Tool: International Research Involving Human Subjects

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Please submit this form if you are conducting human subjects research that involves subjects (including tissue or data) in foreign countries. This form will be assessed after you submit your study to the IRB. If you have any questions please contact the HRPP International Reviewer at irb@ufl.edu or (352) 273-9600.

NOTE: conducting international research may have additional requirements that need to be completed before you can initiate the research. This workflow at https://research.ufl.edu/wp-content/uploads/workflow-international.pdf helps show additional requirements such as:

When IRB approval is required in foreign locations and when that documentation must be provided before IRB approval is issued.
When approval by UF’s Office of Research Integrity, Security, & Compliance (RISC) is required.
When UF IT Security assessment is needed.

Study title*

What is your IRB # (available once you create your project in myIRB)*

PI's name*

First Last

PI's email*

Briefly describe your project*

Does your research include any of the following:*

Are you interacting or intervening directly with research subjects who are located outside of the US?*

Yes

This includes activities conducted online such as surveys or interviews.

Are you receiving data and/or tissue that has been or will be collected by other researchers (collaborators) outside the US?*

Yes

Describe exactly what you are receiving from researchers outside the US:*

Indicate how the data/tissue above is identifiable:*

Identifiable data

Coded data without a Confidentiality Agreement

Coded data with a Confidentiality Agreement

Anonymous data

Identifiable tissue

Coded tissue without a Confidentiality Agreement

Coded tissue with a Confidentiality Agreement

Anonymous tissue

Are foreign researchers helping conduct the research?*

Yes

Provide information about foreign researchers:

Institution Name

FWA # if federally funded

What are they doing?

Which IRB will provide approval for foreign researchers?*

UF IRB

IRB located at foreign site

Other

IMPORTANT: Drug/Device/Biologic research:

The research must undergo full Board review by the IRB. Please note IRB deadlines.
IRB-02 cannot review this type of research.
You will most likely need to obtain in-country IRB approval. Depending on the country there may be significant additional requirements you need to comply with.

List foreign entities you are hiring/subcontracting:*

Foreign entity name

What are they doing?

FWA # (if applicable)

IMPORTANT: Shipping Tissue Samples: be advised that UF has requirements regarding the shipping and transport of tissue samples. Review the information at http://www.ufic.ufl.edu/documents/International_Center_shipping_and_import.pdf to ensure you comply with UF’s requirements and to avoid: refusal of package by the carrier; delays & potential spoilage of package contents; exposure of personnel to hazards; contamination of the environment; damage to aircraft or other property; seizure of the material by authorities; or fines / potential criminal liability for you the shipper, or UF.

For more information contact Sharon Judge at 352-392-1591, sjudge@ehs.ufl.edu, http://www.ehs.ufl.edu/

IMPORTANT: Tissue collection/use REGULATIONS: many countries have additional local regulations about the collection/use of tissue in research. You are responsible for complying with any additional local requirements. You can identify potential requirements with OHRP’s International Compilation at https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html or at Research Ethics Guidelines International Online Navigation Map (REGION) https://www.hsph.harvard.edu/region-map/.

Please describe (a) how/how much you'll be compensating subjects, and (b) how you obtained local regulatory approval to compensate subjects.*

Are you collecting any of the following data elements about the subjects?*

Name

Religious affiliations

Sexual orientation

Employer-union participation

Political affiliations

None of the above

How are subjects consented to participate in the study?*

Written consent will be obtained

Oral consent will be obtained

Other

No consent obtained

Please indicate the funding for this project:*

IMPORTANT re NIH Funding: NIH funded research typically requires local IRB/ethics approval. You will need to provide local IRB/ethics approval to the UF IRB before it will approve the study.

IMPORTANT re DoD Funding: DoD policies require researchers conducting human subjects researchers in a foreign country to obtain in-country IRB approval (in addition to UF IRB approval). We recommend consulting with the UF IRB to describe your research and see what category they expect it to be approved under: nonhuman, exempt, expedited, or full Board. Unless the IRB can approve your research as nonhuman, in-country IRB approval is required.

Secondly, if required, in-country IRB must be registered with the US federal Office of Human Research Protections (OHRP). You can search for OHRP registered IRBs at: https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc. The UF IRB will not finalize their approval until documentation of approval by an OHRP registered IRB in-country is provided. If you cannot locate an OHRP registered IRB in the country you wish to do research, please email operations@research.ufl.edu

IMPORTANT re ED Funding: ED policies require researchers conducting human subjects research in a foreign country to comply with local laws. Researchers should provide a copy of local approvals to their program official and grants management specialist.

IMPORTANT re NSF Funding: NSF policies require researchers conducting human subjects research in a foreign country to obtain in country IRB approval if an appropriate IRB exists. nsf.gov/bfa/dias/policy/hsfaqs.jsp#foreign

IMPORTANT re other federal funding: Please review the policies of your funding agency to see if it requires local IRB/ethics approval. If required, you will need to provide local IRB/ethics approval to the UF IRB before it will approve the study.

IMPORTANT re USAID funding: You have indicated you have USAID funding and are hiring/subcontracting foreigners. Please note that per the USAID Scientific Research Policy, foreigners receiving USAID funds must obtain a Federal Wide Assurance (FWA) from OHRP. You can search to see if the institution you are working with has an FWA at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-status/index.html. If they do not, they can file for an FWA at : https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/file-a-new-fwa/index.html. In addition, be advised that USAID prefers local IRB approval (implication is even if local laws do not require it).

IMPORTANT re USAID funding: You have indicated you have USAID funding. Please note that per the USAID Scientific Research Policy, be advised that USAID prefers local IRB approval (implication is even if local laws do not require it).

Please provide your UFIRST proposal IDs for any funding on this project

UFIRST Proposal ID

Grant Title

Grant PI name

IMPORTANT: Regulatory Requirements of the Host Country: Many countries have additional local regulations for conducting human research. The PI and study team are responsible for complying with any additional local requirements. Requirements are subject to change, so please review and verify before conducting any research involving a foreign site:

OHRP’s International Compilation at https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html
If local IRB review is needed, OHRP’s database for Registered organizations and IRBs is at http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc

IMPORTANT: If UF determines you must obtain in-country ethics/IRB approval, this applies not only to initial review, but also obtaining approval for all revisions to your research, reporting adverse events, and obtaining continuing review (if applicable). As part of your submission to the IRB you must complete and submit the following Attestation Form that you will comply with in-country ethics/IRB requirements: International IRB Attestation Form. Once completed, you would attach this to the Miscellaneous Smart Form page within your myIRB submission. For questions please call: (352) 273-9600.

Studies without federal funding: If your research is minimal risk and does not have federal funding, you must still comply with any requirements of the countries where you are doing research. Our office will notify you if we identify applicable requirements and direct you to obtain appropriate local approvals before starting your research. However, in most situations involving minimal risk research we will not ask you to provide those approvals to us.

What foreign site(s) do you intend to involve in your research?*

Please list the European countries where you intend to conduct your research:*

IMPORTANT: Research involving Burma/Myanmar, China, Cuba, Hong Kong, Iran, Macau, North Korea, Russia, Sudan, Syria, Ukraine or Venezuela You indicated above that you wish to conduct research involving Burma/Myanmar, China, Cuba, Hong Kong, Iran, Macau, North Korea, Russia, Sudan, Syria, Ukraine or Venezuela. There can be significant issues involved with conducting research in these countries. Some of these countries are embargoed and your research may be prohibited. Additional reviews of your research may also be required by General Counsel, the Privacy Office, IT Security, Export Controls, and/or Research Compliance. Due to the issues involved with these countries it can take significant additional time (4-6 months or longer) to obtain all necessary approvals. We recommend that you are proactive in securing these reviews with applicable offices well in advance of when you intend to start your research.

IMPORTANT: FIRST, the European Union has privacy regulation (GDPR) that strictly governs the collection and use of people’s data. Be advised that you will likely need to get written informed consent in these countries. It is our understanding that the UK is adopting a similar privacy regulation as it exits the EU. Lastly, most of the EU countries require IRB/ethics review for any time there is research involving humans.

SECOND, most EU countries require IRB/ethics review for all research.

IMPORTANT: Please be advised that in-country IRB/ethics review is required for all human research: Brazil, Canada, Colombia, and Haiti.

NOTE: this list is subject to change as additional countries are identified.

You selected "Other" above. Please list the other countries where you intend to conduct your research.*

What is the status of obtaining appropriate regulatory approval(s) in the foreign site(s)?*

Foreign regulatory approvals have not been initiated

Foreign IRB or equivalent ethics approval initiated but not yet obtained

Foreign IRB or equivalent ethics approval obtained

Other

You selected "Other" above. Please describe:*

IMPORTANT: Please be sure to attach foreign approvals as part of your application to the IRB (via myIRB on the Miscellaneous smart form).

Will you or any members of your study team who are UF faculty, staff, or students travel to the foreign site(s)?*

Yes

IMPORTANT: UF International Travel (UFIC) Registration & Resources All University of Florida faculty, staff and graduate students who are traveling abroad on University business are required to register with the UF International Center. By completing this registration, faculty, staff, and grad students will be enrolled in the CISI Emergency and Health Insurance Plan. For more information about this and other resources at UFIC please visit: https://internationalcenter.ufl.edu/travel/online-travel-registration

When do you expect to travel to the foreign site(s)?*

US State Department Warnings Any researchers traveling abroad should review the US State Department warnings for international travel: https://travel.state.gov/content/passports/en/alertswarnings.html

Are there any known significant risks for UF researchers traveling to the foreign site(s)?*

No known risks

Risk of violence

Civil or political unrest

Risk of serious infection due to outbreak/epidemic

Other risks

Describe what other significant risks there are to research staff who travel to the foreign site(s):*

Risk to UF researchers traveling abroad: If there are significant risks to UF faculty, staff, or students traveling abroad we recommend consulting with leadership within your college (e.g. department chair and/or dean) and UF’s International Center (https://www.ufic.ufl.edu/Travel.html) to confirm you are approved to travel despite the risks.

How will research data be collected and transmitted to UF?*

Hard copy that is mailed

Hard copy that is transported by researcher

Electronic that is transmitted via the internet

Electronic that is transported by the researcher (e.g. flash drive, laptop)

Other

Describe how the data will be protected (e.g. type of encryption software).*

How will the data be transmitted? Is there a particular software package being used and if so where is it hosted?*

Other: how will data be transmitted/transported?*

Transmitting research data via the internet or utilizing software may require an assessment by UF IT Security. Please verify that you are complying with UF policy. You can learn more at: https://irm.ufl.edu/.

Will you take any equipment with you when you (or your team members) travel to the foreign site(s)?*

UF owned laptop/tablet

UF owned external hard drive or flash drive

UF owned other equipment

Personal laptop/tablet

Personal external hard drive or flash drive

Personal other equipment

No equipment is being taken to the foreign site(s)

Register UF owned laptops/equipment If you are traveling to a foreign country and taking UF equipment (laptop, tablet, etc) with you to store your research data, you must insure your equipment is registered with UF’s myAssets system. Additional information is available at: You can also call Asset Management at (352) 392-2556. http://www.fa.ufl.edu/directives-and-procedures/asset-management/#reporting

What is the make of your personal laptop/tablet? (e.g. Apple, Dell, etc)*

The Office of Research Division of Research Compliance needs this information to verify if there are any Export Control issues that you need to comply with.

Will you permanently export any item (item will remain in country for more than 12 months or remain permanently) OR will the item be out of your effective control (hotel safe, locked facility, etc) at any time?*

Yes

Please list the item(s) with value:*

Item Description

Value in USD$

You should review if your project or travel are subject to Export Control requirements.

Export control flyer: http://dev.edison.research.ufl.edu/compliance/pdf/Export_Control_flyer_1_2016.pdf

UF’s Export control website: http://dev.edison.research.ufl.edu/faculty-and-staff/research-compliance/export-controls.html

Who can we contact if we have questions about this study?*

First Last

Email*

Phone*

Thank you for filling out this form. You must also submit your study via myIRB for this form to be assessed. The International Ancillary will log their review directly in myIRB.

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