If you are mailing a survey to subjects and asking them to return it to you, or doing a phone interview, you must send or read a consent statement which includes the same information as the consent form but is not signed. Examples include chemical substance abuse, sexual activity or attitudes, sexual abuse, criminal behavior, sensitive demographic data, death and dying, detailed health history, etc. The principal determination of sensitivity is whether or not the survey research presents a potential risk to the subject in terms of possible precipitation of a negative emotional reaction. An additional risk consideration is, of course, whether or not there is risk associated with a breach of confidentiality should one occur. With respect to potential psychological risk associated with a survey, the presence or absence of subject identifiers is not necessarily a consideration since the risk may be primarily associated with the sensitive nature of the survey as opposed to being dependent upon confidentiality.
Subject identifiers do, however, become a factor when confidentiality is an issue.
When children are involved as subjects in research using survey or interview procedures, the research is not exempt. For approval in this category you must be using an existing data set without access to identifiers, records review where you have legitimate access to records or a written release by the custodian of the record, or collecting waste tissue after it has been to pathology. When completing the abstract briefly explain the original study, or the origin of the waste tissue, and briefly explain what you intend to do with the data or waste tissue. Explain that you will not get any identifiers linked to the data or if you are, that you have legitimate access to the data, and how you have legitimate access, and that you will not be recording identifiers. Make sure you have appropriate signatures You do not need a consent form You do not need to provide the instruments from the original study.