This sections of the Investigator Manual provides information related to the preparation of consent documents, HIPAA forms, recruitment materials, and other subject-facing materials.

Writing a HIPAA Authorization Form

The HIPAA Privacy Rule is a set of federal regulations providing protections for the confidentiality of health information used in clinical practice, research, and the operations of health care facilities. The intended purpose of the Privacy Rule is to ensure that health information confidentiality risks are minimized.

Studies using or disclosing protected health information (PHI) subject to HIPAA requirements may need to obtain authorization from participants in addition to informed consent. IRB template consent documents include template authorization language.

The authorization form must include all required elements and statements to be valid, unless the IRB has approved an altered authorization form. Review HRP-330- WORKSHEET: HIPAA Authorization, to ensure all elements and statements are addressed.

For exempt studies, altered authorization should be requested as the language included in the information sheet is condensed and does not include all required elements or a signature line.

You are encouraged to use a combined consent and authorization form. In the event you need a separate authorization form, refer to the Office of Compliance HIPAA website for those templates. The VA typically requires a separate authorization. See the section on VA Requirements in this manual for more information.

Preparing Recruitment Materials

All documents that will be used to recruit participants must be reviewed by the IRB. These materials include but are not limited to:

  • Advertisements
  • Website posting
  • Letters and emails
  • Social media posts
  • Scripts for television or radio ads

When preparing your materials, refer to HPR 315 – WORKSHEET – Advertisements to ensure your documents meet IRB requirements and the Recruitment Guidelines section for additional information.

Other Subject-Facing Materials Requiring IRB Review

In addition to the documents noted elsewhere in this manual, the following documents require IRB review and must be uploaded in the ARROW application:

  • Study instruments, including:
    • Questionnaires
    • Interview questions
    • Assessments specific to the study
    • Investigator’s Drug Brochures
    • Device specifications
  • 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

Depending on the study, the IRB may request additional documents required to make regulatory determinations.

Supporting Documents That Do NOT Require IRB Review

Some subject-facing documents do not require IRB review as long as they contain information that is consistent with the protocol or other IRB reviewed documents and do not include new information that would affect subjects’ willingness to take part in the study. These include:

  • Appointment reminders
  • Case report forms
  • Course curriculum content
    • When content of the course is established and will not be altered for the research study
  • Data collection forms
    • This does NOT include survey and other instruments used to collect data directly from subjects.
    • The data collected on these forms needs to be described in the application/protocol.
  • Eligibility determination sheets/forms
    • Note this does not include telephone screening scripts.
  • Instructional materials for subjects
    • 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
  • Medication or pill diaries, study diaries
  • Newsletters/press releases
    • When content does not include recruitment information or describe study results or progress (other than number of subjects enrolled or study status)
  • Internet postings of study descriptions limited to content (i.e., study title, purpose, procedures, basic eligibility criteria, and how to get in touch with the study team) as long as the methods used to recruit subjects are described in the application/protocol (e.g. internet must be an approved tool for recruitment).
    • This does NOT include descriptions of risks/benefits or why someone would want to be in the study.