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Documentation of Physician Consent
After several months of discussion with the JHHS and JHM Legal Departments and investigator focus groups, we are announcing a new policy governing physician consent in clinical research. This new policy requires that a physician-investigator participate in the consent process for clinical research involving the following:
- a drug being studied under an IND;
- a device being studied under an IDE (does not apply to studies that are IDE exempt or non-significant risk); or
- a clinical procedure for which clinical consent by a physician would be required.
The underlying premise for this policy is the physician’s legal duty, under Maryland law, to provide all information material to a reasonable patient’s decision to undergo a clinical therapy or procedure. This means the physician-investigator must document the discussion of the risks and benefits of the study procedures and alternative treatments with the potential participant. We recognize that non-physician consent designees perform a vital role in the consent process and this new policy is not meant to undermine that role. Non-physician consent designees may conduct the balance of the consent discussion (e.g., study schedule, payments, confidentiality) either before or after the physician-investigator discusses the risks, benefits and alternatives. In addition:
- The study team may determine the method, timing and sequence of the consent discussion.
- A mid-level provider listed as a consent designee on the IRB application may obtain consent in place of the physician-investigator if the study procedures are within the scope of the mid-level provider’s practice.
- A new stand-alone Documentation of Physician Consent form is available on the JHM IRB website and may be downloaded and attached to the JHM-IRB approved consent form. For future studies, the Version 15 consent form template will soon be released and it will include this additional signature page.
This policy applies to all JHM-IRB approved studies and must be implemented by study teams no later than July 1, 2015.
We appreciate your assistance in helping us comply with this new policy.
Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation