submit a renewal until all data analysis is complete.

What if I need to modify my study after it has been approved?
You must inform and obtain IPA IRB approval by applying for an amendment for any change to the study’s protocols, consents, staff, or any other items that impact the human subject of the study. If the change is minor and involves no more than minimal risk to subjects, then an expedited review may be performed.

 

Consent

Am I required to obtain written informed consent from all study subjects?
Yes. IPA IRB requires researchers to obtain written consent from respondents. In special instances when this is not possible, researchers must clearly explain the special circumstances in the application and be approved for verbal consent. You can find the consent template on the IPA IRB page.
 

In preparing informed consent forms, must I use the IPA IRB template?
No. However, the informed consents must include all the required elements of the IPA IRB consent checklist, which you can find on the IPA IRB page.

What is a child assent and when do I need it?
With respect for children as developing persons, researchers must ask if they wish to participate in the research. When the human subjects are minors, you must seek assent from the child and an informed consent from the parent or guardian. Assent must be in a language understandable to the children’s age group. For questions on this, please reach out to humansubjects@poverty-action.org.

 

Unexpected and Adverse Events

What do I do if a study subject suffers an adverse event?
All serious or unexpected problems, adverse reactions or injuries must be reported by a study’s Principal Investigator to the IPA IRB within 48 hours. Reportable instances include, but are not limited to:
 

  1. Subject(s) dropping out of study beyond anticipated attrition
  2. Subject(s) requiring medical attention related to the study
  3. Adverse responses to survey or intervention
  4. Reports of subject dissatisfaction related to any aspect of the study
  5. Loss of data or hardware housing data

Serious and/or continuing noncompliance, unanticipated problems determined to be reportable under OHRP guidelines will be reported to the IRB Chair and OHRP within one month of the IRB’s receipt of the report of the problem from the investigator.

If you miss the 48-hour deadline for reporting an adverse event, it is still in the best interest of your project to report the event regardless of when it occurred. IPA is committed to the protection of our human subjects and will work with all Country Programs to ensure appropriate protections occur and that appropriate responses are taken when an adverse event happens.

 

Vulnerable Populations

What are vulnerable populations?
Vulnerable populations include prisoners, pregnant women, and children, as well as additional groups determined by the IRB in the local context or local institutions. If your study seeks out vulnerable groups, you must indicate as such in your IPA IRB application. IPA IRB may require additional actions, such as referrals and other safeguarding information, to protect the rights of human subjects.
 

Can I use students as subjects?
Yes. You must clearly note in the application that you are using students as subjects. IPA IRB has special provisions when students are the target population.

Some academic studies might also be exempt if no surveying is involved. IPA IRB will determine this after reviewing the protocol.

What if I am studying children/ minors?
IPA IRB defines minors per the local laws and regulations. If you are studying minors, you must clearly indicate so on the application form. Generally, assent from minors and consent from parents/guardians are required. You should allot reasonable review time as children are a vulnerable population and a full board review of the study may be required.

 

Gifts

Can I offer subjects a gift for participating in a survey?
Yes, you can offer a respondent a gift for responding to a survey. The gift’s financial cost should be comparable to the amount of compensation the participant lost due to partaking in the survey. Projects are also able to reimburse respondents for other costs related to partaking in the study/responding to the questionnaire (e.g. transportation cost to a central surveying location). If you plan on reimbursing respondents for any reason or offering a gift, you MUST clearly note so in the IPA IRB application. Note that gifts/reimbursements are not required by IPA IRB.

 

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