One of the most important considerations in research involving a human subject is the concept of informed consent. Informed consent refers to both the process of providing participants information about the research, as well as the documentation that is used to ensure that consent for participation is fully informed. This page goes over some of the most common iterations of obtaining, waiving, or altering informed consent in a study. Keep in mind that while there are certain regulatory requirements pertaining to informed consent, there are also a wide variety of ways one might move through that process. Recent studies have shown, for example, that interactive informed consent processes or supplemental videos enhance participants’ understanding of the research process. The information included here is sufficient to gain study approval, but the IRB encourages you to consider your population and how you might best communicate the relevant information about your study.
Unaltered Informed Consent
As you proceed through your protocol submission, please remember that informed consent refers to both the process and the documentation that you will use to inform prospective participants about your research. Informed consent is an ongoing process, requiring investigators to be mindful of new information that may arise as the study moves forward.
Moving forward with the informed consent process in its full and unaltered form can be done in two ways. (1) The research team should obtain signed and dated documentation from the participant and/or their legally authorized representative, where necessary, signifying the participant’s understanding of your study and willingness to participate. (2) Informed consent is presented orally. Two documents are necessary for this process: a) a short form stating that the required elements of informed consent have been presented orally to the subject, signed by a witness to the oral process as well as the participant or their legally authorized representative; and b) a written summary of what will be shared orally, signed by both the participant and the research team member that gives the oral summary to the participant or their legally authorized representative. You’ll note that the oral process is generally as much documentation as the written process; it is most appropriate for times when a translator is being used to obtain informed consent. Simplified verbal informed consent process are available by requesting an Alteration of the Informed Consent Process.
Non-exempt projects are required to adhere to the requirements for informed consent outlined in 45 C.F.R. 46.116. Unless a waiver or alteration has been granted, reviewers for all non-exempt protocols must document the following determinations about your informed consent process:
- Informed consent is being sought from the person who is able to legally grant it
- Informed consent sought on behalf of another person will respect the autonomy of the participant themselves
- The circumstances of informed consent minimize or eliminate the possibility of coercion or undue influence
- Prospective participants or their Legally Authorized Representatives (LARs) are given ample time and opportunity to learn about the study, discuss the study with relevant parties, and ask questions of the study team before agreeing to participate.
- The information that the research team plans to share with the prospective participants is easily understandable to the participant and their LAR, if applicable
- The compensation is not of such a nature that the average targeted participant would be unduly influenced by it
Waivers & Alterations of Written Documentation
Waivers of documentation of informed consent are the most-requested waiver or alteration; it is commonly referred to as using a “Letter of Information” or “Letter of Consent.” This indicates that the participants affirmatively receive all of the required information, but are not required to sign, date, and return the documentation to the research team. The absence of a signature and date is the only difference between this process and the full, unaltered informed consent process. So-called “passive consent” (i.e. consent is implied by the act of sending out information about the study) requires a waiver of all requirements to provide informed consent, which you can read more about on the fourth tab on the side menu (Waivers of Informed Consent).
There are three separate regulatory frameworks under which a research team can seek a waiver of documentation of informed consent, detailed below:
Principal Risk is Breach of Confidentiality
45 C.F.R. 46.117(c)(1)(i) permits research teams to affirmatively present prospective participants with the informed consent documentation, but waive the requirement to get a signature, if the following details apply to the research:
- The principal risk in the study is breach of confidentiality;
- The informed consent document would be the only record linking the participant to the study; and
- The participant or legally authorized representative will be given the option to sign and date a form.
At first glance, this would apply to many studies at USU. However, the process of ensuring that participants have the option to sign and date a form results in logistical difficulties for many research teams (especially for online studies), so this approach is rarely utilized. If you plan to utilize this waiver framework in your study, please ensure that your process allows for participants to choose whether they would like to have documentation linking them to the study.
Non-Research Equivalent Procedures
45 C.F.R. 46.117(c)(1)(ii) permits research teams to affirmatively present prospective participants with the informed consent documentation, but waive the requirement to get a signature, if the following details apply to the research:
- The research is minimal risk and
- The procedures used in the study mirror procedures that take place outside of the research context, and those non-research procedures would not typically require signed consent.
This is the most commonly requested and granted waiver of documentation request. In your protocol submission, please be prepared to share information about the non-research equivalent procedures that your research procedures are most similar to.
Respect for Cultural Norms
45 C.F.R. 46.117(c)(1)(iii) permits research teams to affirmatively present prospective participants with the informed consent documentation, but waive the requirement to get a signature, if the minimal risk research takes place in a distinct cultural community or group in which signing forms is not the norm. In this case, the research team is required to document that the informed consent process took place in an alternative manner. Protocol submissions seeking this waiver should set forth a plan for documenting that informed consent was obtained from participants in lieu of collecting the signatures from participants.
- Letter of Information – last updated 12/6/2019. This document incorporates all of the required and alternative elements of informed consent, but modifies language slightly to reflect that affirmative signatures are not being collected from participants or their Legally Authorized Representatives.
Alterations of Informed Consent
For non-exempt projects, informed consent documentation that has not been altered must include 15 required elements of informed consent, and 11 additional elements that must be included when pertinent to the particulars of the study. An informed consent process that has not been altered must take place before participation in the study begins, under the circumstances described in 45 C.F.R. 46.116, and with appropriate signatures, witnesses, permissions, and copies provided.
An alteration of the requirements of informed consent permits adjustments to the informed consent process and/or documentation, when all of the required elements for an alteration are present. The most common application of an alteration of informed consent is the use of deception, misinformation, or the withholding of pertinent information in a research study. An alteration permits disclosure of certain information at a later time; for example, once participation in a study has ended, or at the completion of all data collection. Researchers wishing to skip the informed consent process all together (i.e. never present participants with all of the required information in advance of study participation) must request a waiver of informed consent rather than an alteration.
To qualify for an alteration, the following criteria must be met:
- The research is minimal risk;
- The research could not practicably be carried out without the requested alteration;
- If the research involves use of identifiable information or biospecimens, the research could not practicablybe carried out without using the information/biospecimens in an identifiable format;
- The alteration will not adversely affect the rights and welfare of the participants; and
- Whenever appropriate, the participants or their legally authorized representatives will be provided with additional pertinent information after participation.
One of the biggest challenges investigators face in receiving an alteration of informed consent requirements concerns demonstrating the applicability of the criteria to the research. For example, it is insufficient to address the minimal risk criterion by simply stating that the research project is minimal risk. The investigator is required to state why the research falls under the definition of minimal risk (the definition for which is provided in the protocol itself). It is up to the investigator to explain to the reviewer why and how these criteria apply to their research when requesting an alteration of informed consent requirements.
Waivers of Informed Consent
Non-exempt studies may request a waiver of informed consent under certain circumstances. A waiver of informed consent should be requested when the research team plans to conduct the study absent informed consent. To qualify for a waiver, the following criteria must be met:
- The research is minimal risk;
- The research could not practicably be carried out without the waiver;
- If the research involves use of identifiable information or biospecimens, the research could not practicably be carried out without using the information/biospecimens in an identifiable format;
- The waiver will not adversely affect the rights and welfare of the participants; and
- Whenever appropriate, the participants or their legally authorized representatives will be provided with additional pertinent information after participation.
One of the biggest challenges investigators face in receiving a waiver of informed consent is demonstrating the applicability of the criteria to the research, rather than simply restating the criteria. For example, it is insufficient to address the minimal risk criterion by simply stating that the research project is minimal risk. The investigator is required to state why the research falls under the definition of minimal risk (the definition for which is provided in the protocol itself). It is up to the investigator to explain to the reviewer why and how these criteria apply to their research when requesting an alteration of informed consent requirements.
Obtaining Informed Consent for Exempt Studies
With the Revised Common Rule coming into effect in 2019, the number of exempt studies at Utah State University have nearly doubled. While the exemption categories are significantly broadened from the pre-2019 Rule (see our Revised Common Rule page for more information about that), they are also more complex. Many new exemption categories require a consent process, certain confidentiality protections, prospective agreement to certain types of interactions, and more.
Whenever a study involves prospective interaction with participants, researchers should seek informed consent prior to participation. The requirements of what information must be shared, however, are considerably more flexible than what must be shared for an Expedited or Convened IRB study. To assist with informing participants about the key information in your study without added form length, the IRB has developed an abbreviated informed consent/letter of information template that you can use for most exempt studies involving legal adults with capacity to render informed consent. Below, you will find all templates that are available for your use in Exempt studies; please review their full descriptions before choosing one for your study.
- **New!** Exempt-Specific Consent Document. This abbreviated document can be used for most exempt research involving adults.
- Informed Consent Template. For more complex exempt studies (i.e. utilizing several different exemption categories) the Informed Consent template might be more appropriate, and you can still delete many of the subheadings.
- Letter of Information Template. If your project deals with sensitive information that is identifiable, consider use of the Letter of Information template so that you can fully communicate the protections built into your study, as compared to the Exempt-Specific Consent Template.
- Family Informed Consent Document. If children are involved with your exempt study (typically, Exemption #1), this template must be used; the Exempt-Specific Consent Document is not available for gaining informed consent from parents regarding their children’s involvement in research.
- HIPAA Authorization. In general, you will not use this in an exempt study; Exemption #4 (“the HIPAA exemption”) requires that access of the records be in a circumstance where “consent would not ordinarily be required.” However, there may be circumstances in which your exempt project involves gaining an Authorization from participants to acquire their Protected Health Information. You may want to contact our office before using this template with your exempt project to ensure the project is not Expedited.
HIPAA & FERPA Authorizations and Waivers
The Health Insurance Portability and Accountability Act (HIPAA)
HIPAA protects individuals’ medical records from unauthorized access and use. Medical records, however, are often integral to learning more about important research questions. There are generally two ways to access this information, called protected health information (PHI), within a human subjects research project: authorizations and waivers. For information on Limited Data Sets and Limited Data Use Agreements, reach out to the Privacy Officer for the entity that maintains the PHI you are interested in.
Authorizations are written and signed permissions to access an individual’s protected health information. A template is available here.
Waivers are available under certain circumstances, closely mirroring the requirements for waivers of informed consent. To qualify for a waiver, the request must meet the following criteria:
- The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals;
- The research could not practicably be carried out without the waiver; AND
- The research could not practicably be carried out without access to and use of the protected individually identifiable health information.
If a waiver is granted, the PI is required to demonstrate all of the following within the protocol:
- An adequate plan to protect the identifiers from improper use and disclosure;
- An adequate plan to destroy the identifiers obtained via the waiver at the earliest opportunity; and
- Written assurances that the protected health information will not be reused or disclosed to any other person or entity, or for other research purposes.
A template for requesting a waiver is available here. While the USU IRB can grant waivers or approve Authorization templates, only the covered entity holding the PHI can determine whether the release is appropriate. Approval by the IRB does not guarantee your access to protected health information, and you must check with the covered entity to ensure that their policies permit the kind of sharing contemplated in your research protocol.
Family Educational Rights and Privacy Act (FERPA)
FERPA protects access to and gives families certain rights over educational records maintained by any educational entity that receives federal funding. It gives certain protections to records that are maintained by the educational entity. Unlike HIPAA, FERPA has no waiver process. Accessing, using, and/or analyzing FERPA-protected records requires Authorization (a template for which is available here) or access under certain criteria, which are enumerated more fully in our FERPA Guidance.
Both the HIPAA & FERPA Authorization templates can be combined with the Informed Consent Templates, all of which are available under the last lab on the left side of this page.
All Templates Related to Informed Consent
|Informed Consent and Assent||This document is the baseline documentation required for Expedited & Convened IRB studies. It is most appropriate for use with adult populations, or where an adult and a child are separately participants in the study.|
|Informed Consent and Assent for Families||This document is adapted from the one above; it is designed for studies in which a parent or guardian is giving informed consent for their child or ward to participate in a study (i.e. children are the primary participants, not both children and their parents).|
|Letter of Information||This document should be used for Expedited & Convened IRB protocols in which a waiver of documentation of informed consent is being sought. It meets all of the requirements for Informed Consent but is modified to leave out a signature or other affirmative responses that are included in the Informed Consent and Assent document, above.|
|Exempt Informed Consent/LOI||This document can be used for most Exempt studies involving adults as their own legal decision-makers. It is significantly shorter than the templates above, given that the regulations specify many fewer required elements|
|Short Form Documenting Oral Consent (English) (Spanish)||This document should be used when the process for obtaining oral consent is utilized. It should be used in conjunction with one of the forms above absent a waiver or alteration request.|
|HIPAA Authorization||Studies that involve the use, access, or disclosure of Protected Health Information require an Authorization or a waiver; this is the Authorization. It may be combined with the Informed Consent template, above.|
|FERPA Authorization||This brief template contains all of the required regulatory elements to access identifiable education records under FERPA. It may be combined with the Informed Consent document, above.|
|Research + Programming Template||This template contains all of the required regulatory elements of the informed consent process, while incorporating more structure to help participants understand the distinction between the research and the underlying program or services the research is being paired with.|
|COVID-19 Informed Consent Update||This new template is available for researchers who are amending their protocol in light of changes required by COVID-19, such as moves to remote research procedures.|
|COVID-19 Resumption of In-Person Research Information Template||This new template is available for researchers who are requesting to resume in-person research activities while in-person research procedures remain under restriction to prevent the spread of COVID-19.|