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Forms, Templates & Instructions

Protocol templates for use with Kuali IRB applications

Protocol Templates

  • Biomedical Interventional Protocol for clinical trials research (based on NIH template) | MS Word

  • Biomedical Non-Interventional Protocol for clinical research | MS Word

  • Social/Behavioral/Educational Research (SBER) Protocol | MS Word

Multi-Site Communication Plan

A multi-site communication plan is used when a study will have multiple sites all relying upon a single IRB. The multi-site communication plan delineates who will be the point of contact between the lead site and the relying site for various types of communication including IRB determinations, COI information, training, ICF language, and more. 

 

  • Multi-Site Communication Plan | MS Word
Consent/Assent Form and Information Sheet templates for use with Kuali IRB applications

Consent Form Templates

UCSD Templates

  • Adult/Parent Permission Consent Form template | MS Word
  • Adolescent Assent template | MS Word
  • Child Assent template | MS Word
  • Exempt Information Sheet template | MS Word
  • Expanded Access Consent Form template | MS Word

UCSD/RCHSD Templates

  • Adult/Parent Permission Consent Form template | MS Word
  • Adolescent Assent template | MS Word
  • Child Assent template | MS Word
  • Exempt Information Sheet template | MS Word
  • Expanded Access Consent Form template | MS Word

Short Form Consent

Procedures for the Use of the Short Form Consent

As noted in the UCSD IRB Standard Operating Policies and Procedures, the written consent form may be either of the following:

  1. A written consent document that embodies the elements of informed consent described in 21 CFR 50.25 and 45 CFR 46.116. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator will give either the subject or the representative adequate opportunity to read it and ask questions before it is signed; or
  2. A "short form" written consent document stating that the elements of informed consent as required above have been presented orally to the subject or the subject's legally authorized representative.

When the short form consent method is used, there will be an impartial witness to the oral presentation, and the following four documents are required:

  1. A copy of the IRB-approved English short form translated into the language in which the subject is fluent. The UCSD IRB-approved English short form has been translated into the following languages:
  2. A copy of the IRB-approved study consent (long form).
  3. A copy of the UCSD Experimental Subject's Bill of Rights translated into the language in which the subject is fluent. The UCSD "Experimental Subject's Bill of Rights" has been translated into the following languages:
  4. If the procedures for using the short form were not previously approved, a revised Research Plan to clearly and specifically outline the procedures that will be used to obtain consent using this method.

These procedures should also address the ongoing process of "informed" consent and the need for providing continued, qualified interpretive services. These four documents require IRB approval before using the short form to obtain consent.

In addition, the following persons need to be present at the time short form consent is being obtained:

  1. The potential participant
  2. The person obtaining consent
  3. A qualified interpreter. The qualified interpreter may be present physically or by some other means, for example by phone or video conference. Note that the interpreter may also serve as the witness only if the interpreter can sign the appropriate documents (see below).
  4. A witness. The witness is an adult who is conversant in the language of the presentation. The witness should be an impartial third party, not otherwise connected with the clinical investigation (for example, clinical staff not involved in the research or a patient advocate) and not be the person obtaining the consent. The purpose of the witness is generally to attest to the voluntariness of the subject's consent and the adequacy of the consent process by ensuring that the information was accurately conveyed and that the subject's questions were answered.

The following signatures are required if the potential participant agrees to enroll in the study:

  1. The participant signs and dates the translated short form and the translated "Experimental Bill of Right"
  2. The person obtaining the consent signs and dates the IRB-approved study document
  3. The witness signs and dates the translated short form and the IRB-approved study consent

Copies of all the documents are provided to the participant.

Once the participant has been consented, the English version of the IRB-approved study consent must be translated into the language in which the participant is fluent. The translated document must be submitted for approval by the IRB (typically using expedited procedures), and provided to the participant as soon as possible but no more than one month after the participant's initial consent.

The short form method should be used only for the occasional and unexpected enrollment of non-English speaking participants.