There are additional considerations for UC Davis researchers who conduct research outside of UC Davis or collaborate with sites external to UC Davis. The specific requirements will vary depending on the following factors:
- The location of the external site;
- The engagement of the external site in the research;
- The type of regulatory infrastructure in place – namely whether the institution has a governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC); and
- The source of funding for the research.
Work may not begin at external sites until the required approvals and assurances are complete.
In This Section
- What is the Requirement?
- Engagement Determination
- How do I Comply with the Requirement?
- International Research
Each site that is engaged in non-exempt human research must have IRB approval. In some cases, funding sources require a single IRB review the research for all engaged sites.
When UC Davis researchers visit sites to conduct research, but the external sites are not engaged in the research, the UC Davis IRB must ensure that the research is appropriate for the site and the population. The IRB may require a Letter of Support from the external site to document their agreement to the research taking place. When the external site is not engaged in research, the external site is not required to have ethics oversight/IRB review.
Sites are “engaged” in human subjects research if personnel from the site perform any of the following duties:
- intervene with subjects to collect data or biospecimens about them by performing research procedures, or by manipulating the environment for research purposes;
- conduct the informed consent process;
- collect or create identifiable, private information about subjects; or have access to identifiable private information about research subjects.
Sites are “not engaged” in human subjects if personnel from the sites will perform only one or more of the following duties:
- receive ONLY deidentified biospecimens or data
- access identifiable data for auditing or monitoring
- facilitate recruitment by informing potential subjects about research or sharing recruitment materials
- perform commercial services for investigators when (1) services performed do not merit professional recognition or publication privileges, (2) services performed are typically performed by those institutions/individuals for non-research purposes; and (3) the individuals do not administer the study intervention being tested or evaluated under the protocol
- perform protocol-dictated services/procedures which would be typically performed as part of routine clinical monitoring or follow-up. [Read GuidanceB(2) before making this determination]
- administer study interventions being evaluated under the protocol on a one-time or short-term basis [Read GuidanceB(3) before making this determination
The IRB must have enough information to determine if the external sites are engaged in research. When completing your New Project submission, ensure sufficient information is provided about each external site and the activities that will be performed there.
Initial Review Application
On the External Sites page, you will be asked “Will you conduct or oversee research at one or more external sites?”. Mark “yes” if you will conduct research at sites outside of UC Davis and its affiliates.
You will be asked for details about each site:
On the Research Location Information page, you will be asked to describe the study setting. In this section, describe the location where recruitment, consent, and research procedures will take place. If research is conducted outside the organization and its affiliates, describe the site-specific regulations or customs affecting the research as well as the local scientific and ethical review structure.
Letters of Support
When research sites are not engaged in the research, a letter of support may be all that is needed from a site. In such cases, the outside site may be a school or other entity that is allowing the UC Davis researchers access to their population for recruitment, while UC Davis investigators are responsible for all contact with participants and analysis of identifiable data. The Letter of Support should be signed by a responsible official at the site, granting access to the UC Davis researchers. The site official is responsible for confirming that the outside site is not engaged in research and that other local requirements are met.
IRB/Ethics Board Approval
When sites are” engaged” in the research, research ethics oversite is required. Each institution that is considered “engaged” in the research must have its own IRB or Independent Ethics Committee approval before research can begin there.
Hospitals, clinics and practices that are not affiliated with academic medical centers may not have an IRB and or FWA program necessary for federally funded research to take place. If you are committed to working with these organizations, you may need to guide the site’s pursuit of assurance of compliance through the FWA program.
What is the Requirement?
When conducting research internationally, local regulations and practices must be taken into consideration. The US Office for Human Research Protections provides an International Compilation of Human Research Standards, which lists over 1,000 laws, regulations, and guidelines on human subjects protections in 131 countries and from many international organizations. Most of the listings provide hyperlinks to the source document.
When conducting research within the European Economic Area (EEA) or collecting data from people located within the EEA, researchers must comply with the General Data Protection Regulation (GDPR).
How do I Comply with the Requirement?
Initial Review Application
On the International Study page, you will be asked “Will you conduct or oversee research outside of the US?”. Answer “yes” if you will personally conduct or oversee in-person research outside the US. If you are working with a collaborator who will conduct or oversee research outside the US, mark “no”.
If you mark “yes,” you will be asked how you will comply with the requirements for the conduct of research in locations outside of the US.
To answer, you can either provide a narrative of the local context and requirements or you can simply upload a copy of the local ethics approval into IRBNet if it has already been received. If you opt to provide a narrative, please provide sufficient information to address the following questions:
Questions for all studies:
- What are the local legal rights of the population?
- Will local contact information be provided to subjects so they can ask questions about their rights?
- How will complaints be reported and to whom?
- Will local contact information be provided to subjects in the event they have research related questions?
- What is the relevance of this research to the area’s needs?
- Will officials in the area be involved in the monitoring of the research? Why or why not?
- How will you disclose the scientific and/or medical facts to individuals who may be unfamiliar with, and distrustful of, these concepts?
- If there are different cultural/societal norms, roles for women in society, and/or roles for family/community, how have they been incorporated into the study and consent process?
- Will local approvals be obtained before beginning the research?
Questions to consider as applicable:
- What is the current economic prosperity of the area? (Applicable if compensation will be provided)
- What is the influence of the local officials on the population? (Applicable if the research will be reviewed by or conducted in collaboration with local officials)
- What is the literacy rate of the area? (Applicable if the study will involve written informed consent or materials that subjects will need to read)
- Will local emergency contact information be provided to subjects? (Applicable if the study is greater than minimal risk)
- Describe the provisions for data and safety monitoring? (Applicable if the study is greater than minimal risk)
Local Ethics Committee Approval
You may be required to obtain approval from a local ethics board (like an IRB) at the other location or in the country where the study is taking place. Whether approval is required will depend on the local regulations, the type of research being conducted, and the risk level of the activities being performed.
For minimal risk research, the IRB can approve the research with a PI attestation that the local ethics review, if required, will be obtained prior to beginning research. In these cases, you will be responsible for obtaining and retaining documentation demonstrating approval has been obtained if required by local regulations. Such approval will not need to be submitted to the IRB.
For greater than minimal risk research, the IRB will not issue approval until you have submitted approval from a local ethics committee.
Consent for collection or use of data subject to GDPR is separate from consent for participation in the research. UC Davis has developed a template GDPR Compliance: Notice and Informed Consent Language for EU/EEA Data Subjects to be used in conjunction with HRP-502 Template Consent forms.
If the study will involve online data collection, the following language should be included in the online consent document/information sheet:
This research study will address topics that may be illegal or socially sensitive where you live. In addition, the use of electronic means of communication (e.g. the internet) may not be secure, private, or confidential in your community. If discussing the topics addressed in this study will represent a possible hazard to you, your family, or your acquaintances freedom, reputation, or social standing please consider these additional risks of participation when deciding whether to take part in this research study.
- OHRP International Compilation of Human Research Standards
- UC Davis GDPR Compliance: Notice and Informed Consent Language for EU/EEA Data Subjects
- UC Davis HRP-332 Review of Local Research Context