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 Consent Document
For new, non-exempt studies and those that do not already have an IRB approved consent document, you should use the appropriate consent template below to create your consent document(s):
Note that all long form consent documents and all summaries for short form consent documents must contain all the required and any additional appropriate elements of informed consent. Review the “Long Form of Consent Documentation” section in HRP-314 – WORKSHEET – Criteria for Approval, to ensure that these elements are addressed. When using the short form of consent documentation, the appropriate signature block from HRP-507 – TEMPLATE CONSENT DOCUMENT – Short Form should be used on the short form.
For exempt projects that will involve interactions with subjects, you may use an abbreviated process for obtaining consent. Consent can be verbal, but, if appropriate, you should provide the following information to participants in writing, such as an information sheet or copy of the script:
- The participant is being asked to participate in a research study;
- A description of the procedure(s) the participant will be asked to complete;
- Participation is voluntary; and
- The investigator’s name and contact information.
- For an exempt consent template, see HRP502a-TEMPLATE CONSENT DOCUMENT- Exempt.
For social, behavioral, and educational studies and other appropriate minimal risk research, a consent wizard is available.
For studies using a consent template provided by a sponsor that conforms to the requirements of HRP 502-TEMPLATE CONSENT DOCUMENT-Biomedical, you do not need to revise the consent document other than to ensure required institutional language is included. For details, see HRP 502c-STANDARD CONSENT LANGUAGE.
- HRP 502c-STANDARD CONSENT LANGUAGE should also be used when creating consent documents for ceded studies. For details, see the Reliance Manual.
For VA studies, VA Consent Templates as well as a document describing local UW language that may be required can be on IRBNet (gov.irbnet.org). For further details on VA requirements, see information presented on IRBNet and the VA research section.
For emergency or compassionate use, see HRP 506-TEMPLATE CONSENT.
We recommend that you date the revisions of your consent documents to ensure that you use the most recent version approved by the IRB. It is also recommended to use gender inclusive language throughout the consent document, when possible (e.g. people of child-bearing potential, rather then females of child-bearing potential).
Prior to submission, investigators are responsible for ensuring that any language addressing provisions for medical care or other services for research-related injuries described in the study’s contract or funding agreement are consistent with what is presented in the consent document.
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 CT.gov-style 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.