Why do medical research
High quality of medical care we enjoy today is built upon years of effort by physicians, physician-scientists, phds, and other medical professionals investigating the causes of and potential treatments for disease. Insights provided by medical research today promise to lessen the impact of our greatest health problems, including diabetes, cancer, and heart disease. As science continues to unravel the molecular workings that underpin disease, we will see profound changes in the approach to researchers are at the forefront in this revolution in medical knowledge. To capitalize on the advances that have been made in our understanding of disease, a majority of our research projects are translational in nature. Translational research seeks to take the medical discoveries that have been made in a laboratory setting and move them into medical practices that can be used by physicians to improve the lives of their you support medical research, you are helping to build the future of medicine. With the partnership of individual and corporate donors, we are able to make significant headway in advancing medical knowledge and improving patient philanthropic partner, the hennepin health foundation (hhf), offers many ways you can support medical research. Hhf supports the mission and goals of mmrf and hennepin county medical center and provides an avenue for individuals and organizations to support our programs and research current issue past the nih director: the value of medical issues / summer 2008 table of an enhanced version of this page please turn javascript involved in good health, whether donating much-needed blood, as nih director dr. Elias zerhouni demonstrates here, with help from phlebotomist la'tesha harris, or participating in clinical trials to advance medical courtesy of director of the national institutes of health, elias zerhouni oversees the activities of the world's leading medical research organization. He spoke with nih medlineplus' christopher klose about the value of medical research and clinical does medical research mean to the average person? But it is important to note that modern medical science, based on molecular biology, only began in earnest with the discovery of the structure of dna in was so important about the discovery of dna? With more than 200 types and subtypes known today, the research challenge is to understand and block all the pathways to cancer so that people don't end up in its irretrievable late does medical research stand today? After 50 years of molecular biology and genetic research, we realize that you don't get to a disease through just one cause or abnormality. Of us have heard about "clinical trials," but don't really understand them and where they fit into the research picture. It established the correlation between cholesterol—from a high-fat diet of milk, cheese, and meat (thought to be good for you)—and heart in the lab, to understand and try to prevent damage from cholesterol, researchers discovered an enzyme that is critical to its formation. When you can demonstrate, in a statistically valid way, through a randomized trial, that the mortality rate from heart disease for x thousand people (treated with an experimental drug, for example) is y percent lower than that of x thousand people who have not been treated with the drug, but with a placebo, you have conclusive medical a public health institution, we want things to be based on strong scientific evidence. People weren't happy with nih for questioning such a long-held practice, but the results proved it was detrimental and has changed medical practice! It is a real tribute to senator specter and other champions in the house and senate that they strongly support medical research, despite the fact there is no immediate political reward for doing 's been the payoff for the american taxpayer? Zerhouni: what you're talking about is an information bank that's going to be wider and more public in a way, but be more effective for researchers and the public. A service of the national library of medicine, national institutes of ute of medicine (us) committee on health research and the privacy of health information: the hipaa privacy rule; nass sj, levit la, gostin lo, editors. Beyond the hipaa privacy rule: enhancing privacy, improving health through detailsinstitute of medicine (us) committee on health research and the privacy of ation: the hipaa privacy rule; nass sj, levit la, gostin lo, gton (dc): national academies press (us); tshardcopy version at national academies presssearch term < prevnext >. Value, importance, and oversight of health researchthe 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 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 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 ts and value of health researchdefinitionsunder both the health insurance portability and accountability act (hipaa) privacy rule and the common rule, “research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
This is a broad definition that may include biomedical research, epidemiological studies,1 and health services research,2 as well as studies of behavioral, social, and economic factors that affect s 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. 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 history of disease; evaluation of health care interventions and services; drug safety surveillance; and some genetic and social studies (lowrance, 2002; lowrance and collins, 2007). Clinical trials can provide important information 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. 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 tively, these forms of health research have led to significant discoveries, the development of new therapies, and a remarkable improvement in health care and public health. Economists have found that medical 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. If the research enterprise is impeded, or if it is less robust, important societal interests are 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. Many other examples of findings from medical records research have changed the practice of medicine 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. 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. 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). Box 3-1examples of important findings from medical database tin 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 (more... Advances in health information technology are enabling a transformation 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 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 ensuring regulatory compliance and protecting patient privacy (box 3-2). 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, (more... 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. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of such devices. Registry data are used to support clinical practice and research, as well as regulatory agencies. Information-based research, such as research using health information databases has many advantages (reviewed by lowrance, 2002). It can also reexamine data accrued in other research studies, such as clinical trials, to answer new questions quickly and inexpensively. 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 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 es in information-based medical research could also facilitate the movement toward personalized medicine, which will make health research more meaningful to individuals. Achieving the goals of personalized medicine will lead to improvements in both the effectiveness and the safety of medical perceptions of health researcha number of studies have been undertaken to gauge the public’s attitude toward research and the factors that influence individuals’ willingness to participate in research. 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 public values health researcha 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 interested 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 maintaining world leadership in health-related research is important. Only 4 percent of americans reported that maintaining world leadership in health-related research is not impor tant (woolley and propst, 2005). Similar results were found in a 2007 survey—76 percent of respondents reported that science plays a very important role in our health, and 78 percent reported that science plays a very important role in our competitiveness (research! 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). Experience when participating in researchlittle is known about the attitudes of individuals who have actually participated in medical research. 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 experience; 76 percent said they would recommend participation in a clinical trial to someone with cancer. Another study found that 55 percent of individuals who participated in a research study would be willing to participate again in a future research study (trauth et al. To participate in researchpublic opinion surveys indicate that a majority of americans are willing to participate in clinical research studies. Found that 63 percent of americans would be willing to participate in a clinical research study (woolley and propst, 2005). Survey also found that 63 percent of americans would be very likely to participate in a clinical research study if asked (research! 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! Surveys also suggest that willingness to participate in research focused on specific diseases is quite high. In one survey, the percentage of 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 depression, and 76 percent for schizophrenia (trauth et al. Respondents with greater knowledge of how research is conducted were more willing to participate (trauth et al. 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! 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). 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. 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. 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.
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. Thus, it is likely that the low number of minority individuals participating in medical research is at least partly due to recruitment techniques that are ineffective for minority populations. The survey that focused on cancer research suggests that one of the main reasons why individuals do not participate in research is lack of knowledge about the availability of clinical trials. In the united states, 48 percent of respondents to one survey reported that a physicians’ recommendation would be a major factor in deciding whether to take part in a research study. Nearly three-fourths of respondents also cited an institution’s reputation as a key factor to consider when deciding whether to participate in a study (research! Twenty percent of respondents in an italian public survey indicated that the presence of a physician as a reference during a research study influenced their willingness to participate (mosconi et al. Sum, surveys indicate that the vast majority of americans have a positive view of medical research, believe that research is beneficial to society, and are interested in health research findings. Although little is known about the attitudes of individuals who have actually participated in medical research, the available evidence suggests that most research participants have positive experiences. Surveys also suggest that a majority of americans are willing to participate in clinical research studies. Similar to the findings in chapter 2, surveys indicate that many factors, in addition to concerns about privacy and confidentiality, can potentially influence an individual’s willingness to participate in medical research, including the type of research and personal characteristics such as health status, age, education, and race. Notably, respondents with greater knowledge of how research is conducted were more willing to participate in ght of health researchhistorical development of federal protections of health information in researchthe development of international codes, federal legislation, and federal regulation of human subjects often occurred in response to past abuses in biomedical experiments (reviewed by pritts, 2008) (box 3-3). The most well-known examples included (1) reported abuses of concentration camp prisoners in nazi experiments during world war ii, and (2) the tuskegee syphilis study begun in 1932, in which researchers withheld effective treatment from affected african american men long after a cure for syphilis was found. Most of the current principles and standards for conducting human subjects research were developed primarily to protect against the physical and mental harms that can result from these types of biomedical experiments. Although the standards apply to research that uses identifiable health information, research based solely on information is not their primary focus. Box 3-3the basis for human subjects protections in biomedical nuremberg code, created by the international community after the nazi war crimes trials, is generally seen as the first codification (more... In the united states, perhaps the most influential inquiry into the protection of human subjects in research was the belmont report. The belmont principles have been elaborated on in many settings, and served as the basis for formal regulation of human subjects research in the united states. In general, states do not directly regulate the activity of most researchers (burris et al. However, the belmont commission’s recommendations were reflected in the department of health and human services’ (hhs’s) policy for protection of human subjects research, subpart a of 45 c. These protections were considered a benchmark policy for federal agencies, and in december 1981, the president’s commission for the study of ethical problems in medicine and biomedical and behavioral research recommended10 that all federal departments and agencies adopt the hhs 1982, the president’s office of science and technology policy appointed a committee for the protection of human research subjects to respond to the recommendations of the president’s commission. The committee agreed that uniformity of federal regulations on human subjects protection is desirable to eliminate unnecessary regulations and to promote increased understanding by institutions that conduct federally supported or regulated research. As a result, in 1991, other federal departments and agencies joined hhs in adopting a uniform set of rules for the protection of human subjects of research, identical to subpart a of 45 c. Eighteen federal agencies have now adopted the common rule as their own respective ew of the common rulethe common rule governs most federally funded research conducted on human beings and aims to ensure that the rights of human subjects are protected during the course of a research project. The common rule stresses the importance of individual autonomy and consent; requires independent review of research by an institutional review board (irb); and seeks to minimize physical and mental harm. Privacy and confidentiality protections, although not defined in a detailed and prescriptive manner, are included as important components of risk in framework for achieving the goal of protecting human subjects is based on two foundational requirements: the informed consent of the research participant and the review of proposed research by an irb.
Scope of the common rulein general, the common rule applies only to research on human subjects that is supported by the federal government. As noted previously, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The common rule, a “human subject” is defined as “a living individual about whom an investigator … conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Private information is considered to be personally identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the common rule applies to most human subjects research conducted using federal funds, but its influence is broader because most institutions that accept federal funds sign an agreement (a federalwide assurance or fwa) with hhs to abide by the common rule requirements in all research, regardless of funding source. Nonetheless, some privately funded human subjects research is conducted outside the purview of federal regulation (goldman and choy, 2001; williams, 2005). Companies and other organizations may voluntarily choose to apply the common rule to their research projects, and many do. However, research projects in which compliance is voluntary are not subject to oversight or disciplinary action by hhs (goldman and choy, 2001; williams, 2005). Common rule requires that a researcher obtain informed consent (usually in writing) from a person before he/she can be admitted to a study (williams, 2005). Informed consent is sought through a process in which a person learns key facts about a research study, including the potential risks and benefits, so that he/she can then agree voluntarily to take part or decide against it. These elements include: an explanation of the purposes of the research, the expected duration of the subject’s participation, the potential risks and benefits of the research, how confidentiality will be maintained, the fact that participation is strictly voluntary, and who the subject can contact to answer questions about the study or about his/her rights as a research certain limited circumstances, the common rule allows an informed consent to be for unspecified future research. For example, under the common rule an informed consent can be used to obtain a person’s permission to study personally identifiable information maintained in a repository for future, unspecified research purposes (hhs, 2003). The most part, the required elements of an informed consent address all types of research, although some are more relevant to biomedical research (e. One required element of informed consent is particularly relevant to research involving personally identifiable health information. The common rule requires an informed consent to include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be utional review boardsadopting the principles of the belmont report, the common rule requires that protocols for human subjects research be reviewed by an irb (box 3-4) before research may begin. The common rule specifies which level of irb review is needed for various types of research and provides criteria for the irb to consider during the review. According to the department of health and human services (hhs) institutional review board (irb) guidebook, “the irb is an administrative body established to protect the rights and welfare of human research subjects (more... The common rule requires that an irb determine the following factors are satisfied to approve proposed research: risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; the selection of subjects is equitable; informed consent will be sought in accordance with the rules and will be documented; when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and when appropriate, adequate provisions are in place to protect the privacy of subjects and to maintain the confidentiality of irb may waive the requirement to obtain informed consent or approve an alteration of the consent form for some minimal risk research. The irb may also waive the requirement for signed consent in certain ized dataas noted above, the common rule considers use of “private identifiable information” to be human subjects research. Data are considered personally identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information accessed by the researcher. However, the common rule exempts from its requirements research that involves: [t]he collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the ise identifiable data may be deidentified or “anonymized” for purposes of the common rule if it is coded and certain other conditions are met (hhs, 2004). Under guidance issued by the office for human research protection, information is “coded” if identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (the code), and a key to decipher the code exists, enabling linkage of the identifying information to the private information or ch involving only coded private information or specimens is not considered to involve human subjects under the common rule if the following conditions are met: the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and the investigator(s) cannot readily ascertain the identify of the individual(s) to whom the coded private information or specimens pertain because, for example:—the key to decipher the code is destroyed before the research begins;—the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;—irb-approved written policies and operating procedures for a repository or data management center prohibit the release of the key to investigators under any circumstances, until the individuals are deceased; or—other legal requirements prohibit the release of the key to the investigators, until the individuals are this standard, when a researcher accesses or receives data that have been coded and does not have access to the identifying key, the research is not considered human subjects research and is not subject to the common rule’s requirements of informed consent or irb review and approval of ement of the common rulethe common rule requirements for informed consent do not preempt any applicable federal, state, or local laws that require additional information to be disclosed to a subject in order for informed consent to be legally l funding can be suspended or withdrawn from an institution when it is found to be in material violation of the common rule. Neither does the common rule expressly provide a research participant with a private right of action. The fda is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations25 involving articles subject to the federal food, drug, and cosmetic act26 (the act), as well as clinical investigations that support applications for research or marketing permits for products regulated by the fda, including drugs, medical devices, and biological products for human use (box 3-5). The food and drug administration (fda) protection of human subjects regulations aim to protect the rights of human subjects enrolled in research involving products that the fda regulates (i. At the same time, hhs adopted the common rule regulations on the protection of human research subjects.
Key differences between fda and hhs regulations include that the fda does not allow for waiver or alteration of informed consent and requires that subjects be informed that the fda may inspect their medical records. In addition, studies of efficacy based solely on medical records research are not permitted to support registration. Health research from practicethe common rule and privacy rule make a somewhat artificial distinction between health research and some closely related health care practices, such as public health practice, quality improvement activities, program evaluations,30 and utilization reviews,31 all of which may involve collection and analysis of personally identifiable health information. However, determining which activities meet the definition of “research” is a major challenge for irbs, privacy boards,32 investigators, and health care practitioners because neither the regulations nor their interpretations by hhs provide clear guidance on how to distinguish research from activities that use similar techniques to analyze health information (iom, 2000a). Inappropriate classification of an activity as research can make it difficult or impossible for important health care activities, such as public health practice and quality improvement, to be undertaken. On the other hand, failure to correctly identify an activity as research could potentially allow improper disclosure of personally identifiable health information without sufficient , standard criteria are urgently needed for irbs and privacy use when making distinctions between health research and related activities, and the committee recommends that hhs consult with relevant s to develop such standard criteria. Hhs is aware of this need, and created a working document titled “what is research? As described below, a number of other models have already been proposed to help determine whether activities should be classified as research in the fields of public health and quality improvement, and these could be instructive for developing hhs guidance. The intent of the committee is not to endorse these particular models, but rather to illustrate the challenges associated with making these distinctions and establishing standard health practice versus public health researchthe belmont report defined health practice as “interventions designed solely to enhance the well-being of the person, patient or client, and which have reasonable expectation of success” (cdc, 1999). Neither the common rule nor the privacy rule provides a specific definition for public health research; rather public health research is included in the general definition of research. However, the privacy rule regulates public health practice differently from public health research (see chapter 4). Early model for distinguishing public health research from public health practice focused on the intent for which the activity was designed, noting that the intent of public health research is to “contribute to or generate generalizable knowledge,” while the intent of public health practice is to “conduct programs to prevent disease and injury and improve the health of communities” (snider and stroup, 1997). For example, the model posits that in public health research, the intended benefits of the project extend beyond the study participants, and the data collected exceed the requirements for the care of the study participants. The model also assumes that public health practice is based on well-established medical interventions and is nonexperimental (cdc, 1999). The foundations for this model are specific definitions of public health research: “the collection and analysis of identifiable health data by a public health authority for the purpose of generating knowledge that will benefit those beyond the participating community who bear the risks of participation,” and public health practice: “the collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a particular community, where the benefits and risks are primarily designed to accrue to the participating community. Stage 1 is applied to all activities, and can be used to distinguish practice from research in the easiest cases. Box 3-6a model for distinguishing public health practice from health practice:Quality improvement versus health researchquality improvement has been defined as “systematic, data-guided activities designed to bring about immediate, positive change in the delivery of health care in a particular setting” (baily, 2008). Quality improvement activities do not require irb or privacy board approval under the common rule or the privacy rule, which classify quality improvement as a component of health care r, in many cases, it is difficult for health care providers, irbs, and privacy boards to determine whether a particular activity is purely for quality improvement, or whether it also entails research. Recently, the hastings center published a report exploring the similarities and differences between research and quality improvement. The report emphasized three fundamental characteristics of quality improvement and three fundamental characteristics of research. The authors argue that individuals have a responsibility to participate in the quality improvement activities because all patients have an interest in receiving high-quality medical care, and the success of a quality improvement activity depends on the cooperation of all patients. The report also assumes that quality improvement activities are based on existing knowledge about human health and should lead to immediate local improvements in the provision of medical contrast, the report notes that participation in research should be voluntary, and decisions to participate should be based on researchers’ full disclosure of all the potential risks and benefits. In addition, the authors assert that research is designed to create new knowledge about human health, rather than relying solely on existing knowledge, and that most research does not result in any direct benefit to the institution where the research is being authors concluded that irbs are not the appropriate body for the ethical oversight of quality improvement activities. They argue that irbs unnecessarily impose high transaction costs on these activities because of the difference in the way they are conducted compared to research. However, the report stated that if a project has the characteristics of both quality improvement and research, the project should be reviewed as both human subjects research and quality improvement (baily et al.
Response to the ongoing confusion over when quality improvement rises to the level of research and requires irb review, the iom jointly hosted a meeting with the american board of internal medicine in may 2008 to discuss this issue. However, no written report from this meeting was produced and no general consensus was importance of effective communication with the publicas noted previously in this chapter, surveys indicate that the vast majority of americans believe that health research is important and are interested in the findings of research studies. The majority of patients also appear to be willing to participate in health research, either by volunteering for a study to test a medical intervention or by allowing access to their medical records or stored biospecimens, under certain conditions. Their willingness to participate depends on trust in researchers to safeguard the rights and well-being of patients, including assurance of privacy and confidentiality, and the belief that it is a worthwhile endeavor that warrants their involvement. Yet patients often lack information about how research is conducted, and are rarely informed about research results that may have a direct impact on their health. The committee’s recommendations in this section are intended to address both the public’s desire for more information about health research and to help fulfill two of the committees overarching goals of the report: (1) improving the privacy and security of health information, and (2) improving the effectiveness of health inating health research resultsethicists have long suggested greater community involvement in health research studies, including more communication about research results (reviewed by shalowitz and miller, 2008a,b). A previous iom report also recommended improved communication with the public and research participants to ensure that the protection process is open and accessible to all interested parties (iom, 2002). Effective communication would build the public’s trust of the research community and is consistent with the principles of fair information patients consent to the use of their medical records in a particular study, health researchers should make greater efforts at the conclusion study to inform study participants about the results, and the importance of those results. A recent united kingdom report on the use of personal data in health research concluded that public involvement in research is necessary for the success of information-based research, and that a public informed about the value of research is likely to have greater enthusiasm and confidence in research and the research community (ams, 2006). A summary of the results alone, while necessary and reasonable, can be seen as a token, and also raises questions about issues such as how best to write summaries, the stage at which results should be disseminated, and how to present research with uninformative outcomes. Most respondents interpreted the results correctly, although incorrect interpretation of the results was associated with increased anxiety, as was dissatisfaction with gh some guidelines for providing and explaining study results to research participants have been proposed, they differ in details because limited data are available on this subject, and thus standards are lacking (partridge and winer, 2002; partridge et al. Broader adoption of electronic medical records may also be helpful in accomplishing this ch registriesone way to make information about research studies more broadly available to the public is through registration of trials and other studies in public databases. Hhs should encourage such registration of trials studies, particularly when research is conducted with an irb/ approved waiver of consent or authorization (see chapter 4). Policy of the international committee of medical journal editors (icmje), adopted in fall 2005, also requires prospective trial registration as a precondition for publication (deangelis et al. 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 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 ing the public about the methods and value of researchas 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 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 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 r, 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. Surveys show that many patients desire not only notice, but also the opportunity to decide whether to consent to such research with medical records. 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. Also, under 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 ing 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 represent the entire population if some people withhold access to their health 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 (more... A universal requirement for consent or authorization in medical records research leads to incomplete datasets, and thus to biased results and inaccurate conclusions. 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 us 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 , hhs and the health research community should work to the public about how research is done and the value it provides. 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 r 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. 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. Genomic research is opening new possibilities for preventing illness and for developing safer, more effective medical care that may eventually be tailored for specific individuals. The increasing use of electronic medical records will further facilitate the generation of new knowledge through research and accelerate 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 s 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 information 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 , the committee recommends that when patients consent to of their medical records in a particular study, health researchers greater efforts when the study ends to inform study participants results, and the relevance and importance of those results. Broader adoption of electronic health records may be helpful in accomplishing this goal, but standards and guidelines for providing and explaining study results to research participants or various sectors of the public are should also encourage registration of trials and other studies databases, particularly when research is conducted with an irb/privacy board approved waiver of consent or authorization, as a way information about research studies more broadly available to . Because many noninterventional studies 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 entional 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 participants will be necessary to derive meaningful r, 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. But educating patients about how health research is conducted, monitored, and reported could also increase patients’ trust in the research community.
Thus, the health research community should work to educate the how research is will also be important for hhs and researchers to convey the health care improvements derived from medical records research, stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability 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 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 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 distinguish 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 health care “practice” rather than health research. However, it can be a challenge for irbs and privacy boards to distinguish among activities that are or are not subject 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 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 , hhs should convene the relevant stakeholders to rd criteria for irbs and privacy boards to use when making decisions about whether protocols entail research or practice. 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 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. The role of state law in protecting human subjects of public health research and practice. The belmont report: ethical principles and guidelines for the protection of human subjects of research. Testimony of the cancer biomedical informatics grid (cabig) data sharing and intellectual capital (dsic) workspace. The importance and value of protecting the privacy of health information: roles of hipaa privacy rule and the common rule in health research. Federal protection for human research subjects: an analysis of the common rule and its interactions with fda regulations and the hipaa privacy rule, crs report for congress. Viewcite this pageinstitute of medicine (us) committee on health research and the privacy of health information: the hipaa privacy rule; nass sj, levit la, gostin lo, editors. Disable glossary linksin this pageconcepts and value of health researchoversight of health researchdistinguishing health research from practicethe importance of effective communication with the publicconclusions and recommendationsreferencesother titles in this al academies collection: reports funded by national institutes related informationpmcpubmed central citationspubmedlinks to pubmedrecent activityclearturn offturn onthe value, importance, and oversight of health research - beyond the hipaa priva... Value, importance, and oversight of health research - beyond the hipaa privacy ruleyour browsing activity is ty recording is turned recording back onsee more... Hill day goal of medical research is to extend the length of life and to improve the quality of life for the population. Medical research includes the basic, applied, and translational research intended to aid and support the body of knowledge in the field of health and medicine. Medical research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy in what are termed clinical trials, and all other research that contributes to the development of new treatments. Medical research helps us learn how our bodies work, why we get sick, and what we can do to get and stay federal government plays an essential role in funding medical research in the united states, primarily through the national institutes of health (nih). The nih is part of the department of health and human services and is made up of 27 institutes and centers, each with a specific research agenda, often focusing on particular diseases or body systems. Billion, the nih is the world’s leading supporter of medical research; research that has had an immeasurable impact on all of our lives by enhancing public health, lengthening life, reducing the burden of illness and disability and most importantly, saving lives. Economy and creates jobs in our of the most important investments our country can make is in medical research, but our ability to do so for the benefit of patients and their loved ones is contingent on a strong, bipartisan commitment from congress to provide the necessary funding for the ic impact of medical research.
Received this much needed treatment because someone else took part in a vital research part in clinical are here: home | introduction. Vast improvements in our knowledge of how the body works, in health and in sickness, have laid the foundations for the dramatic medical advances that have occurred in the past hundred or so years. The scope and pace of medical research are so vast and furious that no person can take it all in. We will never get to the stage when we know all there is to 's a surprise to most people to learn that much of medical practice as it now stands is not based on solid science. Revisiting these treatments with the aim of giving them a more scientific basis is another important reason why medical research will always have a lot of work to get popular view of medical research is that it is something that only goes on in hospitals or in laboratories by people in white coats. These treatments could be drugs, surgical techniques, appliances, therapies, medical gadgets or anything else used in a person’s care.