Informed Consent

Informed consent is one of the cornerstones of ethical research involving human participants.

For all expedited and full review applications, obtaining informed consent is almost always required.

This page explains:

• How to determine whether your project requires informed consent
• General requirements for obtaining consent
• What’s needed for written consent
• What’s needed for oral consent

Does My Research Require Informed Consent?

You likely need informed consent if your project:

• Collects information about individuals that is not anonymous, and
• Involves people who are not public officials or candidates for public office.

Your project requires consent unless:

1. The only record linking the participant to the study is the consent form itself, and disclosure would pose the principal risk (e.g., breach of confidentiality).
2. The study involves no more than *minimal risk and no procedures that normally require written consent outside of a research context.

*“Minimal risk” means the probability and magnitude of harm or discomfort are no greater than those encountered in daily life or during routine exams.

All consent records must be stored securely and confidentially.

Anonymity vs. Confidentiality

• Anonymous data: Participants cannot be identified, directly or indirectly.
• Confidential data: Participants could be identified, but you take reasonable precautions to prevent disclosure, protecting them from legal, financial, or reputational harm.

 

Anonymous = unidentifiable
Confidential = identifiable, but protected

How to Obtain Informed Consent

Consent must be obtained:

• Before participation, and
• Under conditions that minimize pressure or undue influence.

The consent language should be clear and easy to understand (around an 8th-grade reading level).

You cannot include language that asks participants to waive legal rights or release investigators, sponsors, or UAH from liability.

Written Informed Consent

Each participant (or legal representative) must sign a consent form that includes:

Required Elements:

• Statement that the study involves research
• Purpose of the research
• Duration of participation
• Description of study procedures (and identification of any experimental procedures)
• Foreseeable risks or discomforts
• Expected benefits to the participant or others
• Available alternatives or treatments (if applicable)
• Extent of confidentiality protection
• Contact information for:
  • The Principal Investigator
  • The IRB Chair: Jennifer Bail, PhD
    • irb@uah.edu
    • 256.824.2465
• Statement that participation is voluntary, with no penalty for refusal or withdrawal

Additional Elements: (if applicable)

• Explanation of available compensation or medical treatment for research-related injury
• Statement on unforeseeable risks (e.g., to pregnant participants or fetuses)
• Circumstances under which the investigator may terminate participation
• Description of additional participant costs (if any)
• Consequences and process for withdrawing from the study
• Statement that participants will be informed of significant new findings
• Approximate number of participants in the study

Participants must receive a copy of the signed consent form.

Oral Informed Consent

Oral consent follows the same ethical standards as written consent.

You must:

1. Read a consent statement containing all required elements aloud to the participant (and representative, if applicable).
2. Have a witness present for the reading.
3. Obtain IRB approval for the script in advance.
4. Have the participant (or representative) sign a short consent form.
5. Have the witness sign both the short form and the script.
6. Have the researcher sign the script copy.
7. Provide the participant with copies of both documents.

The IRB recommends recording oral consent sessions. Record the reading of the consent form and the participant’s verbal consent.

The OHRP Informed Consent FAQs provide federal guidance on the informed consent process required for human subjects research under 45 CFR 46. This resource explains when informed consent is needed, what elements must be included, and the conditions under which consent may be waived or altered. It helps researchers ensure compliance with ethical and regulatory standards for protecting research participants.