Informed Consent Guidance

The requirement for obtaining informed consent stems from one of the ethical principles listed in the Belmont Report. Respect for persons states first “that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.” This means that potential participants should enter into the research voluntarily and with adequate information. Informed consent is one of key protections listed in the regulations 45 CFR 46 from the Department of Health and Human Services.

What is Informed Consent?

Informed consent is a process that includes providing accurate information about a research study and the purpose of the study. The process involves exchanging information between the investigator and the potential participant, and the communication should continue throughout the study. The amount of information that is presented in the consent form will vary based on the risks and complexity of the study.

Please note that obtaining a signature or verbal consent does not complete the consent process. You must provide participants with any new information throughout the study that may impact their participation and their decision to remain or not in the study.

What can the researcher do to make the Informed Consent process effective?

  1. The process should be conducted in a private place.
  2. The language used should be understandable to the participant.
  3. The participant should be provided with a copy of the consent document(s).
  4. The researcher should answer questions or concerns that the participant may have.
  5. The participant should provide voluntary agreement to participate.
  6. The researcher should provide ongoing information to the participant as the research progresses.
  7. The investigator should make sure that the participant comprehends the information provided. For participants for whom decision making capacity may fluctuate, the researcher must have mechanisms in place to reevaluate comprehension throughout the study.

What are key considerations for obtaining Informed Consent?

  1. Timing – Informed Consent must be obtained from the research participant or guardian before the start of research activities.
  2. Continued Communication – Although the initial presentation of information is critical, the participants should be kept informed throughout the study. The researcher should be available to answer questions as well as to let participants know about any changes in the study that may impact them. Participants should also be aware that they may withdraw at any time for any reason.
  3. Personnel – The researcher(s) involved in the Consent Process should be qualified and appropriately trained not only to explain the research but also to evaluate the participant’s comprehension of the process. Personnel taking part in the Consent Process should be listed in the IRB application.
  4. Decision-making of the participant – The participants should understand the study and what will happen to them during the study. If the researcher finds that the participant is not comprehending, a guardian may be needed. The participants should also not feel coerced to participate; participation must be voluntary.

How does the researcher assess participant comprehension?

  1. The investigator is responsible for ensuring that the participant understands the research and the risks/benefits of participating.
  2. The investigator should answer questions from the participant but should also be asking the participant questions to further the discussion.
  3. The investigator should ask open-ended questions (avoiding yes/no questions). Some sample questions:
    • Describe in your own words what you will be doing if you agree to participate in the study.
    • How may this study help you?
    • What will happen if you decide not to be in the study?
    • What should you do if you have a question about the study?
  4. For a minimal risk study, verbal interaction between the participant and researcher may be sufficient. In some cases, clinical assessment or further testing of decision-making capacity through the use of standardized tests or a post-consent quiz may be needed.
  5. If decision-making capacity changes throughout the study, repeat assessments must be conducted.

What are instances when participants should be “Reconsented”?

  1. New risks or increases in risk have been identified.
  2. Benefits to participants have decreased.
  3. Research where the participants were children when they were enrolled but are now at least 18 years old.
  4. Research procedures have changed that will cause additional burden to participants.
  5. Research where decision-capacity of the participant declines over time.

What are the different types of Informed Consent?

  1. Signed informed consent: This is a written document that is presented to the potential participant. The document is read and signed by the participant and kept as a record by the researcher. The document should be stored for at least 3 years after study completion.
  2. Implied consent: Frequently used in internet-based research. The consent form is presented to the participant, and by performing the research task or activity, the participant consents to participate.
  3. Oral consent: The consent form information is provided to the participant either verbally or in written form, and the participant verbally agrees to participate.
  4. Parental Consent and Assent: If the research involves children (i.e., those under the age of 18 years), then the parent or guardian must typically give parental consent for the child to participate. If the child is capable, the child must also give assent.

Regardless of the format, participants should always receive a copy of the consent document.

What must be included in a consent form?

The basic requirements for the informed consent can be found in the HHS regulations at 45 CFR 46.116(b).

The regulations require that the following be included in the consent form:

  1. A statement that it is research and an explanation of the purpose of the research. There should be an explanation of the procedures and how long they will take, as well as identification of any procedures that are experimental;
  2. A description of any risks;
  3. A description of benefits to the participants as well as the more general benefits of the research. Compensation is NOT a benefit;
  4. A statement describing appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
  6. For research involving more than minimal risk, an explanation should be provided as to whether any medical treatments are available if physical injury occurs and if any mental health services are available if emotional distress is experienced. If so, these resources should be described, along with information about where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant;
  8. A statement that participation is voluntary, refusal to participate will involve loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without loss of benefits to which the participant is otherwise entitled; and
  9. One of the following statements about any research that involves the collection of identifiable private information or identifiable bio specimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable bio specimens and that, after such removal, the information or bio specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant or the legally authorized representative, if this might be a possibility; OR
    • A statement that the participant’s information or bio specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

What do I do if my participants do not speak English?

The consent form must be translated into the language that the participant understands. The translated document must be submitted to the IRB. Documents should be provided to the UMaine IRB along with a translation certification document. The translator must be certified and the certification must be attached with the translation. Exceptions to this requirement can be made on a case by case basis.

Where can I find sample UMaine consent form templates?

Go to the Forms and Samples page on the IRB website. You will find sample consent forms under “Sample Documents.” Please do not use old templates that you have saved on your computer.

Do I need to obtain Informed Consent if my study is exempt?

Yes. Documentation of informed consent (a signature) is not required, but the participants still need to be presented with a consent form. Even though the study is exempt from Federal regulations, this does not mean that it is exempt from the ethical principles of the Belmont Report.


References:

University of California San Francisco: Obtaining and Documenting Informed Consent Guidance

Northwestern University: Informed Consent Guidance

Duke Health: Consent Guidance

University of Wisconsin: IRB Guidance: Informed Consent