Consent Toolkit

 

  • Below are the templates for biomedical, sociobehavioral, verbal and assent forms, and "modular language" to plug in if applicable to your study.
  • Guidance for informed consent documentation and process, short forms in other languages, guidance on the who can serve as interpreters, and our "stamping template" are in the sub-tabs at left

NOTE: On 12/14/2018, the ICF and ICF/HIPAA templates were updated for the Revised Common Rule. Even if your study is not fedearlly funded, make sure you use our updated templates.

 

Screening Consent Template

To determine if you need to consent your subjects to be screened (in person, on the phone, or online), please see the section at hte 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.

Modular Language for Consent Forms

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

Certificates of Confidentiality and NIH- or CDC-funded Research

On October 1, 2017, an NIH policy became effective that automatically provides Certificates of Confidentiality (CoC) to to all NIH-funded human sujbects research (for studies ongoing on or after December 13, 2016). 

The CDC also implemented a policy that allows the IRB to determine if a study should have a CoC, in which case the CDC must be notified and must provide the CoC.

Ensure that required consent form language - already within our templates - is added when your study has a CoC. Also, See our CoC page for more information about applying for CoC's for non-NIH/CDC studies. Make sure to discuss with your IRB analyst before submitting your application. 

Clinical Consent/HIPAA Templates

Note: "Saas" indicates a template with a header designed to be used in the updated eIRB system. Pre-existing studies should remove the current header on approved consent documents before submitting continuing reviews or modifications to make their forms compatible.

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?".

Sociobehavioral Consent Template

Assent Templates

SaaS Assent Template (ver. 06-16-20)

 

Verbal Consent & HIPAA Authorization Template

The following documents should be used only when the IRB has waived "documentation" (i.e. signature) of consent or HIPAA authorization.

Additional Templates

  • 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)

AVAMC Templates

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.

More on Consent for Screening...

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 screning 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 screning 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.