Ethnographic research presents special challenges to investigators as it can be difficult to accurately describe the nature of the ethnographic research within the confines of the IRB-1 or IRB-5 protocol application forms.  Therefore, we have created a separate form for submission of qualitative or ethnographic research, the IRB-9 form.  The IRB appreciates that ethnographic research has the following special characteristics (Arwood, T., and McGough, H., 2007 PRIM&R SBER Conference):

• It is experiential
• It is interactive
• It is not easily bounded by time and place
• It is often exploratory
• It morphs easily and often (new questions emerge during research)
• The boundaries between normal activities and communication and data collection are blurred

In order for the IRB to understand these special characteristics and the nature and scope of a particular ethnographic research project, the following issues should be addressed in the IRB application form, if applicable to the research.

Participant Population

• The kinds of people who will be involved in the research should be described.  If there are different groups or categories of people, the groups and the approximate number of participants in each group anticipated to be enrolled must be described.  If an exact number of people to be enrolled are unknown, a range should be provided.  An amendment should be submitted to the IRB when/if actual numbers exceed those estimates.

Description of Procedures

• The length of time to be spent at the field site(s) should be described.  If unsure, an approximate length of time should be provided (e.g., one year, two summer months, etc.).  An amendment should be submitted to the IRB when/if actual dates exceed those estimates.
• The research techniques that will be used to conduct the research (such as participant observation, interviews, focus groups, use of public, private governmental or other records, administration of test, etc.) should be described.  The topics or research domains to be covered as well as what will be observed (such as individual behaviors, community rituals, societal norms, etc.) should be described.  This will help the IRB get a sense of what will be learned from and about the participants in the research.
• Explain how the maximum number of participants is determined or what criteria will be used to determine when data collection is completed.

The research site(s) or location(s):

• Explain where the research will be conducted and explain why this particular research setting was chosen.
• Has the researcher conducted research at this site or with the population previously?  If so, briefly describe the topics and duration of your previous research.
• Is local governmental or community permission to conduct research required at any of the sites?  If so, explain how you will obtain this permission.  If there is formal documentation of this permission, attach it to the application form or indicate when it will be received and forward to the IRB.
• Will you work with local collaborators (interviewers, interpreters, translators, guides, etc.)?  If so, please explain who these collaborators are and how they will be involved in the research.  Will they need to obtain local ethics committee approval for their role in the study?
• Many countries have the expectation that foreign scholars will collaborate with local scholars and institutions.  Explain whether this applies to your research and if local IRB or other type of ethical review board approval will be obtained.

 Risks and Inconveniences

Risk of harm in ethnographic research is usually limited to what may result from invasion of privacy, stigmatization, or breach of confidentiality.  Harm may happen to individuals and to the groups or communities to which they belong.

• Identify the risks of harm that may result from this research.
• Describe the steps you will take to minimize the risks of harm.  If harm occurs, what plans do you have to manage it?
• If there are different risks of harm for different groups of participants, please identify the risks for each group.  Sometimes this cannot be known in advance of entering the field.  If unanticipated problems occurrence research has begun, the incidents must be reported to the IRB.  When appropriate, the study can be modified to address any issues that arise.

 Benefits

• Is it possible that individuals who take part in your research can reliably expect a direct benefit from taking part?  If yes, describe.
• Describe the anticipated benefits of this research for the community you will study, for your profession, or for society in general.

Confidentiality

• Describe how you will find out how people in this setting feel about the fact that you will write articles about them.  Will you consult with the people from whom you collected data before you publish?
• Are any portions of the research material you may collect not publicly available and expected by community standards to be private?  If yes, describe the materials that are private and explain (1) how you will store the private information or materials while you are in the field so that the confidentiality of the data is protected; (2) explain how you will store the private information or materials after you leave the field so that confidentiality is protected; (3) explain whether you will retain information that could lead to identification of the research site and explain any negative consequences this could have; (4) explain if you will record any direct participant identifiers (such as names or contact information) that could be linked to the private research material.
• If you will record identifiers (# 4 above) explain why and describe how you will protect against disclosure of this information or explain why this is not necessary.  If you will retain the identifiers linked to the data, explain (1) how long the identifiers will be kept, (2) how confidentiality will be maintained during this period, (3) who will have access to data (such as sponsors, advisors, government agencies, etc.).  In each case, explain whether they will have access to study data with identifiers or only to coded data with no access to the identifying study code.  If identifiers will be maintained indefinitely, explain why.  For example, do you intend to re-contact participants or communicate with them over a long period of time, or is the data identifiable by its nature (recordings, genealogies, etc.).  Explain how you will protect the data from a breach of confidentiality or why this is not necessary.
• If you will retain data that may place participants at risk for criminal or civil liability or be damaging to their financial standing, employability or reputation, please explain.  It may be advisable to obtain a federal Certificate of Confidentiality.
• The IRB acknowledges that sometimes it is not possible or desirable to maintain anonymity.  For example, when a researcher works with a small group of people only found in a particular region with whom others have worked.  In order to advance ethnographic knowledge about the group, their identity must be made known.

Sometimes individuals or whole communities do not want to remain anonymous.  If this is the case, please describe why.  If there are differences in the community about this, describe how this will be handled.

Consent Procedures/Process

• Explain how you will introduce yourself as a researcher to potential participants.  If you already know them, please explain the circumstances.
• How will you inform people about your research and obtain their consent to participate?  If you plan to use an oral consent process and to work informed consent procedures into your introduction to a group, or the beginning of an interview, please provide a general script or a list of points you will cover.
• Describe how people in this setting let you know if they don’t want to talk with you.
• Identify who is responsible for giving consent in the research setting (for instance, if a tribal council or community leader provides consent for the entire group).  Sometimes the consent process can be multi-layered in community settings.  Be sure to describe what the full process is in the setting in which the research will take place.
• Describe how you will handle situations in which group consent is provided, but individuals to not want to participate and vice versa.

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