Give Input On The Informed Consent Process

Research versus Clinical Care

Although there is a clear distinction between a research clinical setting and clinical care, the distinction becomes more complicated when the research is taking place in a clinical care setting. Since many rare disease clinical trials take place in a clinical setting, it is important for you to understand what this means and how it may affect the informed consent process, including the return of test results. 

  • Research clinical trial setting:
    • Protects participants from harm. 
    • Focuses on understanding the effectiveness and safety of investigational therapy.
    • May not directly benefit participants, but instead benefit future patients.
    • May limit the return of an individual’s results. 
    • Requires Institutional Review Board (IRB) approval to return a result that may be potentially medically relevant to a participant, but falls outside the original scope of the approved clinical study protocol. 
    • It is the participant’s responsibility to follow-up on disclosed results with their own medical provider, including having the result verified by a clinical laboratory.
    • Is not the same as health care provided by a personal medical care provider.
    • Gathers and assesses certain measures or clinical outcomes at specific times.
    • Publishes results, although participants are not identified individually.
    • Does not enter a participant’s data into their individual medical records.
  • Clinical care setting, no research involved:
    • Provides care that is in the best interest of the patient.
    • Addresses the needs of individual patients.
    • Makes real-time decisions about health care plans, including trying different treatments.
    • Uses treatments and therapies known to be safe and effective.
    • Maintains confidentiality of medical records.
    • Records health care in a patient’s individual medical records.
    • Permits patients to access all test results and information included in the medical records.
  • Research in a clinical care setting:
    • Provides the investigational therapy as part of participants’ health care.
    • May provide the investigational therapy as an addition to current treatment rather than replacing current treatment.
    • Follows protocols of a research study and the therapy may not directly benefit the participant.
    • Gathers and assesses certain measures and clinical outcomes at specific times.
    • Enters data from measures and clinical outcomes as part of participant’s medical records.
    • Permits patient to access all test results and information included in the medical records.
    • May require IRB approval to return results of potential medical significance that fall outside the original scope of approved study protocol. The result will be verified in a clinical lab prior to being disclosed and the clinicians involved in the study will provide next-step guidance  
    • Publishes results, although participants are not identified individually.
    • Researcher may be part of the clinical team. 
    • Needs very clear informed consent to distinguish what is research and what is part of clinical care.
  • You can learn more about the differences between research, clinical care, different research settings, and the return of potentially medically significant results in the following resources.

Resources

Consent Requirements
Informed Consent for Clinical Trials U. S. Food and Drug Administration (FDA) (link)
Informed Consent FAQs U.S. Department of Health and Human Services (HHS) (link)
Research versus Clinical Care
Clinical Research Versus Medical Treatment U. S. Food and Drug Administration (FDA) (link)