CHAPTER 13

13.0.1 Purpose

With increased focus of funding agencies and researchers on approaches to public health research and the influence of social and political systems on behavioral and health outcomes, there is increased potential for more faculty to become involved in community-based research. Due to this increased interest and focus, it is important for the University, researchers, and the IRB to understand the distinctions along a continuum of community-based research. As with research involving individuals, all parties to the research, especially the IRB, must consider both individual and community interests, risks, and potential benefits.

13.0.2 Principles

When conducting or participating in community research activities, the University desires to engage the community, strengthen community linkages, and respect community values. Human research has historically been guided by principles relating to risk and benefits to the individual research subject. Community-based research interacts with the community that goes beyond interactions with individual potential research subjects and, therefore, requires consideration of the risks and benefits to the stakeholder community.

Because there is a continuum of involvement between university researchers and communities, a single set of guidelines is not appropriate. However, all research involving communities should follow best practices for respectful and productive relationships. The following principles, in addition to those principles for human subject research, guide the research:

The researcher should:

• Be aware and respectful of community interests that go beyond those of individual potential research subjects.
• Identify potential community stakeholders as well as individual research subjects.
• Inform the community stakeholders and potential research subjects about the research.
• Invite feedback regarding concerns about the research from community stakeholders and individual potential research subjects.
• Respect the community partner’s interest in the project and be open to ways that the community might benefit or want to use the information.
• Disseminate research findings to both community stakeholders and individual research subjects.

Principles for close community partnership research (sometimes referred to as Community-based Participatory Research or CBPR) will want to do all the above along with:

• Having research address community-defined needs, questions or problems, and strives to combine knowledge with action to achieve necessary changes.
• Recognizing research as a partnership and being open to the guidance of community insight and experience.
• Having the partnership appropriately balancing power and decision-making between the researchers and the community participants in a way that is mutually acceptable.
• Partners making clear and open communication an ongoing priority by striving to understand each other’s needs and self-interests.
• Partners recognize race, ethnicity, class, and other aspects of culture matter and talk openly about these issues.
• Feedback among all stakeholders in the partnership, with the goals of continuously improving the partnership and its outcomes.
• Realizing partnerships can dissolve and plan a process for closure.

13.0.3 IRB Review Process

The IRB review process will include an assessment of whether the IRB application submission includes sufficient information to assess a community-based research focus using the principles above. Additionally, IRB staff try to include IRB members and/or consultants with expertise in community-based participatory research by identifying and recruiting investigators and community members whose experience reflects such knowledge.

13.1.1 General

When performing human subject research in foreign countries, expectations of the University are that the research activities are consistent with the ethical principles and guidelines contained in the Belmont Report and provide levels of subject protections equivalent to those provided when performing human subject research at the University. It is also expected that researchers will comply with local laws and consider the cultural context of the country in which the research is taking place.

When performing human subject research in other countries, University researchers are expected to comply with U.S. regulations and guidelines and any applicable regulations of the country in which the research is performed. Researchers will consult with the Export Control division of the Research Protections office to ensure that countries or foreign individuals that are involved in research are allowed to collaborate in that research. In addition, for biomedical research there are international guidelines that may be applicable and with which the University researchers should be familiar, e.g., The Declaration of Helsinki, the International Conference of Harmonization – Good Clinical Practice (E6) Guidelines and the International Compilation of Human Research Standards compiled by Office for Human Research Protections.

Special Note: If you are or will be conducting research outside of the United States, please be aware that UTEP currently has an international travel policy that involves approval for student/faculty/staff travel to areas of high risk. Please refer to the official UTEP International Travel Policy for more details, and to see whether your travel requires review.

13.1.2 PI Considerations

Federal regulations for oversight of transnational research, as well as expectations of the HRPP accrediting body, the Association for Accreditation of Human Research Protection Programs (AAHRPP) require that when conducting transnational research the researcher:

• Will provide the same or equivalent protection to human subjects in research conducted in other countries.
• The protections need not be the same as provided in the U.S. but should be equal in function or effect.
• Respect subject autonomy and dignity.
• Protections should encompass the ethical principles of respect for people, beneficence, and justice.
• Is aware of local laws, regulations, political and socio-economic factors, and cultural context in all locations where the research is conducted.
• Researchers must have sufficient knowledge of the local context to enable carrying out of the research in ways that protect the rights and welfare of subjects.
• Knowledge of the local context may influence all aspects of research design.
• Will comply with local laws and adhere to cultural norms.
• Will demonstrate whether the university or researcher has permission to conduct research in the country by local ethics committee review and approval or by certification (approval) by the local government when there is no local ethics committee.

Post-approval monitoring of transnational research will follow the same procedures used for monitoring of locally conducted research as described in Section 3.18. Monitoring will usually consist of a face-to-face meeting with the investigator to discuss the conduct of the research prior to beginning or at some time during the conduct of the study when the investigator is located at UTEP.

13.1.3 Reviewer Considerations

There are also requirements and expectations for reviewing proposed transnational research. Generally:

The IRB must ensure that equivalent protections are provided to research subjects enrolled in research in another country, and will make determinations and decisions based on laws and knowledge of the country in which the research will be conducted, such as:

• If there are laws or guidance related to human research subject protections.
• If there are other laws that will need to be factored into the research.
• If the local or government has their own required approvals.

Reviewers should review the U.S. Department of Health & Human Services International Compilation of Human Subjects Protections for more information on making these determinations.

More specifically, IRB reviewers and the IRB will require certain information to fulfill the requirements in the submitted protocol. For example, the information provided should include but not be limited to:

• Whether the researcher speaks the language of the country in which participants will be enrolled and the research will be conducted. If the researcher does not speak the local language, describe how communication with the research subjects will be accomplished.
• Whether the researcher is familiar with the local customs and culture or whether a local collaborator will be used, and the involvement of the local collaborator will have in the conduct of the research.
• Whether the subjects will be paid and, if paid, the amount and how it relates to the local economy and subject income.
• If consent is obtained, how or from whom will consent be obtained along with the following information, if applicable:
  • Describe local customs/culture in which the subject might not have the autonomy to provide consent, and a family member or other person will be providing consent to participate.
  • How the researcher will assure that there is no coercion for participation if a person other than the subject will be providing consent.
• If written documentation of consent is obtained, and:
  • If so, a description of how or from whom the consent will be translated.
  • If not, a description of how consent will be documented or if there are cultural/other prohibitions regarding use of consent forms.
• Describe how the privacy for the subjects and confidentiality of their research data will be assured and if there is a local custom that research data be revealed to someone other than the subject.
• Describe how the communications with the University IRB/local Ethics Committee (EC) will be achieved for requesting study amendments or reporting unanticipated problems.
• For student researchers, a description of how the academic advisor/faculty sponsor will oversee conduct of the research.

13.1.4 Exemptions

A great deal of research in the social and behavioral sciences poses no more than minimal risk to subjects and may qualify for exemption. Performance of research in another country does not exclude the research from consideration for exemption.

There may be other factors, specific to the locale, that could disqualify the research from exemption.

Even in exempt research, informed consent, parental permission, and child assent may be ethically appropriate and/or required under local law.

13.1.5 Risk Assessment

The IRB must ensure, perhaps through consultation with experts, as needed, that the risk assessment is accurate for the foreign site. Research methods that have minimal risk in the U.S. might have greater than minimal risk when conducted at certain foreign sites. The following must be given consideration:

• Questions that might be innocuous in the U.S. could be offensive at certain foreign sites.
• Assuring and maintaining confidentiality may be difficult in other countries.
• Breach of confidentiality in the research locale could have dangerous consequences.
• There may be dangers to the researcher depending on political or other factors.

13.1.6 Informed Consent

• The informed consent process must honor local customs.
• Some cultures may have a different authority structure for consent.
• The local consent structure may seem coercive and clash with the researcher’s, reviewer’s, or IRB/EC’s views on autonomy.
• Surrogate consent/permission should not substitute for a subject’s informed consent unless the IRB/EC has approved an alteration or waiver to the consent process.
• The consent process/form should contain all required elements of informed consent unless waived by the IRB/EC.
• Consent is best obtained using the language that is most familiar to the subjects considering:
  • Some languages/dialects are not written.
  • Subjects may be unable to read.
  • There may be words in the foreign language that do not translate to/from English.
  • If researchers are not fluent in the local language, interpreters/translators who are fluent should be used.
• Documentation of consent may be difficult because:
  • Subjects may be illiterate.
  • In some cultures, it may be inappropriate to ask for a signature.
  • There may be legal implications when signing documents.
  • Subjects may be suspicious, distrustful, or fearful they are giving up their rights when asked to sign documents.
• Alternate consent procedures may have to be considered such as:
  • Use of pictures, video, or computers.
  • Alternate forms of documentation such as thumbprints.

13.1.7 International Research Involving Children

The following should be considered when the research involves children:

• When a child is considered an adult in the locale of the research.
• The relationship between parents and their children in a specific country.
• Acceptable and effective parental permission processes.
• If child assent is acceptable/permissible by local custom.
• If there are laws pertaining to orphans.

13.1.8 Communication with IRB/EC and Faculty Sponsor

With the research occurring outside of the country, there should be consideration on how the communication between the researcher and the University will take place. The protocol should describe the following:

• How communication will occur with the University IRB and the local EC.
• How ongoing review, study amendments, or reporting of unanticipated problems or complaints will be handled and by whom.
• If it is a student researcher abroad, the student’s knowledge of the country and how the student will communicate with their faculty advisor.

List local contact in case Principal Investigator or faculty sponsor cannot be reached.

13.2.1 Definitions and Examples

Deception: involves deliberately misleading subjects about research purposes or activities by intentionally providing inaccurate or false information and/or by withholding information, with the intention of misleading subjects about the research purpose or procedures.

Active Deception: Intentionally providing inaccurate or false information to participants.

• Participants take a quiz and are falsely told a result regardless of performance.
• Participants are observed unaware that they're in a research study to see how they react to unattended valuables in a public location.

Incomplete Disclosure: Information about the real purpose of the research is deliberately withheld or concealed from participants.

Passive Deception:

• Omits important information if providing full study details would affect participant behavior and their choice to participate.
• Researchers record participants without knowledge or consent.
• Participants think that they are evaluating fictional job applicants when the survey examines their tendency to discriminate.

Behavioral intervention: involves the performance of a cognitive, intellectual, educational, or behavioral task; or the manipulation of the subject’s physical, sensory, social, or emotional environment.

13.2.2 Background and Rationale

Research involving deception and incomplete disclosure involves intentionally communicating information to research subjects in a way that produces false beliefs. Obfuscation or withholding information at the outset of a study is also considered deception. Any research in which information is withheld until subjects have participated to some degree should be considered as a deception study. This type of research methodology is sometimes used to:

• Improve study validity,
• Assure study integrity, or
• Allow data collection that would otherwise be unobtainable because of defensiveness, shame, etc.

13.2.3 Guidelines

The following are general guidelines regarding the design, review and conduct of studies involving deception and incomplete disclosure:

• Use of deception and incomplete disclosure is usually only acceptable for studies that are minimal risk.
• The use of deception/incomplete disclosure should have no adverse effects on the well-being of participants.
• The IRB must have sufficient information to determine that the value of the research outweighs the risk of waiving some aspects of the requirement for full disclosure in the informed consent process.
• There is no reasonable alternative to scientifically and effectively address the research question without the use of deception/incomplete disclosure.
• Participants are not deceived about any aspect of the study that would alter their willingness to participate.
• Participants should be informed prospectively of the use of deception/incomplete disclosure and consent to its use when appropriate.
• Debriefing should be accomplished as soon as it is appropriate, and the deception/incomplete disclosure explained to subjects.
• Inform participants of their right to withdraw their data, if they wish, and how that will be accomplished.

13.2.4 PI Requirements

Principal Investigator(s) should address the following items in the relevant documents:

• Explain the reason(s) for use of deception/incomplete disclosure in the study design. Specifically, address why complete disclosure would compromise the scientific validity of the study.
• Describe the extent of the deception/incomplete disclosure in detail and how it relates to the study aims and design.
• Justify and discuss how the proposed research, involving deception/incomplete disclosure, involves no more than minimal risk to subjects. Consider all levels of increased risk subjects could experience because of the deception/incomplete disclosure methodology.
• Justify and discuss why there are no feasible or scientifically valid alternative methods, which do not involve deception/incomplete disclosure, to conduct the research.
• Describe the methods for prompt disclosure to debrief subjects. This should be accomplished as soon as possible after subjects complete research-related activities. Also describe how you will ensure that subjects leave the study setting with a clear and accurate understanding of the deception/incomplete disclosure and the reasons for using this methodology.
• Request an alteration of informed consent.

13.2.5 Potential Risks

There are several potential risks associated with the use of deception/incomplete disclosure, and these should be considered when designing the study:

• Subjects may feel that they were coerced to act against their will. If so and if they had been completely informed, they may have chosen not to participate.
• Subjects may feel ashamed, guilty, stressed, or embarrassed because they now have knowledge about themselves that they otherwise would not have known or would not want to know.
• Subjects may feel a loss of control that will cause distrust and suspicion regarding human subject research in general.
• The research may undermine the trust in professional standards governing human subject research.

13.2.6 Debriefing Requirements

Debriefing is an essential part of the informed consent process and is mandatory when the research study involves use of deception or incomplete disclosure. The debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants, and the reason(s) why it was necessary to deceive them. It should also include other relevant background information pertaining to the study. When required elements of informed consent are waived or altered by the IRB, in accordance with criteria provided in the regulations, participants must be debriefed at the end of the study. Debriefing can occur via email, in-person, virtually over Zoom, etc.

At a minimum, the debriefing statement should include the following:

• Label the document as “Debriefing Statement”
• Study title
• PI name and contact information for follow-up questions
• Student researcher’s name and contact information, if applicable, for follow-up questions
• Thank participants for taking the time to participate in the study
• Explain what was being studied (i.e., purpose, hypothesis, aim) in lay terms
• Explain how participants were deceived
• Explain why deception was necessary to carry out the research
• Explain how the results of the deception will be evaluated
• An opportunity for participants to withdraw consent after the true purpose of the study is revealed.
• Participants should be given at least 48 hours to make this decision and provide contact information for the contact to withdraw from the study.

Generally, participants will be debriefed immediately following their participation in the study. However, a delay between finishing research tasks and debriefing might be necessary at times. For example, if early participants might reveal study details to subsequent participants, thereby impacting study validity, then a delayed debriefing might be warranted.

In such cases, the consent form must state that subjects will be debriefed later after the study is complete. In addition, the consenting section in the IRB protocol must provide scientific rationale and/or justification as to why delayed debriefing is necessary.