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l Introduction PROGRESS IN UNDERSTANDING people and society and in better- ing the human condition depends on people's willingness to par- ticipate in research. In turn, involving people as research par- ticipants carries ethical obligations to respect their autonomy, mini- mize their risks of harm, maximize their benefits, and treat them fairly. The U.S. government instituted policies designed to protect human research participants in the 1960s. Those policies, which gained regu- latory force beginning in 1974, have evolved over the past 40 years in response to the concerns of Congress, executive agencies, researchers, and the public. Often those efforts were energized by media reports of unethical, even life-threatening, research. Today, most federal agencies that fund or conduct research on humans have adopted the "Federal Policy for the Protection of Human Subjects," known as the Common Rule (see Box 1-1, at the end of the chapter). The Common Rule lays out a set of protections and related requirements applicable to all re- search on human participants that is conducted, funded, or overseen by federal agencies or conducted at institutions receiving federal funds that have agreed to these protections for all research at their sites. ~ The Common Rule provides for the establishment of institutional re- view boards (IRBs) to review and monitor individual research projects with human participants. It charges IRBs to assess harms, risks, and benefits of proposed research and to protect participants by requiring investigators to follow appropriate informed consent procedures and other procedures. It distinguishes "minimal-risk" research (see Chap- ter 2), which may receive an expedited IRE review, from research that is subject to full review (see Box 1-2, at the end of the chapter). Key actors in the U.S. human participant protection system, with legal obligations under the Common Rule, are federal agencies that sponsor research with human participants, the Office for Human Re- search Protections (OHRP) in the U.S. Department of Health and Hu- man Services (DHHS), officials of institutions that conduct federally funded research, research investigators, and IRBs, of which there were iThe Common Rule does not apply to privately funded research conducted or spon- sored by organizations that receive no federal funds or oversight. 9
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10 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH an estimated 4,000 in 1998 (Gunsalus, 2001:fn61. Other actors in the system include federal agencies and other organizations that provide data for research use, scientific professional associations, advisory com- mittees to federal agencies, Congress, advocacy groups for participants, and associations of research organizations. THE ISSUES At present, the participant protection system is widely perceived to need improvement. Prom the perspective of high-risk clinical research (e.g., trials of experimental drugs), a primary concern is that the linch- pins of the system IRBs may not be able to provide a sufficient level of review to protect research participants from serious injury and even death.2 Systemic problems of underfunding and work overload of IRBs are believed to be major contributors to this situation. Also, in this view, federal regulatory agencies, until recently, have been lax in their oversight of IRBs (see, e.g., Office of Inspector General, 1998b). From the perspective of research in the social, behavioral, and eco- nomic sciences (SBES), the generic concerns with the participant pro- tection system are the same as in all disciplines namely, that the sys- tem protect research participants as Filly as possible while not placing more burdens on the conduct of useful research than are necessary to ensure that the research is ethical. In addition, three specific concertos are paramount (although not unique) to SBES research. The first concern involves the practice of informed consent. Al- though there is wide consensus on the role of informed consent in protecting and respecting the rights of human research participants, in practice the IRB review system appears to pay too little attention to the process of helping individuals decide about participation and too much attention to documenting consent to formally satisfy federal re- quirements. Often, the result is the creation of a consent form with hard-to-understand "boilerplate" language that does not really enable prospective participants to appropriately assess the risks and benefits of participation (see, e.g., Sieber, Plattner, and Rubin, 20021. A second concern is that new information storage and retrieval technologies, such as the Internet, are challenging traditional prac- tices for protecting the confidentiality of research data. It is likely that those involved in the human participant protection system, including IRBs and investigators, are paying too little attention to the ways in 2A recent example was the death of a healthy young woman participant in a study about asthma medications. In response, OHRP suspended research involving human participants at Johns Hopkins University, regardless of risk (Keiger and De Pasquale, 2002).
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INTRODUCTION 11 which technological and other changes in the research environment are increasing the risk of disclosure of the identity of participants in research (see, e.g., Sweeney, 20011. Such disclosure is often the pri- mary risk to participants in SBES research. A third concern is that increasing scrutiny of and pressures on IRBs and the research institutions in which they exist are creating a bias to- ward overly protective review practices. This bias is likely to influence choices about informed consent practices. It is also likely to lead to choices by IRBs to subject research protocols to levels of review, such as full board review, that are not needed to protect participants in re- search that poses no more than minimal risk of harm. More stringent review than is necessary often delays research, sometimes results in inappropriate changes in research designs, and creates cynicism in the research community about the proper role of human participant pro- tection (see, e.g., American Association of University Professors, 20011. Moreover, because IRE resources are limited, full review of minimal- risk research contributes to the burden on IRBs and limits their ability to devote sufficient attention to research that needs fuller scrutiny. PANEL CHARGE AND SCOPE In 2001 the Committee on National Statistics, in collaboration with the Board on Behavioral, Cognitive, and Sensory Sciences (both stand- ing committees of the National Academies' National Research Coun- cil), established our Panel on Institutional Review Boards, Surveys, and Social Science Research. Our panel's charge was to examine the structure, function, and performance of the IRB system as it relates to SBES research and to recommend research and practice to improve the system. Our panel's work was intended to complement the work of the Com- mittee on Assessing the System for Protecting Human Research Partic- ipants of the Institute of Medicine (IOM), which issued its final report, Responsible Research, in October 2002. When the IOM committee be- gan its study in 2000, it was intended to focus its attention primarily on biomedical research, particularly such high-risk research as clin- ical trials of experimental medical treatments, which have generated most of the public concern. Therefore, our panel was to pay particular attention to SBES research using such methods as surveys, structured interviews, participant observation, laboratory and field experiments, and analyses of existing data. We commend the IOM report, which stresses that research partic- ipant protection in the United States is a dynamic system of many ac-
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12 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH tars. The report contains recommendations for almost every actor in the system, including the Congress, OHRP, high officials of research in- stitutions, IRBs, researchers, and individual participants themselves.3 The IOM recommendations are designed to improve the performance of the participant protection system. Many of them, such as a rec- ommendation for better data on research injuries, are also designed to bolster public trust that the system minimizes the risks of harm to participants as far as is humanly possible and also enables valuable, ethically responsible research to proceed. No research can be totally risk free, but the public deserves to know that the system for protecting research volunteers is operating well; further, that the system is capa- ble of adapting expeditiously to changes in the research environment that call for changes in the protection system. The IOM report includes as Appendix B a letter, dated July 1, 2002, that our panel sent to the IOM committee to provide input to the com- mittee's deliberations from an SEES perspective. The letter provided our panel's initial recommendations on four topics: requirements for informed consent, particularly for advance written consent; protection of confidentiality of information obtained from participants; proce- dures for determining what research should be exempt from IRE re- view or should receive expedited review; and system-level issues, such as training of researchers and accreditation. This, our final report, elaborates on the issues raised in our let- ter and provides more extensive background information and support- ing material. In it, we have adopted the systems perspective of the IOM committee's report, which recognizes that appropriate interac- tions among all of the components of the participant protection system are necessary for the system to operate responsibly and effectively. Be- cause of the time and resources available for the panel's work, we do not address every aspect of the protection system. We address some issues and perspectives briefly (e.g., education and training for IRBs and researchers) and three topics in depth: . We consider informed consent in terms of the obligation of IRBs to focus more on the consent process and less on the consent form, the obligation of SBES researchers to conduct research on effective consent processes and documentation, and the obliga- tion of OHRP to provide guidance that will enable IRBs and re- searchers to make participant protection paramount in consider- ing consent procedures for specific research protocols. 3 Except in citing regulatory language, we have followed the IOM report language of human research "participants" instead of the more commonly used term, "subjects."
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INTRODUCTION 13 · We consider confidentiality protection in terms of the need for IRBs, investigators, and OHRP to recognize the increasing risks of disclosure in today's computing environment with the ready availability of rich data files on the Internet and sophisticated matching software. We emphasize the role that federal statisti- cal agencies and data archives can play in providing access to data while minimizing the risk of disclosure. . We consider review procedures for minimal-risk research in terms of the obligation of researchers to build a body of evidence about perceived and actual harms in SBES research, the obligation of IRBs to review research at a level commensurate with risk, and the obligation of OHRP to provide guidance to IRBs and re- searchers about appropriate use of different review procedures and to establish a data system to understand and monitor the op- erations of IRBs. Because our charge is to consider human research participant pro- tection issues for SBES research, our expertise and our report reflect that charge (e.g., most of the examples we cite are from SBES research or, in some cases, SBES research in a medical setting). Our findings and recommendations, however, have broader application because the boundaries between research domains are not and cannot be sharply drawn. Also, much research today is multidisciplinary in the compo- sition of the research team, the methods used, and the objectives of the research. Furthermore, both biomedical and SBES research cover the full range of risks to participants: biomedical research includes high- risk clinical trials of experimental drugs, but it also includes much minimal-risk research (e.g., surveys about diet, exercise, or medical treatment and epidemiological studies of the spread of infections); and SBES research also spans the spectrum of risks. EIowever, our analysis and recommendations are usually couched in terms of SBES research or, sometimes, in terms of "research," in keeping with our charge and expertise. We discuss human participant protection issues for SBES research in the context of the Common Rule (45 CFR 46, subpart A), which ap- plies generally to all human participants and has been adopted by most agencies that sponsor research with humans (see Box 1-1~.4 We do not have the expertise and do not address issues of added protections for children, pregnant women, and prisoners, which are covered in other 445 CFR 46, from which we quote extensively in our report, is the DHHS enactment of the Common Rule; other agencies' enactments are found in other volumes of the Code of Federal Regulations.
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14 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH subparts of 45 CFR 46 (see Box 1-21. Infants and children are the subject of much research in such fields as developmental psychology and the sociology of families, and the protection issues for children in SBES research likely merit a full study of their own. Because SBES covers such a wide variety of fields and topics, we could not hope to examine specific issues in every field to the same extent. For example, we draw somewhat more heavily on studies and data about protection issues in surveys and secondary analyses than in some other fields. Nonetheless, our focus on issues of informed con- sent, confidentiality protection, and the review process is relevant to and useful for the full range of SBES disciplines. ACTIVITIES At its first meeting, our panel received input from the IOM com- mittee and its sponsors, as well as representatives of several profes- sional associations representing the SBES disciplines, ongoing advi- sory committees, and federal agencies. The panel considered relevant reports of other groups that have given attention to the protection of participants in SBES research, including those of the American Associ- ation of University Professors (2001), the Association of American Uni- versities (2000), the National Bioethics Advisory Commission (2001), the DHHS-chartered National Human Research Protections Advisory Committee (NHRPAC),5 the NHRPAC Behavioral and Social Science Working Group, and the National Science Foundation's ad hoc Social, Behavioral, and Economic Subcommittee for Human Subjects (20021.6 The panel reviewed the history of human research participant pro- tection from the perspective of SBES research. It reviewed the few existing studies of the operation of IRBs for relevant information on variation in procedures across IRBs and trends across time, relying particularly on two relatively comprehensive studies, both surveys: one by Bell, Whiten, and Connelly (1998), and one by Cooke, Tannenbaum, and Gray (19781. The panel also examined the IRB guidelines of 47 major research universities, as posted on their Internet web sites, to gain a more up-to-date picture of IRB requirements and guidance with respect to SBES research in large research institutions. Similarly, the panel reviewed human research participant protection guidelines of 5 this committee was replaced by the Secretary's Advisory Committee on Human Research Protections in October 2002; see Appendix B. 6We were not able to obtain input directly from participants in SBES research, who cover a wide range of populations or else represent the general population as distinct from a group of patients with a specific disease as is characteristic of much clinical research.
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INTRODUCTION the major SBES professional associations. Finally, the panel brought to bear the expertise of its members, some of whom have served on IRBs or have written in the field of research ethics, and most of whom have conducted research with human participants in a variety of SBES fields. ORGANIZATION OF REPORT Our report has seven chapters and five appendices. Chapter 2 re- views basic concepts and background information that is central to our findings and recommendations. Following a summary of principles and practices for human research participant protection that were ar- ticulated in the landmark Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Re- search, 1979), the chapter considers more fully issues of harm, benefit, risk, and minimal risk. It then reviews the available evidence on IRB review of different types of projects and, as context, provides examples of SBES research and issues for participant protection. Chapter 3 provides historical background, covering the history of federal policies and regulations for human research participant pro- tection in the United States with an emphasis on SBES research. Chapter 4 covers issues of informed consent and its documentation. It reviews the limited available evidence on how IRBs interpret the fed- eral regulations on consent, recommends research to improve consent procedures and documentation for different types of SBES research and populations studied, and considers such issues as consent proce- dures for special populations, third-party consent, when signed written consent is unnecessary or inappropriate, and the use of deception in research. Chapter 5 reviews the history of confidentiality protection for data from participants in SBES research and the changing research envi- ronment that increases the threats to confidentiality. It provides rec- ommendations for increased attention to confidentiality protection in ways that do not unnecessarily hinder access to data, particularly for secondary analysis. Chapter 6 provides recommendations for promoting the use of the flexibility in federal regulations for exempting and expediting minimal- risk research. It also recommends research to build knowledge on risks and harms in SBES research and data collection for better understand- ing the IRB system and how to enhance procedures for carrying out its oversight function.
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16 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH Chapter 7 addresses system-level issues that are of particular rele- vance to the SBES research community. Such issues include ways to facilitate IRB-researcher interaction and the participation of SBES re- searchers in the development of national policy for human participant protection. Our report has five appendices: changes in federal regulatory lan- guage from 1974 to the present (A); list of organizations and resources for human research participant protection (B); the agenda for the panel's first meeting (C); descriptions of studies of IRB operations, in- cluding the panel's review of selected IRB websites of major research universities (D); and a paper commissioned by the panel from George Duncan, "Confidentiality and Data Access Issues for Institutional Re- view Boards" (E). The panel's recommendations are addressed to various actors, in- cluding IRBs, federal agencies, data archives, and SBES researchers. Several recommendations call for OHRP to provide guidance to IRBs and researchers, in recognition of OHRP's leadership role in the fed- eral system. OHRP responsibilities include not only monitoring the op- erations of IRBs that review DHHS-funded research, but also provid- ing guidance on human research participant protection for the federal and nonfederal sectors, developing educational programs, and exercis- ing leadership for human participant protection for the U.S. govern- ment in cooperation with other federal agencies.7 7See 67 Federal Register, 10217, March 6, 2002; see also ht~p://ohrp.osophs.dhhs.gov [4/10/03].
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INTRODUCTION 17 BOX 1-1 Key Features of the Common Rule The complete text of the Common Rule is in Title 45 Code of Federal Regulations (CFR) section 46, subpart A (from which all quoted material below is taken). Every federal agency or department adopting the Common Rule publishes it in a section of the CFR dedicated to that agency. At present ten departments and seven agencies have adopted the Common Rule by regulation, executive order, or legislation: the Departments of Agriculture; Commerce; Defense; Education; Energy; Health and Human Services (DHHS); Housing and Urban Development; Justice; Transportation; and Veterans Affairs; and the Agency for International Development, the Central Intelligence Agency, the Consumer Product Safety Commission, the Environmental Protection Agency, the National Aeronautics and Space Administration, the National Science Foundation, and the Social Security Administration. The Food and Drug Administration has its own set of human participant protection regulations for research and evaluation of drugs and other products it regulates (21 CFR 50, 56), which are nearly identical to the Common Rule. DHHS and a few other agencies have also adopted additional protections for specific populations of research participants: subparts B. C, and D apply to pregnant women, human fetuses, and neonates; prisoners; and children, respectively. (See Chapter 3 for the history of federal protections for human research participants; see Appendix A for changes in regulatory language from 1 9 74 to the present.) Applicability · "This policy [with some exceptions, see "Exempt Research" below] applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research." Definitions . Research—"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." . , _ · Human subject "a living individual about whom an investigator (whether professional or student) conducting research obtains (1 ) data through intervention or interaction with the individual, or (2) identifiable private information." · Minimal risk—"the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." Assurances · Process and materials by which a research institution assures the federal government that it will comply with the Common Rule for all research conducted at its site. Institutions must provide a list of IRB members and attest that its IRB(s) will uphold the Common Rule requirements. The government reviews the submission and decides to issue a federal-wide assurance (FWA). (The FWA process replaces a previous multiple project assurance process, which required institutions to submit additional materials, such as IRB procedures.)
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18 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES SEARCH BOX 1-1 (continued) IRBs . . Membership—at least five members with varying backgrounds, including at least one scientist and one nonscientist, and at least one member not affiliated with the research institution. Authority may approve, require modifications to, or disapprove all research covered under the Common Rule at its site (some IRBs review research from more than one institution); may suspend or terminate research that violated IRB requirements or resulted in unexpected serious harm to subjects; no covered research may proceed without IRB approval. Operations must review research at meetings attended by a quorum (or use an expedited procedure, see below); must approve research by a ma jority of those present, notify investigators in writing of its decision, and re-review approved research at least once a year. Exempt Research · Six categories of research are exempt from the Common Rule. They are: "(1 ) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. "(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. "(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. "(4) Research involving the 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 subjects. "(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
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INTRODUCTION 19 BOX 1-1 (continued) "(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture." Expedited Review · IRBs may review certain kinds of minimal-risk research and minor changes in approved research by an expedited procedure (see Box 1-2). This review is done by the IRB chair or one or more members designated by the chair. Criteria for IRB Approval of Research · Risks to subjects are minimized. · Risks are reasonable in relation to anticipated benefits and the importance of knowledge to be gained. · Selection of subjects is equitable. · Informed consent will be sought from each sub ject or his or her legally authorized representative. . Informed consent will be appropriately documented. · When appropriate, data collection will be monitored to ensure safety of subjects. When appropriate, there are adequate provisions to protect privacy and maintain data confidentiality. Informed Consent · Unless waived by an IRB, investigators cannot involve humans in research without obtaining informed consent. · The information provided in seeking informed consent must include eight elements (e.g., "description of any reasonably foreseeable risks or discomforts to the subject") and may include one or more of six added elements (e.g., "any additional costs to the subject that may result from participation in the research") (see Chapter 4). Informed consent elements may be waived under specified circumstances. Documentation of Consent . . · Unless waived, consent must be documented by a written, signed consent form. IRBs may issue a waiver when (1 ) the consent document is the only record linking the participant and the research, and the principal risk is the potential harm from a breach of confidentiality, or (2) the research is minimal risk and involves no procedures for which written consent is normally required outside the research context (e.g., a telephone survey).
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20 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH BOX 1-2 Categories of Research for Which Minimal-Risk Protocols Can Receive Expedited Review (1 ) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. (2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 1 10 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. (3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (I) sputum collected after saline mist nebulization.
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INTRODUCTION 21 BOX 1-2 (continued) (4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. (5) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101 (b)(4). This listing refers only to research that is not exempt.) (6) Collection of data from voice, video, digital, or image recordings made for research purposes. (7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.) (8) Continuing review of research previously approved by the convened IRB as follows: (a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) Where no subjects have been enrolled and no additional risks have been identified; or (c) Where the remaining research activities are limited to data analysis. (9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. SOURCE: Verbatim quotes from 63 Federal Register 60364-60367 (November 9, 1 998).
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22 PROTECTING PARTICIPANTS ED FACILITATING SOCIAL ED BEHAVIORAL SCIENCES SEARCH BOX 1-1 (continued) . . 6 "(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. "(4) Research involving the 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 subjects. "~5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. "~6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture." Expedited Review IRBs may review certain kinds of minimal-risk research and minor changes in approved research by an expedited procedure (see Box 1-21. This review is done by the IRB chair or one or more members designated by the chair. Criteria for IRB Approval of Research · Risks to subjects are minimized. · Risks are reasonable in relation to anticipated benefits and the importance of knowledge to be gained. · Selection of subjects is equitable. · Informed consent will be sought from each subject or h authorized representative. · Informed consent will be appropriately documented. is or her legally
Representative terms from entire chapter: