Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

Informed Consent

Documentation of the Consent Process

The consent form signed by the subject in the original must be kept in the study files. A copy of the signed consent form must be given to the subject. If the research involves protected health information, a HIPPA authorization is required. At UVa, the HIPAA authorization is combined with the research consent form.

If there are two or more consent forms, each should be clearly labeled as to which subject population is addressed (i.e., subject/ subjects, normal controls, family members). Type must be clear and readily legible, in standard size, which is 10 to 12 points. Twelve (12) point-type is preferred.

Principal Investigators may not make any changes to the text of the informed consent and authorization form approved by the IRB without the IRB's prior written approval. In cases where a Principal Investigator is requested to change the text of the informed consent documentation by other third parties, the revised informed consent document must be resubmitted to the IRB for approval prior to initiating the study.

If videotapes are to be made for research purposes, the consent form should state when the tape will be erased, that the subject has the right to demand erasure at any time, and the circumstances, if any, under which the tape might be used for purposes other than the research described in the protocol (e.g., educational purposes).

A note regarding the consent process should be placed in the source documents and in the medical record if the subject is a patient. This note should contain the date of consent, how subject was able to demonstrate understanding of the consent etc.