8b.Appendix G: International Research
When performing human subjects research in other countries, researchers
remain under University purview and thus must act according to the ethical
principles set forth in the SU IRB Policy and Procedures. All protocol
submissions involving international research must receive prior approval from
the appropriate local authority,
organization, or IRB equivalent. Where no equivalent board or group exists,
investigators must obtain approval from local experts or community leaders. The
SU IRB will not approve any protocol without previously documented "local
Federal regulations for oversight of international
research, together with the Association for Accreditation of Human Research
Protection Programs (AAHRPP) also make the following stipulations:
The level of knowledge about the local context and local
law required for approval is based on the degree of risk to potential research
participants. Higher risk studies require more thorough considerations of local
context and inclusion of strategies to mitigate harm than do minimal risk
studies. In such cases, the IRB may request consultation with experts in the
particular international setting.
All researchers should review the US Department of Health and Human Service
International Compilation of Human Subjects Protections. In addition, researchers conducting biomedical
research should be familiar with applicable international guidelines: e.g., The
Declaration of Helsinki, the International Conference of Harmonization – Good
Clinical Practice (E6) Guidelines, and the International Ethical Guidelines for
Biomedical Research Involving Human Subjects published by the Council for
International Organizations for Medical Sciences (CIOMS).
Note: If you are or will be conducting research in an
international setting, be sure to visit the Seattle University Education Abroad
website for international travel policy that involves approval for
student/faculty/staff travel to areas of high risk. Please refer to the Seattle University Education Abroad Health
and Safety site for more details, and to
see whether your travel requires review.
Due to local customs, and cultural and religious norms, alternate
methods of informed consent may be necessary. Surrogate consent/permission may not be substituted for a subject's
informed consent unless the IRB has approved an alteration or waiver to the
consent process. In these cases, protocol submissions must include a completed Appendix A: Request for Waiver or Alteration of Informed Consent Process,
detailing the cultural norms or conditions requiring alternate methods. Researchers
must pay special attention to maintaining sensitivity to local cultural norms
and applicable law, including issues such as the following: disclosure of
scientific and/or medical facts to individuals who may be unfamiliar with and
distrustful of the concepts to be studied; differences in cultural and societal
norms; differences in the role of women in society; differences in the
role of family and community in the consent process; multiple local languages;
and literacy level. Alternate consent procedures might
include, for example: use of pictures, video, or computers, or alternate forms
of documentation such as thumbprints.
Research methods that have minimal
risk in the US might have greater than minimal risk when conducted at certain international
sites. In preparing protocol submissions, researchers must consider the
Many research studies in the social
and behavioral sciences pose no more than minimal risk to subjects and may
qualify for exemption, even if conducted in an international setting. However,
even in exempt research, informed consent, parental permission, and child
assent may be ethically appropriate and/or required under local law.
The following should be considered
when the research involves children:
In some circumstances, the University may be
required to obtain prior approval from a U.S. government agency before allowing
foreign nationals to participate in research, collaborating with a foreign
company, or sharing research results with foreign nationals. For example, the
Treasury Department’s Office of Foreign Assets Control (OFAC) regulates trade
embargoes, sanctions, and travel restrictions and restricts exportation of
information and research articles to embargoed entities and persons.
HIPAA regulations do not apply to health
information obtained and held at international sites; however, researchers must
comply with all applicable local privacy laws. If identifiable health
information collected at an international site is stored within a Seattle
University HIPAA-covered component, it becomes subject to HIPAA regulation.
Depending on the nature of the data
to be collected and its sensitivity in the local culture, the research may need
to implement a range of suggested data protection measures, for example:
Paper files: Secure data in the research field by means of a lock box
or locking file cabinets whenever possible. In some remote sites, physically
securing records may be difficult and alternate approaches such as maintaining
records in English in an area where English is not understood can be effective.
Use notebooks interspersed with random travel notes to hinder unauthorized
access to respondent data.
Electronic Data: The collection of data must comply with local law relating
to data privacy and security, as well as applicable US law. As a matter of best
practices under US law, researchers and other IRB-approved study personnel
should use only password-protected computers and/or encrypted files and limit
access to necessary study personnel. If the information to be collected is
politically sensitive either in the country or in the US, researchers may wish
to consider storing data by uploading encrypted data files to Seattle
University servers and then securely deleting the files from the laptop on-site
to avoid unlawful or unauthorized confiscation of data. Researchers should use
caution in connecting through insecure connections such as Internet cafes.
Please remember that US export control laws may affect the ability to travel
outside the United States with US laptops and other electronic storage devices.
Similarly, US Customs may control re-importation of these devices.
assistants/translators: In instances
where the data to be collected has the potential to cause social
stigmatization, researchers and other study personnel should use care in
selecting an appropriate field assistant or translator to ensure that
participant confidentiality is maintained. Graduate students from a regional
University are sometimes hired in this role, provided that they are
sufficiently external to the community of interest to assure confidentiality.
In other cases, local customs require that the translator/field assistant be
drawn from the community. In this case, the researcher/study personnel should
train the field assistant in the confidentiality requirements of the study and
train the assistant about not unduly influencing a participant to respond to
questions that s/he may otherwise not wish to answer.
Location of data collection: Researchers should consider the appropriateness of
locations where any interactions with participants will occur, considering
whether or not there may be issues related to being seen speaking to the researchers
or the possibility of being overheard.
Seattle University researchers must notify the SU
IRB promptly if any change in research activities occurs after the start of the
project, or if the change leads to or results in the foreign site’s engagement
in the research (e.g., a site previously “not engaged” begins consenting
The researcher must make adequate provisions for communication
from the international site to the University. The protocol must include
descriptions of the following:
In certain cases, the SU IRB may require the
Please direct all questions to: firstname.lastname@example.org or