While clinical trial insurance is a necessity for any company that conducts clinical trials, many companies do not adequately fulfill their responsibilities when it comes to informed consent. Informed consent requires a deliberate process. This is not just a form that research coordinators push onto subjects.

Here, we'll take an in-depth view of informed consent and how you can protect yourself by building a strong protocol for informed consent.

Go Beyond the Minimum Requirements

The Code of Federal Regulations does explicitly offer guidelines for informed consent, but the process of actually obtaining consent is not clear to many providers of clinical trials.

All subjects face a critical threshold when they are presented with informed consent forms. This is why clinical trials providers need to exercise great caution if they are working with a vulnerable segment of the population. Children, the elderly and mentally impaired people may not fully grasp the attributes of informed consent. As such, separate protocols should be established when obtaining their consent.

Here are the most traditional forms of finding participants for clinical trials:

• The participant volunteered or took part in a recruitment program.
• The participant is already part of a group of patients under study.
• The clinical trial providers are offering the trial as a treatment option after informing the patient of the risks and benefits.

Encourage Participants to Ask Questions

While we clearly understand how patients learn about clinical trials, less is known about why certain people decide to participate. As a result, clear communication becomes very important in the clinical trial environment. Research coordinators should encourage participants to ask as many questions as possible. A structured communication plan will help protect providers from errors and omissions claims.

Organizations should attempt to make the informed consent document as short as possible. All participants should clearly understand the document, and it should be worded in layman's terms, but should contain comprehensive information about the trial.

Clinical trial administrators should build rapport with patients, and should disclose all facts regarding the study. Clinical trial administrators should go over each segment of the informed consent document slowly and clearly, and should check with the subject to make sure they understand everything.

More and more studies are showing that participants are unaware of the risks and benefits of clinical trials. This further emphasizes the need for organizations to distinguish between what is research, and what is routine medical therapy.

HIPAA Regulations and Informed Consent

Clinical trial administrators also must clearly follow HIPAA regulations that pertain to clinical trials. HIPAA does require all participants to sign an authorization document  including all required information.

It's obvious that all clinical trials providers are at risk for litigation. However, good life sciences insurance will cover the expenses incurred as a result of a lawsuit. Insurance professionals can also help advise sponsors and clinical research organizations regarding the informed consent process.

If you conduct clinical trials, be sure you establish a strong relationship with your insurance carrier. With a comprehensive clinical trial insurance policy, your company will be covered in the case of any litigation.