Submitting Protocols with Special Populations/Concerns

 Special Population: Non-English Speaking Populations

and International Research Projects

 Click on the topic below for more information about:

• Informed consent for non-English speaking populations
• Literacy and informed consent
• Review of research activities by other countries and communities
• Cultural considerations in research and informed consent

Informed Consent for Non-English Speaking Populations

• It is the responsibility of the principal investigator to insure that the information provided during the consent process is comprehensible to the potential participants.  If there are non-English speaking participants to be recruited, the consent documents - including both written consent forms and oral consent and assent (for children) scripts - should be submitted both in English, and in the language of the target population. The investigator should document the qualifications of the translator, whether themselves or another person, in that language. Are they native speakers or the language? If not, what sort of training have they had? Since the goal of these scripts is effective communication, it's important that the translator have extensive conversational experience in the target language, and not just "academic" training.
• It is helpful, particularly for protocols that may involve more than minimal risk,  to have the consent documents "back-translated" into English, so we can assess whether essential information has been accurately communicated in the target language.
• One element of informed consent which may need modification with participants in these studies is the contact information for the Investigator or the UFIRB. Participants may not have access to or experience with phones or email, for example; or it may be impracticable to have them phone an international number to contact a supervisor or the IRB office. In such cases, the PI should explain how participants will be provided with appropriate contacts for any questions about the research, or their rights as participants. In some instances it would be helpful to have a member of the local community act as a liason in this capacity.
• If the research itself involves direct interactions with participants, it is important that the individuals who will be interacting with participants in these studies be fluent in that language, whether it is merely to be ready to answer questions that might arise during the consent phase, or to conduct in-depth interviews. The investigator should explain in the protocol who will be interacting with participants, and again describe their qualifications and experience in that language and culture.

Literacy and informed consent

• Particularly in certain international settings, potential participants may be illiterate.  Obviously, neither a written informed consent document nor signed documentation of consent makes sense in such cases. Oral consent scripts, with a waiver of documentation of informed consent (i.e. signed consent) may be proposed under these circumstances.

Review of research activities by other countries and communities.

• In addition to review by the UFIRB, research projects to be conducted in other countries may require approval by various agencies from those countries. This may involve anything from informal approval from the local community, to more formal review by regional or national bodies analogous to the IRB. It is the responsibility of the investigator to determine the appropriate mechanisms for such local review and consent, and to include a description of those mechanisms, and a statement of how they will be implemented before the start of any data collection.
• The OHRP recently established a database of contacts for exploring the requirements for international research in many countries. If your research involves work in one of those countries, this is a good place to begin learning about human research protections in those communities.  Although currently the bulk of the focus of those protections concern biomedical issues such as drugs and biological specimens, there is a growing interest aspects of resaerch protections more appropriate to social and behavioral science research activities.

• It is not uncommon for expectations and concepts about research to be different among different cultures and  communities. This may be especially true among non-English speaking populations in foreign countries.
• These cultural differences can mean a reluctance to sign any form, which can be seen as a potential threat in cultures where signatures are not the norm for economic or contractual social agreements. It is appropriate in such cases for the researcher to request a waiver of the requirement for signed documentation of consent, and obtain oral consent for participation.
•  Similarly, participant attributes that may define your target population - or that are disclosed as part of your research - a disorder, disease, ethnic or religious identification, sexual orientation, and the like, may be benign in our culture, but stigmatizing and potentially very harmful in another culture. In such cases, any additional steps that will taken to protect the privacy of individuals or the confidentiality of this information, both during recruitment and in other phases of the research, should be explicitly described.
• In general, you should explain in the protocol (a) how you will be able to identify such cross-cultural issues in your work (have you become familiar with the conventions or that culture? Do you have a local collaborator who is sensitive to these kinds of issues?), (b) any potential for such problems in your project, and (c) the steps that will been taken to minimize any additional risks that these may create.
• A helpful resource for thinking about these kinds of issues is the American Anthropological Association's statement about ethnographic research and IRBs.