Informed Consent Information

Obtaining the informed consent for participation in research is perhaps the most fundamental ethical obligation in conducting human subjects research.  It is one of the most important means by which individuals are able express their choice as to what will and will not happen to them and act in a manner consistent with their own, personal goals and values.  The Belmont Report identifies 3 key components to the consent process. 

• Information: The prospective participant must be provided with sufficient information to allow them to make a considered choice whether, or not, they wish to participate in the research.  The revised Common Rule specifies that the prospective participant “must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.” (45 CFR 46.116(a)(4)) 
• Comprehension:  The information provided to the individual must be able to be understood by that person.  There are many potential barriers to adequate comprehension.  
• Voluntariness:  Valid informed consent requires that the decision to participate be made voluntarily.  Situations that present the possibility of coercion or undue influence may lead individuals to make decisions that are not truly consistent with their goals and values, and that might differ if they were presented with the choice in the absence of such pressures.

The need for individuals participating in research to have a full understanding of the research study is important to ensure participant safety.  Many of the drugs that are being tested and procedures being performed come with significant toxicities and risks of harm to participants.  The safety of the participant requires them to have an awareness and understanding of the potential adverse events they may experience so that they may take appropriate actions and report them to the investigator.  The written informed consent document serves as the basis of the discussion between the investigator and the participant, and is an important reference document, providing study participants with information as to what to expect, and what do and whom to contact in certain situations.  Many participants refer to this document throughout the study as a source of important information. 

• • Capacity to give consent: what is it? Who has it? (Bioethics Grand Rounds-02/05/2020) Videocast
  • Conducting Informed Consent During the COVID-19 Outbreak (OHSRP Guidance 7/13/2020)
  • OHSRP Education Series presentations:
    • Important Changes to Informed Consent: The Regs, the Policies, the Procedures and Forms, Oh My (4/3/2020) Slides and Videocast
    • Informed Consent One Year after the 2018 Common Rule Revisions: Updated Information and Processes (1/14/2020) Slides and Videocast
  • OHRP Informed Consent FAQs
  • OHRP Simplifying Informed Consent (November 2020)