Social and Behavioral Sciences Institutional Review Board

Fieldwork and Waiver of Signed Informed Consent
Fieldwork, or ethnographic research, involves observation of and interaction with the persons or group being studied in the group's home, work, and play environments. Ethnographers listen to what people say and watch what they do on a daily basis, often for months, even for years. They transform what they discover into knowledge and theory, some researchers from a descriptive point of view focusing on art and cultural preservation, and others from a more analytic background based on the social sciences.

Fieldwork is a process that develops as the research progresses. The ethnographers must initially gain entrée to the community, which allows their immersion in the culture. The middle stages of the ethnographic method involve recruiting informants or consultants, and working through community networks to gain yet more informants in a snowball process. The researcher continues gathering data through observations and interviews. In inductive research, the investigator analyzes data to develop grounded theory at the end. Unlike many deductive researchers, ethnographers often work without specific hypotheses and may not know the specific wording of open-ended interview questions. The Office of Human Research Protections and Social and Behavioral Sciences Institutional Review Board recognize that this long complex process is difficult to specify in a protocol for the IRB.

Therefore, the Office of Human Research Protections has recommended the following with respect to fieldwork:

After gaining access to the fieldwork setting, the ongoing demands of scientifically and morally sound research involve gaining the approval and trust of the persons being studied. These processes, as well as the research itself, involve complex, continuing interactions between researcher and hosts that cannot be reduced to an informed consent form. Thus, while the idea of consent is not inapplicable in fieldwork, IRBs and researchers need to adapt prevailing notions of acceptable protocols and consent procedures to the realities of fieldwork

(see http://www.hhs.gov/ohrp/irb/irb_chapter5.htm#h4)

In keeping with the spirit and letter of the above, the SBS IRB does not exempt projects conducted in the field from the consent requirement, but it can waive the requirement for written documentation of consent. In some settings, the process of signing the consent form can be perceived as risible, demeaning, offensive, threatening, or even riskier than participating in the research itself.

The federal regulations give IRBs authority to alter or waive the required consent in certain circumstances (Sections 46.116(c)-(d)). The IRB may waive requirement to obtain a signed consent form for some or all of participants if:

(1) the research involves no more than minimal risk to subjects.

(2) the waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) the research could not practicably be carried out without the waiver or alteration; and

(4) whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study.

When the documentation requirement is waived, the IRB requires that the researcher provide subjects with a written or oral statement in their own language containing the elements of informed consent, when appropriate. Researchers are required to inform participants of the primary purpose of the research project and of any procedures that they will undergo. Additionally, participants are to be informed of their rights regarding the study (voluntary participation, protecting anonymity and privacy) and any risks or benefits associated with the project.

Subjects in-country should be given local contacts for any questions they may have about the research or about their rights. In the past, researchers have used as local contacts, the US embassy or consul and faculty members in their field at nearby universities. This local contact information should be included on informed consent forms, along with the SBS IRB contact information, as the IRB realizes that language barriers exist and that subjects are more likely to get in touch with local sources of information about the project.

Researchers planning to conduct research in the field should justify their proposed method of documenting consent in the protocol submitted to the IRB. The justification should include a description of local cultural values if they constrain the typical informed consent process.

To request a waiver of informed consent, investigators must complete the waiver form and submit to the IRB at the time of application submission.

The request form in rich text format may be downloaded: Waiver of Signed Consent. It is the responsibility of the investigator to request the waiver. The IRB must document that a waiver was granted in the minutes of the convened meeting at which the protocol was approved.