April 16, 2020 IRB Special Communication: Use of Remote Interpreters when using a Short Form Consent for Research

Institutional Review

Board (IRB)

April 16, 2020 IRB Special Communication

Use of Remote Interpreters when using

a Short Form Consent for Research

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 REQUIRED 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.

Summary

When a VRI or OPI is used for a research consent process, a remote interpreter checklist MUST be completed for each subject and filed in the research record and the medical record as applicable.

The person obtaining consent is responsible for acquiring and completing the checklist. This is not a responsibility of the interpreter services department.

Many of the procedures are the same as when an interpreter is present however the additional requirements necessary are:
Asking verbal permission from the interpreter to record their name and ID number in the witness signature section; and
Asking the interpreter to confirm with the subject that they understood the information about the research and had the opportunity to ask questions.
the exact wording of what needs to be ask of the remote interpreter is specified in the checklist. There is also a section in the checklist to document that both these requirements have occurred.

This checklist and the associated short forms (in multiple languages) may be found on the Informed Consent page of our IRB website.

The use of this checklist will be audited. You may be asked for evidence that the form was used.

Please review and familiarize yourself with the steps required in this checklist.

We also used this opportunity to develop a checklist that the research team can use to guide the consent process when a short form is used and the interpreter is present . This is not a required form but you may find it helpful.

Please feel free to contact the IRB staff with any questions you have.

* Witness signature is limited to confirming that the information was presented orally to the subject, parent or legally authorized representative in a language they could understand, and that the individual had the opportunity to ask questions .

Contact/Questions

IRB Website

IRB@childrens.harvard.edu

617-355-7052

Office Location:

Landmark Center 7 East

Mailstop: BCH 3164