During the recruitment process, members of the research team must make initial contact with potential subjects in person or by letter prior to initiating any telephone contact, unless there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study. (NOTE: This does not apply to situations where a Veteran calls in response to an advertisement. If existing information from sources such as a medical record or database, research or non-research, are used to identify human subjects, there must be an IRB approved HIPAA waiver for this activity in the new protocol.)

• Any initial contact by letter or telephone must provide a telephone number or other means that the potential subject can use to verify that the study constitutes VA research.
• If a contractor makes the initial contact by letter, the VA investigator must sign the letter.