What Is the Purpose of an Institutional Review Board
Chest. 2015 November; 148(five): 1148–1155.
Institutional Review Boards
Purpose and Challenges
Received 2015 Mar 23; Accustomed 2015 Apr 30.
Abstract
Institutional review boards (IRBs) or inquiry ideals committees provide a cadre protection for human research participants through advance and periodic independent review of the upstanding acceptability of proposals for human inquiry. IRBs were codification in US regulation just over three decades agone and are widely required past law or regulation in jurisdictions globally. Since the inception of IRBs, the research landscape has grown and evolved, as has the system of IRB review and oversight. Prove of inconsistencies in IRB review and in application of federal regulations has fueled dissatisfaction with the IRB organisation. Some complain that IRB review is time-consuming and burdensome without clear prove of effectiveness at protecting human subjects. Multiple proposals have been offered to reform or update the electric current IRB system, and many culling models are currently being tried. Electric current focus on centralizing and sharing reviews requires more attending and evidence. Proposed changes to the US federal regulations may bring more changes. Data and resourcefulness are needed to further develop and test review and oversight models that provide adequate and respectful protections of participant rights and welfare and that are appropriate, efficient, and adaptable for electric current and future research.
Institutional review boards (IRBs) or equivalent bodies provide a core protection for human participants in biomedical and behavioral enquiry in the The states and > 80 other countries around the earth. 1 IRBs are charged with providing an independent evaluation that proposed research is ethically acceptable, checking clinical investigators' potential biases, and evaluating compliance with regulations and laws designed to protect human subjects.
Independent review of clinical inquiry by an IRB is required for United states studies funded by the Department of Wellness and Human Services (DHHS) and other U.s. federal agencies, as well as for enquiry testing interventions—such as drugs, biologics, and devices—that are under the jurisdiction of the U.s.a. Nutrient and Drug Administration (FDA) (Table 1 ii,3 ). United states research institutions can and frequently practice extend federal regulatory requirements to all of their human subjects research. Research conducted outside of the United states but funded by the US government is subject field to the same Usa federal regulations and and so requires IRB review or equivalent protections. 4 Research conducted outside of the Us, not under an investigational new drug that submits data to the FDA for a new drug or biologic license application, must comply with Good Clinical Do guidelines, which include review and approval by an contained review committee and informed consent. five Regulations and laws in many other jurisdictions around the globe also require review by an contained enquiry ethics committee or IRB. 6 Regulatory bodies in the European Union, Japan, Usa, Canada, Australia, and Nordic countries, among others, follow Good Clinical Practice guidelines such as those delineated past the International Conference on Harmonisation, which require blessing past an independent ethics committee or IRB. vii IRBs or enquiry ethics committees, composed of a group of people independent of the specific enquiry, review proposed research plans and related documents before a study can begin and then periodically (usually annually) for the study duration. The goal of IRB review is to assure that the rights and welfare of participating research subjects will be adequately protected in the pursuit of the proposed research written report. To be ethically acceptable and comply with regulatory requirements, the IRB determines that risks to subjects are minimized and reasonable in relation to the importance of the knowledge the study is expected to produce, that the process and outcomes of subject field selection are fair (including delineated inclusion and exclusion criteria), and that in that location are adequate plans for obtaining informed consent.
Tabular array ane ]
Selected US Regulatory Requirements for IRBs (Paraphrased)
| Regulation | Requirements |
| Membership (45CFR.46 107; 21CFR.56.107) | At least 5 members of varying backgrounds, both sexes, and > 1 profession |
| At least ane scientific member, 1 nonscientific member, and 1 unaffiliated member | |
| Members sufficiently qualified through diverse experience and expertise to safeguard subjects' rights and welfare and to evaluate research acceptability related to laws, regulations, institutional commitments, and professional standards | |
| At least one member knowledgeable well-nigh whatsoever regularly researched vulnerable groups | |
| Members report and recusal for conflicts of interest | |
| Ad hoc experts as needed | |
| Functions/operations (45CFR.46 108; 21CFR.56.108) | Follow written procedures for initial and continuing review and for any changes and amendments |
| Written procedures for reporting unanticipated problems, risks, and noncompliance | |
| Quorum of majority at convened meetings. Approval requires majority vote | |
| Review (45CFR.46 109; 21CFR.56.109) | Authority to corroborate, require modifications of, or disapprove research |
| Require informed consent and documentation (or approve a waiver one ) | |
| Notify investigators in writing | |
| At least annual continuing review | |
| Criteria for approving (45CFR.46 111; 21CFR.56.111) | IRB should determine that risks are minimized; risks are reasonable in relation to anticipated benefits, if any, and the importance of the expected noesis; subject selection is equitable and attention to vulnerable populations; informed consent will be sought and documented; adequate provisions for monitoring; acceptable provisions to protect confidentiality; additional safeguards for subjects vulnerable to compulsion or undue influence |
| Dominance (45CFR.46. 113; 21CFR.56.113) | Institutional officials cannot approve inquiry that is disapproved past the IRB (45CFR.46 only) |
| The IRB can append or terminate inquiry for serious impairment or noncompliance | |
| Records (45CFR.46. 115, 21CFR.56.115) | Records of enquiry proposals, meetings, actions, correspondence, members, and so along |
History of IRBs in the United States
Recognizing that review by impartial others might mitigate conflicting differences in the upstanding responsibilities of md-investigators to research subjects from those of physicians to their patients and, thus, help to protect the rights and welfare of research subjects, James Shannon, Physician, Director of the National Institutes of Health (NIH), in 1965 proposed that all NIH enquiry involving man subjects be evaluated past an impartial panel of peers to ensure its ethical integrity. His idea derived, at least in part, from a model that began at the NIH Clinical Center when it opened in 1953, which was a model of group peer review for research involving good for you volunteers. 1 In 1966, US Public Health Service policy requirements for ethical review, which were expanded to all Department of Health Instruction and Welfare (the DHHS predecessor) research past 1971, were non well enforced. 1 Regulations for the protection of human being subjects for DHHS, published in 1974 (45CFR.46), included a requirement for grouping ethics review and the term "institutional review board" was introduced. The World Medical Association also introduced review by an independent committee for oversight of science and ethics into the 1975 revision of the Annunciation of Helsinki. 8 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Enquiry, established past the Usa Congress after revelations of the US Public Wellness Service syphilis studies at Tuskegee, authored the Belmont Study which explicated ethical principles underlying the deport of human subjects inquiry. 9 The Commission'south contributions, including integration of the Belmont principles, were incorporated into updated US regulations in 1981. The 1981 DHHS regulations were later on adopted past 16 federal agencies (non including the FDA) in 1991 as the Common Rule. The FDA required an IRB commencement in 1981 (Title 21 Lawmaking of Federal Regulations, office 56), although some investigators funded by pharmaceutical companies already used oversight committees. x The near extensive proposed changes to the Common Rule since 1991 were issued by the DHHS in an Accelerate Notice of Proposed Rule Making in 2011 in an attempt to enhance protections and efficiency. eleven,12 Public comments were solicited and a Discover of Proposed Rulemaking is nether development, only as of this writing has not been published (Fig i).
Timeline of regulations and guidance regarding IRB review. ANPRM = Advance Notice of Proposed Dominion Making; DHEW = US Department of Health, Education, and Welfare; DHHS = Department of Health and Human Services; FDA = Us Food and Drug Assistants; IRB = institutional review board; NIH = National Institutes of Wellness.
US regulations at 45CFR.46 subpart E and 21CFR.56.106 require IRBs to be registered with the DHHS Office of Human being Enquiry Protections (OHRP), which is responsible for monitoring compliance with the Mutual Rule. Research institutions that receive DHHS funds file with OHRP an assurance that the establishment will comply with federal regulations, called a Federal Wide Assurance. thirteen Each assurance has to include at least one internal or external IRB registered with OHRP. The FDA requires registration of IRBs but does not require prospective assurances of compliance; sponsors and investigators include evidence of IRB review when they submit information to the FDA.
Changes to Research
At the fourth dimension that IRBs were codification in regulation, single-site clinical research was the predominant paradigm. Advances in knowledge, engineering, and resource over the subsequent decades have significantly changed the face of enquiry. Growth in public and private spending fourteen,15 as well every bit evolving scientific opportunities have created novel challenges for IRBs. The majority of clinical trials are at present multisite, and some include > 100 sites, often with sites in multiple countries. 16 In addition to multicenter and multinational research, IRBs review, for example, proposals for research with stored samples and data, cell-based and stem cell therapies, emergency research, social science research, and community-based research. IRBs operate under the same regulatory structure and apply similar procedures despite a wide range of types of research posing disparate risks to subjects' rights and welfare. Furthermore, the complexity of oversight has changed with the evolution of new entities involved in clinical research, such as contract enquiry organizations, data and safe monitoring committees, clinical trial coordinating centers, accrediting associations, and commercial IRBs, amid others.
Changes to IRBs
Concurrently, the number of, investment in, and responsibilities of IRBs accept connected to increase. Most research institutions, universities, and wellness-care facilities take at least i IRB, and the majority has more than ane. 17 In addition, in that location are a number of contained or commercial IRBs. xviii Increasingly, IRBs are tasked with responsibilities beyond those required by federal regulation, including, for example, review of conflicts of interest, compliance with privacy regulations, training of investigators, scientific review, and monitoring of clinical trial registration, among others. IRBs do indeed have responsibility for reviewing the science to appraise the soundness of the design and the risks and benefits of the proposed enquiry, however, many institutions accept a dissever scientific review process that precedes and complements IRB review.
Dissatisfaction and business concern about what is perceived equally an expansive mission and bureaucracy of IRBs has also mounted. Investigators and others criticize the IRB system equally dysfunctional and "more concerned with protecting the institution than research participants." xix Some claim that IRBs are overburdened 20 and overreaching. Researchers, institutions, and some IRB members mutter about burden: excessive paperwork, inflexible interpretation of regulatory requirements, attending to inconsequential details, and "mission pitter-patter"—the expanding obligations of IRBs that seem to have little to exercise with protection of research participants. 21 Fearfulness of regulatory admonition has fueled a focus on compliance with regulations. 22 Some perceive the excessive or "hyper" regulation as seriously affecting or stifling research productivity and adding cost without adding meaningful protections for participants. 23,24 Clinical investigators complain that the IRB review process is inefficient and delays their research for what seem similar pocket-size modifications. 25 The public hears nearly bug and fears that research might be unsafe and existing protections ineffective or inadequate. 26,27
Charles McCarthy, the first managing director of the US Office for Protection from Research Risks (the OHRP predecessor) noted, "[IRBs] have become more insightful and sophisticated…But unless [the Human Enquiry Protection Organization] is considered to exist an evolving and expanding mechanism, adapting to the problems of each period of history, it is in danger of becoming fossilized and ineffective." 28 Flexibility and adaptability are important characteristics not ordinarily attributed to IRBs. The challenge is how to evolve, aggrandize, and conform IRBs to the current exigencies of research in a rational and meaningful way. As noted by Cohen and Lynch, 29 the organization is "ripe for a major course correction."
Reform: Needs, Attempts, and Challenges
Recognition of the need for a robust arrangement of protecting human research subjects within the changing research landscape has led to various proposals for reform and suggestions for alternative models. xxx‐35
Reform proposals offer changes to address some of the various factors that are problematic for IRBs and for those who use them. Even so, reform efforts have been somewhat paralyzed by the tension between those who find the electric current system inadequate and those who find information technology also overreaching. 36,37 Nonetheless, many grant that multiple reviews for a unmarried study are duplicative, atomic number 82 to significant delays in inquiry without adding meaningful protections, and can result in inconsistencies that bias the science. 38,39 Additional reasons for considering reform of the current oversight arrangement include inherent conflicts of interest, inadequate resources, the emergence of new research methodologies, and bereft expertise of members, among others. 40 IRBs also grapple with how to respond to evolving enquiry methods, and loftier profile cases in which regulators disagree with or disapprove of IRB decisions tin can fuel uncertainty and anxiety. 41,42
Various systems of pre-IRB review take gained traction equally a way to improve IRB efficiency: Major issues and gaps can be identified and corrected through prereview before an IRB sees the proposal. Institutions are also adopting a framework that more explicitly recognizes the essential roles of the institution, investigators, and research teams in add-on to IRBs in protecting man subjects. 43 Several alternatives to the traditional model of single IRB review or review at each site of a multisite report accept been developed and tried (Table ii). 44‐53 Proposed revisions to the Common Dominion include a recommendation for a single IRB of record for domestic multisite trials. 9 More recently, the NIH called for comments on a draft proposal for a unmarried IRB review for NIH-funded multisite trials. 54 NIH is as well currently funding several empirical studies of key IRBs with the goal of informing policy development relevant to central IRBs. 55 Despite these significant efforts, many challenges remain in changing the procedure of IRB review, including questions of liability, toll structures, and incentives, and uncertainty about the relative merits of proposed models. 56
Table ii ]
Alternative Models for IRB Review
| Type | Explanation | Examples |
| Local IRB review | Single-site study or review at each site for single site or multisite studies | Most inquiry institutions have ≥ i IRB at the site that review research conducted at that site. |
| Shared IRB review | ||
| Reliance | An institution formally "relies" on the IRB of another establishment for review of a particular study or set of studies. | Increasingly ≥ one site partner with some other IRB through a reliance understanding. Run into, for example NIAID, CHOP, and others. |
| Shared review | Concurrent regional or central and local review | Indian Health Service |
| Centralized review | ||
| Central IRB | Central IRB established to review all studies of a blazon, each site accepts the fundamental review | National Cancer Institute'due south Central IRB (ii adult, i pediatric, one cancer prevention and control) |
| American Academy of Family Physicians National Research Network IRB | ||
| Veterans Assistants cardinal IRB | ||
| A group of institutions form an alliance and create a new central IRB to serve as IRB for group. | Biomedical Research Brotherhood of New York (BRANY) | |
| OR | The IRB at Massachusetts General Hospital is designated as IRB of record for all NINDS-funded NeuroNext institutions. | |
| An existing IRB is designated as the central IRB for all sites of a network. | ||
| One of the existing NIH intramural IRBs is designated as the central PHERRB for public health emergencies. | ||
| Contained/commercial | A freestanding IRB (non part of an establishment) is employed to review single or multiple site studies. | Western IRB, Chesapeake IRB, many others |
| Federated model | Allows sites to choose amid multiple options including reliance, shared review, local review, or facilitated review. All options include a delivery to sharing IRB submissions and determinations among study sites. | National Children's Written report (NICHD) |
Need for Testify
Reform proposals frequently recognize the need for data about what works and for creative and testable means of achieving the appropriate combination of protecting the rights and welfare of participants with meaningful and efficient IRB review that promotes high quality, relevant, and timely enquiry. Evidence about how well IRBs are performance, how effective they are, and how they could be more efficient would provide useful guidance for reform efforts. 57 Existing studies describe IRB structure, process, or outcomes and show that IRB judgments are inconsistent, as is their application of a standard gear up of regulations. 58,59 Practices and decisions vary between and within IRBs often without justification, including determinations about take a chance level, inclusion criteria, and the ceremoniousness of methods of recruitment and consent. 55,sixty Despite complaints about inconsistency, independence and local evaluation make some IRB variation inevitable. Moreover, it is difficult to detect a report or to place metrics able to mensurate how effective IRBs are at ensuring the ethical conduct of enquiry or protecting enquiry participants. 61 Improving effectiveness requires clear and measurable goals for IRBs and ethical justification for regulatory requirements. 62
Many of these factors converge for critics of the IRB system: growing requirements and costs, 63,64 bureaucratic burden, vague goals, and limited evidence of effectiveness.
"The available bear witness indicates that in that location are substantial direct and indirect costs associated with IRB oversight of research. IRBs also operate inconsistently and inefficiently, and focus their attending on paperwork and bureaucratic compliance. Despite their prevalence, there is no empirical evidence that IRB oversight has any benefit whatever—let alone benefit that exceeds the toll." 65
Both normative analysis and empirical prove are needed to understand how to better the current organization and optimize protections for contemporary research. If the goal is primarily to protect inquiry participants from risk, for example, then more analysis of what risks count and more empirical bear witness about research risks would provide direction for how nosotros are doing and where the gaps are. As Taylor 66 notes, "whether and how to protect is inescapably normative and inescapably empirical." In its 2011 report Moral Science: Protecting Homo Participants in Human being Subjects Research, the President'due south Commission recommended that federal agencies involved in the funding of human subjects enquiry "develop systematic approaches to appraise the effectiveness of human subject protections and aggrandize support for research related to the upstanding and social considerations of man bailiwick protections." 67
Centralizing IRB Review
Primarily driven by concerns about redundant review, burden, and delay, much attention has been given to the idea of single or fundamental IRB review for multisite studies as an alternative to local IRB review at each site. Multiple reviews also have the possibility of jeopardizing the science by introducing bias. 37 Institutions participating in multisite studies are permitted by federal regulations 68 to utilise arrangements that centralize or share reviews, yet relatively few use these options. Many proposals for reforming or updating guidance and regulations have recommended unmarried or key review for multisite studies. 10,28‐31,35 Lingering resistance to adopting key or unmarried review for multisite trials appears to be based on concerns about the importance of local context, local accountability and liability, discomfort with relinquishing control over the review, uncertainty about the quality of review by other IRBs, and logistical concerns such as cost-sharing. 30,54 There is a paucity of data evaluating how unmarried or primal review compares to review at local sites regarding quality of review, satisfaction, resources utilise, or efficiency.
Conclusions
IRBs accept an of import role in protecting human research participants from possible harm and exploitation. Independent review by an IRB or equivalent is an important role of a system of protections aiming to ensure that ethical principles are followed and that adequate and appropriate safeguards are in place to protect subjects' rights and welfare while they contribute to ethically and scientifically rigorous research. Over the four decades since IRBs were codified into regulations, IRB review and oversight has developed and matured as part of a robust system that provides "substantial protections for the health, rights, and welfare of research subjects." 69 However, during that same flow, enquiry methods and opportunities have evolved, the domains of oversight have expanded, and the research enterprise has grown and diversified. The rules, norms, procedures, and even articulation of the goals of IRB review have not kept pace. Although ethical principles underlying research with homo subjects take non inverse, their implementation and actualization requires refinement and adaptation to respond to changing scientific and social contexts. Data, creativity, regulatory flexibility, and continued dialogue are needed to optimize the implementation of principles and to assistance shape the future structure, organisation, processes, and outcomes of review and oversight by IRBs and related players. These efforts will support progress in clinical inquiry, public trust in the enterprise, and protection of the participants that make inquiry possible.
Acknowledgments
Conflict of involvement: None alleged.
Role of sponsors: The sponsor had no role in the design of the written report, the collection and analysis of the information, or the preparation of the manuscript.
Other contributions: Views expressed are the author's and do not necessarily represent those of the National Institutes of Wellness or the Department of Health and Homo Services. The writer is grateful for the review and helpful suggestions of Scott Kim, MD, PhD, and Charlotte Holden, JD.
ABBREVIATIONS
| DHHS | Section of Health and Man Services |
| FDA | US Food and Drug Assistants |
| IRB | institutional review board |
| NIH | National Institutes of Health |
| OHRP | Office of Human Inquiry Protections |
Footnotes
FUNDING/SUPPORT: Work on this article was supported by the Clinical Centre, Section of Bioethics, in the National Institutes of Health Intramural Inquiry Program.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.
References
1. McCarthy C. The origins and policies that govern institutional review boards. In: Emanuel East, Grady C, Hunker R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Printing; 2008:541-550. [Google Scholar]
4. U.s. Code of Federal Regulations. Championship 45CFR.46.101 (h). [PubMed]
v. US Code of Federal Regulations. Championship 21 CFR 312.120; guidance for industry and FDA staff FDA acceptance of foreign clinical studies non conducted under an IND oftentimes asked questions.Usa Food and Drug Administration website. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf. Accessed Apr 12, 2015.
6. US Department of Health and Human Services. Office of Human Inquiry Protections (OHRP). International compilation of homo subjects standards. US Department of Wellness and Homo Services website. http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html. Accessed March 1, 2015.
8. Riis P. Letter from...Kingdom of denmark. Planning of scientific-upstanding committees. BMJ. 1977;2(6080):173-174. [PMC gratis article] [PubMed] [Google Scholar]
nine. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Inquiry. The Belmont Report: Upstanding Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Section of Wellness Education and Welfare; 1979. DHEW Publication Os 78-0012 1978. [PubMed] [Google Scholar]
10. Bowen A. Models of institutional review lath function. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Enquiry Ethics. New York, NY: Oxford University Press; 2008:552-559. [Google Scholar]
11. Office of Human Subjects Protection. Advanced find of proposed rulemaking (ANPRM) for revision to Common Rule. United states Department of Wellness and Human Services website. http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html. 2011. Accessed February 10, 2015.
12. Emanuel EJ, Menikoff J. Reforming the regulations governing research with human being subjects. North Engl J Med. 2011;365(12):1145-1150. [PubMed] [Google Scholar]
13. Office of Human being Research Protections. IRBs and assurances. US Department of Health and Homo Services website. http://www.hhs.gov/ohrp/assurances/index.html. Accessed Feb ii, 2015.
14. Office of Budget: appropriations history by institute/centre (1938 to present). National Institutes of Wellness, Office of Budget website. http://officeofbudget.od.nih.gov/approp_hist.html. Accessed March iii, 2015.
16. Mascette AM, Bernard GR, Dimichele D, et al. Are cardinal institutional review boards the solution? The National Heart, Lung, and Blood Constitute Working Group'due south written report on optimizing the IRB process. Acad Med. 2012;87(12):1710-1714. [PMC costless commodity] [PubMed] [Google Scholar]
17. Clan for the Accreditation of Human Inquiry Protection Programs. 2013 Metrics on Human Research Protection Program Performance. Washington, DC: Association for the Accreditation of Human Research Protection Programs; 2014. [Google Scholar]
xix. Fost Due north, Levine RJ. The dysregulation of human subjects research. JAMA. 2007;298(18):2196-2198. [PubMed] [Google Scholar]
twenty. Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel'south back: multicenter clinical trials and local institutional review boards. Ann Intern Med. 2001;134(2):152-157. [PubMed] [Google Scholar]
21. Gunsalus CK, Bruner EM, Burbules NC, et al. Mission creep in the IRB world. Science. 2006;312(5779):1441. [PubMed] [Google Scholar]
22. Weil C, Rooney L, McNeilly P, Cooper K, Borror K, Andreason P. OHRP compliance oversight messages: an update. IRB. 2010;32(two):i-6. [PubMed] [Google Scholar]
23. Infectious Diseases Society of America. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Clin Infect Dis. 2009;49(3):328-335. [PubMed] [Google Scholar]
24. Silberman M, Kahn KL. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Q. 2011;89(iv):599-627. [PMC free article] [PubMed] [Google Scholar]
25. Whitney SN, Alcser K, Schneider C, McCullough LB, McGuire AL, Volk RJ. Principal investigator views of the IRB arrangement. Int J Med Sci. 2008;v(2):68-72. [PMC free article] [PubMed] [Google Scholar]
26. Lemonick M, Goldstein A, Park A. Human guinea pigs. Time. April 22, 2002. [Google Scholar]
27. Gilbert South. Trials and tribulations. Hastings Cent Rep. 2008;38(two):fourteen-18. [PubMed] [Google Scholar]
28. McCarthy C. The origins and policies that govern institutional review boards. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Enquiry Ethics. New York, NY: Oxford University Printing; 2008:550. [Google Scholar]
29. Cohen IG, Lynch HF, eds. Introduction. Human Subjects Inquiry Regulation, Perspectives on the Future. Cambridge, MA: MIT Printing; 2014:2. [Google Scholar]
30. Clan of American Medical Colleges.Alternative Models of IRB Review Workshop summary. Washington, DC: Department of Wellness and Human Services; 2005. [Google Scholar]
31. Summary of the 2006 National Conference on Alternative IRB Models: optimizing human bailiwick protection. Association of American Medical Colleges website. https://world wide web.aamc.org/download/75240/data/irbconf06rpt.pdf. November 2006. Accessed January 5, 2015.
32. Mascette AM, Bernard GR, Dimichele D, et al. Are central institutional review boards the solution? The National Eye, Lung, and Blood Institute Working Group's report on optimizing the IRB procedure. Acad Med. 2012;87(12):1710-1714. [PMC complimentary commodity] [PubMed] [Google Scholar]
33. Federman D, Hanna K, Rodriguez L, eds. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academies Press; 2003. [Google Scholar]
34. Klitzman R, Appelbaum PS. Research ethics. To protect human subjects, review what was done, not proposed. Scientific discipline. 2012;335(6076):1576-1577. [PMC free commodity] [PubMed] [Google Scholar]
35. Woods A, Grady C, Emanuel EJ. Regional ethics organizations for protection of man enquiry participants. Nat Med. 2004;10(12):1283-1288. [PubMed] [Google Scholar]
36. Kim S, Ubel P, DeVries R. Pruning the regulatory tree. Nature. 2009;457(29):534-535. [PubMed] [Google Scholar]
37. Bank check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of cardinal institutional review boards for multicenter clinical trials in the United States: a review of the literature. Clin Trials. 2013;10(4):560-567. [PubMed] [Google Scholar]
38. Ledford H. Man-subjects research: trial and fault. Nature. 2007;448(7153):530-532. [PubMed] [Google Scholar]
39. Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med. 2010;363(17):1591-1593. [PubMed] [Google Scholar]
forty. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants inquiry: identifying problems to evaluate reform proposals. Ann Intern Med. 2004;141(4):282-291. [PubMed] [Google Scholar]
41. Wilfond BS, Magnus D, Antommaria AH, et al. The OHRP and SUPPORT. N Engl J Med. 2013;368(25):e36. [PubMed] [Google Scholar]
42. Fanaroff JM. Ethical back up for surfactant, positive pressure level, and oxygenation randomized trial (SUPPORT). J Pediatr. 2013;163(5):1498-1499. [PubMed] [Google Scholar]
43. Speers M. Evaluating the effectiveness of institutional review boards. In: Emanuel East, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford Academy Press; 2008:560-568. [Google Scholar]
44. Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med. 2002;346(18):1405-1408. [PubMed] [Google Scholar]
45. National Cancer Establish Central IRB Initiative. National Cancer Institute website. https://ncicirb.org/cirb. Accessed March 1, 2015.
46. Graham DG, Spano MS, Manning B. The IRB challenge for do-based research: strategies of the American Academy of Family unit Physicians National Research Network (AAFP NRN). J Am Board Fam Med. 2007;20(2):181-187. [PubMed] [Google Scholar]
47. Office of Research and Development. VA central institutional review lath (IRB). US Department of Veterans Affairs website. http://www.inquiry.va.gov/programs/pride/cirb. Accessed March 1, 2015.
48. BRANY institutional review board services. Biomedical Research Alliance of New York (BRANY) website. http://www.branyirb.com. Accessed February three, 2015.
49. Kaufmann P, O'Rourke PP. Primal institutional review board review for an academic trial network. Acad Med. 2015;90(iii):321-323. [PMC costless article] [PubMed] [Google Scholar]
53. Slutsman J, Hirschfeld S. A federated model of IRB review for multisite studies: a report on the National Children'southward Study federated IRB initiative. IRB. 2014;36(6):1-six. [PubMed] [Google Scholar]
54. Request for comments on the draft NIH policy on the utilize of a single institutional review lath for multi-site inquiry. National Institutes of Health website. http://grants.nih.gov/grants/guide/observe-files/Not-OD-15-026.html. Published December 3, 2014. Accessed March ii, 2015.
56. Flynn KE, Hahn CL, Kramer JM, et al. Using fundamental IRBs for multicenter clinical trials in the U.s.a.. PLoS ONE. 2013;eight(1):e54999. [PMC free article] [PubMed] [Google Scholar]
57. Coleman CH, Bouësseau MC. How do we know that research ideals committees are really working? The neglected role of outcomes assessment in research ideals review. BMC Med Ethics. 2008;9:half dozen. [PMC costless commodity] [PubMed] [Google Scholar]
58. Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what nosotros still need to learn. J Empir Res Hum Res Ethics. 2011;6(1):3-19. [PMC free commodity] [PubMed] [Google Scholar]
59. Lidz CW, Appelbaum PS, Arnold R, et al. How closely practice institutional review boards follow the common rule? Acad Med. 2012;87(7):969-974. [PMC free article] [PubMed] [Google Scholar]
60. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal hazard and benefit standards for pediatric research? JAMA. 2004;291(four):476-482. [PubMed] [Google Scholar]
61. Grady C. Do IRBs protect human research participants? JAMA. 2010;304(10):1122-1123. [PubMed] [Google Scholar]
62. Presidential Commission for the Study of Bioethical Problems. Further analysis and recommendations: recommendation v. In: Moral Science: Protecting Participants in Human Subjects Research. http://bioethics.gov/sites/default/files/Moral%20Science%20June%202012.pdf. 2011. Accessed February 10, 2015.
63. Wagner T, Murray C, Goldberg J, Adler J, Abrams J. Costs and benefits of the National Cancer Institute Central Institutional Review Board. J Clin Oncol. 2010;28(4):662-666. [PMC free article] [PubMed] [Google Scholar]
64. Sugarman J, Getz K, Speckman JL, Byrne MM, Gerson J, Emanuel EJ; Consortium to Evaluate Clinical Research Ethics. The cost of institutional review boards in academic medical centers. N Engl J Med. 2005;352(17):1825-1827. [PubMed] [Google Scholar]
65. Hyman D. Institutional review boards: is this the least worst nosotros tin practice? Northwestern University Law Review. 2007;101(two):749-774. [Google Scholar]
66. Taylor P. Introduction to office Ii—protection of vulnerable populations. In: Cohen One thousand, Lynch H, eds. Man Subjects Inquiry Regulation, Perspectives on the Future. Cambridge, MA: MIT Press; 2014:63. [Google Scholar]
68. US Code of Federal Regulations at 45CFR.46 and 21CFR56.
Manufactures from Chest are provided hither courtesy of American College of Chest Physicians
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631034/
0 Response to "What Is the Purpose of an Institutional Review Board"
Post a Comment