Get Informed Consent
Find tools to implement the informed consent process for your research participants including language guidance, document templates, and operational best practices
What is informed consent in research?
Informed consent is not just a form to sign or a one-time conversation. Explore the elements of the informed consent process and learn more about the rights of research participants.
Informed consent process overview and requirements (NIH)
Documentation information
Informed Consent Form (ICF): Templates and editing
Informed Consent Form (ICF): Templates and editing
Find templates and learn more about the required components of the informed consent form.
Informed Consent Form templates from the UMN IRB
All UMN studies are required to use the template for their designated research type (Biomedical: #592, Social/Behavioral/Education: #582). Consult the red instruction text within the template for editing guidance.
Plain language guidance
Using clear language that is easy to understand is critical for IRB approval and facilitating a successful consent process.
HIPAA and additional required documentation
HIPAA and additional required documentation
HIPAA authorization form and requirements
Find templates, policies, and best-practices related to HIPAA authorization for research participants.
HIPAA authorization for non-English speaking participants
There are additional steps and documentation requirements for HIPAA authorization for non-English speaking participants. These are required regardless of if you use the Short Form consent process or a translated ICF.
Consent process documentation
In addition to the main research consent, study teams need to provide documentation of the consent process itself. Items that must be documented are that the participant was given enough time to review the consent form, they had the opportunity to ask questions and that they received a signed copy of the consent form.
Short form and waivers of consent
Learn more about emergency use authorization, compassionate use waivers, and the short form consent process.
Support for sponsor-provided informed consent form templates
Support for sponsor-provided informed consent form templates
The University of Minnesota's Institutional Review Board (IRB) can negotiate consent language directly with any sponsor that provides a consent template as part of the study initiation process. Study teams should contact their IRB representative to discuss this process and next steps.
Remote consenting and REDCap eConsent
Remote consents
Completing the informed consent process through either phone or video call is called remote consenting. A mailed paper consent document may be used or you can incorporate eConsents.
eConsent process and REDCap
Research teams wishing to use a digital platform in lieu of a paper consent document need to select an approved platform. View the guide above for guidance. Note, eConsenting is different from remote consent. eConsents can also be used for in-person consent conversations.
Language and conversation best practices
Using plain language
For research participant consent to be truly informed, research teams must use clear language in all communication including documents, conversations, and correspondence. Some areas to consider:
- Avoiding complex scientific and medical terms: Research teams should explain the purpose, design, and considerations for their study in a way that the general public can understand. For biomedical studies, clinical terminology should be avoided. Explore these suggestions for common research terms from Northwestern University.
- 5th–8th grade language: All participant-facing communication should be at no higher than an 8th grade reading level. Research teams should use short sentences within forms and emails. Use the Hemingway Readability Checker to check your current communication.
- "Show, don't tell": Beyond the required informed consent form, study teams should consider using supplements to visually communicate critical information to participants. Examples include using infographics, tables, and short videos. See these additional consent supplements and participant instruction ideas and submit any participant-facing materials to the IRB for approval prior to use.
Conversation structure
Prior to signing the informed consent form, research teams are required to give enough time for participants to think about their voluntary participation in the research study and ask questions of the study team.
Consider how you will structure your informed consent process to ensure that participants are fully informed and don't feel rushed. While some teams do one main consent conversation, many teams like to have a brief, remote conversation to frame the study, provide a copy of the informed consent form to the participant to read at their own pace, then have a more detailed conversation on a different day.
Remote consenting can be a good option for some study teams. For more information, see the Documentation section above.
Ensuring comprehension
Staff or faculty leading consent conversations should check in with their participants throughout the process to ensure comprehension, particularly in critical areas of informed consent like study purpose, risks, and benefits.
The teach-back method is a clinical communication approach that research teams can tailor for their consent conversations.
Teach-back method: Brief video
Another medical conversation approach that can be tailored for all research teams, regardless of discipline, is shared decision making.
Special populations and situations
Certain populations may be at a higher risk of coercion if they participate in research studies. Children, pregnant individuals, and incarcerated persons are all protected vulnerable populations. Learn more about the federally required protections for these populations.
Additional special populations that may be at a lower, but still elevated, risk of potential coercion include individuals with cognitive impairments, medical students, lower socioeconomic status populations, health system/university employees, unhoused/highly-mobile people, and individuals with select disabilities. These populations may require additional parameters for recruitment and consent.
In addition to federal regulations, there are Minnesota laws that impact research activities. Populations impacted by Minnesota law include, but are not limited to, minors, adults deemed cognitively incapacitated or incompetent, and persons with psychiatric involuntary holds or commitments.
In some situations, there may be a waiver of the traditional informed consent process of an investigational drug, device, or biologic due to emergency use situations. These may include:
- Life-threatening situation or severely debilitating (diseases or conditions that cause major irreversible morbidity)
- No standard acceptable treatment is acceptable
- Necessitates the use of the investigational drug or biologic or device
- Not sufficient time to obtain IRB approval
For more information: Emergency use authorizations UMN IRB webpage
For individuals with certain life-threatening or serious conditions, an Investigational Device Compassionate Use waiver may be warranted. Compassionate use cases generally fall under the following circumstances:
- The patient has a life-threatening or serious disease or condition;
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; and
- Potential patient benefit justifies the potential risks of the investigational device.
Prior FDA approval is needed before compassionate use occurs. For more information: Device compassionate use: UMN IRB webpage
Non-English-speaking populations
Individuals that speak languages other than English require additional informed consent protections. The two main use cases for consenting non-English speaking populations are detailed below. Both processes require an approved interpreter and have additional HIPAA authorization requirements. Learn more about the available interpreter services, including a comprehensive guide and webinar.
Short form informed consent process
Short form informed consent process
This process is used when the study team unexpectedly identifies a non-English speaking prospective participant. A shortened, non-study-specific consent form is presented alongside the standard, approved English study ICF and an approved interpreter (see below) conducts the consent process.
The short form process can only be used a limited number of times and has additional requirements, including having a witness who speaks both languages in addition to the translator. The IRB has a library of consent short forms in common languages (Form #507).
For more information, watch the IRB overview workshop and reference the section titled "What about participation of individuals with limited English proficiency, meaning non-English speakers?" in the IRB Investigator's Manual and continue to the subsequent sections (page 58 as of Feb 2025).
Translated ICF and participant documents
Translated informed consent forms and participant documents
Study teams should use a translated informed consent forms and any participant documents if they are expecting to encounter multiple non-English speaking participants (e.g., recruiting from non-English speaking communities, clinic serves a high population of non-English speaking patients.
Requirements for certification of translated versions vary based on the IRB risk classification and if any study staff are native speakers. For more information, reference the IRB Short Form Worksheet (#317) and the IRB Investigator's Manual section titled "What translation or certification services are acceptable or required?" (page 60 as of February 2025).
Training and additional resources
The University and our research affiliates offer a range of training opportunities on informed consent in research.
CTSI's Informed Consent in Human Research Series is the primary live training offering. Part I is aimed at individuals onboarding to research and Part II can be offered either as onboarding or as continuing professional development.
Self-paced eLearning
Self-paced eLearning
Assessing Capacity to Consent in Research
Provides researchers an overview of key concepts, IRB policies, standard operating procedures, and a checklist developed to ensure these protections for participants with potentially diminished or fluctuating capacity. This training may be required by the IRB for certain studies and includes information on administering the UBACC and MacCAT-CR. UMN login required.
Research Ethics
Ideal for individuals interested in learning how historical events in research have impacted informed consent requirements. UMN login required.
Supplemental CITI modules
In addition to the training modules required for study personnel, the CITI program offers additional modules on informed consent, including protections for vulnerable populations and special situations. Select "add a course" at the bottom of your CITI Dashboard to explore available offerings.
Ongoing professional development
Ongoing professional development
Clinical Research Professional Development Series
The CTSI's professional development series for clinical research professionals offers seminars on a range of topics, including informed consent. A library of recordings is available for university affiliates. Past consent topics have included:
- REDCap eConsent: Best Practices & Demo:
Recording: REDCap eConsent
- Undue Influence in Informed Consent:
Recording: Undue Influence
- Using the HIPAA Authorization Form:
Recording: HIPAA Authorization Form
IRB "Lunch and Learn" Series
IRB staff lead regularly scheduled lunch conversations covering topics related to IRB topics, including aspects of the informed consent process.
Past consent topics have included:
- Elements of Consent: Recording
- Minnesota laws affecting research: Recording
- Overview of the Short Form process: Recording
Essentials for Regulatory Specialists
A hybrid workshop ideal for individuals looking to grow their skills in consent-related regulatory practices.
External offerings
External offerings
Simplifying informed consent
This recorded seminar from HHS's Office of Human Research Protections (OHRP) discusses practical examples on how to discern meaningful information for potential participants, how to present information simply, and materials to ensure consent processes fulfill their goal of enabling potential participants to make informed decisions about whether to participate in the research.
Developing consent protocols and procedures
This seminar from the NIH's Office of Clinical Research Education and Collaboration Outreach is part of a series titled "Introduction to the Principles and Practice of Clinical Research (IPPCR)." Enroll in the series
Participant-centered informed consent training
This 95-minute, on-demand module is offered by HHS's Office of Human Research Protections (OHRP).