Informed Consent (Cont.)

When a Signed Consent Form Can Harm a Participant (Vignette)

A social scientist proposed a study in which subjects would be asked to discuss privately with their romantic partner a past disagreement. Because the questions are embarrassing, the researcher proposed that complete anonymity, including to the researcher, be preserved. This was aimed to encourage participation and protect the subjects. -

The lessons:

• The risk in this project is the harm resulting from a breach of confidentiality. The regulations allow the IRB to waive documentation of informed consent ((§ 116 (d)), and ethical considerations mandate that they do so, in order to reduce the risk to the subjects. If the IRB were to require signed informed consent, risk to subjects could increase.
• Documentation of informed consent is not an end in itself, but should be a tool to decrease risk of unexpected harm to participants.