Essential Elements of a Research Consent Form

By Adam Landsman, DPM, PhD, FACFAS

There is little doubt about the important role clinical research plays in our profession. Thus, it is vital for practitioners who conduct clinical research to adhere to the highest ethical standards to protect the patient and the integrity of the study. A key part of such ethical conduct is ensuring that patients understand exactly what their participation in a clinical trial will entail. A well-crafted research consent form will accomplish this goal.

A consent form must disclose the many peculiarities that differentiate a clinical research trial from standard treatment. For example, patients will have no control over the type of treatment they receive. And, if they are part of a control group, they will receive no treatment at all – an important consideration for many patients.

Keep in mind that all consent forms must contain certain provisions, and that what follows is meant to be neither a comprehensive list nor mutually exclusive to those required provisions. With that in mind, here are some elements essential to a good research consent form: 

• Describe the Time Commitment– Both of the study and of each individual session
  
• Compensation– What payments, if any, will the patient will receive? If nothing other than free medical care will be provided, this should be clearly stated.
  
• Risks and Dangers– Describe the dangers and/or risks involved in participation. Tell the patient if you will be drawing blood, taking urine, taking X-rays or performing any other sort of tests.
  
• Alternatives– Describe the common alternative treatments, rather than those used in the study.
  
• Severance– Explain the subject’s right to end participation in a study at any time, without penalty. Also, be sure to state whether study materials in the subject’s possession must be returned.
  
• Remedies– If complications arise during the course of a study, clearly state how those complications will be treated. The study sponsor usually funds such treatment, so be sure the research consent form clearly states if this is not the case.
  
• Releases– Obtain the patient’s approval for later use of any images or video for marketing, professional review, teaching, etc.
  
• Confidentiality– Ensure confidentiality by assigning code numbers to each test subject, and disclose who will have access to these records (the FDA, other investigators, site monitors, etc.)
  
• Approvals–At the top of the first page, provide the name of the Institutional Review Board (IRB) that approved the research consent form. Include a telephone number where questions or complaints may be directed.
  
• Emergency Contacts– The study subject should be given a telephone number to reach the principal, co-investigator, or research nurse, 24 hours a day, 7 days per week.
  
• Understanding– Subjects must indicate their comprehension as to the nature of the study. They must certify that all of their current questions have been answered prior to the study’s commencement. If the study subject is a minor, a parent or guardian must sign on their behalf. A witness must also sign the document to ensure all signatures are genuine. A copy of the completed form must be given to the test participants.