SOP #39 International Research/Community Based Research

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 39
Updated: 5/23/24
Created: 10/8/2021

 

Policy

All human subjects research in which U.S. investigators are involved, and which would be subject to the U.S. federal regulations if it were conducted wholly within the United States, must comply with the federal regulations for the protection of human subjects in all material respects. Recognizing that laws, regulations, guidance, and customs may differ in other countries, research may be approved if the procedures prescribed by the [foreign] institution afford protections that are at least equivalent to those provided in the US regulations (45CFR46.101(h)). Where the two sets of standards present a conflict, the research must meet the higher standard.  When the IRB determines that the research is exempt from the requirements of 45 CFR 46, the investigators are responsible for ensuring that research complies with local regulations and requirements.

 

Purpose

The purpose of this SOP is to describe the process for reviewing research that will be conducted by CSS researchers outside of the United States.  This SOP also applies to community based research where the participants are of an immigrant culture within the United States.

 

Definitions

Ethics Committee A group of individuals who have knowledge about the local laws and/or

traditions/customs who are also responsible for ensuring the safety and ethical treatment of subjects in proposed research projects.

Engagement in Research An individual is considered engaged in human research when he/she for the purposes of the non-exempt research project, obtains:

  1. data about the subjects of the research through intervention or interaction with them;
  2. identifiable private information about the subjects of the research; or 
  3. the informed consent of human subjects for the research; 
  4. an award through a grant, contract, or cooperative agreement for research involving human subjects; or
  5. interacts 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.

An institution is considered engaged when its employees or agents conduct the above activities or when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.

International Human Research  Research conducted outside the United States using participants from the local community. Such research involving CSS  investigators remains subject to the review and approval authority of the CSS IRB and the obligations undertaken by the CSS IRB in its Federal Wide Assurance on file with the OHRP.

 

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.

International Location  Any location outside of the United States.

Community Based  Any location within the United States.

 

IRB of Record – Dual IRB’s

Single IRB (Reliance) cannot be used for international sites. Even if the research would usually require a single IRB, each country must have its own approval or determination that oversight is not required.  

The requirement for the use of a single IRB in cooperative research only applies to U.S. institutions and the portion of the collaborative research conducted within the United States.

(Content created by Office for Human Research Protections (OHRP)

Content last reviewed November 14, 2022)

 

IRB International Review Considerations

In addition to standard IRB review (See, CSS IRB SOP #27 Initial Review), the IRB should consider the following in the review of international research: 

  • The researcher and research staff are qualified to conduct research in that country including knowledge of relevant laws, regulations, guidance, and customs. Investigators are strongly encouraged to collaborate with an individual or organization with expertise in the region. Based upon study location and risk level, the IRB may require a local site collaborator.
  • The IRB should be flexible when different, but equivalent protections are appropriate based on the country. Where the two sets of standards present a conflict, the research must meet the higher standard.
  • The consent process and consent documents are appropriate for the languages of the subjects and communication with the subject population. Arrangements are considered to communicate with the subjects throughout the study (e.g. to answer questions). 
  • The IRB considers how modifications to the research will be handled when the investigator is in the field with no means of external communication. The IRB and investigators should consider as many contingencies (e.g., survey questions) as possible when research is initially reviewed and approved. 
  • The IRB considers how complaints, non-compliance, protocol deviations and unanticipated problems involving risks to participants or others are handled. 
  • The IRB considers how post-approval monitoring will be conducted. 
  • The IRB considers if the investigator has obtained the appropriate host country permissions to conduct research (e.g., institutional, governmental, or ministerial, IRB or EC, local or tribal). When appropriate the IRB communicates and coordinates with the local institutions or ethics committees. 
  • The IRB considers mechanisms for communicating with the investigators and research staff when they are conducting the research in other countries.

 

When are Site Permissions Required?

When research is conducted at any site other than CSS sites or facilities, an authorized individual from the proposed research site must provide written permission that the research can be conducted. This requirement may be waived if the local ethics approval affords access to the site, if research will be conducted in a truly public location, or if the research is conducted remotely. 

Required elements:

  • Reference the title of the study displayed in the IRB application
  • Confirm the authorized individual understands the intent of the research and activities to be performed
  • Must include a statement permitting the research to be conducted at that site ● The document is signed and dated.

 

What Training is Required to Conduct International Research?

Prior to conducting international research, the CSS IRB recommends that all study team members complete the CITI International Research course. This course is comprised of two modules: International Research-SBE and Consent and Cultural Competence.  

The Protocol PI should submit with the protocol application verification that all key personnel (including all those recruited from the research site) who are participating in the international research study have received human research training before the study is initiated…If the locally recruited personnel elect to use a local training program, documentation from the provider of that training program must be provided to the IRB as part of their review. This training is in addition to any specific protocol instructions that the IRB may require the Protocol PI to provide to any key personnel recruited from the research site. 

In addition, 45 CFR 46.101(h) states that, “When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy….In these circumstances, if a [federal] department or agency head determines that the procedures prescribed by the [foreign] institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy.

 

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.  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 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 

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 CSS IRB and a foreign IRB/ethics board are involved), the PI should clearly designate in the application whether CSS is considered the primary institution responsible for the conduct of the study or whether CSS 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 CSS 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 CSS.

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 provided 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 (at a minimum, recruitment materials, consent/assent/permission forms, and study instruments). All translated documents must be submitted for IRB review prior to final approval and research initiation.

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.

Community Based Research

There are many immigrant populations in the US with varying degrees of assimilation, and many of the issues listed above may apply to reviewing research on these populations in the US. For example, knowing their culture and customs and their hierarchy of authority in family and communities. Also, language issues must be addressed, not only a translated consent form, but the ability of the subjects to ask questions and get answers in their language at the time of consent and throughout the study. Again, the researchers must have significant knowledge about the populations they are studying, and the IRB should know something about the population to be able to make appropriate decisions during the review. 

 

Questions to be considered as Community Based Research studies are developed, and issues that the IRB will consider when reviewing CBR, are as follows:

  • How was the community involved or consulted in defining the need for the proposed research (i.e., getting the community’s agreement to conduct the research)?
  • How was the community involved or consulted in generating the study research plan?
  • How will the research procedures, including recruitment strategies and consent processes be assessed to ensure sensitivity and appropriateness to various communities (e.g., literacy issues, language barriers, cultural sensitivities, etc.)?
  • How will the community be involved in the conduct of the proposed research?
  • How will community members who participate in the implementation of the research be trained and supervised?
  • How have “power” relationships between investigators and community members on the research team, and in subject recruitment strategies been considered to minimize coercion and ]undue influence?
  • What are the risks and benefits of the research for the community as a whole?
  • How will boundaries between multiple roles (e.g., investigator, counselor, peer) be maintained, i.e., what happens when the investigator/research staff is the friend, peer, service provider, doctor, nurse, social worker, educator, funder, etc.)
  • How will the research outcomes be disseminated to the community?
  • Is there a partnership agreement or memorandum of understanding to be signed by the investigator and community partners that describes how they will work together?

 

References

45 CFR 46.101(h)

IRB EasyEd. Reviewing International Research.  Volume 2 Number 12 © 2016 Apex Ethical               

OHRP Guidance – International, https://www.hhs.gov/ohrp/international/index.html

OHRP - International Compilation of Human Research Standards  International Compilation of Human Research Standards | HHS.gov

The University of St. Thomas   - International Research with Human Subjects https://www.stthomas.edu/media/irb/doc/SOP_InternationalResearch_01.17.19.pdf

Children’s Hospital of Philadelphia – Review of International Research  https://irb.research.chop.edu/policies

Maine Medical Center – Maine Health Human Resource Protection Program https://mmcri.org/wpcontent/uploads/2019/01/MaineHealth-2018-Common-Rule-HRPP-SOPs.pdf

The University of Houston - International Research Policy    https://uh.edu/research/researchsecurity/international-research/index.php

The University of Pittsburgh - International Research   https://www.hrpo.pitt.edu/international-research

Cornell University - International Human Research - https://researchservices.cornell.edu/policies/irbpolicy-14-international-human-research

Hennepin Health International Research Checklist -  https://www.hhrinstitute.org/wpcontent/uploads/757-WORKSHEET-International-research.docxhttps://www.hhrinstitute.org/wpcontent/uploads/757-WORKSHEET-International-research.docx

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