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What Do Regulators Classify as "Research"?

Lead Author(s): Bernard Lo, M.D.

The federal regulations define research as a "systematic investigation designed to develop or contribute to generalizable knowledge." Classifying an activity as research means that federal regulations, including requirements for IRB review and informed consent, may be applicable. Conversely, if an activity is not considered research, IRB review and special provisions for informed consent are not required.

The findings of research must be disseminated in order for others to take advantage of them. Many IRBs operationalize the concept of generalizable knowledge by asking if the investigator plans to or hopes to publish the findings or present them at a professional meeting. If so, the activity is considered research by the IRB. Furthermore, many journals do not publish empirical research studies if IRB approval has not been obtained (or an exemption has been granted). Another rule of thumb is to ask whether or not the investigator would still carry out the project if the results could not be disseminated; if not, the activity should be considered research.

It is difficult to decide whether or not some activities should be classified as research, as the following examples indicate.

Innovative Clinical Care

According to the Common Rule, intention is crucial - research is intended to produce generalizable knowledge. Research needs to be distinguished from unproven or innovative clinical care, whose goal is benefiting the individual patient. Not every new, different, or unproven medical activity is considered research. For example, when treating an individual patient, a physician may use higher-than-usual doses of a medication or use it for an indication that the FDA has not approved. Similarly, a surgeon may modify a surgical procedure to try to improve it or to take into account individual anatomical variation. Because such unproven or innovative clinical care is intended to improve the individual patient's health, it is not considered research. Therefore no IRB oversight is required these activities.

Analyzing a Case Series

In a retrospective case series, the physician reviews the medical records of patients to gather data that has already been collected as part of clinical care. Because the any test or treatment has already been carried out, the only risks are breaches of confidentiality.Whether or not the case series is designated as research or not depends on the intention of the physicians carrying out the review. If they plan to present it at a conference whose audience outside their own institution or publish it, it should be considered research.

Physicians carrying out a retrospective case series for research should keep in mind that research with existing data that was collected for clinical purposes may not require IRB review and approval.If the investigator records data from the medical records and existing specimens in a manner that does not allow participants to be identified, the activity is exempt from IRB review. At UCSF, investigators need to file a brief form to certify that the research project qualifies for an exemption.

Some case series have a prospective component, as when a physician decides to standardize the clinical and laboratory evaluation of patients who receive an innovative drug or procedure. The intention may be both to improve patient care and also to derive generalizable knowledge through a case series. If the physician would carry out the standardized evaluation even if the case series could not be done, the additional tests can considered enhancements in care that do not require IRB review. In pragmatic terms, the issue is whether the physician would carry out the standardized evaluations even if he knows there is no funding to conduct the case series.

STUDY 2. LAPAROSCOPIC CHOLECYSTECTOMY (CONTINUED). The case series in Study 1 revealed an unexpectedly high number of cases of bile duct injury. The surgeon plans to monitor more carefully for biliary tract complications. He plans to add CT scans of the biliary tract to the liver function tests routinely done at follow-up visits. If he can obtain funding for a research assistant, he will carry out another case series taking advantage of these additional outcomes data.

Quality Improvement

Quality improvement (QI) projects may substantially improve patient outcomes while posing little risk. Their intention is not to generate generalizable knowledge but to improve outcomes in a particular patient population. For instance, QI projects may try to correct the underutilization of interventions that have been proven to be effective, such as cancer screening tests and drugs to prevent heart attacks. In many QI projects, benefits are highly probable. The QI project leaders generally have clinical authority and thus can readily implement the project's findings. Furthermore, the interventions in the project may be known to be effective in similar situations. In QI projects to implement evidence-based practice guidelines, the risks are simply those inherent in good clinical care and can be characterized as minimal risk. In many other QI projects, the interventions are small-scale changes in the process of care, whose effects are closely monitored [Berwick, 1998 #49]. Examples include educational seminars, individual feedback to physicians, and standardized orders. Indeed, many QI projects may pose less risk than standard clinical care, where changes in practice are carried out but not systematically evaluated. Close oversight of such QI projects may be counterproductive, serving only to delay them or make them prohibitively expensive.

There is considerable overlap between QI and research. Both QI and research may use the same methodologies of chart review and the administration of questionnaires. If a project is classified as quality improvement, it requires very little oversight under the HIPAA federal health privacy regulations, which allow individually identifiable health information to be used for QI without obtaining patient authorization or additional confidentiality protections. The Common Rule does not explicitly address QI, but many IRBs exempt QI because the intention is to improve patient outcomes, not to generate generalizable knowledge. Some IRBs consider a QI project to be research only if the results are to be published or disseminated beyond the clinical unit where the project is carried out.

Topic revision: r13 - 14 Feb 2012 - 11:26:19 - MaryBanach
BERDpedia.WhatIsResearch moved from Main.WhatIsResearch on 08 Feb 2008 - 05:50 by MichaelGold?
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