An Institutional Review Board (IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects. IRBs exist to protect the rights, safety, and welfare of human subjects involved in research projects, consistent with ethical principles and federal, state and local regulations. For human subject research conducted internationally, additional local regulations and international standards apply.
Human subjects research at IPA is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56.
In 2007, IPA established an IRB that would provide ethical oversight to international studies that were primarily randomized trials with vulnerable populations in low- and middle-income countries where IPA operates. The IRB is hosted by IPA and its administrative functions are handled by IPA staff, but it is independent of IPA staff, management, and researchers. The membership of the IPA IRB is diverse in affiliations and is composed of members who are external to IPA. The IRB convenes on a monthly basis. For additional information on meeting dates, please see IPA IRB Meeting Dates.
IRB approval is a fundamental part of IPA’s research quality protocols. To submit a study protocol for review, download the relevant IRB Form and submit via the appropriate link in the right sidebar. IPA requires that all IPA-implemented projects must be reviewed by a U.S. or a similar IRB institution, as well as a nationally recognized (or equal) IRB in the country where research is taking place (if such an IRB exists) before the start of any human subject research activities. This process is the responsibility of the Principal Investigator. The IPA IRB is available to review studies conducted, managed, or funded by IPA in any of the following situations:
- where another institution is not providing a review.
- where another institution chooses to defer to the IPA IRB as a primary approver. The institution will send IPA IRB an IRB Authorization Agreement on their institutional letterhead.
- where the PI’s university, donor, or partner organization requires it. In this instance, IPA IRB will review the study as a secondary approver pending the primary institution’s approval.
Studies that receive federal funding must be reviewed by an IRB registered with the U.S. Department of Health and Human Services’ Office of Human Research Protections (OHRP). Institutions engaged in research that is federally funded must file and maintain a Federalwide Assurance (FWA) with OHRP, identifying in the FWA the IRBs on which it is reliant. In addition, the Institution must have in place a current IRB Authorization Agreement with the named IRB.
If any member of the public wishes to raise a concern about the safety of human subjects participating in IPA IRB-approved activities or to request submission and approval documentation related to an IPA IRB-approved study, they may contact firstname.lastname@example.org.