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
- Compensation– What payments, if any, will the patient will receive?
If nothing other than free medical care will be provided, this should be clearly
- 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
- 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.