Informed Consent

Informed consent can be obtained several ways:

Written and signed consent is the most familiar approach, where participants sign a detailed consent form after reviewing information about the study's purpose, procedures, risks, benefits, and their rights.

Verbal consent is often appropriate for low-risk studies, where researchers document oral agreement rather than requiring signatures. This is often used before interviews or focus groups, or when written documentation poses the primary risk. An information sheet, "postcard consent," or script should be submitted to COMIRB for review. These methods of consent are approved as a "waiver of documentation of consent," where documentation refers to the subject's sugnature.

Electronic consent uses digital platforms to present information about the study and to capture the participants agreement. Consent is documented explicitly with an electronic signature, or implicitly through, for example, the participant's choice to complete an electronic survey.

Waiver of consent may be granted by COMIRB in limited circumstances. Waiver of consent means participants are not informed about part or all of the study before they are enrolled.

For research on children, the child's assent is typically obtained in addition to consent from one or both parents.

For adults who are unable to provide consent, consent is obtained from a legally authorized representative (LAR) or a proxy decision maker unless consent is waived.

Write your consent forms and information sheets with plain language. You want participants to easily understand your study. If you need suggestions for plain language descriptions of common research procedures, risks, or concepts, the following resources may be helpful:

 

COMIRB's Standard Language Options

 

NCCN Informed Consent Language Database

 

MRCT Clinical Research Glossary

 

Plain Language Medical Dictionary

Regulatory Background:

"Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension." (45 CFR 46.116(a)(5)(i))

Relatively simple research studies which can be explained with a short consent form would meet this requirement. Longer consent forms must begin with a Key Information section.

General Guidance:

Be succinct. If the Key information section is more than a page and a half, it is probably too long. Remember that more detailed descriptions of the study will follow later in the consent form.

Purpose of the Study:

“We are doing this study to learn more about ….
[No more than 2-3 short sentences. If the study involves unapproved drugs or devices, state that the drug or device is “investigational.”]

- For many clinical trials of a drug or device, a single sentence can adequately describe the purpose of the study. For example, "We are doing this study to learn about the safety and effectiveness of [drug/device] for the treatment of [diagnosis/condition]. You can elaborate later in the consent form.
- For clinical studies investigating a biologic outcome instead of a health outcome, a couple sentences may be necessary to explain the science.
- For first in human studies, state, “This is the first time ___ has been given to humans.”

Procedures:

If you agree to participate, the following will happen:
[Less than half a page. Summarize the main procedures only. Identify the arms of the study, if applicable. Do not include detailed descriptions of each procedure. Do not include optional procedures. Summarize length of participation in terms of total visits and total length of time (i.e., 12 visits over 2 years).]

- Identify the main procedures or events. Leave detailed descriptions of the procedures for later in the consent form.
- If subjects undergo screening, state simply, "You will have a visit to see if you are eligible for the study." Leave details of screening procedures for later in the consent form.
- If the study involves multiple arms, identify the arms of the study.
- If study involves randomization, say subjects do not get to choose which arm they are in. Leave details of the randomization process for later in the consent form.
- If the study is blinded, say subjects will not be told which study treatment they are receiving.
- Summarize the length of participation in terms of approximate number of visits and/or total length. For example, You will be asked to make about 10 study visits over one year." Leave details of the visit schedule for later in the consent form.
- Do not describe optional procedures in the Key Information.

Risks:

Participation in this study involves risks, including the following:
[Less than a third of a page. Summarize the most important and/or serious risks.]

- Summarize the most important risks to participants. The most important risks include the most serious and most expected risks of the intervention.
- Do not list every reasonably foreseeable risk. A full description of risks will be included later in the consent form.
- Leave estimates of likelihood and categorizations of specific risks for later in the consent form.
- Omit minor risks of research procedures which are not investigational. For example, in the context of a clinical trial of a drug or device, do not list the risks of blood draws for study labs under Key Information.
- It is unnecessary to include risks of loss of privacy/confidentiality in the Key Information section. The actual risks of loss of privacy/confidentiality are minimal and are covered in detail later in the consent form.
- Do not list risks of optional procedures.
- For research on approved drugs, devices and procedures, you may find clear summaries of risks on other web sites for hospitals or academic medical institutions.

Benefits:

There is no guarantee that your health will improve if you join this study. This study may lead to information that could help patients and health care providers in the future.

- Do not re-state the purpose of the study.
- If there is no prospect of direct benefit to the subject, revise the first sentence to read, “You will not directly benefit from being in this study.”

Alternatives:

Routine care for your condition involves [summary]. You do not have to participate in this study to receive treatment for your condition.

- If participants can receive the study intervention without participating, state, "You may be able to receive any of the treatments in this study without participating in this study."
- If palliative care is a reasonable option; "You can choose to receive supportive care."
- Omit this section if the study is not a health intervention, e.g., when the alternative is simply not to participate.
- Do not include participating in other research unless it is clear there is an open study locally for which the subject is likely eligible.

Using AI

The university has licensed Copilot as part of Office 365. COMIRB has no objection to using this service for editorial assistance for writing the Key Information section (or any part of the consent form except our required language).

You are responsible for the final product so edit the results carefully.

The wording in COMIRB template consent forms regarding injury, costs, and HIPAA may not be edited.

Electronic consent or "e-consent" refers broadly to a process by which researchers use a digital platform to obtain a legally effective electronic signature from a research subject.

A few important issues to keep in mind:
- If you will be obtaining HIPAA Authorization, the electronic system must be HIPAA compliant.
- If your research must be conducted under an IND or IDE, the electronic system must be 21 CFR Part 11 compliant.
- If you are obtaining consent from residents in Europe, the electronic system must be GDPR compliant. See COMIRB GDPR Guidance.

The study team will need training on how to use the digital platform and how to be certain that participants have completed all necessary steps (usually several) to finalize their electronic signature before they are enrolled in the research.

For more information see COMIRB guidance on e-consent.

See COMIRB guidance on enrolling children in research.

Review COMIRB guidance about conducting research with adults with impaired decisional capacity.

Consent Process

To enroll participants who are unable to read or understand English, you may obtain informed consent in one of two ways:

- Provide a consent form that has been translated from English into a language the potential participant understands, or
- Use a short form consent translation provided by COMIRB and, if applicable, a HIPAA translation.

In both cases, the involvement of an interpreter and prior IRB approval of the inclusion of non-English speakers is required.

Translating the consent form

1) Get the English version of the consent form approved by COMIRB.
2) Have a translation service translate the approved consent form.
3) Submit an amendment to COMIRB to approve the translation. Upload a certificate from the translation service.

Options for translation services can be found here.

Additional links on the use of short forms

- COMIRB translations of short forms and HIPAA authorizations
- COMIRB Guidance: Short Form Consent Process for Non-English Speakers

COMIRB has a template consent form for tissue banking and/or specimen collection.

We recommend that the consent form cover a variety of potential uses of tissue samples, even if immediate plans for the samples may be very specific. Potential uses include genetic analysis, creation of cell products, and sharing data and specimens with researchers at other academic institutions, the government or private industry. If your consent form does not cover one of these uses, and you later propose such a use, you may be required to reconsent participants.

Consent forms should also discuss the possibility that data from the research may be shared in a restricted or public data repository in the future. Some scientific journals make data sharing a requirement for publication (e.g., PLOS). The NIH also requires data sharing as a condition of award, so, if the consent form does not discuss broad sharing of data, the samples may be ineligible for use for future NIH awards without re-consent

 

Most research involving only online surveys is "Exempt" under IRB regulations. Participants should still be informed about the study before they agree to participate.

Start with our Information Sheet Template. We recommend that you post this information on the first page of the online survey and end with one of the following statements:

1) "If you agree to participate, please continue and complete the survey."

2) "If you agree to participate and to provide your consent electronically, please [check an "I agree to participate box," type your initials, type your name.].

If the research is "Expedited" rather than "Exempt," COMIRB can still approve this as informed consent. Option 1 can be approved as a waiver of documentation of consent. Option 2 can be approved as signed electronic consent.

HIPAA authorization must be obtained from any subject enrolled in a study involving the collection and/or disclosure of Protected Health Information (PHI), unless COMIRB has approved a full waiver of HIPAA authorization for that study. As most research taking place at CU Anschutz or our affiliate healthcare involves some form of access to PHI, study teams should typically use one of COMIRB’s combined informed consent and HIPAA authorization template (available on the COMIRB Forms page) when enrolling subjects.

HIPAA authorization is not required for research in which investigators do not access or collect PHI.

For survey research, self reported health information may or may not be considered PHI depending on where the participants are recruited. Contact COMIRB if you have questions about this.

Please see COMIRB guidance on waivers.

If you need a consent form for emergency use, single-patient IND, or other compassionate use that does not require full IRB review and approval, start with the Compassionate Use consent form template. Edit the consent form by including descriptions of the drug or device, the procedures and risks.