Consent Toolkit

To determine if you need to consent your subjects to be screened (in person, on the phone, or online), please see the section at the bottom of this page for more information on consent for screening (also available in our FAQs page), and you may use this template. It can be used in person, or as a verbal (phone) script, or may be formatted to be presented online. If HIPAA does not apply to your study, please remove the HIPAA-related content.

• Verbal Screening Consent/HIPAA (DOCX)(ver. 06-16-20)

• SHB Consent Template (ver. 10-24-22)

Utilize your completed HIPAA worksheet to identify the HIPAA language you need to include in the consent. Note: If study team is performing study activities at Children's Healthcare of Atlanta, Grady Health System, Saint Joseph's Hospital, Emory Johns Creek Hospital, customize each instance of Emory with the other location as well.

• HIPAA worksheet indicates HIPAA applies to research (Accessing PHI, treating and billing to third party payor, research at a covered entity). Insert this HIPAA language: HIPAA Applies to Research Records (ver. 04-01-24)

• HIPAA worksheet indicates HIPAA doesn't apply to data once it's in my research records (obtaining PHI but no treatment and billing to third party payor for research). Insert this HIPAA language: Obtaining PHI_No treatment and Billing_HIPAA doesn't apply to research records (ver. 04-01-24)

• The research is not accessing, using, or storing any PHI from a covered entity. Include confidentiality language: Confidentiality language when HIPAA does not apply to study at all

• HIPAA_IIHI_Confdentiality Language Inserts for Verbal Consents (ver. 09-12-23)

For additional guidance, see this HIPAA guidance (PDF) (ver. 09-12-23).

Some external IRBs such as the NMDP IRB REQUIRE use of a stand-alone HIPAA Authorization. In only these circumstances use the templates below:

• Stand alone HIPAA Applies to Research Records  (ver. 04-01-24)
• Stand alone Obtaining PHI No treatment and Billing HIPAA doesn't apply to research record (ver. 04-01-24)

See section above for the HIPAA and confidentiality language to insert in consent forms. 

• Biomedical Consent Template: This latest template version is titled BIOMED-ICF-24-11.
  • New studies created in eIRB on or after October 1, 2024 which use the biomedical template must use a version dated BIOMED-ICF-24-09 or later.
    
  • Updates published with the latest BIOMED-ICF version (24-11) include: revised medical record language, additional guidance for injury and cost language options, and the addition of optional consent documentation fields for the main study.
• For studies involving Saint Joseph's and Johns Creek: IRB-approved consent form and protocol must be sent for review to Rebecca Heitkam at Saint Joseph's hospital for approval prior to commencing research at Saint Joseph's or Johns Creek Hospitals (not required for chart reviews or research solely at the Emory Clinic space). See: guidance for conducting clinical research and/or clinical trials at Emory St. Joseph's Hospital (DOCX)
• For studies involving Children's Healthcare of Atlanta: Children's Healthcare of Atlanta is an entity distinct from Emory. When doing research that involves CHOA, please see the "Collaborative Research" section at left (CHOA information at bottom of page), and always submit this form to the CHOA IRB even when Emory is the IRB of record: CHOA IAA Acknowledgement Form
• Emory Expanded Access (IND/IDE) ICFHIPAA (ver. 10-21-21)
• Revocation Letter (ver. 01-24-20)  Please note that this document does not get stamped by the IRB.
• Signature Page for Winship Studies (new version posted 12-07-23)

See our Collaborative Research/Single IRBs/Reliance Agreements page for external IRB requirements

• Assent Template (ver. 1-27-23)

The following documents should be used only when the IRB has waived "documentation" (i.e., signature) of consent or HIPAA authorization. The HIPAA, IIHI, or Confidentiality language for inserting in to the consent are linked above in the HIPAA section. 

• Verbal Consent (Emory or Emory and Children's)

For online consent:

When the IRB waives the signature requirement, you can use the text in the Verbal Consent templates above, but remove the areas at the bottom for names and signatures, and replace with a statement like the following (can be your choice of language):

"If you would like to participate, please proceed to the survey."

The consent text would be displayed at the top of the online survey, or as a first page of a multi-page survey.

You may also add a checkbox or text box for initials for the person to indicate their agreement to participate. If identifiability is not a concern, you may also allow people to enter their full name (and contact information if needed), either as part of the survey or in a separate form, e.g., if offering compensation.

• Case Study HIPAA Authorization (DOCX) - to be used even when no IRB oversight is required for your case study/series, but when it is practicable to contact the case(s) and you may be publishing any identifiable information (direct or indirect identifiers)

• HUD Patient Information Sheet (DOCX) - for protocols using Humanitarian Use Devices under the FDA regulations

• Researcher Guidance for using the Psychology Student Recruitment Pool (DOC)

Do I need consent for screening subjects, in person, over the phone, or online?

• Yes, if your study falls under HIPAA and you're going to record identifiable health information/PHI (in this case, you need HIPAA authorization; since you are obtaining that, it's logical to also include at least some elements of informed consent as well)
• Yes, if your screening involves any procedures beyond asking questions and collecting existing information/specimens (see Procedures note below)
  • Procedures that do require screening consent could include even non-invasive things like fasting
• No, if your study does not fall under HIPAA at all and screening does not involve any procedures
• No, if your study falls under HIPAA, but you are not going to record any identifiable health information, and screening does not involve any physical procedures

Procedures that do NOT require screening consent include:

• obtaining information through oral or written communication with the prospective subject or legally authorized representative, or
• obtaining identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
• Remember, if HIPAA applies and you will record PHI, then HIPAA authorization is required.

To avoid the HIPAA authorization requirement for screening questions:

• In person or telephone-based screening: You can avoid the need for a screening consent/HIPAA if you do not record any identifiable, private information about the person being screened (health-related or otherwise). For example, you could have the research staff read out the eligibility criteria, and even verbally ask for replies.

If any boxes are checked or answers recorded during screening, they would have to be on an anonymous sheet (i.e. not even a subject ID number that will be linked to a name). If the person is eligible per the screening checklist, then you can separately record their contact information to schedule the first study visit. Again, the screening checklist could in no way be connected to the contact information.

This works for studies that do not need to retain any identifiable information about screen fails, and where detailed information about the subject is not needed prior to the first study visit

This will NOT work if you intend to ask the subject to do any study procedures prior to coming in for the first visit (e.g., abstaining from taking their normal medication).

• Internet-based screening: Even IP address is considered an identifier, so avoid having people click boxes on eligibility checklists when they first land on your study website; just display the criteria and let them click to proceed if they think they're eligible. Only start collecting their information once they have given consent to be in your study. You can still ask them to submit their contact information to set up further study interaction, though, as long as you aren't attaching that to any screening questionnaire responses.

See our verbal screening consent template available on our website. If HIPAA does not apply to your study (per the eIRB smartform; i.e,. no treatment and no billing), then you can remove any HIPAA authorization language from the document.

In all cases where you are not using a full, regulatorily-required consent process, ethics still requires you to ask permission and to explain why you are asking the questions. Wording such as ‘In order to see if you are eligible for the study, I need to ask you a few questions. I won't be recording your answers. Is that OK?’ is adequate.