SPECIAL CIRCUMSTANCES
WHAT IF I’M CONDUCTING FIELD RESEARCH OUTSIDE OF THE U.S.?
Field research done outside of the United States, especially in non-English speaking societies or non-western societies, can pose special problems in obtaining written informed consent. It should be obtained if possible, using consent forms written in the subject’s primary language. If it cannot be obtained in writing, then the investigator must provide the Committee with a statement of the reasons why it should waive written informed consent, and a description of the alternative method of obtaining oral consent which the investigator has devised. This alternative method must be appropriate to the subjects and to their culture.
CAN I USE DECEPTION IN MY RESEARCH?
This area raises special and serious problems. The investigator should consider carefully why deception is necessary to the research, and indicate to the Committee why he or she feels it absolutely must be part of the research. Present federal rules prohibit the use of deception techniques that place the subject at more than minimal risk.
Any research involving deception MUST include a debriefing of the subject after he or she participates in the research. This debriefing involves clearly explaining to the subject just where the deception occurred, how it happened, and why it was used. A description of how and when this debriefing will occur must be included in your project description.
WHAT DO I DO IF SOMETHING CHANGES IN MY RESEARCH DESIGN?
If the investigator finds that he or she has to make changes in the research as originally described in the protocol approved by the HSC, the investigator must inform the HSC of the changes BEFORE he or she begins to carry them out. This can be done by sending a memo to the Committee, signed by the responsible faculty investigator, describing the proposed changes. The HSC will consider these during its next scheduled meeting, and inform the investigator of its decision immediately afterward. It should be noted that even relatively minor changes should be reported, and so should ADDITIONAL techniques or procedures: for example, if the original protocol did not mention a follow-up procedure, but the investigator now realizes that he or she really should use one.
WHAT DO I DO IF SOMETHING GOES WRONG IN MY RESEARCH PROJECT?
Report the adverse event, whatever it is, to the Committee immediately. This covers a broad field of possibilities: it could be anything from a subject receiving a serious physical injury during their participation in the research, to a complaint from a subject about some aspect of the research. What happens from there depends on the nature of the adverse event.
