Quality Improvement Can Be Good Research

Abstract

Where is the line between a quality improvement project and a research study? Making the distinction can be challenging, but it's necessary because when the threshold to research is crossed, an institutional review board (IRB) needs to be involved, according to Ed Davidson, PharmD, MPH, assistant professor of clinical internal medicine at Eastern Virginia Medical School, Norfolk. Speaking at the AMDA Foundation Long-Term Care Research Network's Fall Conference in November, Dr. Davidson discussed ways to distinguish between a quality improvement (QI) project and research, and how to pursue successful QI studies. Where is that cutoff point? According to Dr. Davidson, research generates new knowledge and tests hypotheses. It may be generalizable to other patients, situations, and settings. On the other hand, QI examines internal processes, guides actions toward improvement, and examines internal institutional processes and specific issues. Research requires informed consent if human subjects are involved, or there must be justification for a waiver of consent. For QI, informed consent generally is not necessary. Research follows a specific scientific framework, while QI focuses on real-world processes. One important difference between QI and research is what happens with the resulting data. Research is presented and available to others, often through publication in a journal article. QI data are used by a specific institution or organization to self-assess quality and make improvements in specific processes. The findings aren't meant to be published or disseminated widely. The IRB can be a big help to researchers and practitioners. The IRB will look at a QI project and determine whether it constitutes research and so requires informed consent, said Dr. Davidson. An IRB member himself, he noted, “We will look at the level of risk involved—minimal or more than minimal.” Quoting from federal regulations, he noted, “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and or of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” He urged practitioners to talk to their IRBs before they begin projects—to save themselves time and trouble. There are four levels of IRB evaluation, Dr. Davidson observed. These are: ▸ Evaluation for involvement of human subjects. ▸ Exemption from regulations addressing IRB review. ▸ Expedited IRB review. ▸ Full review. “The IRB has oversight authority to determine if a study can be classified as ‘not human subjects research,’” said Dr. Davidson. These projects may be research by definition, while not involving human subjects, or other projects such as quality assurance or program evaluations that do not meet the definition of research. Even if the IRB determines that a QI project actually is research, it may be exempt from the IRB regulatory oversight. Research that qualifies for exempt status includes studies in educational settings that involve normal educational processes or tests, survey procedures, interview procedures, or observations of public behavior—unless subjects can be identified and disclosure places them at risk of criminal and civil liability, or unless subjects are elected or appointed or candidates for public office. In these special cases, federal statute requires maintenance of confidentiality. Collections and studies of existing data, documents, records, and pathologic/diagnostic specimens also may be exempt, said Dr. Davidson, if these sources are publicly available or if the information is recorded in such a way that subjects cannot be identified. Research that qualifies for expedited reviews includes clinical studies of drugs or devices for which neither an investigational new drug (IND) application nor an investigational device exemption (IDE) is required, collection of blood samples, prospective collection of biological specimens for research purposes by noninvasive means, and/or collection of data through noninvasive procedures routinely employed in clinical practice (excluding x-rays or microwaves). Other studies that may meet the requirements for expedited status include those that involve materials that have been collected or will be collected solely for nonresearch purposes; collection of data from voice, video, digital, or image recording made for research purposes; and/or research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Not every study requires informed consent. For example, Dr. Davidson noted, an IRB “may waive the need for consent—or alter consent elements—if it finds that research involves no more than minimal risk, that the rights and welfare of subjects will not be adversely affected, that research could not be practicably carried out without waiver or alteration, or that the subjects will be provided pertinent information after participation.” One of the most common mistakes practitioners make when they come to an IRB with a project, said Dr. Davidson, is that they haven't prepared sufficiently for how they will protect privacy and de-identify data. He noted that items to exclude for de-identification include the basics such as names, addresses, zip codes, dates beyond years, telephone and fax numbers, e-mail addresses, and social security numbers. However, de-identification needs to go further and exclude biometric identifiers, device IDs and serial numbers, medical record numbers, certificate/license numbers, health plan beneficiary numbers, and other information. “You have to let the IRB know specifically what you will do to protect privacy. This includes presenting an adequate plan to protect identifiers for improper use [or] disclosure, an adequate plan to destroy identifiers at the earliest opportunity, and an adequate written assurance that personal health information will not be disclosed,” said Dr. Davidson. Practitioners shouldn't get discouraged if they are unsure about how to proceed with their project, Dr. Davidson observed. “IRBs have trained people to help investigators put together study protocols and processes and protect patients and researchers alike. We want to help you conduct safe, productive studies. “We actually have a subcommittee that meets for 1–2 hours before the IRB meeting to review QI projects, including those from physicians in the community.” Senior contributing writer Joanne Kaldy is a freelance writer in Hagerstown, Md., and a communications consultant for AMDA and other organizations.