IRB Guidance: Informed Consent
Informed Consent is a federal requirement intended to provide clear and concise information that a reasonable person would want in order to decide whether or not to participate in the research. Information should be written in such a way as to be easily understandable to the participant population included in the research.
Unless the IRB approves a waiver of informed consent, no researcher may involve a human subject in research unless he/she has obtained the informed consent of the participant.
The Consent Process and Documentation
The default consent process is for a researcher to have the participant sign a written document called an Informed Consent Form. However, the IRB has the ability to approve any number of other consent processes—but it is the responsibility of the researcher to provide the IRB with an appropriate justification as to why an alternative to the signed consent form is most appropriate for the study that is being reviewed.
Consent forms must be presented to the IRB in the format in which they will be used. Although not all inclusive, the following are examples of common alternatives to the signed consent form:
Waiver of signed consent (no signature is obtained)
- Oral consent
- May be appropriate for telephone interviews, when there may be literacy issues, or when a signed document is not culturally appropriate.
- Information sheet
- Largely used for mailed surveys: “By completing and mailing back this survey, you are consenting to participate in the research.”
- “Click here” type of online consent
- Research where obtaining a signature is impracticable in an online environment.
- Most appropriate for deception research, where the true purpose or another major element(s) of the research is not revealed until the end of the study.
- Secondary data analysis
- Unless identifiers are needed in order to meet the aims of the research, non-identifiable data should be used whenever possible.
- Observation of non-focal participants, so long as any data collected about those persons is completely de-identified/in aggregate.
- NOTE: This does not apply if any form of audio/visual recording is being conducted during observation.
Documentation of Consent for the Participant
- Participants should always be offered a copy of the consent document, whether it is in-person, e-mail, online, or a copy of the oral script.
- Participants also need to have access to contact information for the PI and the IRB. In rare events where the IRB determines that having a copy of the consent document in their possession could present a risk to participants (i.e. some international sites), a business card or similar method can be provided to research participants that contains contact information.
Regardless of the format of the consent process, consent documents must include the following Required Elements of Informed Consent:
- The study should be clearly identified as a (UW-Madison) research study.
- Title of the study (one that matches one of the titles given on the first page of the IRB application)
- Include a description of the purpose of the study.
- Describe what the subject’s participation will involve, including the estimated duration/time commitment.
- Any potential risks (and steps the researcher has in place to mitigate those risks) **Risks must match those outlined in the Arrow application. Those risks could include:
- Sensitive topics, or questions that evoke an emotional response.
- The risk of a breach of confidentiality.
- Any potential benefits:
- There are typically no direct benefits to participating in minimal risk research.
- Steps to ensure confidentiality of research records:
- A statement of who will have access to data, protection and security measures for data such as the use of pseudonyms, data encryption, password protection(s), and secure storage of all data including audio, video, and photos (as applicable).
- If collecting/using private identifiable information or identifiable biospecimens, one of the following statements must be included regarding future research:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
- Any compensation:
- Parking pass, gift cards, extra credit, etc.
- Ensure that the amount or type of compensation is not coercive.
- Compensation is not a benefit and should be listed in a separate section of the consent form.
- Whom to contact with questions:
- Campus contact information (wisc.edu email and/or phone) should be listed for the PI/researcher(s). If a campus phone number is not available, personal numbers can be listed. **Please consider participant privacy and confidentiality when using a personal cell phone, and that your number will be available to potential participants for as long as that number remains active.
- IRB contact information as follows:
- If you have any questions about your rights as a research participant or have complaints about the research study or study team, call the confidential research compliance line at 1-833-652-2506. Staff will work with you to address concerns about research participation and assist in resolving problems.
- A statement that participation is voluntary:
- Participants must have the ability to skip or decline to answer any questions and subjects can withdraw at any time.
- The majority of modifications requested by the IRB are due to consent form errors. The Consent Form Wizard is a tool for those submitting to the ED/SBS IRB to help ensure all federally required elements of consent are included. Access to this tool can be found at:
- The Wizard aids in creation of a template consent document that researchers must then proofread and edit to an acceptable format for the intended audience. Also, the elements of consent outlined in the consent document should mirror what is in the IRB application (e.g., the risks outlined in the consent should be the same as the risks outlined in the application).
- The Wizard is only recommended for those submitting to the ED/SBS IRB as it does not address some issues common to biomedical research. For those submitting to the HS IRB, please be sure to use the templates provided on their website instead.
Assent for minors
- Any research activity that includes minors as participants must also include an Assent process.
- Recruitment of minor participants must begin with the parent or guardian.
- Once parent/guardian consent is obtained, minors may be recruited and provide their own assent.
- Assent forms should be written at an age-appropriate level.
- Typically written assent would only be obtained from minors age 11 and older. Those under age 11 would likely provide oral assent.
- If the consent document will be presented in a language other than English, translated documents are required to be uploaded to the ARROW application prior to final IRB approval.
- Required for research taking place in private homes and/or where the Study Design indicates that information that might require reporting could be obtained.
- When written consent is approved by the IRB, the approved consent form will have an approval date stamped on it.
- NOTE: This does not apply if the project is determined by the IRB as Exempt
- Only the most current stamped consent forms should be used; outdated consent forms should not be presented to participants.
- For consent process(es) other than signed consents, the Study Team should have a process in place for how the researcher(s) will document that each person from whom data was collected provided informed consent through the appropriate approved method.
- Along with other research data, the complete, signed consent forms must be stored and retained on campus for at least 7 years after the completion of the study. These and/or other documentation that consent was appropriately obtained may be requested for review during an audit process.