International Research

Introduction

When conducting international research, additional review and documentation are required from both the international site and the Pitt IRB. It is imperative that you start the process early and request a consultation with the IRB staff during the initial planning stages. 

HRP consultation can be requested at askirb@pitt.edu

When is IRB review required?

All human subjects research conducted by UPMC and/or University of Pittsburgh faculty, staff, or students, regardless of funding source or the location at which the research will be conducted, requires submission to the Pitt IRB.

What training is required to conduct international research?

Prior to conducting international research, all study team members must complete the CITI International Research course. This course is comprised of two modules: International Research-SBE and Consent and Cultural Competence.

How far in advance should I submit my international application to the Pitt IRB?

Minimal Risk applications should be submitted to the Pitt IRB a minimum of 2 months prior to Investigator approval deadlines. Submission 3 months prior is highly encouraged.

For Greater Than Minimal Risk applications the location and topic of the research may require the Pitt IRB to employ a foreign consultant with the appropriate expertise to assist in the ethical review. Locating and enlisting the assistance of consultants may make the review process take significantly longer.

Do not make specific travel plans or purchase plane tickets until you have received all foreign and domestic approvals. There is no guarantee of IRB approval by a given deadline.

What additional regulatory reviews are needed?

When research is conducted outside the United States, investigators must comply both with the U.S. regulations and with the local policies and regulations governing the international research sites. This is true whether the researchers are traveling to the foreign location or conducting their research remotely.  Local policies and regulations are often governed by an ethics committee, which is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. This ethics committee may also be referred to as an Institutional Review Board (IRB), an Independent Ethics Committee (IEC), an Ethical Review Board (ERB), or Research Ethics Board (REB).

It is important to do your homework early and, whenever possible, enlist a local collaborator to help you address that site’s requirements and assist in identifying who to contact and what is required to obtain ethics reviews and permissions to conduct research at that international site. All documentation, including ethics reviews, site permissions, and memos of cultural appropriateness, must be uploaded in English.

Single IRB (Reliance) cannot be used for international sites. Even if the research would usually require a single IRB, each country must have its own approval or determination that oversight is not required.

Where can I locate information on foreign research regulations for the specific country where I plan to conduct research?

Investigators can begin to educate themselves about applicable foreign research regulations, by specific country, using the resources below:

There is a high level of variability in the procedural details across international research regulations. However, the majority of foreign regulations are based upon the foundational ethical guidelines provided within the International Conference of Harmonization (ICH) and the Council for International Organizations of Medical Sciences (CIOMS).

What is required for Minimal Risk studies?

Depending on the international site, local ethics committee review may or may not be required. If it is required, it should be uploaded in the Supporting Documentation section. If it is not required, the PI must provide documentation to that effect.

One of the following should be uploaded as Supporting Documentation:

1. A Letter of approval from an Ethics Committee.

Required elements:

  • Reference the title of the study displayed in the IRB application
  • Clearly state the planned research was reviewed and approved
  • Document is dated
  • Provided on the official letterhead of the signatory

OR

2. Documentation that the local regulations do not require a local ethics review

Required elements:

  • Provided on the official letterhead of the signatory
  • Document is dated
  • Clearly state the planned research does not require local regulatory oversight
  • Confirm the Regulatory Official understands the intent of the research and activities to be performed
  • Reference the title of the study displayed in the IRB application

If local ethics review is not required then the IRB may request a memo of cultural appropriateness. The Memo of Cultural Appropriateness (PDF) should be authored by an individual completely independent of the study who is highly knowledgeable about the culture in the region where the research will be conducted. This document must be specific to the proposed research. Blanket statements about research within a particular country or culture are not sufficient. Required elements:

  • Reference the title of the study displayed in the IRB application
  • Describe the expertise of the individual preparing the letter to address the local cultural and social norms
  • Confirm they understand the intent of the research and activities to be performed
  • Confirm the planned study does not conflict with local and cultural norms
  • Document is dated

If the culture of the research location is suitably similar to the United States, this requirement may be waived if the PI provides what the IRB deems to be sufficient reasoning.

What is required for Greater than Minimal Risk studies?

Studies that are designated as greater than minimal risk require a formal ethics review within the country where the research will be conducted.  Not all countries have an ethics review committee and the oversight may be addressed by the Department of Ministries or other governmental entities. 

A Letter of Approval from an Ethics Committee, required elements:

  • Reference the title of the study displayed in the IRB application
  • Clearly state the planned research was reviewed and approved
  • Document is dated
  • Provided on the official letterhead of the signatory

When are site permissions required?

When research is conducted at any site other than UPMC or Pitt facilities, an authorized individual from the proposed research site must provide written permission that the research can be conducted. This requirement may be waived if the local ethics approval affords access to the site, if research will be conducted in a truly public location, or if the research is conducted remotely. 

If site permission is required, you must upload to following question #6 for each site after selecting “International or Culturally Different” on Research Sites page.

A  Site permission letter (PDF) from authorized individual. 

Required elements:

  • Reference the title of the study displayed in the IRB application
  • Confirm the authorized individual understands the intent of the research and activities to be performed
  • Must include a statement permitting the research to be conducted at that site
  • The document is signed and dated

Do I need a local collaborator?

Investigators are strongly encouraged to collaborate with an individual or organization with expertise in the region. Based upon study location and risk level, the IRB may require a local site collaborator.

What are the additional requirements for enrolling non-English speaking participants?

The initial Pitt IRB submission should only include the English version of documents that will be used with research subjects, (recruitment materials, consent documents, data collection materials, etc.). Once the materials are approved both by the Pitt IRB and foreign Ethics Committee, the approved documents should be translated and submitted as a Modification including the final translated documents, back translations (if required) and a signed translator certification form. The documents may not be used until this Modification is approved.

For more detailed guidance, please see Non-English Speaking Participants.

What additional information must I provide in my IRB application if I want to compensate participants in foreign countries?

If the laws and regulations of the foreign country permit research participants to receive monetary compensation for their time, the PittPRO application (Recruitment Methods #4) must describe the planned amount of compensation in both US and foreign currency.  For studies that do not require local ethics approval, the compensation must be placed in the context of average daily wage and/or purchasing power.

Note: The University has additional policies and procedures, not overseen by the IRB, dictating how participant payments in foreign countries are implemented. For more information on the topic of compensation outside of the U.S. visit the University of Pittsburgh Global Operations website.

Can I submit to the Pitt IRB before I have ethics approval from my international site?

You are permitted to submit to the Pitt IRB before foreign ethics approval is granted. In these cases, the Pitt IRB approval letter will be contingent and will state no research activities may begin until a Modification providing documentation of foreign ethics approval is submitted to and approved by the Pitt IRB.

How can I locate a Foreign Ethics Committee to provide review and approval of my study?

Research studies supported by U.S. Federal funds are required to undergo foreign IRB review by an Ethics committee that holds a Federal Wide Assurance (FWA). Investigators of U.S. Federally funded research studies can search the OHRP “Database for Registered IORGs and IRBs, Approved FWAs and for Documents Received by OHRP in the Last 60 days” to locate foreign IRBs that hold an FWA:

  • Choose the "FWAs" tab
  • Press the “Advanced Search” link
  • Select the appropriate country & Search

Non-federally funded studies can use this same search to locate and contact a foreign ethics committee/IRB.

Summary of Required Documents by Review Type

graphic of required documents

Additional University Policies Related to Conducting University Business Outside of the U.S.

When affiliates of the University of Pittsburgh are engaged in international projects there are additional University Policies and procedures that must be followed. For a summary of all University policies relating to international projects, please visit University of Pittsburgh Global Operations.

There are additional University Policies and procedures when materials and/or data enter or leave the country. There are also additional considerations when research is conducted in embargoed or sanctioned countries. For further information, please visit the Office of Trade Compliance.

What information must I provide in my IRB application regarding the local site and culture?

It is imperative that investigators be fully informed about the local site and cultural context before submitting to the Pitt IRB. Select “International or Culturally Different Sites” in item 1 of Research Sites. This will prompt a series of questions about the research site, as well as a place to upload documentation, including memos of cultural appropriateness and local ethics committee approval. If non-English documents have been approved by the local ethics committee, they may be uploaded at the time of initial submission.

 

v. 8/14/2023