By Lenis L. Archer, J.D., M.P.H. and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Investigators who manage clinical trials involving human subjects rely on their participants to comply with research study parameters. However, ensuring this compliance is much easier said than done. Following are several tips that researcher’s and principal investigators might employ to improve compliance.
When Research Subjects Don’t Follow the Rules.
Often, subjects in clinical studies don’t do as they are told. Surprise! Trial participants may self-report full compliance in a study’s direction and protocols, when in fact, they are not. Many research subjects fail to take drugs correctly by taking an improper dosage or taking the drugs at inappropriate times. It’s not that the subjects do not want to comply or desire to be deceptive. Often, it’s merely oversights or forgetfulness at play and the subject does want to be fully compliant.
Participants’ Rule-Breaking Has Ethical and Regulatory Consequences.
The failure of participants to comply fully in a study can have devastating consequences. Chiefly, the results obtained by the study are compromised, which can affect the approval of the drug and its recommended dosage. In addition, important medical side effects may not be clearly identified.
Ultimately, the burden of these consequences will fall on the investigators, who could face sanctions for ethical and legal violations.
Here are Five Tips that Will Help Investigators Encourage Compliance in Study Subjects:
1. Increase Monitoring Measures – Incorporate ways to monitor subjects in your study design. While this may increase cost in the short term, ultimately the results of the study will be more accurate.
2. Provide Clear Guidance – Take the time to provide study participants with ample resources and guidance on how to remain in compliance during their study.
3. Remove the Fear Factor – Create an environment in which study subjects are comfortable reporting their noncompliance.
4. Learn from the Rule-Breakers – Make sure to gather lessons from individuals who are non-compliant. Take the time to ask questions that will assist in you in designing and conducting future clinical trials.
5. Be Honest – Investigators should never let their desire to be published or advance career prospects cloud their ethical and regulatory responsibilities. Provide accurate data regarding noncompliance and how noncompliance was remedied.
6. Implement Reminders – Implement systems to remind patients when regular activities (such as taking vital signs, recording symptoms or taking medications) are required. Implement systems of text messaging or telephoning patients for those that may be non-compliant.
Investigators, consider these tips to ensure that noncompliance of subjects does not have an oversized effect on your study results AND your reputation as a scientist.
Have you ever participated in a study as a research subject? Do you think that intensified policing and guidance are effective strategies for reducing participant rule-breaking? Please leave any thoughtful comments below.
Contact a Health Care Attorney that is Experienced in the Representation of Clinical Research Compliance and Misconduct.
The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of clinical research compliance and misconduct. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers and investigators who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.
Van Tassel, Katherin. “Guest Blogger Professor Rebecca Dresser: When Research Subjects Don’t Follow the Rules.” (Dec. 23, 2014). From:
Dresser, Subversive Subjects: Rule-Breaking and Deception in Clinical Trials, 41 J.L. Med. & Ethics829 (2012).
About the Authors: Lenis L. Archer is as attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.
George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area.
KeyWords: Research compliance, clinical trials, human research subjects, research misconduct, research parameters, clinical research investigator, defense attorney, defense lawyer, health law, health care law, health law attorney, health care lawyer, health law firm, The Health Law Firm
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
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