CASE STUDY #2

You have submitted a protocol for a minimal risk study. The IRB approves your protocol. In your submission the informed consent process will involve documenting subjects’ consent using the IRB approved consent form. You are in the field and are speaking to a subject eligible for enrollment into your study. You discover you do not have the consent documents with you. You have described all the study procedures to the subject and allowed ample time for the subject to consider whether to participate. The subject indicates he does not need anything in writing and agrees to participate.

Question: Is it OK to continue with the research activities with this subject?