Q. I have been approached by a clinical trial management group to conduct clinical trials. What are the risks involved in participation?
A. The National Institutes of Health (NIH) reports more than 260,000 clinical research studies are under way, in all 50 states and 203 countries. Clinical trials and research carry implications for patient/participants and liability, in addition to the care you provide to patients who are not enrolled in a clinical trial. 

For instance, clinical trials entail additional ethical considerations, detailed informed consent and patient monitoring, as well as HIPAA and data reporting requirements. When deciding if you want to be involved or enroll your patients in a clinical trial, it’s wise to consider the following factors.

• Is there a written agreement or contract between you or your practice and the pharmaceutical, biological, medical or manufacturing company or trial sponsor?
• Will you be the principal investigator?
• Does the agreement or contract between you and the trial sponsor contain a hold-harmless or indemnification agreement?
• Does the trial sponsor require you to obtain additional limits of professional liability?
• Is the clinical trial being conducted under the auspices of an Institutional Review Board (IRB)?
• Is the IRB in the United States, or is the IRB located “off shore”?
• Is the IRB affiliated with a hospital?
• Is there a detailed informed consent that specifically addresses why a patient might want to participate in the trial? Does the consent include a discussion of the potential risks of the patient’s participation? Is the consent written at a level that a patient can easily understand?
• Does the clinical trial include “vulnerable” patient populations, such as minors, the mentally or developmentally disabled, the elderly, pregnant women or prisoners? This may require additional consent. For example, if a minor is involved, the patient’s  assent is required in addition to the parent’s consent.
• Do you have the additional time and appropriately qualified staff to manage the responsibilities associated with the clinical trial?
• Are there any billing or compliance issues that may arise as a result of enrolling your patients in the clinical trial?
• There is a potential for class action suits from research participants.

Risk management experts suggest physicians take the following steps before agreeing to participate.

• Have the clinical trial agreement reviewed by legal counsel.
• Develop a policy and procedure or process to standardize the management of clinical trials.
• Ensure adequate patient/participant monitoring.
• Ensure compliance with the clinical trial protocol.
• Review your adverse-event reporting system, and include any additional reporting required by law and regulations in relation to the clinical trial.

Physicians insured by ProAssurance may contact our Risk Resource Department for prompt answers to risk management questions by calling (844) 223-9648 or via e-mail.
Additional clinical research/trial information can be found online. 

References:
www.nih.gov/health-information/nih-clinical-research-trials-you/news
ECRI Institute, Healthcare Risk Control, Risk Analysis Ethics 4.2 Clinical Trials: Risk, Safety, and Liability.