Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval

Version date: November 19, 2012

The purpose of this guidance is to assist study teams in determining when IRB review and approval of various types of documents is required. This guidance provides common examples and should not be considered an exhaustive list.  If revisions are made to documents that require IRB review, these updates would need to be submitted to the IRB as a change of protocol.  Please note that even when a document appears as one that IRB review is not required, the IRB can still request a copy for review if the committee thinks that the document is necessary for its review.  If you have questions about whether a study-related document requires IRB review, please contact the IRB Office at 608-263-2362 or email AsktheIRB@medicine.wisc.edu.

IRB Review Required

  • Formal study protocol
  • Informed consent documents, including
    • Consent forms
    • Oral consent scripts or information sheets used when documentation of informed consent will not be obtained
    • Screening scripts
  • Information sheets that supplement consent forms
  • HIPAA authorization forms, if HIPAA language is not integrated into the consent documents, and permission to contact forms to release contact information to individuals outside the study team for recruitment purposes
  • Study instruments, including
    • Questionnaires
    • Interview questions
    • Assessments specific to the study
  • Investigator's Drug Brochures
  • Device specifications
  • Recruitment materials, including
    • Advertisements
    • Website posting (see below for exception)
    • Communications informing subjects about a study (e.g., letters, emails, telephone scripts, Facebook postings)
  • Communications to subjects that
    • Disclose the study condition/treatment/arm to which they were assigned when a study has been unblinded
    • Describe new information about study progress or study procedures

IRB Review Conditional

The following table describes materials that may or may not require IRB review because IRB review is contingent on their content.

 Document Type  IRB Review Required  IRB Review NOT Required
 Appointment reminders
  •  If the subject has been lost to follow-up and an additional contact is being made to encourage subjects to continue participation in the study
  •  If the communication a) simply includes a reminder about dates and times of study visits described in IRB-approved consent documents or b) is part of a pre-planned final visit should a subject withdraw early from the study
 Case report forms for individual subjects
  •  If the documents capture information about procedures not included in the formal study protocol
  •  If the documents capture information about procedures included in the formal study protocol
 Communications to study participants disclosing imaging results or results of other study tests to participants
  •  If the testing or imaging are performed solely because of research participation; or
  • The testing or imaging are investigational; or
  • The testing or imaging are presented differently than would occur as part of subjects' standard clinical care
  •  If the testing or imaging were conducted as part of subjects' standard clinical care and are commensurate with standard clinical care
 Course curriculum content
  •  When content is created or altered for a research study
  •  When content of the course is established and will not be altered for the research study
 Data collection forms
  •  For any study without a formal protocol
  •  If the data collection form is embedded in a formal protocol and details how information will be recorded
 Eligibility determination sheets/forms
  •  If the documents capture different or additional information about eligibility determination/screening than described in the formal protocol
  •  If the documents capture the same information about eligibility determinations/screening described in the formal study protocol.  Note this does not include telephone screening scripts.
 Grants
  •  When the UW, UWHC, or VA holds the grant
  •  When the grant is not held by UW, UWHC, or VA
  •  A sub-contract may be required
 Instructional materials for subjects, e.g., UWHC Health Facts for You or instructions for collecting urine
  •  If the materials contain information about procedures or medications not otherwise described in the study protocol or contains information about study risks
  •  If the materials are limited to the technical description of procedures or medications described in the study protocol and do not contain information about study risks
 Manuals of Procedures
  •  If the documents contain information about risks not included in the formal study protocol (or if a formal study protocol is absent)
  • If the documents go beyond technical details about procedures described in other study documents
  •  If the documents contain information about risks or procedures included in the formal study protocol; or
  • If the documents include technical details about procedures described in other study documents
 Medication or pill diaries, study diaries
  •  If the documents capture information about procedures not included in the formal study protocol
  •  If the documents only capture information about procedures included in the formal study protocol
 Newsletters
  •  When the content contains details that can be considered to encourage subject enrollment or continued participation, such as describing the potential benefits of the research or payment information; or
  • When content describes study results or new information about the study that could affect subjects' willingness to take part in the research
  •  When content does not
    • include recruitment information
    • describe study results or progress (other than number of subjects enrolled or study status)
    • include new information that could affect subjects' willingness to take part in the research
 Package inserts
  •  When an Investigator's Drug Brochure is unavailable for a drug under study
  •  When an Investigator's Drug Brochure is available for a drug under study and provided to the IRB
 Thank you cards, holiday cards, birthday cards
  •  If the communication includes new information that would affect subjects' willingness to take part in the study
  •  If the communication does not include new information that would affect subjects' willingness to take part in the study
 Website postings in public sites describing research studies
  •  When the posting contains details that encourage subject enrollment, such as describing the potential benefits of the research or payment information
  •  If the postings are in line with type of information included on the ClinicalTrials.gov website.  The IRB application, however, should describe when information about the study will be posted on the web




Keywords:protocol, IDB, questionnaires, advertisements, communication to subjects, document, documents diary wallet card, birthday card, supplemental, reminder   Doc ID:27488
Owner:Faye L.Group:Health Sciences IRBs
Created:2012-11-28 13:20 CSTUpdated:2017-10-02 12:10 CST
Sites:Health Sciences IRBs
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