For the IRB current guidance for informed consent documentation and process, including the use of family members and research staff as interpreters, please go to this page.
NOTE: As of 12/14/2018, the ICF and ICF/HIPAA templates comply with the Revised Common Rule. Even if your study is FDA or DOJ regulated, make sure you use our updated templates.
Document Stamping Template
All eIRB Consent forms, HIPAA Authorization forms, and Revocation Letters should be on this template which includes a "stamping header." The consent templates below are already placed on the appropriate stamping template.
To determine if you need to consent your subjects to be screened (in person, on the phone, or online), please see the section below 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 (ver. 11-18-15)
This language is to be inserted as applicable into the biomedical templates below; see templates for indication of where to place the modular language. It includes language on things like Certificates of Confidentiality, genetic research, incidental findings, etc
- Modular Language for Consent Forms (ver. 12-14-2018)
To be presented to prospectively-enrolled subjects on NIH-funded studies for which informed consent is not waived. This is required as of October 1, 2017, the effective date of the NIH policy providing automatic CoC's to all NIH funded human sujbects research ongoing on/after December 13, 2016
Certificate of Confidentiality Addendum (ver. 10-4-17)
Spanish Version (ver. 10-4-17)
Note: As of Oct 1, 2013, the Emory IRB is now requiring a combined Consent & HIPAA form for all applicable new studies. This is to reduce noncompliance with HIPAA authorization. Currently approved studies are encouraged to move to the new format if enrollment will continue , but may continue with separate forms.
- Emory Biomedical Consent/HIPAA Template (ver. 12-14-2018)
- Emory Biomedical Consent Template-HIPAA does not apply (ver. 12-14-2018)
- If Using Site-specific consent forms below instead for studies for which HIPAA does not apply, refer to this form as a model
- Emory Biomedical Consent/HIPAA Template - obtaining PHI from covered entity, but no treatment or billing for research (ver.12-14-2018)
- This form should be used if you need to access data from a covered entity, but once the data is in your research records, HIPAA no longer applies (because there is no treatment nor billing involved in your study)
- CHOA Consent/HIPAA Template (ver. 12-14-2018)
- CHOA Consent/HIPAA Template for studies conducted at CHOA and Hughes Spalding (ver 12-14-2018)
- NOTE: 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
- Grady Consent/HIPAA Template (ver. 12-14-2018)
- St. Joseph/Johns Creek Consent/HIPAA Template (ver. 12-14-2018)
- Note special guidelines in the margin regarding instructions for birth control per the Catholic religious directives
- 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
- Emory Expanded Access (IND/IDE)/HIPAA Template (ver. 10-17-17)
For studies reviewed by Western IRB (WIRB), WIRB is no longer using the WIRB Emory-specific consent template previously provided on this webpage. Study teams will now be required to use the Sponsor's template or WIRB's master template and plug Emory-specific provisions into the appropriate places using the tracked changes features. For more information about this process, please go to our WIRB page and look under "What do I need to know about consent and HIPAA authorization documents?".
For studies reviewed by National Cancer Institute's IRB (NCI CIRB), NCI CIRB now has new consent form policy guidelines which can be accessed here and here. Study teams will now be required to use NCI CIRB's template and plug only certain Emory-specific provisions into the appropriate places. For more information about this process, please go to our NCI CIRB page and look under "What do I need to know about consent and HIPAA authorization documents?".
For studies reviewed by other central IRBs, the reviewing IRB or coordinating office will work with you on consent form requirements, and the Emory IRB should verify the correct Emory-specific language prior to use, regardless of whether the reviewing IRB requires that. Usually, the reliance specialist checks that you have taken the reviewing IRB's approved consent template and added certain Emory-specific provisions during Emory's local context review process. Note that HIPAA language and/or assent form language may be left to our institution to incorporate. It is the Emory study team's responsibility to work with the Emory IRB to ensure that the language is correct. For more information, visit the XIRB page and look under "What happens after my reliance request form has been approved?".
- Case Study HIPAA Authorization - 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 identifible information (direct or indirect identifiers)
- HUD Patient Information Sheet - for protocols using Humantarian Use Devices under the FDA regulations
For guidance on VAMC templates, please go to the Atlanta VAMC Website where you may find information regarding current template updates and changes. That page can also provide copies of consent documents with the changes tracked, emphasizing portions that have been updated with the latest version.
For more information about VA studies, please see our section on Conducting Human Research Studies at the Atlanta VA.
Do I need consent for screening subjects, in person, over the phone, or online?
- Yes, if your study falls under HIPAA and you're asking for identifiable health information (PHI)
- Yes, if you need to collect identifiers as part of the screening
You may be able to avoid the need for a full consent process in some cases:
- 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.
If you do need to collect identifiable private information as part of screening, we have a 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 of course still require 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.