Informed Consent Guidance

Human Research Protections Program

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The principle of informed consent applies to all research: surveys, interviews, experiments, exercise studies, and so on. But even if a project does not meet the formal definition of research, a consent process (even if informal) helps protect research participants and shows the ethical choice to uphold the Belmont Report principle of respect for persons. Every participant needs enough information to make an informed decision whether to 1) enroll in your study, 2) keep participating, and 3) allow you to use their data for study purposes.

Informed consent isn’t a “one and done” event obtaining a signed form or a verbal “okay.” It should be an ongoing, transparent process that reflects a relationship of trust between you—the researcher—and participants. Throughout the study, you should be available to answer questions, encourage participants to ask questions or express concerns, tell them about any changes in study procedures or risks, and let them withdraw from the study for any reason at any time.

If you are the principal investigator, you should make sure all study team members are qualified to explain the research and trained to evaluate whether a potential participant understands study information. (List anyone who will be part of the consent process in the Study Team section of the HRPP application.)

  • Only individuals 18 years of age or older may consent to participate in a research study.
  • Minors under 18 may provide assent.
  • Parents/guardians may provide permission (note: not parental consent) for their child(ren) to participate in a research study.
  • Individuals with decisional impairments might require permission from a Legally Authorized Representative (LAR).
     

Stages of Consent

Online Consent

  • Online surveys usually involve implied consent because they end with a statement such as “By clicking to begin the study, I provide my consent to participate (although I understand my participation is voluntary, and I can stop at any time) and acknowledge that I am at least 18 years of age.” For simple or advanced surveys, Qualtrics offers help (with visual instructions) for building consent into your online surveys.

Oral Consent

  • In-person surveys, interviews, or focus groups involving non-sensitive information might use an oral consent process. Oral consent could involve saying or signing “yes” or giving a gesture like thumbs up.
  • Oral consent might also be appropriate if you will collect sensitive, personal information but not any identifiers (i.e., a person’s signature on a consent form would be the only information linking that person to the study). Generally, do not collect signed (written) consent unless necessary.
  • If your research population doesn’t have a written language or written consent would not be culturally appropriate, you will need to present all consent material in a manner (e.g., through an interpreter) or language appropriate for the population and document consent through another method (e.g., keeping a list and using a witness).


Written Consent

  • Obtaining signed forms will be most appropriate if you will collect direct identifiers and studies involve more sensitive information or involve physical activities or tasks. Remember: if you choose a written consent process, the research will not be anonymous.

Other Considerations

  • Multiple groups of participants and multiple activities require separate forms or approaches. Don't combine consent forms between populations and tasks. For example, you need separate forms if you will interview instructors and students. You also should have separate consent processes for someone who takes a survey and then agrees to participate in an interview.
  • When choosing a consent process, keep in mind that practicable is not the same thing as possible. If obtaining written consent would be the most appropriate, ethical process for your study, you should use that approach even if it might be inconvenient for you (due to conflicting schedules, additional time, minor travel). On the other hand, obtaining written consent might be impracticable, such as if you are not in the same physical location as a participant (e.g., phone or Zoom interview) or if you never interact directly with a participant (e.g., online survey or secondary data analysis of medical charts).

Use only HRPP templates and customize them for your specific study.

Required elements of consent: 

  • Study Title and HRPP Study Number
  • Your Name, Department/School, WWU email (Faculty adviser, if applicable)
  • (if applicable) Study Team (include anyone who will be part of the consent or research activities, or who will see identifiable data)
  • Research Purpose
  • Summary of Activities and Approximate Time Commitment (e.g., 40-question survey that will take about 30 minutes, 1-hour interview, 10-minute light jog). This section should also explain whether any activities are experimental. [State “You will be asked to” vs. “You might be asked to.” Participants need to know exactly what the research will involve.]
  • (if applicable) Conflict of Interest
  • Reasonable Risks/Discomforts and Benefits [If no significant risks exist, you may state “I do not anticipate any risks to you participating other than those you might encounter in daily life.” Or you can add, “but (describe briefly any possible risks/discomforts).”]
  • Incentives, if any (Or state “You will not receive any incentive or gift for participating in this study, but participating will not cost you any money.”)
  • Confidentiality Measures (You must indicate that under certain circumstances, the WWU Human Research Protections Program or IRB might have reason to access study data. Student must indicate that their advisers will have access to data as well.)
    (if applicable) Future Data Use
  • Explanation of Right to Withdraw at Any Time
  • Statement of Voluntary Participation (with no penalties for refusal or withdrawal)
  • Contact information for you and the WWU HRPP

Audio and/or Visual Recording

  • If you wish to use identifiable images or videos for any purpose other than data analysis, you must obtain written participant permission.
  • Describe what you will do with any video or audio data after finishing the study (destroyed, erased, archived, etc.) and when (after transcription, 3 years, 5 years, etc.).
  • Clarify on the recruitment materials and consent form whether audio/video recording is required to participate in the study or whether participants may opt out of some or any recording (e.g., they may turn off cameras for recorded Zoom interviews but may not opt out of audio recording).
  • If recording will be optional, either obtain separate written permission for video recording or you may obtain recorded verbal permission to audio record. For example: Please sign and date below if I may video record this interview. Or Please state whether I have your permission to audio record this interview.
  • Remember that in group settings, if you do not have an individual’s permission to record (audio or video), that person should not participate. (For educational studies, you might need to develop alternate activities for those who decline participation due to recording.)

Online Surveys

  • You must acknowledge that transmitting data electronically could pose risk to confidentiality.
  • Surveys using crowdsourcing platforms like Prolific or Amazon Mechanical Turk (MTurk) should also indicate limits to confidentiality. Review the HRPP Online Consent template for language guidance.
  • Don’t force any survey responses (including demographics) unless you have a methodological reason (which you need to explain in your protocol application). Test your entire survey to make sure participants can progress without forced responses.
  • Encourage participants to print the initial consent page for their records before beginning the survey. At the end of the survey, add a “thank you” page with your name and contact information, in case participants have questions after completing the survey.
  • If you will collect email addresses or names to provide an incentive, provide a separate link that is not tied to response data.

Additional Tips

  • If you are the only researcher, use the pronoun “I” not “we.”
  • Keep language appropriate for your population. For non-specialists, keep language level at about 8th-grade reading level. Don’t use acronyms or jargon that participants might not know. (However, for professionals or specialists, you want to use appropriate terminology to show that you have the expertise to connect with them.)
  • Use at least 12-point type for readability.
  • Depending on your study population, you might consider using supplemental consent materials, if appropriate: brochures, drawings, PowerPoint presentations, or even videos of yourself explaining the study to potential participants.

Initial Consent (Assent/Permission)

  • Online Surveys: Consent typically occurs at the time of the activity when the individual reads the study information and chooses to complete the survey.
  • Oral Consent: Provide an information sheet (perhaps by email or at the beginning of the research activity) with all necessary consent information. Ask whether anyone has questions and then whether they wish to participate. Their oral confirmation and decision to participate (and continue to participate) may represent their ongoing consent.
  • Written Consent: Provide a consent document that includes all necessary information and give participants an opportunity to ask questions before providing their signature. They should always be able to keep a copy of the consent document.
  • Electronic Consent: Participants should use a valid e-signature or print, sign, and scan a signed document to return to you. (Typing one’s name onto a form does not constitute signed consent.)

NOTE: At any time, if a participant indicates “No” through words or body language (adult or minor), do not continue the consenting process.

Ongoing Consent (Assent/Permission)

  • For in-person data collection activities, be mindful and monitor participants for possible hesitancy or reluctance. Check in and ask whether they have questions or concerns. Remind them that they may pause or stop at any time without consequences.

Post-Data Collection Consent

Remind participants that at any point after data collection, they have the right to ask you to remove or not use their identifiable data. (You cannot offer this option if you do not collect direct identifiers or enough indirect identifiers to reasonably figure out a person's identity.)
 

Further Consent Considerations

Some studies use incomplete disclosure or deception to avoid a biased participant response or for other methodological reasons. But this practice affects a person’s ability to make a fully informed decision whether to participate in a study. To address this concern, you must debrief participants when a study finishes as part of the ongoing consent process. Then, after debriefing a participant, you need to offer the opportunity for them to reconsider and withdraw their data.

Include all debriefing scripts with your original HRPP protocol submission. 

With populations such as minors or individuals with limited decisional capacity, you as the investigator (or appropriate study team members) need to be sure that potential participants fully understand all aspects of the study. One way to assure understanding before initial consent is to ask participants open-ended questions:

  • “Please tell me in your own words why we are doing this study.”
  • “Please describe to me what things I am asking you to do in this study.”
  • “What else would you like to know about this study?”
  • “What might be something good about being in this study
  • “What might be something bad or uncomfortable about being in this study?”
  • “Why am I asking you to be in this study?”
  • “Where will the study take place?” or “How long will it take for you to do these study activities?”
  • "If you have questions during the study, who can you talk to?”
  • “If you decide you don’t want to do this study, what should you do?”

Avoid or limit closed-ended questions that ask for “yes” or “no” answers:

  • “Do you understand what I am asking you to do?”
  • “Do you have any questions?”
  • “Do you understand that there might be some risks?”

See additional recommendations from the Office for Human Research Protections for research involving individuals with impaired decision making.

You and your research team need to know that an individual providing signed consent is the person who will participate in the research. But federal law does not require that signatures in research settings reflect an individual’s legal or “government” name. As long as the purpose is honest, a person may sign with the name they use in everyday life. (For example, a transgender person may sign a consent form with their preferred name, even if their legal name is their “deadname.”)

You should reconsent participants if significant changes occur to aspects of a study as described in the original consent form.

  • Reobtain written consent if changes might affect whether individuals wish to continue participating:
    • You will add additional study activities or tasks.
    • You become aware of new risks to participation.
    • Study activities will take significantly longer than originally stated.
    • A new principal investigator or different study team will take over an ongoing study. (You do not need to reconsent if this information would not reasonably impact someone’s choice to remain in the study, but you do need to provide updated contact information for the new researcher/s.)
    • You do not need to reconsent if you are merely adding or removing other key personnel such as research assistants or adding co-investigators.
  • Reobtain verbal consent for minor changes, for example if risks decrease or study activities will be fewer or shorter.

•    General Requirements for Informed Consent: 45 CFR 46.116 — Department of Health and Human Services (DHHS)
•    Documentation of Informed Consent: 45 CFR 46.117 (DHHS)
•    Tips on Informed Consent — Office for Human Research Protections (OHRP)
•    Informed Consent of Subjects Who Do Not Speak English (OHRP)