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In human subject research, informed consent is how we try to make sure a person clearly understands all the important details about a decision, including what will happen to them and to their information, the risks, benefits, and the other options available, before they agree to be in a study. It is an essential legal and ethical rule that helps protect a person’s right to make their own choices.

Consent is a process that usually involves a discussion and an opportunity to ask questions and ensure understanding. The process is delivered by the qualified researcher or their documented designee and includes:

  • Providing Information about the study, including the purpose of the research, what participants will be asked to do, how long it will take, any potential risks or discomforts, expected benefits (if any), alternatives to participating, and how their data will be used and protected.
  • Ensuring Understanding. The researcher must make sure the participant truly understands the information. This may involve using simple, clear language, answering questions, and checking the participant’s comprehension of the information provided.
  • Voluntary Agreement to be in the research. Participants must choose freely to take part, without pressure or coercion. They are told that participation is voluntary, and that they can refuse or withdraw at any time without penalty.
  • Documenting Consent. Obtaining consent includes providing participants with a document, called an informed consent form, that is approved by the IRB and signed by the participant or their legally authorized representative. In many cases, a written copy should be given to the person signing the informed consent document.
  • Ongoing Process. Informed consent is not just a one-time step. It continues throughout the study. Participants are updated if anything changes that might affect their decision to stay in the research.

 

Templates

To get started, the IRB recommends you use one of our consent templates to write your consent document. Our templates are designed to help you meet the legal requirements for consent, and if your study includes protected health information (PHI), authorization.

There are many ways to document consent and (if applicable) authorization. Go to the section on this page titled “Examples to Help You” to see other ways you can document consent.

Properly preparing and formatting your documents for submission to the IRB is an important part of ensuring a timely review. One of the most common revisions the IRB staff requests is related to formatting documents with our “watermark footer” so ERICA can stamp your forms. Make sure you are well-versed in the IRB’s document requirements.

Submitting Documents for IRB Approval

Future Use of Data & Biospecimens

The IRB reviews and approves research that involves the collection, use, storage, and re-use of all biospecimens, human tissue, blood, or genetic material that are generated within, transferred to, or transferred from the University of Utah and its covered entity, as well as all associated data generated from the biospecimens. The University of Utah IRB does not utilize the option for broad consent (45 CFR 46.116(d)).

If collecting private information or biospecimens for future use is part of a larger study, the University of Utah allows either a separate consent form, or you may include this information in the main consent form. If it is included in the main consent form, it must have a clearly labeled section for the biospecimen bank or data repository.

We have detailed guidance on this topic that goes into depth about contributing to and building repositories, using collected data and biospecimens for research, and data and material transfer agreements. You can explore these topics and more on our Future Use of Data & Biospecimens page.

Future Use of Data & Biospecimens

When collecting or using data or samples for research, the consent process must include specific required information. To help you, two sample templates are available. These templates contain all required language and can be adjusted to fit your study.

Data and Biospecimen Retention & Future Use Consent Template

  • Discussion

    The purpose for collecting the identifiable private information or identifiable biospecimens should be explained. If biospecimens are collected, state the type of sample (e.g., blood, urine, tissue, etc.).

    The level of specificity for the purpose and types of future research is determined case-by-case. Authority is given to the IRB to determine how specific a consent form should be, based upon the following regulatory requirements and guidelines.

    Sample Language

    • We would like to keep [insert specific biospecimen, e.g., blood, urine, tissue, etc. and/or description of information].Option for specific disease/condition:Your [sample and/or information] may be used in future research about [insert specific disease or condition] to help us learn more.Option for no specific disease/condition: We don’t know what kind of future research will be done but we hope to learn more about diseases and how to treat them.Option for University of Utah-managed biospecimen bank or data repository: Your [sample and/or information] will be kept by Dr. [insert name] who manages the [biospecimen bank or data repository] at the University of Utah.

      Option for a sponsor-managed biospecimen bank or data repository: Your [sample and/or information] will be kept by the study sponsor, [insert sponsor name], who manages the [biospecimen bank or data repository].

    Regulatory References

    • 45 CFR 164.508(c)(1)(iv)

  • Discussion

    Some studies are designed exclusively for the purpose of banking biospecimens or creating a data repository.  If collecting identifiable private information or identifiable biospecimens for future research is the sole purpose of the study, this must be made clear to the participant.

    Other studies are designed to include the collection of identifiable private information or identifiable biospecimens as a sub-study to a larger study. For these studies, it should be clear whether or not it is mandatory to participate in the biospecimens banking or the data repository if the participant wants to be in the full study.

    You may not condition participation in a treatment/interventional trial upon mandatory participation in a tissue bank or data repository.  Participation in the tissue bank or data repository must be optional for treatment/intervention trials. For a more detailed review of the regulatory references, please read the IGS: Regulatory References - Consent Language for Future Use of Information and Biospecimens.

    Sample Language

    • Option for mandatory biospecimen banking or data repository (e.g., sole purpose of research study is to save samples or information for future research): If you do not want your [samples and/or information] to be saved for future research, you should not participate in this study.  No matter what you decide to do, your decision will not affect your medical care.
    • Option when choice given to bank biospecimens or information (note: participation in a biospecimen bank or data repository must be optional for treatment/intervention trials):You do not have to participate in the [biospecimen bank or data repository] to be in the main part of this study.  No matter what you decide to do, your decision will not affect your medical care.  You can tell us your choice by initialing one of the choices below:
      Option Description
      ___ YES,

      (initial)

      		 my [sample(s) or information] may be saved for future [specify a specific condition/disease] research.
      ___ NO,

      (initial)

      		 my [sample(s) or information] must be destroyed at the end of this research project.

    Regulatory References

    • 45 CFR 46.116(a)(2)
    • 45 CFR 46.116(b)(8)
    • 45 CFR 164.508(b)(3)(i)

  • Discussion

    State whether personally identifiable information will be collected with the sample.  Include the type of identifiers (name, date of birth, etc.) that will be collected.

    If identifiers are collected, state who will have access to the identifiable information (i.e. the Investigator, the sponsor, the other future investigators, etc.).

    In order to allow maximum flexibility for sharing samples and identifiers with future researchers, the IRB encourages you to state that samples and identifiers may be shared within the local institution, as well as the local affiliate institutions.  Local affiliate institutions include the University of Utah, VA SLCHCS, and Primary Children’s Medical Center. [N/A if the bank is managed exclusively by the sponsor on an external institution.]

    If identifiers are collected, state whether participants can choose to have their samples de-identified (de-identified means no identifiable link back to the participant exists).

    Sample Language

    • Option for de-identified samples: Your sample will not have your name or other personal information linked to it.  No one will be able to tell that you gave us the sample.  Your sample may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. The only information we will keep with the sample is information like your age and what disease you have.
    • Option for de-identified data: The information we collect from you will not have your name or other personal information linked to it.  Your de-identified information may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. The only information we will keep is information like your age and what disease you have.
    • Option for coded data: Your information will be coded so that your name is not kept with the rest of the collected data.  Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link back to the rest of your data later we need to.  Your information may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. Dr. <<insert name>> will not give your name to other researchers who want to use your information and will only give them the data without identifiers.
    • Option for coded samples: Your sample will be coded so that your name is not on the sample.  Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link your sample back to you later if we need to.  Your sample may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. Dr. [insert name] will not give your name to other researchers who want to use your sample and will only give them information like your age and what disease you have.
    • Option when choice offered regarding removal of identifiers from samples: We would like to code your sample so that your name is not on it.  Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link your sample back to you later if we need to.  But if you do not want us to keep your name or any other identifying information with the sample, you can choose to have your sample remain anonymous.  You can tell us your choice by initialing one of the choices below:
    Option Description
    ___ YES,

    (initial)

    		 my personal identifiers can be kept with my sample(s). All information will be kept secure and confidential.

     
    ___ NO,

    (initial)

    		 my name and identifiers must be removed from my sample(s).  My sample(s) cannot be linked back to me.

     

    Your sample may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative.

    • Option when choice given to de-identify data: We would like to code your information so that your name is not on it.  Dr. [insert name] and the University of Utah will keep your name in a separate place so that we can link your data back to you later if we need to.  But if you do not want us to keep your name or any other identifying information with your data, you can choose to have your data remain anonymous.  Your data may be shared with researchers at the University of Utah and at other institutions without additional informed consent from you or your legally authorized representative. You can tell us your choice by initialing one of the choices below:
    Option Description
    ___ YES,

    (initial)

    		 my personal identifiers can be kept with my data. All information will be kept secure and confidential.

     
    ___ NO,

    (initial)

    		 my name and identifiers must be removed from my data.  My data cannot be linked back to me.

    Regulatory References

    • Coming soon

  • Discussion

    Describe the procedures that participants should follow if they want to withdraw their biospecimens from the tissue bank or remove their information from a repository.

    Sample Language

    • Option for de-identified samples: Because we will not keep your name or other identifying information when we store your sample, you will not be able to have the sample removed from the bank later.
    • Option for de-identified data: Because we will not keep your name or other identifying information when we store your data, you will not be able to have your information removed from the data repository later.
    • Option for coded samples: You can have your sample removed from this biospecimen bank later.  You will need to contact [insert name] at [insert contact information].
    • Option for coded data: You can have your information removed from this data repository later.  You will need to contact [insert name] at [insert contact information].
    • Option when choice offered regarding removal of identifiers from samples: You can have your sample removed from this biospecimen bank later.  You will need to contact [insert name] at [insert contact information].  If you decide to have your identifiers removed from your sample, you will not be able to withdraw your sample later because it cannot be linked back to you.
    • Option when choice given to de-identify data: You can have your information removed from this data repository later.  You will need to contact [insert name] at [insert contact information].  If you decide to have your identifiers removed from your data, you will not be able to withdraw your data later because it cannot be linked back to you.

    Regulatory References

    • Coming Soon

  • Discussion

    The participant should be informed about the potential for development of a commercial product.

    This statement should address any biospecimens collected for future use (i.e., secondary use). It should be noted that if the study will be collecting biospecimens for use in a main study (i.e., the study uses biospecimens for both the main study and also collects biospecimens for future/secondary research), a statement must be made regarding commercial profit for the main study if subject to the Final Common Rule (2018 Common Rule). If a single statement is used to address both the use in the current research project and the future/secondary research use, it must clearly acknowledge both aspects.

    Sample Language

    If research participants will receive any payments related to products with commercial or product development, adjust the sample language as needed.

    • “The use of your data and biospecimens may lead to new tests, drugs, devices, or other products or services with commercial value. These products or services could be patented and licensed. There are no plans to provide any payment to you should this occur.”

    Regulatory References

    •  45 CFR 46.116(c)(7)

  • Discussion

    State whether the future results or findings will be given back to the participant.  If results or findings will be disclosed, describe the process for this interaction.

    Sample Language

    • Option for not disclosing future results:  Because the results from future research will not directly affect your health care, we will not share the results from future studies with you or your doctors.
    • Option for not disclosing future result because of de-identification: Because your [information/sample] cannot be linked back to you, we will not share the results from future studies with you or your doctors.

    Regulatory References

    •  45 CFR 46.116(c)(8)

Examples to Help You

A participant's consent must be documented in the research record as proof that the participant:

  1.  Was given the choice to participate,
  2.  Was given the necessary information about the study, and
  3.  Gave their affirmative consent before beginning the study.

This seems simple enough, but documenting consent can be complicated when you add local institutional policies, state and federal laws and regulations, legal considerations, and the long list of specific requirements that may be applicable to a study.

We recommend you begin with our template and use our Consent Document Checklist to ensure you have included all of the information that is required. This checklist is a simplified version of the checklist the IRB staff uses to review your documents.

Consent Document Checklist

A detailed version of our checklist is included here. We’ve divided the elements of informed consent into different categories that are applicable if your research involves specific elements.

There are many ways to document consent and (if applicable) authorization. Go to the section on this page titled “Examples to Help You” to see other ways you can document consent.

Properly preparing and formatting your documents for submission to the IRB is an important part of ensuring a timely review. One of the most common revisions the IRB staff requests is related to formatting documents with our “watermark footer” so ERICA can stamp your forms. Make sure you are well-versed in the IRB’s document requirements.

Submitting Documents for IRB Approval

Language Access for Non-English Speaking Participants

Information that is given to a potential research subject must be in a language understandable to the subject. This means that a researcher must conduct the consent process in a language that the participant understands.

There are some options available for ensuring your participants have access to the consent in their language. The University of Utah HRPP has provided many resources to the research community to ensure participants have the opportunity to be included in research, even if they have limited English proficiency.

  • Translations for Spanish Are Required. Local policy requires all prospective research with participant interaction conducted by University of Utah researchers within the state of Utah, to have provisions for including people who speak Spanish. Please review our policy on Spanish-Speaking Individuals in Research on our website.
  • Translations for Other Languages are Encouraged. Full translations of your consent documents in other languages are encouraged. The standards outlined in our Spanish policy are applicable to other languages, including the requirement to provide a translation certification. We encourage you to work with the Office of Research Participant Advocacy (OPRA) to get your documents fully translated. The IRB may also require full translations when appropriate.
  • Short Forms. Because there are situations when getting a full translation of the long consent document is impractical, the IRB may consider it appropriate to use a translated short form in combination with an oral interpretation of the full English consent document.A short form is like a cover letter to the full consent form that tells the participant what to expect during the oral consent process discussion of the study. When using the short form process to obtain and document consent, strict rules must be followed according to the federal regulations. Review our Short Forms Consent Process Instructions for Use page on our website for a full outline of the requirements.Visit our Translations Library to learn more and browse our translated short forms.

Translation Library for Short Forms

If you are using a Short Form to obtain consent from individuals with limited English proficiency, visit our Translations Library to find our short forms translated into multiple languages. The Short Form is a method to document informed consent and can be a tool to help research teams conduct the consent process in a language understandable to their participants. Review our Short Forms Consent Process Instructions for Use page on our website for a full outline of the requirements.

In the Library, you will also find the University of Utah Research Participant Volunteer's Bill of Rights. The Volunteer Bill of Rights is available for researchers to disseminate or for participants to download for themselves.

Describing the Process in Your Application

In the IRB application, you will be asked to describe the process for obtaining consent from your participants. The IRB recommends you practice obtaining consent for your study with someone and write down what you did. Adjust your process as needed to ensure it will work with a real potential participant. On the Consent Process page of the IRB application, describe the process you used in practical terms, so the IRB reviewers can follow along.

Consent information must:

  • Be clear, organized, and easy to understand
  • Help participants understand why they might or might not want to join the study
  • Avoid simply listing facts without context

Researchers typically present this information both:

  • In a written consent document
  • Through a conversation with the participant

Remember, consent is a process that usually involves a discussion with an opportunity to ask questions and ensure understanding. Documenting consent using an informed consent document is only part of what you need to do. The process is a discussion delivered by the qualified researcher or their documented designee and includes providing information about the study, ensuring understanding and voluntary agreement to be in the research, and an ongoing process that continues throughout the study.

  1. Begin with a concise and focused presentation of key information. Informed consent should start with a clear and short summary of the most important information to help people decide if they want to participate in the research.

    What needs to be included depends on the study. In general, the beginning of the consent form should briefly explain:

    • That the study is research and participation is voluntary
    • The purpose, length, and procedures of the study
    • Possible risks
    • Expected benefits
    • Alternative options, if any

For simple, low-risk studies, the entire consent form may be short and meet these requirements. For more complex studies with higher risks, the consent form may be much longer. In these cases, the key information at the beginning should still be short (just a few pages) and highlight the most important points. More detailed information can be included later in the document.

Information given in the summary at the beginning does not need to be repeated later in the consent form.

We recommend you read more about this on our Concise Summary page.

 Go to the Concise Summary Page

  1. Minimize the possibility of coercion and do not use exculpatory language. Researchers should take steps to avoid pressuring people or influencing their decision to join a study. In the ERICA application, they should describe how consent will be obtained and what they are doing to prevent pressure or undue influence.

    Participants must be given enough time and opportunity to ask questions and decide if they want to take part. Someone from the study team should be available to answer any questions.

    It’s important that participants do not feel pressured to join. Giving them time to think helps reduce this. For studies that require quick decisions, researchers should find other ways to reduce pressure.

    If the study includes people who may be more vulnerable to pressure, extra safeguards may be needed.

    Informed consent may not include exculpatory language. This means that the consent should not include language that waives or appears to waive any of the participant’s legal rights or releases the investigator, sponsor, or institution from liability for negligence.

  2. Ensure the language used in the process is understandable to the participant. Information that is given to the subject should be in a language understandable to the subject. This means that you must give information in a language that the participant understands. Use the language (English, Spanish, Vietnamese, etc.) that the participant speaks, reads, and understands.

    Read more about this in the section titled “Language Access” on this page.

In addition, complex terms, technical or medical terminology should be avoided or explained in lay language.  Use terms that are appropriate for the participant's understanding. For the general population, this means simplifying scientific terms, using short sentences, etc.

  1. Provide all the information and detail necessary to make an informed decision. Researchers must give participants all the information they need to make an informed decision about joining a study. This includes not only required elements of consent, but also anything a reasonable person would want to know before participating.

    Participants must also have the opportunity to ask questions and discuss the information before deciding.

    Some studies may require extra details like mandatory disease reporting, privacy protections, and future use of samples. Other review groups within the Human Research Protection Program (HRPP) may require specific information to be included in the consent process (e.g. Conflict of Interest, radiation safety).

    All consent processes must include required elements. Depending on the type of study and applicable regulations, additional elements may also be necessary. Researchers must ensure all required information is clearly communicated, whether spoken, written, or both.

  2. Give the participant an opportunity to ask questions before providing consent. It is important that participants understand what you have told them about the study. If the participant has questions about the study, the study team should ensure an appropriate individual is available to answer those questions.
  3. Give the participant enough time to consider being in the study. It is important the participants do not feel undue pressure to be in the study. Giving them enough time to think about their choice helps to reduce this pressure. It is recognized that some studies have urgent timelines for enrolling in a study.  In these cases, the study team must consider additional ways to reduce the pressure.
  4. Document that the participant's consent was obtained before beginning study procedures. Give a copy of the signed consent form to the participant. This is required in cases where consent is documented with a signature on a consent form.

    A participant's consent must be documented in the research record as proof that the participant was given the choice to participate, was given the necessary information about the study, and gave his/her affirmative consent before beginning the study.

Consent (and authorization) are commonly documented by obtaining a signature from the participant and then keeping the signed document in the research record. A copy of the signed document must also be given to the participant.

There are instances when the participant cannot give legally effective consent for themselves, such as when the participant is less than the age of majority or is cognitively impaired. There are also instances when getting a signature is not reasonable or practical.

Consent Process Examples

Consider the example scenarios below when designing your consent process. These examples may not be appropriate for all studies and should be customized to specific research when proposed to the IRB.

Consent Process Example

Description

Mailed or online questionnaire using a consent cover letter

When a questionnaire is minimal risk, a waiver of documentation of consent is often justified. When a consent cover letter accompanies the questionnaire, consent to participate is given by completing and returning the questionnaire.

Telephone consent process when a signed consent form is required 

Though a signed consent form may be necessary before beginning study procedures, it may be appropriate to obtain consent over the phone before the first study visit.

Opt-out parental permission for children's participation in research conducted at an elementary school

Based on the nature of a research project and according to the preferences of an individual school or school district, it may be acceptable to inform parents of research conducted at an elementary or secondary school and use an opt-out model if a parent wishes to have their child excluded from the study.  This model requires a waiver of documentation of consent in order to waive the signature requirement.

Consent process for non-English speaking participants using Interpreter Statement and Witness Signature

When a full translation of the consent form cannot be obtained, it may be appropriate to enroll a non-English speaking participant using a translated short form. A fully translated document has different witness requirements but still requires documentation of an interpreter being present during the consent process.

Consent process using FDA-compliant electronic consent (eConsent) in REDCap
A consent process using REDCap eConsent that requires FDA 21 CFR Part 11 complaince requires preparation in REDCap and a thorough explanation in the IRB application. This example provides an outline of how a study team can prepare and utilize FDA-compliant eConsent in REDCap.

Studies Using a Single IRB

Multi-site studies using a single IRB (SIRB) model require additional considerations. Balancing the need to maintain consistency of the information presented to participants and local considerations can be challenging. The University of Utah recommends you use a two-part consent model for your multisite SIRB study.

You can read more about how to Design Your SIRB Consent Documents on our dedicated SIRB website. If you are preparing a Utah-specific consent document for a study where we are relying on an external SIRB, the University of Utah’s Consent Document Language is also available.

Assent

Assent is when a person agrees to take part in a research study even though they cannot legally give full consent. This usually applies to children or adults with limited decision-making ability. Even though they cannot sign a consent form, asking for their assent helps respect their feelings and right to have a say.

Assent is a two-part process. It does not replace informed consent. Researchers must obtain assent from the participant and formal consent (permission) from their parent, guardian, or legally authorized representative. Like informed consent, the assent process is an interactive, continuous conversation rather than a one-time signature.

The IRB has an Assent template to help you get started. We also recommend you familiarize yourself with our local policies related to assent. Utah has specific laws that affect assent for children, and for adults with cognitive impairment.

Assent Document Template

Basic Elements of Informed Consent

The following basic elements of informed consent are described in the Common Rule, FDA, and International Conference on Harmonization (ICH). Additional elements of informed consent necessary under other regulations, such as Veterans Health Administration (VHA), Department of Defense (DoD), or HIPAA will have an additional checklist.

  • Discussion

    An explanation that the study involves research and the purpose of the research should be included. Briefly tell the participant why this research is being done, why the individual is being invited to participate and how this study will address the problem.

    Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement that consent is being sought for research and the purpose of the research should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

    Sample Language

    • You are being asked to take part in a research study. Before you decide, it is important to understand why this study is being done and what will happen.

      Please take time to read this information and talk about it with family or friends if you want. Ask the study team if anything is unclear or if you would like more information. Take time to decide if you want to take part in this study.

    • This study is being done to <<explain purpose of the research using simple, accurate language>>. This study is conducted by <<insert sponsor, granting agency, investigator, etc.>>.

    Regulatory References

    • 45 CFR 46.116(b)(1)
    • 21 CFR 50.25(a)(1)
    • ICH GCP 4.8.10(a) and (b)

  • Discussion

    The expected duration of participation should be stated. If applicable, include the total length of time that the participants will be involved both in the active study and for follow-up.

    Informed consent should begin with a concise and focused presentation of the key information. It is expected that a statement with the expected duration should be a part of that concise summary. For more about the concise summary, please see the Consent Process Checklist page.

    Sample Language

    • "The anticipated time for your participation in this research is approximately <<insert time, e.g. 1 hour, 3 hours, 1 day>>."
    • "The length of time you may spend in the study may be for as long as you are receiving benefit and will depend on your response to the treatment and whether you are having any side effects."

    Regulatory References

    • 45 CFR 46.116(b)(1)
    • 21 CFR 50.25(a)(1)
    • ICH GCP 4.8.10(s)