The International Research Data Source is an opportunity to provide additional details about studies where data collection occurs beyond US borders.
Traditionally, international research involves the researcher flying to a distant location to gather data from participants in that country. While those studies are still an important part of international research, it is possible to conduct international research and stay in Charlottesville as well. If your study includes any of the following, you will need to create at least one International Research Data Source:
- International Primary data source: data are collected by the principal investigator and/or the research team, and data are collected outside of the United States.
- International Secondary data source: data are collected by an individual or institution other than the principal investigator and/or research team, and data are collected outside of the United States.
Like the Participant Group or Data Source section, you have the option to add multiple International Research Data Sources. Most studies will likely only need one International Research Data Source but if you have multiple locations, particularly if the locations involve multiple IRB reviews and/or local researcher/mentors, creating more than one International Research Data Source is advisable.
The location can be specific or broad, as needed (i.e. Munich, Germany vs Europe) as long as it makes sense with the study. If the study takes place in multiple locations, consider making multiple International Research Data Sources.
Is there a local researcher or local mentor associated with this site?
If you are student researcher (undergraduate/graduate) the board expects you to have a qualified local researcher or mentor who can guide you through the nuances of collecting data in your international location. This individual should be qualified to advise you about local customs, laws, and expectations regarding research, recruitment and consent processes, ethical reviews, and data collection/storage. If you are accessing data from an international source and not traveling abroad, there may be some instances in which a faculty sponsor with adequate experience can act as the “local mentor,” but you should contact our office first before making this determination. The local mentor should be listed on the protocol in the Personnel Section (either as a UVA or Non-UVA Sub Researcher) and needs to have CITI training or an equivalent human subjects research training certification. Faculty are not required to have a local mentor.
Does this site require a local IRB or ethical committee review?
The Office for Human Research Protections has information on over 100 countries regarding their expectations for ethical committee review as well as information about human subject research laws. See their International site for more resources on researching your international location. If you determine that you will need a local IRB/ethical committee review, you will need to provide our office with contact information for the other IRB as well as documentation of their approval. You can upload the documentation in the Permissions section. If you receive approval after the IRB-SBS review is complete, email your pre-reviewer and ask them to add the documentation to your protocol.
GDPR - General Data Protection Regulation
GDPR applies to select data when collected from individuals located in the European Economic Area (EEA) and/or the United Kingdom (UK). GDPR regulates the collection, use, disclosure or other processing of personal data. If you are collecting personal data in the EEA or UK, or if your participants reside in those areas, you are subject to the GDPR. If your participants are EEA or UK subjects but are outside of the EEA or UK when the data collection occurs, the data collected is not subject to the GDPR.
While many of the US federal regulations mirror the requirements in the GDPR, the GDPR requires researchers to provide additional consent form content and conduct specific processes related to data collection. For more in depth information, see Research in an International Setting: GDPR. As a basic explanation, you will want to use the GDPR Informed Consent Addendum to ensure that you have provided participants with the appropriate information required by the GDPR.
As part of the GDPR question in iProtocol, you will encounter the following list:
- Information about a Subject's Health
- Racial or Ethnic Origin
- Political Opinions
- Religious or Philosophical Beliefs
- Trade Union Membership
- Sexual Orientation
- Data concerning a person's sex life
- Biometric Data
- Genetic Data
- Criminal Activity
You will mark any that apply. In the GDPR Informed Consent Addendum, you will find this same list. You will need to include the items that you marked in the protocol in the consent form as well (and delete the items that don’t apply) and in some cases, provide more specific details about the data you will collect.
Will you require a translator in order to interact with participants?
If you are conducting a study where the participants speak a language other than English and you are not fluent in the language, you will need a translator. When determining fluency, you should verify that your language skills are adequate for the technical information you will provide participants. For example, you may feel confident discussing weather or even politics, but do you feel confident that you can discuss the concepts in the consent form at a level that makes sense to the participants in their native language? In addition, are you confident that you can write appropriate recruitment and consent form materials? If not, you should have a translator.
You are not required to list the translator in the Personnel Section nor do they need CITI training. However, we will want to know what you will look for in a translator and what you will do to train them to protect participant confidentiality and privacy.
Are recruitment/consent materials required for this site? / Will recruitment/consent materials be provided in a language other than English?
Briefly describe the process for translating the recruitment and consent materials. This may be somewhat redundant if you have already discussed a translator but it is important for the board to understand this process as not all studies engage a translator.
- Select the “create new International Research Data Source” link.
- Provide the source’s name in the text box. Select “Continue” to save data and return to the main protocol view.
- You will see a “Protocol was successfully updated” message. Click on the “return to protocol” link to continue adding content to the protocol.
- If you need to create additional International Research Data Source, go back to the “create new International Research Data Source” link. If there is one or more International Research Data Source, you can “copy” that data source and use the content you already created as a template for a new data source. You can edit the text as needed once the new data source is created.
- Once an International Research Data Source is created, find the new data source in the “International Research Data Source” list and select “go to” or simply scroll down the page to find it.
- Select “Edit all” or select individual questions to edit the content. When you are done with edits, select “Continue” to save data and return to the main protocol view.
- International Research Data Sources can be deleted by clicking the “delete” box on the right side of the International Research Data Source and confirming the deletion on the next page.
- Documentation of outside ethics review is attached or no outside ethics review is required.
- Consent form includes text and/or addendum that is appropriate for accessing data subject to the GDPR (if the GDPR applies to the study).
- Protection for international research participants is appropriate, consistent, and equivalent with US participants.
- Translation of study information/experience is appropriate for the participants in the study.