Ericka L. Adler, JD, LLM has practiced in the area of regulatory and transactional healthcare law for more than 20 years. She represents physicians and other healthcare providers across the country in their day-to-day legal needs, including contract negotiations, sale transactions, and complex joint ventures. She also works with providers on a wide variety of compliance issues such as Stark Law, Anti-Kickback Statute, and HIPAA. Ericka has been writing for Physicians Practice since 2011.
Physicians must consider both the benefits and burdens before participating in clinical studies.
Physicians often find themselves looking for extra practice income to offset ever-decreasing reimbursement options. One popular way to generate additional income for some practices is through participation in clinical studies. Beyond additional income, participating in these studies may expand treatment options for patients and provide access to the most current scientific research initiatives, thereby improving a practice’s reputation and overall quality of care. As with any new venture, however, there are some potential complications of which you should be aware.
For example, clinical studies often involve an extensive time commitment and specific documentation requirements, most of which will affect the physician directly. Failure to follow often strict research protocols may result in you not meeting benchmarks for payment, not being considered for future clinical studies and, perhaps most importantly, compromising outcomes of the study itself. Accordingly, it is important to create safeguards to ensure the integrity of any research study and to protect the well-being of the participants.
In particular, if you are involved in a clinical study, it is recommended you abide by the following guidelines:
1. Ensure that the clinical study relates to your scope of practice. This will increase the likelihood that you have appropriate training to conduct a successful clinical study and have the proper equipment and systems in place.
2. Depending upon your practice affiliations, you may need approval from an Institutional Review Board (IRB) before participating in any study. Also, make certain that the person/entity sponsoring the study has obtained approval from their respective IRB. You must familiarize yourself with all IRB guidelines and ensure that you follow all associated directives and ethics requirements.
3. If you are treating a patient who is eligible to participate in the clinical study you are conducting, know that the informed consent process must differentiate between your role as a provider and researcher. Accordingly, it is recommended that if you are the patient’s treating physician then someone else should obtain the patient’s informed consent to enroll in the clinical study. Your patients should never feel pressured into participating in a research study.
4. The informed consent process should involve notifying participants of the nature and source of funding you are receiving and should also include information on what type of funding exists if potential complications arise due to a patient’s study participation. It is important to have all of these disclosures in writing.
5. Financial compensation for a clinical study can implicate healthcare fraud and abuse laws. In order to mitigate regulatory considerations, any financial compensation received must be fair market value for the performance of specific, legitimate services. Compensation should never vary according to the volume of participants you enroll, and you should not accept payment exclusively for referring patients to clinical studies.
6. When entering into a contract to participate in a research study, make certain that you have access to final study results and that there is no provision allowing the research sponsor to delay or obstruct ultimate publication of such results. With much at stake for both you and study participants, it is important these results are released as efficiently and effectively as possible.
As is the case with starting any new endeavor, there are burdens associated with the potential benefits of clinical study participation. Practices may incur expenses related to study participation that are not covered by the study itself, including, but not limited to, arranging for appropriate space, procuring appropriate supplies and hiring qualified staff. No matter what your circumstances, however, it is best to ensure that appropriate safeguards and precautions are in place. The guidelines discussed above are a great starting point. Moving forward, as always, it is important you talk with knowledgeable legal counsel.