Who should be listed on consent forms?

Federal regulations and UW standards require that each participant in a research study be provided with adequate information about the study, including who is conducting it. Including the names and contact information of the study team at the top of a consent form is an effective way to tell subjects who is conducting the study. The question sometimes comes up about exactly who should be listed. The principle is that subjects should be able to get in touch with those with whom they have had contact during the study, or others who can speak with knowledge and authority about the study and subjects' involvement. Typically, that includes:

• The lead researcher or principal investigator (and usually the co-investigators)
• Those who obtain informed consent
• Those with whom the subject will have regular contact during the study, such as study interviewers, coordinators, and nurses
• Faculty advisors (for student research only)

It usually does not include:

• Data entry staff or statisticians, or co-investigators who will not have contact with subjects
• People who provide a one-time service (x-ray, blood draw, eye exam, etc.)
• People who are available for emergency purposes only.

Exceptions to this standard may occur, but they are granted on a case-by-case basis by the reviewing Committee. Alternative arrangements must not defeat the main purpose of the standard requirement, which is to provide research subjects with a clear idea of (a) who are the responsible members of the study team and (b) how they can be contacted.

Additional information about consent may be found at:

• University of Washington Human Subjects Manual