Research conducted by University of Houston investigators in foreign countries is under the purview and guidelines of the University of Houston Institutional Review Board (IRB),. While the IRB cannot impose its standards for written documentation on other cultures, all standards for ethical conduct and informed consent must be upheld. While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different traditions, laws, mores, and institutions may require different research practices, particularly regarding informed consent, recruitment strategies, and documentation. Therefore special attention must be given to local laws, customs, culture, and religious norms in designing protocols, drafting written consent documents or proposing alternative methods of obtaining informed consent. As a prerequisite to UH IRB approval, all research conducted in foreign countries by UH investigators must have documentation of “local approval” as described further in this policy.
Scope of Policy
This policy applies to all research projects involving the participation of human subjects in foreign countries being conducted by University of Houston faculty, staff, or students.
- Independent Ethics Committee (IEC): A specially constituted review body whose responsibility is to ensure the protection of rights, welfare and safety of research participants.
- Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
- Research Engagement: An individual is considered to be engaged in research if they receive an award through a grant, contract, or cooperative agreement for research involving human subjects; or interact for research purposes (whether funded or non-funded) with any research subjects (e.g. recruitment, performing invasive or noninvasive procedures, manipulating the environment, obtaining informed consent), including those obtaining identifiable private information or identifiable specimens for analysis.
Role of the Principal Investigator (PI)
The IRB requires that all PIs involved in the conduct of international research adhere to ethical principles as outlined by federal regulations (See 45 Code of Federal Regulations 46). When conducting international research the PI must:
- Provide equivalent protections to human subjects in foreign countries. The protections need not be the same as provided in the U.S. but should be equal in function or effect (See Belmont Report).
- Comply with any applicable regulations of the country in which the research will take place. (Refer to The International Compilation of Human Research Standards).
- Have sufficient knowledge of the local context (laws, regulations, culture and political and socio-economic factors) to enable the design and conduct of the research in ways that protect the rights and welfare of subjects. The IRB recommends that a local collaborator be included on the research team to ensure that the design and conduct of the research conforms to local regulations/customs.
- Be aware of and adhere to any additional international guidelines that may be applicable when conducting biomedical research, (e.g. Declaration of Helsinki, International Conference on Harmonization - Good Clinical Practice E6). It should be noted that the Health Insurance Portability and Accountability Act (HIPAA) regulations do not apply to countries outside the US. However, once identifiable health information is transferred to a HIPAA-covered entity all U.S. HIPAA regulations apply.
- Arrange for the training of all members of the research team, including those involved in data collection at the local site.
- Be aware of any special sponsor-specific requirements for funded projects involving international research.
- Be familiar with export control regulations. Training in export control may be required. See Export Control Regulations and Resources for information on export control and training requirements.
- Be aware of travel warnings and restrictions before arranging travel to international countries. The U.S. Department of State informs the public of conditions in other countries that may threaten the safety and security of US citizens. Refer to U.S. Passports & International Travel for travel alerts, travel warnings and country specific information.
Guidelines for Obtaining IRB Approval
PIs proposing international research are expected to submit a new protocol application to the IRB for review, and are advised to start the process as early as possible. When applying for IRB approval the PI must:Obtain Local Approval: Documentation of local approval is required for all research involving subjects outside the U.S. The research must be reviewed and approved by an IRB in that country, (See the Office for Human Protections Database for Registered IRBs to search for registered IRBs worldwide), the local equivalent of an IRB, such as an Independent Ethics Committee, or local expert(s) or community leader(s).
Processing times to obtain local approval will vary. Therefore, additional time should be allowed for the preparation of the application and obtaining all required approvals. The type of local approval required is dependent upon the level of risk imposed upon participants involved in the research.
- If the research poses no more than minimal risk a written affirmation from local experts or community leaders may be submitted. Local experts/community leaders must not be engaged in the research but must be able to attest to the host country’s standards for human subject protection and must confirm that the protocol conforms to these standards.
- If the research involves more than minimal risk to participants, all possible efforts must be made to confirm if a local IRB or ethics board is available in the country where the research will take place. The approval letter from this body is required as an attachment. In addition:
- The foreign IRB/ethics board contact information must also be included on the informed consent document(s).
- In all cases where a foreign institution is also engaged in the research (i.e. both the UH IRB and a foreign IRB/ethics board are involved), the PI should clearly designate in the application whether UH is considered the primary institution responsible for the conduct of the study or whether UH is a collaborator in a study led by a foreign entity. (Note: this designation will often be determined by research funding, however consultation with the IRB is highly recommended if such designation is unclear.)
- In the absence of a foreign IRB/ethics board approval (
only if such a committee does not exist), a written statement from an individual who has the authority to ascertain that the research is ethical/acceptable within the context of that country's culture must be obtained and reviewed by the IRB.
- Research involving more than minimal risk and for which no local ethics board is available is considered on a case-by-case basis only. The IRB reserves the right to request additional information and/or determine that research is not approvable without further formal review in the country of interest.
- It should be noted that research methods involving no more than minimal risk in the U.S. may have greater than minimal risk when conducted at certain foreign sites. Therefore, the PI must assess risk levels based on the cultural context.
- Designate a contact within the country that would be available to speak to subjects as necessary about the research; in addition to the required UH investigator contact information, this individual and his/her contact information must also be provided in the informed consent document.
- Provide a description of the international site where research activities will take place. This description should include relevant information regarding applicable laws, culture, language, and socio-economic status of the target population.
- Provide a description of the role of local collaborators who may be included on the research team.
- Provide a description of how data collected will be stored in the international location and how it will be transported to UH.
- Indicate if the PI speaks the language of the region/society where the research will be conducted. If the PI does not speak the local language, a description of how communication with the research subjects will be accomplished must be included in the application.
- Submit all documents that will be provided1 to participants during recruitment and the duration of the study in English and the language of the host country/society as applicable. Translated documents may be submitted after English versions have been approved by the IRB to avoid multiple edits. All translated documents must be submitted for IRB review prior to final approval and research initiation, and require a Translation Assurance Form (DOC). If a professional service is utilized for translation (recommended), the certification document must also be uploaded with the documents.
- Indicate if participants will be paid and, if paid, the remuneration should be described in terms of both US and local currency. A description of the payment in relative terms (i.e. payment equates to a day’s work, hourly salary and other local reference) should be included.
- Describe how communications with the local approving body will be achieved for requesting amendments or reporting unanticipated problems. A copy of these communications should be provided to the IRB for review and approval prior to initiation of the revised procedures.
- Provide a description of how the faculty sponsor will oversee the conduct of international research conducted by students.
- Indicate how informed consent will be obtained along with the following considerations, as applicable:
- Describe local laws, customs and/ or culture which could suggest that the subject might not have the autonomy to provide consent, and for which an alternate consent process may be required (for example, authorization by a legally authorized representative, surrogate, tribal head, etc.)
- How will the PI ensure that there is no coercion or undue influence to participate if a person other than the subject is involved in the consent process?
- Will written documentation of consent be obtained? If not, provide a description of how consent will be documented or if there are cultural/other prohibitions to documenting consent.
- Describe how the privacy of the subjects and confidentiality of their research data will be assured. Take into consideration whether there are local customs suggesting that research data may be revealed to someone other than the subject.
Further Considerations Regarding Informed Consent
The PI or other members of the research team must obtain the voluntary informed consent of all study participants. The informed consent process must be sensitive to local laws and cultural norms. If a participant is not capable of providing consent, permission for participation may be granted by a legally authorized representative or surrogate as applicable to local laws. The consent discussion must be in the language understood by potential participants.
When international research projects involve the use of children as research subjects, the PI must provide the IRB with sufficient information to verify the age at which participants in such jurisdictions have the ability to consent to participate in research (including any medical treatments or procedures if applicable). If participants are below this age, parental permission is required per 45 CFR 46.408. If parental permission is culturally inappropriate, the PI must submit evidence to prove that this is the case. Proof may include specific regulations, a letter from a member of UH faculty or other subject matter expert who can attest to the cultural inappropriateness of the requirement for active parental permission. An alteration of the parental permission process may be granted at the discretion of the IRB as long as the research does not place the participants at untoward risk. If active parental permission is not required, an informational letter informing the parents of the research written at a literacy level that would be understood by the parents, may be required and should be prepared and sent to the parents by the most expeditious method possible.
The IRB is aware that methods of obtaining informed consent may need to be revised or waived depending on cultural differences. For example, in some societies signatures represent the surrender of the spirit or soul to the researcher and other societies do not use written language. In such cases, which are somewhat rare, alternate methods of obtaining informed consent may be proposed for review and approval. Investigators may meet with IRB staff to discuss conditions that may require a waiver of written consent or alternative forms of consent. The IRB will review alternate methods of obtaining consent taking into consideration factors that include:
- Disclosure of scientific and medical facts to individuals who may be unfamiliar with and distrustful of the concepts.
- 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.
- Literacy level.
The performance of research in another country does not exclude the research from consideration for exemption. A great deal of research in the social and behavioral sciences poses no more than minimal risk to participants and may qualify for exemption. (See Exempt Categories for information regarding exempt research). However, there may be other factors, specific to the locale that would disqualify the research from exemption. PIs should be aware that even in exempt research, informed consent, parental permission, and child assent may be ethically appropriate and/or required under local law.
PI Responsibilities After IRB Approval
Upon obtaining IRB approval and after commencing research activities, the PI must:
- Report all serious and unexpected adverse events and unanticipated problems involving risk to subjects others (e.g. a breach of participant confidentiality resulting in local ramifications) to the IRB. If a local ethics board is used, provide IRB with all board approval letters for study initiation, revisions, and continuing review of the study.
Considerations for IRB Review
The charge of the IRB in reviewing and monitoring international research projects conducted by UH investigators is to ensure the ethical and equitable treatment of human subjects. The IRBwill make determinations and decisions based on local laws and knowledge of the country/ society in which the research will be conducted.
The IRB will ensure that the risk assessment is accurate for the foreign site. For research involving no more than minimal risk, the IRB will review information about the context of the research through evidence provided by the PI and /or a consultant in the foreign country. For research that poses more than minimal risk, the IRB may include a consultant (e.g. local official, foreign graduate students, faculty, and staff who are natives of or have lived in the country) who is knowledgeable about the local country’s customs, laws, and cultural norms in the review of the protocol. In reviewing international research proposals the IRB will:
- Confirm local approval
- Assure that the appropriate translations of the informed consent documents where applicable, are provided.
- Ensure that the research team is familiar with the local customs and culture and understand the level of involvement that local collaborators will have in the conduct of the research.
- In addition to standard review, consider additional factors unique to research in other countries to enhance human research protections, such as:
- The economic prosperity of the area.
- The influence of local officials on the population.
- The safety of the research team and whether the country or area allows foreign visitors.
- The nature of the procedures conducted.
- The literacy rate of the area.
- The local legal rights of the population.
- How complaints will be reported and to whom.
- The relevance of the research to the area’s needs.
- The possibility of including officials from the area in the monitoring of the research.
- Assure that adequate provisions are outlined for data and safety monitoring keeping in mind that some foreign IECs and local/community experts may not conduct continuing reviews of approved research.
- Reserve the right to approve international research projects for short durations if there are any concerns about the design and/or conduct of the research.
For information on International Ethical Guidelines for Biomedical Research, see the Council for International Organizations of Medical Sciences.
For further information regarding the protection of human subjects, see the Office for Human Research Protections.
For information on Institutional Review Boards and Independent Ethics Committees in select countries, see the Global Research Ethics Map - Harvard School of Public Health.
1 At a minimum, recruitment materials, consent/assent/permission forms, and study instruments.