Informed Consent

Informed Consent Requirements:

Informed consent is an ongoing process, not just a form that is signed.  Informed consent assures that potential participants understand the nature of the research project and can make an informed, voluntary decision about participating or not participating. The language used to present the information needs to be appropriate for the targeted subject population.  Researchers should keep in mind that (a) individuals should be provided with enough information about a study and what it requires of them to be able to make a truly informed choice, and (b) individuals have the right to participate or not participate in a study and those who decide to participate may withdraw their consent from the study at any time for any reason, without incurring negative consequences. 

The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. Documentation of informed consent must comply with 45 CFR 46.117. The PI is responsible for ensuring that informed consent is obtained in writing from the subject or the subject’s legally authorized representative (e.g., parent or legal guardian), is understandable to the subject (or representative), is obtained in circumstances that are not coercive and that offer the subject (or representative) sufficient opportunity to decide whether he or she will participate. If any participants are members of vulnerable populations, 45 CFR 46 Subpart B, Subpart C, and Subpart D describe additional informed consent requirements.

The informed consent process and documents in research studies that involve health information may need to include statements that meet the requirements of Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The informed consent form may not include exculpatory language in which the subject or representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the PI, sponsor, or institution (or its agents) from liability for negligence.

  1. the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs;
  2. the research could not practicably be carried out without the waiver or alteration.

The IRB may waive the requirement for a signed informed consent form if the following requirements are met:

  1. the research involves no more than minimal risk to the participants;
  2. the waiver or alteration will not adversely affect the rights and welfare of the participants;
  3. the research could not practicably be carried out without the waiver or alteration; and
  4. whenever appropriate, the participants will be provided with additional pertinent information after participation.

Informed consent procedures must be delineated in the procedures portion of the application to the IRB.  Any waivers to the procedure or documentation must be requested, as well (as per stipulations noted above).  For studies in which the documentation of informed consent is waived, a letter of invitation to participate, which includes the elements of informed consent, may be appropriate.

Improving Informed Consent: Innovations in Form and Process

Click here to access a pdf or recorded webinar addressing the current practices around informed consent, identify shortcomings, and offer ideas for improvement.  Some of the topics discussed will be:

  • Tensions between an optimally written form and a quality consent process: striking the appropriate balance
  • Regulatory constraints associated with limited English language proficiency and low-literacy populations: preparing to meet the needs of these groups
  • Innovations in consent forms: using the Short Form and exploring developments of the Association of American Medical Colleges (AAMC) and National Cancer Institute (NCI) working groups
  • A case study on oral consent: identifying common assumptions about comprehension and assessing the subject’s understanding
  • A case study on institutional review board (IRB) review of a consent form: identifying IRB responsibilities, including ensuring consistency between the consent form and consent process