When nurses embark upon a research project, they must be guided by more than an idea, their curiosity and a plan of action. They also need to abide by applicable federal, state and local regulations and laws related to research. At Cleveland Clinic’s 12th Annual Nursing Research Conference in May, Peggy Beat, Esq., RN, discussed the importance of research compliance in a session entitled “Research Dos and Don’ts: Stories from a Corporate Compliance Perspective.”
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“Within research, we are guided by a ton of principles,” says Beat, a registered nurse and Senior Director of Research Compliance at Cleveland Clinic. “We have so many masters that sometimes we’re not sure what rules we have to follow, who we have to listen to and what regulations and laws we have to be careful of.”
Peggy Beat, Esq., RN
Healthcare organizations set up compliance programs to ensure that their employees are aware of and take steps to comply with relevant laws and regulations. Corporate compliance affects nearly every facet of a hospital, from licensing of healthcare professionals to billing protocols and safeguarding medical records. “We provide the stop signs along the road that help prevent chaos and help us do the right thing from both an ethical and business standpoint,” says Beat, who specializes in research compliance.
Just as in other areas, compliance is critical to research. “Compliance with laws, regulations, policies and study protocols breeds quality,” Beat explains. Her team helps ensure that researchers don’t inadvertently run afoul of the law – and unfortunately there are many ways to do so. Researchers may get in hot water for not obtaining informed consent from research subjects, deviating from protocols approved by the Institutional Review Board (IRB), not maintaining adequate medical records for each study subject, improperly billing study sponsors and more.
Beat cites three major laws or regulations that affect human subject research in a healthcare setting:
During her presentation at the Nursing Research Conference, Beat focused on privacy in research. She reminded the audience that although privacy rules can seem onerous to researchers, “it really is about putting patients first.” Privacy laws are an individual right to keep personally sensitive information private and secret.
The Privacy Rules state that a hospital must protect the privacy of patients. In order for a hospital to provide patient information to someone else, the patient must give approval. There are three exceptions where information may be released without patient approval:
To protect study subjects, researchers have to protect the following identifiers linked with health information:
“Any one of those identifiers linked with health information has to be protected,” Beat explains. “For a covered entity to release protected information outside their walls for purposes of research, there has to be written permission in place.” There are occasions when researchers can release limited data sets, including dates; city, state and ZIP codes; and unique identifying numbers, characteristics and codes. This requires IRB approval and an executed data use agreement. The other option for sharing data is to remove all identifiers.
Privacy in research is paramount. In 2015, there were 255 recorded data breaches, according to the Office of Civil Rights (OCR). Perhaps the most well publicized breach was when Anthem Health Insurance became the victim of hacking, putting the privacy of 78.8 million individuals at risk. Beat offers these four tips for safeguarding data:
“Because we deal with data all the time in research, privacy is such an important aspect,” concludes Beat. “Safeguarding data, along with ensuring the integrity of the data, are critical.”
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