How is Privacy Maintained During Clinical Trials?June 22 , 2020
Keeping participant information private during clinical trials is of utmost importance. Fortunately, federal regulations provide confidentiality guidelines. Aside from an ethical standpoint, protecting the identity of individuals who take part in studies gives a sense of comfort and security in making the decision to do so. In addition to federal laws and regulations, many states have enacted their own laws and regulations to protect the confidentiality and privacy of individuals receiving health care.
There are specific records that must be kept confidential. Human research participants are always privacy protected, with additional protections in place for pregnant women, prisoners, and children. The federal government’s Health Insurance Portability and Accountability Act (HIPAA) mandates privacy protections for individually identifiable health information, such as identity, diagnosis, or treatments participants receive during a trial. In most cases, for disclosure to occur, a patient must give his or her full consent. There are exceptions to the rules, however.
In some cases, it is possible to breach the confidentiality of a participant. For example, the information in a participant’s medical record can be disclosed to people within a health program, or between health programs. Extreme cases including criminal activity, suspected child abuse or neglect, and medical emergencies are also cases where it is permissible to release confidential items. If a participant has a disease that may pose a risk to the general public, a concern related to our current COVID-19 pandemic, then such communicable diseases are reported to local health authorities and to the National Notifiable Diseases Surveillance System (NNDSS).
So, how are private records kept safe? When not in use, written records covered by the confidentiality regulations are put in a secure room, a locked file cabinet, a safe, or other secure place. Once a program is complete or a participant leaves a study, the program must destroy participant-identifying information unless the study site has permission to transfer patient information, or the law requires that the site keeps these records for a period. Of course, records an office maintains are sealed and put away. Research teams also put additional measures in place to ensure that its members are following Good Clinical Practice (GCP) recommendations.
Study sites go through rigorous training on the security of medical records during studies. Documents such as a Certificate of Confidentiality provide additional protection for clinical research because privacy is fundamental to medicine and maintaining great trust between patients and staff.