Give Input On The Informed Consent Process

Consent Requirements

The goal of informed consent for clinical trials is to make sure participants are fully aware of all aspects of the research study from their perspective. Taking the time to learn the elements of the informed consent process as it applies to clinical trials can help you understand information you can share with the Sponsor about the target participant population that may affect this process. 

The Code of Federal Regulations states that, for research in humans, informed consent must include the following elements:

• A basic description of the study:
  • Explicitly states that the individuals are participating in research and explains the purpose of the study, a proposed timeline, and gives a general overview of the procedures (including a basic description and timeframe for each).  
  • Can also provide more specific information such as why the participant is eligible to be involved in the study.  
  • Must also include any possible future use (secondary research use) of personal identifiable information (PII).
    • PII is any data that could potentially be used to identify a particular person. 
    • Examples include a person’s full name, Social Security number, address, and email address
• Risks or discomforts: 
  • Explains any reasonably foreseeable risks or discomforts that may result from participation in the study and the steps the investigators have taken to minimize these risks.  
  • Risks can include psychological stressors, financial burdens, and population specific difficulties.
• Benefits:
  • Describes potential benefits to participants that may reasonably be expected.
  • Explains, if applicable, that there may be no foreseeable benefit to the participants. 
• Alternatives to participation: 
  • Discloses any currently available procedures or treatments that may offer an effective alternative to participating in the clinical trial.
  • For many treatment studies, especially for rare diseases, there may be no other effective alternative.
• Compensation if more than minimal risk: 
  • Explains if compensation and/or medical treatment is provided in the event a  research-related injury occurs.
  • Includes  a description of  the compensation or medical treatment that may be provided or where more information about the process can be found. 
• Confidentiality:
  • Provides information about privacy protection.
  • Explains how records that include personal identifying information will be stored and/or disposed.
  • Discloses the possibility that the FDA may access records which include PII.
• Contact Information:
  • Lists who to contact if a potential participant has more questions or wants to understand more about research participants’ rights.
  • Explains who to contact if a research-related injury occurs.
• Voluntary participation statement and procedures for withdrawal:
  • Explicitly states that all participation is voluntary and that the subject can stop participating at any time during the study. 
  • Outlines whether there are possible consequences of leaving a trial before it is completed. For example, the investigational therapy may require a slow tapering of dosage to avoid withdrawal symptoms.
• When applicable, the informed consent must also address:
  • The potential for commercial profit based on the research.
  • If and how clinically relevant information will be returned to participants.
  • The inclusion of whole genome sequencing.
  • Any reasons why the research participant’s inclusion in the clinical trial may be ended by the clinical trial investigator. For example, a participant may be excluded from the study if they fail to follow the procedures of the clinical trial or have changes in lab values that fall outside of the clinical trial limits.
  • The approximate number of research participants that will be enrolled in the study.
• Beyond the actual written content of the consent, requirements include: 
  • Information in the informed consent must be easily understood by potential participants (or their guardians). Complex scientific or research terms should be avoided.
  • There should be no pressure to sign. Participants should be given ample time to discuss the information with friends and relatives, as well as their own doctor or other trusted medical professionals.
  • A contact person who is able to answer any relevant questions about the clinical trial should be available to any potential participant. There should be ample time to discuss any questions with the contact person prior to signing the informed consent. 
• You can read more details about elements of informed consent in the following resources:
  • • FDA: Informed Consent for Clinical Trials  
    • U.S. Department of Health and Human Services (HHS): Informed Consent FAQs
    • SageBionetworks: Elements of Informed Consent  

Resources