Alternative Consent and Risk Reduction Procedures

For Ethnographic Work in IRB-SBS Protocols

Institutional Review Board for the Social and Behavioral Sciences

University of Virginia

The IRB recognizes that ethnography and participant observation are different from experiments conducted in a laboratory or classroom, and that the standard written consent form may be inappropriate or in some cases hazardous. The IRB also recognizes that such qualitative methods often involve casual conversations with dozens or hundreds of participants. In most such cases, when the researcher is interacting in a way that is not unusual for that culture, no formal consent is needed. The issue of informed consent arises primarily in the case of principal informants, that is, individuals who will be interviewed at length and whose identity is known to the researcher. It is in these cases that risks are most likely to arise, both for the participant and for the researcher. For more information about consent, please see

In evaluating your plan for obtaining informed consent (Question #8 on the protocol) the IRB will make its approval rest on your protection of subjects’ rights relative to three main issues:

1) Risk. Please be explicit and complete in enumerating the potential risks that your project may entail. The IRB does not expect research to be risk free, but it has an obligation to evaluate the risks and benefits of each proposal, and it is often difficult for the IRB to assess risks in other cultures.

2) Degree to which participants are fully informed. The standard written informed consent agreement covers the most important points about which participants must be informed. If you are going to use a oral consent procedure, or if you choose to make up a written form that is more appropriate for your research population, you should still be sure to inform participants of these major points: what they will be asked to do, what risks they might be exposed to, how you will handle the interview in terms of confidentiality, and most importantly, that participation is fully voluntary and that they can end the interview and withdraw from the study at any time without penalty.

3) Documentation of consent. The standard written informed consent agreement provides you with documented proof that participants gave informed consent, and it partially protects you and the University of Virginia from later charges of misconduct. The IRB recommends that written documentation of informed consent be obtained whenever it is appropriate and possible to do so. However, if in your judgment obtaining written consent is inappropriate or risky in itself, please explain why, and explain what you will do to document consent. One alternative is to tape record the interview, or at least the informed consent procedures. A second procedure is to have a witness (e.g., a research assistant) record in written notes that the participant was fully informed, and gave consent. Under some circumstances the IRB will accept the most minimal documentation: a note in your own records stating that you followed your informed consent procedure and obtained fully informed consent. If you choose to use this minimal documentation procedure, you should explain why no other form of documentation is appropriate. The greater the risk to the participant, the greater the burden on the researcher to justify an unconventional means of documenting consent.

Please cut and paste the following questions into question #8 of your protocol, and then answer them in such a way that you address the three issues listed above. The more fully you address these three issues, the more likely the IRB is to approve your proposal. For question #14(about risk) you may then write “See #8". A sample script for obtaining oral consent in an interview is given at the end of this document.

8a. Describe in detail how you will obtain consent from participants. If you choose to work informed consent procedures into the beginning of the interview, please provide an approximate script.

8b. Is the population you will be working with generally literate? ___No ___Yes

8c. Does the population speak English? ___No ___Yes (If no, answer the questions below.)

Describe your language proficiency in the participants’ native tongue (conversational, fluent, don’t speak the language):

Will you use a translator? ___No ___Yes

If yes, please consider issues of confidentiality with the translator. Describe the translator’s relationship with the participants and describe the instructions you will give to the translator regarding confidentiality.

8d. If it became widely known that you (or someone associated with you) were interviewing or otherwise associating with an informant, would that expose the informant to any risk from any authority (e.g. government agencies, police, employers, parents, etc.)? ___No ___Yes (Please describe.)

8e. If the content of the interview was read or heard by others, would this be likely to place the informant at risk of status loss or some other social or legal difficulty?

___No ___Yes (Describe.)

8f. Are there any other possible risks (physical, psychological, professional, or personal) to informants? ___No ___Yes (Describe.)

8g. What will you do to protect informants from the risks discussed above?

Sample answer to question #8a:

The population I will be working with has low rates of literacy and is not accustomed to signing forms, except at government offices. A written consent form may therefore be intimidating. I will therefore inform participants about the study and their rights orally, and I will document their consent as part of the tape-recorded interview. Because my interviews will involve potentially sensitive matters of [religion/politics/sexuality, etc.] I will take extra measures to safeguard the confidentiality of the interviews. I will not record the participant’s name on the cassette, or in the interview, and will link interviews to participants using a code number that is recorded in my field notes. I will also specifically tell participants that they can ask me to turn off the tape recorder at any point during the interview. I will begin each interview with the following spoken introduction:

As you know, I am an ______(i.e. anthropologist) from the University of Virginia, in the United States. I am conducting a study on ______, and I would like to ask you some questions about that. I would like to tape record our conversation, so that I can get your words accurately. If at any time during our talk you feel uncomfortable answering a question please let me know, and you don’t have to answer it. Or, if you want to answer a question but do not want it tape recorded, please let me know and I will turn off the machine. If at any time you want to withdraw from this study please tell me, and I will erase the tape of our conversation. I will not reveal the content of our conversation beyond myself and people helping me whom I trust to maintain your confidentiality. I will do everything I can to protect your privacy, but there is always a slight chance that someone could find out about our conversation. Now I would like to ask you if you agree to participate in this study, and to talk to me about ______. Do you agree to participate, and to allow me to tape record our conversation?

Institutional Review Board for the Social and Behavioral Sciences • University of Virginia

One Morton Dr Suite 500 • P.O. Box 800392 • Charlottesville, VA 22908-0392

Email: • Tel: 434-924-5999 • Fax: 434-924-1992

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Revision date: 09/01/07