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3 The Value, Importance, and Oversight of Health Research The previous chapter reviewed the value of privacy, while this chapter examines the value and importance of health research. As noted in the introduction to Chapter 2, the committee views privacy and health research as complementary values. Ideally, society should strive to facilitate both for the benefit of individuals as well as the public. In addition to defining health research and delineating its value to individuals and society, this chapter provides an overview and historical perspective of federal research regulations that were in place long before the Privacy Rule was implemented. Because a great deal of medical research falls under the purview of multiple federal regulations, it is important to understand how the various rules overlap or diverge. The chapter also explains how the definition of research has become quite complex under the various federal regulations, which make a distinction between research and some closely related health practice activities that also use health data, such as quality improvement initiatives. The chapter also reviews the available survey data regarding public perceptions of health research and describes the importance of effective communication about health research with patients and the public. CONCEPTS AND VALUE OF HEALTH RESEARCH Definitions Under both the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule, “research” is defined as “a 

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 BEYOND THE HIPAA PRIVACY RULE systematic investigation, including research development, testing and evalu- ation, designed to develop or contribute to generalizable knowledge.” This is a broad definition that may include biomedical research, epidemiologi- cal studies,1 and health services research,2 as well as studies of behavioral, social, and economic factors that affect health. Perhaps the most familiar form of health research is the clinical trial, in which patients volunteer to participate in studies to test the efficacy and safety of new medical interventions. But an increasingly large portion of health research is now information based. A great deal of research entails the analysis of data and biological samples that were initially collected for diagnostic, treatment, or billing purposes, or that were collected as part of other research projects, and are now being used for new research purposes. This secondary3 use of data is a common research approach in fields such as epidemiology, health services research, and public health research, and includes analysis of patterns of occurrences, determinants, and natural his- tory of disease; evaluation of health care interventions and services; drug safety surveillance; and some genetic and social studies (Lowrance, 2002; Lowrance and Collins, 2007). The Importance of Health Research Like privacy, health research has high value to society. It can provide important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs and use. The different approaches to research provide complementary insights. Clinical trials can provide important infor- mation about the efficacy and adverse effects of medical interventions by controlling the variables that could impact the results of the study, but feedback from real-world clinical experience is also crucial for comparing and improving the use of drugs, vaccines, medical devices, and diagnostics. For example, Food and Drug Administration (FDA) approval of a drug for a particular indication is based on a series of controlled clinical trials, often 1 Epidemiology is the study of the occurrence, distribution, and control of diseases in populations. 2 Health services research has been defined as a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations (IOM, 1995). 3 The National Committee on Vital and Health Statistics has noted that “secondary uses” of health data is an ill-defined term, and urges abandoning it in favor of precise description of each use (NCVHS, 2007a). Thus, the committee chose to minimize use of the term in this report.

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 HEALTH RESEARCH with a few hundred to a few thousand patients, but after approval it may be used by millions of people in many different contexts. Therefore, tracking clinical experience with the drug is important for identifying relatively rare adverse effects and for determining the effectiveness in different populations or in various circumstances. It is also vital to record and assess experience in clinical practice in order to develop guidelines for best practices and to ensure high-quality patient care. Collectively, these forms of health research have led to significant discoveries, the development of new therapies, and a remarkable improve- ment in health care and public health.4 Economists have found that medi- cal research can have an enormous impact on human health and longevity, and that the resulting increased productivity of the population contributes greatly to the national economy (Hatfield et al., 2001; Murphy and Topel, 1999) in addition to the individual benefits of improved health. If the research enterprise is impeded, or if it is less robust, important societal interests are affected. The development of Herceptin as a treatment for breast cancer is a prime example of the benefits of research using biological samples and patient records (Box 3-1) (Slamon et al., 1987). Many other examples of findings from medical records research have changed the practice of medi- cine as well. Such research underlies the estimate that tens of thousands of Americans die each year from medical errors in the hospital, and research has provided valuable information for reducing these medical errors by implementing health information technology, such as e-prescribing (Bates et al., 1998; IOM, 2000b). This type of research also has documented that disparities in health care and lack of access to care in inner cities and rural areas result in poorer health outcomes (Mick et al., 1994). Furthermore, medical records research has demonstrated that preventive services (e.g., mammography) substantially reduce mortality and morbidity at reasonable costs (Mandelblatt et al., 2003), and has established a causal link between the nursing shortage and patient health outcomes by documenting that patients in hospitals with fewer registered nurses are hospitalized longer and are more likely to suffer complications, such as urinary tract infections and upper gastrointestinal bleeding (Needleman et al., 2002). These find- ings have all informed and influenced policy decisions at the national level. As the use of electronic medical records increases, the pace of this form of research is accelerating, and the opportunities to generate new knowledge about what works in health care are expanding (CHSR, 2008). 4 See Standards for Privacy of Individually Identifiable Health Information, 64 Fed. Reg. 59918, 59967 (preamble to rule proposed November 3, 1999) for a discussion on the benefits of health records research.

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 BEYOND THE HIPAA PRIVACY RULE BOX 3-1 Examples of Important Findings from Medical Database Research Herceptin and breast cancer: Data were collected from a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University of San Antonio (1974–1992, from across the United States). Data were collected prospectively with audits for verification, and recurrences were recorded through systematic patient follow-up. This database was analyzed to identify prognostic factors, and the results showed that amplification of the HER-2 oncogene was a significant predictor of both overall survival and time to relapse in patients with breast cancer. This information subsequently led to the development of Herceptin (trastuzumab), a targeted therapy that is effective for many women with HER-2–positive breast cancer. Folic acid and birth defects: Medical records research led to the discovery that supplementing folic acid during pregnancy can prevent neural tube birth defects (NTDs). Studies in the 1970s found that vitamin (folate) deficiency and use of anticonvulsive drugs that deplete folate were associated with higher rates of NTDs, and studies in the 1980s found that use of folate supplements was associ- ated with decreased rates. Population-based surveillance systems showed that the number of NTDs decreased 31 percent after mandatory fortification of cereal grain products. Effects of intrauterine DES exposure: Starting in the 1940s, diethylstilbestrol (DES) was used by millions of pregnant women to prevent miscarriages and other disorders in pregnancy. In the 1970s, retrospective studies of medical records began to show that infants exposed to DES during the first trimester of pregnancy had an increased risk as adults of breast, vaginal, and cervical cancer as well as reproductive anomalies. In November 1971, the FDA sent a FDA Drug Bulletin to all U.S. physicians advising them to stop prescribing DES to pregnant women and ordered that prevention of miscarriage be removed from Indications and pregnancy be added to Contraindications in the physician-prescribing information for DES. Patient safety: Health services research estimated that tens of thousands of Americans die each year from medical errors in the hospital. A 1998 study led by David Bates (Brigham & Women’s Hospital) found that computerized order entry of prescriptions at Brigham & Women’s Hospital reduced medical error rates by 55 percent; rates of serious errors fell by 86 percent. In response to this ground- breaking work, hospitals around the country are installing their own computer- ized physician order entry systems. For example, The Leapfrog Group—a large national coalition of more than 100 public and private organizations that provide health care benefits—includes computerized physician order entry as one of the safety standards it encourages hospitals to adopt.

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 HEALTH RESEARCH Mortality risks of antipsychotic drugs in the elderly: In 2005, the FDA issued a public health advisory stating that the atypical (second generation) antipsychotic medications increase mortality among elderly patients. This decision was based on the results of 17 placebo-controlled trials with such drugs that enrolled a total of 5,106 elderly patients with dementia who had behavioral disorders. Fifteen of the studies showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients (approximately 1.6-1.7–fold increase in mortality), most often due to heart-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). However, the risk of death with older, conventional agents was not known. Results from two subsequent retrospective reviews of 27,000 and 37,000 medical records of elderly patients who had been treated with either conventional or atypical antipsychotic drugs indicated that conventional antipsychotic medications are at least as likely as atypical agents to increase the risk of death among those patients. As a result, the FDA now requires that the prescribing information for all antipsychotic drugs includes the same infor- mation about this risk in a boxed warning and a warnings section. Child safety: Using the Partners for Child Passenger Safety (PCPS)—an ongoing child-focused, real-time, crash surveillance system established with the State Farm Insurance Companies in 1997—Flaura Winston (Children’s Hospital of Pennsylvania) found that only 25 percent of children between 3 and 7 years of age were appropri- ately restrained in crashes; children in seat belts alone were at a 3.5-fold increased risk of serious injury. Winston’s analysis of PCPS data led to the rapid adoption of belt-positioning boosters as the appropriate form of restraint for children once they have outgrown car seats. Appropriate restraint by children in this age group has doubled, and child fatality from crashes is at its lowest level ever. Obesity: Eric Finkelstein (RTI International) used data from the late 1990s to find that obesity is responsible for up to $92.6 billion in medical expenditures each year; approximately half of obesity-related health care costs are borne by Medi- care and Medicaid. A 2002 study by Roland Sturm (RAND) found that the effects of obesity on a number of chronic conditions were larger than those of smoking or problem drinking. Since then, obesity has been escalated to the top of the list of health care priorities, and policy makers have appropriated funds for federal agencies to fund health services research that encourages people to understand the effects of diet and exercise on their health. Rural health: Stephen Mick (Virginia Commonwealth University) and colleagues examined rural hospital performance in the late 1980s and early 1990s and found that activity typical of urban hospitals is beyond the capacity of most rural facilities and recommended that a new federal approach would be required to preserve rural acute-care services. This work helped form the intellectual basis for Medi- care’s highly successful Critical Access Hospital program, which was designed to improve rural health care access and reduce closures of hospitals that provide essential community services. continued

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 BEYOND THE HIPAA PRIVACY RULE BOX 3-1 Continued Workforce and health outcomes: In 1997, Jack Needleman (University of California–Los Angeles) and Peter Buerhaus (Vanderbilt University) analyzed more than 6 million patient discharge records from 799 hospitals in 11 states. They found that patients in hospitals with fewer registered nurses stay hospitalized lon- ger and are more likely to suffer complications, such as urinary tract infections and upper gastrointestinal bleeding. This research established a causal link between the nursing shortage and outcomes, and helped move the nursing shortage into the public’s eye and onto policy makers’ radar. In 2002, Congress passed the Nurse Reinvestment Act to increase the domestic supply of nurses. SOURCES: Bates et al. (1998); FDA (1971, 2005, 2008); Finkelstein et al. (2003); Gill et al. (2007); Herbst et al. (1971); IOM (2000b); Mick et al. (1994); Needleman et al. (2002); Pitkin (2007); Schneeweiss et al. (2007); Slamon et al. (1987); Thorpe et al. (2004); Veurink et al. (2005); Winston et al. (2000). Advances in health information technology are enabling a transforma- tion in health research that could facilitate studies that were not feasible in the past, and thus lead to new insights regarding health and disease. As noted by the National Committee on Vital and Health Statistics, “Clinically rich information is now more readily available, in a more structured format, and able to be electronically exchanged throughout the health and health care continuum. As a result, the information can be better used for quality improvement, public health, and research, and can significantly contribute to improvements in health and health care for individuals and populations” (NCVHS, 2007a). The informatics grid recently developed with support from the National Cancer Institute (Cancer Biomedical Informatics Grid, or caBIG) is an example of a how information technologies can facilitate health research by enabling broader sharing of health data while still ensur- ing regulatory compliance and protecting patient privacy (Box 3-2). Science today is also changing rapidly and becoming more complex, so no single researcher or single site can bring all the expertise to develop and validate medical innovations or to ensure their safety. Thus, efficient shar- ing of information between institutions has become even more important than in previous eras, when there were fewer new therapies introduced. The expansion of treatment options, as well as the escalating expense of new therapies, mandates greater scrutiny of true effectiveness,5 once efficacy 5 Effectiveness can be defined as the extent to which a specific test or intervention, when used under ordinary circumstances, does what it is intended to do. Efficacy refers to the extent to which a specific test or intervention produces a beneficial result under ideal conditions (e.g., in a clinical trial).

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 HEALTH RESEARCH BOX 3-2 caBIG (Cancer Biomedical Informatics Grid) The National Cancer Institute’s caBIG Data Sharing and Intellectual Capital Workspace’s mission is to enable all constituencies in the cancer community— including researchers, physicians, and patients—to share data and knowledge through an informatics grid “by addressing the legal, regulatory, ethical, policy, academic, proprietary, and contractual barriers.” The caBIG strives to achieve this objective through a number of different initiatives. First, caBIG provides decision support tools for institutions that share data through the informatics grid. This analytic framework is intended to encour- age institutions to make consistent analysis of legal, regulatory, and ethical con- straints on data sharing. The program has identified four sets of considerations for institutions to analyze: (1) intellectual property considerations, (2) privacy and confidentiality considerations, (3) IRB and ethical considerations, and (4) sponsor considerations. Second, caBIG has identified a number of best practices and processes for facilitating the approval of data sharing agreements via the caBIG infrastructure. Currently identified best practices include suggestions for conducting the patient informed consent process in a manner that permits data to be shared via caBIG, standardizing expectations for sharing unpublished data, creating recommenda- tions for developing contract clauses for sponsored research projects that permit broad data sharing, and providing information documents for IRBs and Privacy Boards to use in reviewing proposals for data sharing via caBIG. Third, caBIG has created model documents intended to facilitate and expe- dite the arrangements between institutions to share data. These include model informed consent provisions, model researcher questionnaires and data shar- ing checklists, and security-related agreements. Finally, caBIG has developed security policies and requirements for systems that are attached to or access the caBIG infrastructure. Under caBIG, each institution retains legal responsibility for the research data it generates; this includes responsibility for complying with the HIPAA Privacy Rule, the Common Rule, as well as any applicable state laws. The institutions also retain the right to determine who they will share their data with, what type of data (deidentified versus identifiable) they will share and under what terms and conditions. The advantage to conducting research within the caBIG technical infrastructure is that the program has identified the common legal and ethical considerations that apply to all researchers across the country, and has simplified the process for sharing data. In addition, the caBIG infrastructure has increased institutions’ trust in one another because “everyone is playing by the same rules” and a common set of expectations exist. Recently, the BIG Health Consortium was developed to extend the concept of caBIG beyond cancer research, and to link all stakeholders in biomedicine through a new biomedical configuration. SOURCES: Big Health (2008); NCI (2008); NCVHS (2007b).

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 BEYOND THE HIPAA PRIVACY RULE has been demonstrated. This requires registries of patient characteristics, outcomes, and adverse events. Large populations are required to facili- tate comparison of patient populations and to calculate risk/benefit esti- mates. For example, INTERMACS6 (Interagency Registry for Mechanically Assisted Circulatory Support) is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute, Centers for Medicare & Medicaid Ser- vices, FDA, clinicians, scientists and industry representatives. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regula- tion and reimbursement of such devices. Similarly, the Extracorporeal Life Support Organization (ELSO),7 an international consortium of health care professionals and scientists who focus on the development and evaluation of novel therapies for support of failing organ systems, maintains a registry of extracorporeal membrane oxygenation and other novel forms of organ system support. Registry data are used to support clinical practice and research, as well as regulatory agencies. Another example is the database developed by the United Network for Organ Sharing (UNOS) for the col- lection, storage, analysis and publication of data pertaining to the patient waiting list, organ matching, and transplants.8 Launched in 1999, this secure Internet-based system contains data regarding every organ donation and transplant event occurring in the United States since 1986. Information-based research, such as research using health information databases has many advantages (reviewed by Lowrance, 2002). It is often faster and less expensive than experimental studies; it can analyze very large sets of data and may detect unexpected phenomena or differences among subpopulations that might not be included in a controlled experimental study; it can often be undertaken when controlled trials are simply not possible for ethical, technical, or other reasons, and it can be used to study effectiveness of a specific test or intervention in clinical practice, rather than just the efficacy as determined by a controlled experimental study. It can also reexamine data accrued in other research studies, such as clinical trials, to answer new questions quickly and inexpensively. However, information- based research does have limitations. Often it has less statistical rigor than controlled clinical studies because it lacks scientific control over the original data collection, quality, and format that prospective experimental research can dictate from the start. In addition to these scientific limitations, because 6 See http://www.intermacs.org. 7 See http://www.elso.med.umich.edu. 8 See http://www.unos.org/Data.

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 HEALTH RESEARCH of its relational and often distant physical separation from the data subjects, and the sheer volume of the records involved, obtaining individual consent for the research can be difficult or impossible. Advances in information-based medical research could also facilitate the movement toward personalized medicine, which will make health research more meaningful to individuals. The goal of personalized medicine is to tailor prevention strategies and treatments to each individual based on his/her genetic composition and health history. In spite of the strides made in improving health through new treatments, it is widely known that most drugs are effective in only a fraction of patients who have the condition for which the drug is indicated. Moreover, a small percentage of patients are likely to have adverse reactions to drugs that are found to be safe for the majority of the population at the recommended dose. Both of these phenomena are due to variability in the patient population. Revolutionary advances in the study of genetics and other markers of health and disease are now making it possible to identify and study these variations, and are leading to more personalized approaches to health care—that is, the ability to give “the appropriate drug, at the appropriate dose, to the appropri- ate patient, at the appropriate time.” Achieving the goals of personalized medicine will lead to improvements in both the effectiveness and the safety of medical therapies. Public Perceptions of Health Research A number of studies have been undertaken to gauge the public’s atti- tude toward research and the factors that influence individuals’ willingness to participate in research. The surveys reviewed in this chapter focus on interventional clinical trials. A review of survey questions to gauge the public willingness to allow their medical records to be used in research can be found in Chapter 2. The Public Values Health Research A number of studies suggest that most Americans have a positive view of medical research and believe that research is beneficial to society. A recent Harris poll found that nearly 80 percent of respondents were inter- ested in health research findings, consistent with previous survey results (Westin, 2007). A study in 2005 compiled data from 70 state surveys and 18 national surveys and found that the majority of Americans believe main- taining world leadership in health-related research is important. Seventy- eight percent of respondents said that it is very important, and 17 percent said that it is somewhat important. Only 4 percent of Americans reported that maintaining world leadership in health-related research is not impor-

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0 BEYOND THE HIPAA PRIVACY RULE tant (Woolley and Propst, 2005). Similar results were found in a 2007 survey—76 percent of respondents reported that science plays a very impor- tant role in our health, and 78 percent reported that science plays a very important role in our competitiveness (Research!America, 2007). The Virginia Commonwealth University 2004 Life Sciences Survey also found that most Americans have a positive view of research. In this study, 90 percent of respondents agreed that developments in science have made society better; 92 percent reported that “scientific research is essential for improving the quality of human lives”; and 84 percent agreed that “the benefits of scientific research outweigh the harmful results” (NSF, 2006). Overall Experience When Participating in Research Little is known about the attitudes of individuals who have actually participated in medical research. However, the available evidence suggests that most research participants have positive experiences. A recent Harris Poll found that 13 percent of respondents had participated in some form of health research, and 87 percent of those felt comfortable about their experience (Westin, 2007). In a study focused on cancer, 93 percent of respondents who participated in research reported it as a very positive expe- rience; 76 percent said they would recommend participation in a clinical trial to someone with cancer. Most physicians surveyed in this study stated that they believe clinical trial participants receive the best possible care, and have outcomes at least as good as patients receiving standard cancer treatment (Comis et al., 2000). Another study found that 55 percent of indi- viduals who participated in a research study would be willing to participate again in a future research study (Trauth et al., 2000). Willingness to Participate in Research Public opinion surveys indicate that a majority of Americans are willing to participate in clinical research studies. In 2001, a compilation of studies commissioned by Research!America found that 63 percent of Americans would be willing to participate in a clinical research study (Woolley and Propst, 2005). This percentage has remained stable over time. A 2007 Research!America survey also found that 63 percent of Americans would be very likely to participate in a clinical research study if asked (Research!America, 2007); 68 percent of respondents reported that their desire to improve their own health or the health of others was a major factor in deciding whether to participate in a clinical research project (Research!America, 2007). Other surveys also suggest that willingness to participate in research focused on specific diseases is quite high. In one survey, the percentage of

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 HEALTH RESEARCH respondents indicating a willingness to participate in a medical research study was 88 percent for cancer, 86 percent for heart disease, 83 percent for a noncurable fatal disease, 79 percent for addiction, 78 percent for depres- sion, and 76 percent for schizophrenia (Trauth et al., 2000). Respondents with greater knowledge of how research is conducted were more willing to participate (Trauth et al., 2000). Another study found that 8 of 10 Ameri- cans would consider participating in a clinical trial if faced with cancer. More than two-thirds of respondents said they would be willing to partici- pate in a clinical trial designed to prevent cancer (Comis et al., 2000). Americans also seem to be very supportive of medical research that relies on genetic data. A 2007 survey found that 93 percent of Americans supported the use of genetic testing if the information collected is used by researchers to find new ways to diagnose, prevent, or treat disease (Genetics & Public Policy Center, 2007). Two separate surveys found that 66 percent of Americans would be willing to donate their genetic material for medical research (Genetics & Public Policy Center, 2007; Research!America, 2007). However, despite this apparent positive view of genetic research, 92 percent of Americans reported they were concerned about their genetic information being used in a “harmful way” (Genetics & Public Policy Center, 2007). Many factors, in addition to concerns about privacy and confidential- ity (Genetics & Public Policy Center, 2007; Research!America, 2007), may influence an individual’s willingness to participate in a medical research study. The Trauth survey found that individuals with higher income levels, with a college or graduate degree, or with children were more likely to participate in research. Age affected willingness to participate: 57 percent of respondents ages 18–34 were willing to participate in research, but only 31 percent of respondents ages 65 or older were willing (Trauth et al., 2000). Other factors that potentially influence an individual’s willingness to participate in research are race and ethnicity. It is well documented that minorities participate in health research at a much lower percentage than white Americans. Many cultural, linguistic, and socioeconomic barriers could be responsible for this difference (Giuliano et al., 2000), and study results have been variable on this issue. Several studies suggest that the low participation rates by racial and ethnic minority groups are due to their strong distrust of the medical research community compared to the general population (Braunstein et al., 2008; Corbie-Smith et al., 1999; Farmer et al., 2007; Grady et al., 2006; Shavers et al., 2002). However, other evidence suggests that the low percentage of minorities participating in research is related to minority groups’ lack of access to the research community (Brown et al., 2000; Wendler et al., 2006; Williams and Corbie-Smith, 2006). Thus, it is likely that the low number of minority individuals participating in medical research is at least partly due to recruit- ment techniques that are ineffective for minority populations.

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 BEYOND THE HIPAA PRIVACY RULE many noninterventional studies are conducted with an IRB/Privacy Board approved waiver of consent or authorization, including those studies in a registry could be an important method for increasing public knowledge of such studies. Informing the Public About the Methods and Value of Research As noted previously, clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better under- stand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study subjects will be necessary to derive meaningful results. However, many patients probably are not aware that their medical records are being used in information-based research. For example, the recent study that used focus groups to examine the views of veterans toward the use of medical records in research found that the majority of participants (75 percent) were not aware that “under some circumstances, [their] medical records could be used in some research studies without [their] permission,” despite the fact that a notice of privacy practices, which included a statement that such research could occur, had been mailed to all participants less than a year prior to the study (Damschroder et al., 2007). Moreover, surveys show that many patients desire not only notice, but also the opportunity to decide whether to consent to such research with medical records. Those surveys further indicate that patients who wish to be asked for consent for each study are most concerned about the potentially detrimental affects of inappropriate disclosure of their personally identifi- able health information, including discrimination in obtaining health or life insurance or employment. As noted in Chapter 2, strengthening security protections of health data should reduce the risk of security breaches and their potential negative con- sequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported on could also help to ease patient concerns about privacy and increase patients’ trust in the research community, which as noted above is important for the public’s continued participation in health research. For example, datasets are most often provided to researchers without direct identifiers such as name and Social Security number. Furthermore, identi- fiers are not included in publications about research results. Also, under

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 HEALTH RESEARCH both the Privacy Rule and the Common Rule, a waiver of consent and authorization is possible only under the supervision of an IRB or Privacy Board, and a waiver is granted only when the research entails minimal risk and when obtaining individual consent and authorization is impracticable (see the previous section and also Chapter 4). Finally, professional ethics dictate that researchers safeguard data and respect privacy. Conveying the value of medical records research to patients will be important. Surveys show that people are more supportive of research that is relevant to them and their loved ones. At the same time, educational efforts should stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research (Box 3-8), but datasets will not repre- sent the entire population if some people withhold access to their health information. In addition, an educated public could also decrease the potential for biased research samples. A universal requirement for consent or authoriza- tion in medical records research leads to incomplete datasets, and thus to biased results and inaccurate conclusions. Some large medical institutions with a strong research history and reputation (e.g., Mayo Clinic) can obtain authorization and consent rates as high as 80 percent, but the 20 percent BOX 3-8 Selection Bias in Health Research When researchers are required to obtain consent or authorization to access each individual’s medical record for a research study, it is likely that individuals’ willingness to grant access will not be random, and will vary in a way that may bias the study results—a phenomenon known as selection bias. A study sample is biased if certain members are underrepresented or overrepresented relative to others in the population. A biased sample causes problems because any statistic computed from that sample has the potential to be consistently erroneous. The bias can lead to an over- or underrepresentation of the corresponding parameter being studied in the population. Typically this causes measures of statistical sig- nificance to appear much stronger than they are, but it is also possible to cause completely illusory artifacts. In either case, conclusions drawn from a biased sample are likely to be invalid. The requirement to obtain consent or authoriza- tion may lead to a biased study sample because those who decline to participate may be more or less likely than average to have a particular health problem. This may be especially problematic if the research topic entails sensitive or potentially embarrassing information, such as HIV infection. SOURCES: Casarett et al. (2005); Jacobsen et al. (1999).

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 BEYOND THE HIPAA PRIVACY RULE who refuse have distinct demographic and health characteristics. In fact, even a refusal rate of less than 5 percent can create selection bias in the data (Jacobsen et al., 1999; see Chapter 5 for more detail). Conveying to the public the importance of health care improvements derived from medical records research and stressing the negative impact of incomplete datasets on research findings may increase the public’s participation in research and their willingness to support information-based research that is conducted with IRB or Privacy Board oversight, under a waiver of patient consent or authorization. Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required (Box 3-1). For example, analysis of medical records showed that infants exposed to diethylstilbesterol (DES) during the first trimester of pregnancy had an increased risk of breast, vaginal, and cervical cancer as well as reproductive anomalies as adults. Similarly, studies of medical records led to the discovery that folic acid supplementation during pregnancy can prevent neural tube defects. Thus, HHS and the health research community should work to edu- cate the public about how research is done and the value it provides. All stakeholders, including professional organizations, nonprofit funders, and patient organizations, have different interests and responsibilities to make sure that their constituencies are well informed. For example, the American Society of Clinical Oncology and the American Heart Association already have some online resources to help patients gather information about research that may be relevant to their conditions. But coordination and identification of best practices by HHS would be helpful, and research is needed to identify which segments of the population would be receptive to and benefit from various types of information about how research is done and its value in order to create and implement an effective plan. Greater use of community-based participatory research, in which community-based organizations or groups bring community members into the research process as partners to help design studies and disseminate the knowledge gained,39 could help achieve this goal. These groups help researchers to recruit research participants by using the knowledge of the community to understand health problems and to design activities that the community is likely to value. They also inform community members about how the research is done and what comes out of it, with the goal of providing immediate community benefits from the results when possible. 39 See http://www.ahrq.gov/research/cbprrole.htm.

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 HEALTH RESEARCH CONCLUSIONS AND RECOMMENDATIONS Based on its review of the information described in this chapter, the committee agreed on a second overarching principle to guide the formation of recommendations. The committee affirms the importance of maintaining and improving health research effectiveness. Research discoveries are central to achieving the goal of extending the quality of healthy lives. Research into causes of disease, methods for prevention, techniques for diagnosis, and new approaches to treatment has increased life expectancy, reduced infant mortality, limited the toll of infectious diseases, and improved outcomes for patients with heart disease, cancer, diabetes, and other chronic diseases. Patient-oriented clinical research that tests new ideas makes rapid medical progress possible. Today, the rate of discovery is accelerating, and we are at the precipice of a remarkable period of investigative promise made possible by new knowledge about the genetic underpinnings of disease. Genomic research is opening new possibilities for preventing illness and for develop- ing safer, more effective medical care that may eventually be tailored for specific individuals. Further advances in relating genetic information to predispositions to disease and responses to treatments will require the use of large amounts of existing health-related information and stored tissue specimens. The increasing use of electronic medical records will further facilitate the generation of new knowledge through research and acceler- ate the pace of discovery. These efforts will require broad participation of patients in research and broad data sharing to ensure that the results are valid and applicable to different segments of the population. Collaborative partnerships among communities of patients, their physicians, and teams of researchers to gain new scientific knowledge will bring tangible benefits for people in this country and around the world. Surveys indicate that the majority of Americans believe that health research is important, are interested in the findings of research studies, and are willing to participate in health research. But patients often lack infor- mation about how research is conducted and are rarely informed about research results that may have a direct impact on their health. Effective communication could build the public’s trust of the research community, which is important because trust is necessary for the public’s continued participation in research. Moreover, direct feedback could lead to improved health care for study participants if the results indicate that an altered course of care is warranted. Thus, the committee recommends that when patients consent to the use of their medical records in a particular study, health researchers should make greater efforts when the study ends to inform study participants about the results, and the relevance and importance of those results. Broader adop- tion of electronic health records may be helpful in accomplishing this goal,

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 BEYOND THE HIPAA PRIVACY RULE but standards and guidelines for providing and explaining study results to research participants or various sectors of the public are needed. HHS should also encourage registration of trials and other studies in public databases, particularly when research is conducted with an IRB/ Privacy Board approved waiver of consent or authorization, as a way to make information about research studies more broadly available to the public. Numerous clinical trial registries already exist, and registration has increased in recent years, but no centralized system currently exists for dis- seminating information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional stud- ies are conducted with an IRB/Privacy Board approved waiver of consent or authorization, including such studies in a registry could be an important method for increasing public knowledge of those studies. Interventional clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic health records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study partici- pants will be necessary to derive meaningful results. However, many patients are likely not aware that their medical records are being used in information-based research, and surveys show that many patients desire not only notice, but also the opportunity to decide about whether to consent to such research with medical records. As noted in Chapter 2, strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported could also increase patients’ trust in the research community. Thus, HHS and the health research community should work to educate the public about how research is done. It will also be important for HHS and researchers to convey the value of health care improvements derived from medical records research, and to stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizabil- ity of health research, but datasets will not be representative of the entire population if some people withhold access to their health information. A universal requirement for consent or authorization in information-based

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 HEALTH RESEARCH research may lead to incomplete datasets, and thus to biased results and inaccurate conclusions. Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required. To ensure that beneficial health research and related activities continue to be undertaken with appropriate oversight under federal regulations, it will be important for HHS to also provide more guidance on how to distin- guish the various activities. The Privacy Rule makes a distinction between health research and some closely related endeavors, such as public health and quality improvement activities, which also may involve collection and analysis of personally identifiable health information. Under the Privacy Rule (as well as the Common Rule), these activities, which aim to protect the public’s health and improve the quality of patient care, are considered and health care “practice” rather than health research. Therefore, they can be undertaken without consent or authorization, or an IRB/Privacy Board waiver of consent or authorization. However, it can be a challenge for IRBs and Privacy Boards to distinguish among activities that are or are not sub- ject to the various provisions of the Privacy Rule and the Common Rule, and inappropriate decisions may prevent important activities from being undertaken or could potentially allow improper disclosure of personally identifiable health information. To address these difficulties, a number of models have been proposed that outline the criteria IRBs and Privacy Boards should use to distinguish practice and research. For example, one recent model provides a detailed checklist for IRBs and Privacy Boards to use in determining whether an activity is public health research and required to comply with the research provisions of the Privacy Rule, or public health practice that does not need IRB/Privacy Board review. The committee believes that standardizing the criteria is essential to support the conduct of these important health care activities. Thus, HHS should convene the relevant stakeholders to develop standard criteria for IRBs and Privacy Boards to use when making deci- sions about whether protocols entail research or practice. There should be flexibility in the regulation to allow important activities to go forward with appropriate levels of oversight. Also, it will be important to evaluate whether these criteria are effective in aiding IRB/Privacy Board reviews of proposed protocols, and whether they lead to appropriate IRB/Privacy Board decisions. These changes suggested above could be accomplished without any changes to HIPAA by making them a condition of funding from HHS and other research sponsors and by providing some additional funds to cover the cost.

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