Since of the establishment of IPA’s internal 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 us and outside the host country (e.g. Canada or the U.K.) Is already providing reviewing?
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 US 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 US federal regulations (45 CFR pt. 46). When no other US 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 “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 US, see the question “Do I need IPA IRB review if an international institution, outside the US 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).

Please note that IPA does not require our research projects to seek IPA review and approval if a project already has approval from another institution (e.g. our collaborating researcher’s academic institution IRBs). 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 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, 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?
No. Currently, IPA IRB is only able to review studies funded or implemented by IPA.

Does IPA IRB review cost money?

Yes. Any study seeking IPA IRB review will be charged $2,000 for the entire duration of the study which include first review, all subsequent renewals, and amendments. This charge should have been budgeted within each research project already.

Can IPA IRB exempt some research from review?
Yes. US 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 us and outside the host country (e.g. Canada or the U.K.) Is already providing reviewing?
You MAY NOT need IPA IRB review if an international institution outside the US 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 US 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.

We advise that you discuss IRB during the project development process together with your donors, PIs, and implementing partners so that you have adequately budgeted for the appropriate IRB costs.

 

Local IRB Review

When do i need to seek irb review from within the country of the study?
IPA IRB Guidelines requires that if the location of the country where you are conducting research is outside of the US, you need to apply for local IRB review if a local research review body exists. 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. US 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. 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 National Institute of Health (NIH) Human Subjects Training course can be taken here. Collaborative Institutional Training Initiative (CITI) at University of Miami course can be taken here.

What types of human subjects training does IPA IRB recognize?
IPA IRB recognizes both NIH Human Subjects and Collaborative Institutional Training Initiative (CITI) at University of Miami. Additional Human Subjects Trainings may be valid on 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.

 

IPA IRB Application Process

Is there a deadline for submitting applications to IPA IRB?
IPA IRB reviews applications on 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 website. 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 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), questtionaire, 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 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. A study should close its IRB review only after data analysis is complete.

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 seperate document. Please adhere closely to the consent template verbiage and consent checklist provided in the attached Appendix when drafting your consent. Note special considerations when surveying children.
    • If paper based surveys are being used, identifying information-page 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 ten 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.

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.

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.

 

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 US 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 rolling basis by IRB Coordinator or person(s) designated by the IRB Chair.

It generally takes 2 weeks 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 protocols is deemed of minimal risk, it will be reviewed on rolling basis by IRB Coordinator or person(s) designated by the IRB Chair via expedited review process. It generally takes 2 weeks 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 IRB Coordinator or the chair will refer a study to the full IRB Board if a protocol is determined as non-minimal risk, or when necessary. The Board will review the study at the monthly meeting, propose changes, or grant a decision.

How often does IPA IRB meet?
IPA IRB meets once per month. The 2018 IPA IRB meetings occur on the third Thursday of every month. These dates are posted on the IRB 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 studies approved by IPA IRB requirecontinuing review. A Renewal Application must be completed 60 days prior to expiration. 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. You are not required to fill out a separate amendment form if the amendments are only taking place after the renewal is approved.

If you are making changes to the study before the renewal date, please file a separate amendment.

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 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.

 

Collaboration with other institutions

What if i am collaborating with other institutions?
If you are seeking IPA IRB review,in the application clearly indicate any close collaborators, list them in the consent form, and 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. Click here 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 as co-principal investigator 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 seek review 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 researcher to obtain written consent. In special instances when this is not possible, researcher must be clearly explain the special circumstances in the application and be approved for verbal consent. You can find the consent template here on Box.

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 consents checklists.

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 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 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 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 additional groups determined by the IRB in the local context or local institutions. If your study seeks out vulnerable groups, you must note so in your IPA IRB application. IPA IRB may require additional actions to protect rights of human subjects.

Can I use students as subjects?
Yes. You must clearly note on 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 part-taking 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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