The IRB allows the use of the short form consent for minimal risk research when the subject/family does not speak English. The short form process assures that information included in the approved consent form is verbally discussed with the subject/family in a language they understand. When short forms are utilized, the IRB-approved consent serves as a summary on what needs to be verbally presented to subjects. A short form in the applicable language specifies that the required elements of consent have been verbally communicated. The subject or parent/guardian signs the short form to document that the verbal consent process occurred. Informed consent documents for research that involve greater than minimal risk (i.e. drug trials) must be translated into the applicable languages. Limited exceptions for use of the short form for subjects or protocols that involve greater than minimal risk may be considered by the IRB with sufficient justification.
There continues to be an increasing need for the use of interpreters when enrolling non-English speaking subjects into research. When a short form is utilized, it is always preferable to have an interpreter present; however, this is not always possible. The Hospital has contracted with services that provide a
VRI (Video Remote Interpreter) or an
OPI (over the phone interpreting). These services are also utilized by the clinical research community. Federal regulations pertaining to the use of a research short form require a witness signature on the forms that are signed. The Hospital’s interpreters agree to serve as a witness in accordance with the way we have defined witness*. When interpreters are present they will sign the required forms; however when a VRI or OPI is used there is no opportunity for the remote interpreter to sign as a witness.
Over the past year we have worked with Interpreter Services, regulatory agencies, BCH General Counsel and the company providing services for remote interpreters to develop a process that meets regulatory requirements when a remote interpreter is utilized for a short form.
We have developed a
Checklist to be completed and filed with the research record when remote interpreters are used for interpreting when a short form is utilized. The Checklist can be found on the
Informed Consent page of our IRB website