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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Suggested Citation:"DEFINITIONS." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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APPENDIX C 141 OPERATION OF ACCREDITATION PROGRAM VAMCs to be accredited will submit documents to demonstrate their compliance with accreditation program standards. A team of certified surveyors will visit each VAMC to be accredited. Surveyors will verify the VAMC's compliance with each standard and record their assessments in a structured report. The VAMC will be allowed to comment on the report's accuracy. The Program Accreditation Committee will review the surveyors' report and any VAMC comments, and issue an accreditation decision. PROGRAM COMPONENTS UNDER DEVELOPMENT Work is still underway to finalize data collection methods and protocol sampling strategies. These will be formalized in guidelines for surveyors. Sampling issues under consideration include how many protocols to sample and how to stratify samples to provide meaningful information about issues that present infrequently in some institutions. In addition to work on the sampling strategies, work is underway to determine the scoring of elements and requirements, including those that are applicable only in some instances (e.g., requirements relating to planned emergency research). First-year scoring will be more lenient than scoring in future years, when it will be possible to provide more advance notice of standards. Finally, the threshold scores required to achieve each accreditation outcome will be determined after each element's and requirement's relative weight has been determined. Comments on sampling and scoring are invited along with comments on the standards, requirements, elements, data sources, and review methods presented. DEFINITIONS ADVERSE EVENT (AE) Any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An AE can be any unfavorable and unintended sign, symptom, or disease. AFFILIATE'S HUMAN RESEARCH PROTECTION PROGRAM The HRPP of a VAMC's academic affiliate. See HRPP. CERTIFICATE OF CONFIDENTIALITY Where data are being collected from subjects about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences), researchers can obtain an advance grant of confidentiality from the Public Health Service that will provide protection even against a subpoena for research data. FDA FORM 3454 The financial disclosure form required by the FDA to reveal/ identify any potential financial conflict of interest that an investigator(s), sub- investigator(s), or their spouse and children may have that is applicable to the submission of marketing applications for human drug, biological product, or device for each covered study.

APPENDIX C 142 FEDERAL WIDE ASSURANCE (FWA) An agreement or contract between the institution and OHRP, on behalf of the Secretary, HHS, stipulating the method(s) by which the organization will protect the welfare of research subjects in accordance with the regulations. The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization's responsibilities for meeting the requirements of 45 CFR 46. The FWA replaces all other previous forms of assurance (i.e., MPA, SPA, etc.). FOOD AND DRUG ADMINISTRATION (FDA) The federal agency responsible for the regulation of food, drugs, and cosmetics, including the human subject research performed for FDA-regulated articles. HUMAN RESEARCH PROTECTION PROGRAM (HRPP) The systematic and comprehensive approach by an organization to ensure human subject protection in all research. The implementation of any part of the program may be delegated to specific committees, individuals, or entities (i.e., academic affiliate or another VAMC) by the organization. HUMAN SUBJECT A living individual about whom a research investigator (whether professional or student conducting research) obtains data through intervention or interaction with the individual or identifiable information. INSTITUTION The individual VAMC. The institution retains ultimate responsibility for human subject protection in research conducted at their facility and/or by their staff. INSTITUTIONAL REVIEW BOARD (IRB) An independent committee comprised of scientific and non-scientific members established according to the requirements outlined in Title 38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U. S. Code of Federal Regulations. INVESTIGATIONAL DEVICE EXEMPTION (IDE) The process by which the FDA permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. INVESTIGATIONAL NEW DRUG APPLICATION (IND) The process by which new drugs or biologies, including the new use of an approved drug, are registered with the FDA for administration to human subjects. An IND number is assigned by the FDA to the drug or biologic for use in tracking. INVESTIGATOR (Principal investigator) An individual who conducts an investigation, that is, under whose immediate direction research is conducted, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. INVESTIGATOR/SPONSOR A term defined in the FDA regulations as an individual with responsibility for initiating and conducting a research study. LEGALLY AUTHORIZED REPRESENTATIVE An individual, judicial, or other body authorized under applicable law to consent on behalf of a

APPENDIX C 143 prospective subject to the subject's participation in the procedure(s) involved in research. MEDWATCH The FDA Medical Products Reporting Program, is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the manufacturer and to ensure that new safety information is rapidly communicated to the medical community, thereby improving patient care. The purpose of the MedWatch program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products. MEMORANDUM OF UNDERSTANDING (MOU) A legal agreement outlining the details of the relationship between organizations, including the responsibilities of each. Such an agreement is used by the VAMC to delineate the terms and conditions under which it may utilize another entity's IRB. 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. MULTIPLE PROJECT ASSURANCE (MPA) An agreement or contract between the institution and OPRR, on behalf of the Secretary, HHS, stipulating the method(s) by which the organization will protect the welfare of research subjects in accordance with the regulations. The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization's responsibilities for meeting the requirements of 45 CFR 46. MPAs will be replaced by FWAs. POLICY A principle or course of action to guide decision-making. PROCEDURE See Standard Operating Procedure (SOP). PROTOCOL A plan that includes, at minimum, the objectives, rationale, design, methods, and other conditions for the conduct of a research study. PROTOCOL FILE The documents maintained by the IRB administration containing the protocol, investigator's brochure, IRB/investigator communications, and all other supporting materials. QUALITY IMPROVEMENT (QI) The effort to assess and improve the level of performance of a program or institution. QI includes quality assessment and implementation of corrective actions to address any deficiencies identified. RESEARCH A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. SAFETY REPORTS (IND/IDE) Written reports from sponsors notifying the FDA and all participating investigators of any adverse experience associated with the use of a drug that is both serious and unexpected. SERIOUS ADVERSE EVENT (SAE) Any event that results in death, a life- threatening situation, hospitalization or prolonged hospitalization, persistent

APPENDIX C 144 or significant disability/incapacity, or a congenital anomaly/birth defect. SAEs require reporting to the sponsor and the IRB. SPONSOR Any person or entity who takes responsibility for and initiates a clinical study. The sponsor may be an individual, pharmaceutical company, device manufacturer, governmental agency, academic institution, private organization, or other organization. STANDARD OPERATING PROCEDURE (SOP) A formalized established series of steps for the uniform performance of a function or activity. UNEXPECTED ADVERSE EVENT Any adverse event that has not previously been observed (e.g., included in the investigator brochure). VULNERABLE SUBJECTS Individuals whose willingness to volunteer in a research study may be unduly influenced or coerced and individuals with limited autonomy.

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APPENDIX C 195 Process for Submitting Comments (due by May 15, 2001) Please address all comments to VAHRP: • E-mail (preferred method) to vahrpap@ncqa.org. You will receive an e- mail confirmation of receipt. • Mail to VAHRPAP, NCQA, 2000 L Street, N.W., Suite 500, Washington, D.C. 20036 • Fax to 202-955-3599, Attention – VAHRPAP. Please provide the following information: • Name • Position • Organization Please organize comments as described below. • Word document (preferred method) formatted as below. Domain Issue* Comment Privacy and Confidentiality Requirement 1.B Should the IRB minutes be Data source/method included as a possible data source/method for evaluating IRB assessment of provisions to protect privacy in individual proposals? All Data Source/method Is a one-year look-back period an appropriate timeframe for adequate evaluation of an HRPP? * Issue may address a global comment, a specific requirement or element, the data sources or methods

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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