PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
➤ Gửi thông báo lỗi ⚠️ Báo cáo tài liệu vi phạmNội dung chi tiết: PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”he Protection of Human Subjects in Research?Report of a Work Group Convened by the National Center for Ethics in Health Care of the Veterans Health Administration on Behalf of the Secretary of Veterans Affairs39722Executive SummaryThe Secretary of the Department of Veterans Affairs charged the Work PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”Group on Post Traumatic Stress Disorder (PTSD) and Vulnerable Populations in Research to examine the tension between the need to study veterans with PPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
TSD to help improve their condition and the need to protect veterans with PTSD from further risk, given their potential vulnerability as research partShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”h (USH) for the following questions:1Is it ever ethically permissible for the Veteran's Health Administration (VHA) to support the conduct of research on veterans with PTSD?2Are veterans with a diagnosis of PTSD considered vulnerable" for the purpose of applying guidelines for the protection of huma PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”n subjects in research?3Should veterans with a diagnosis of PTSD be afforded special consideration and/or extra protections under VHA guidance to protPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
ect human subjects in research?a.If yes. what criteria would ưigger the application of special consideration and/or extra protections?b.If yes. what sShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”e Federal employees from six different agencies, met three times over the course of sixty days to discuss the charge, receive testimony and comments from national experts inside and outside of VHA, and deliberate on recommendations for VHA leadership. The Work Group answered the charge questions as PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”follows:QUESTION 1: Is it ever ethically permissible for VHA to support the conduct of research on veterans with PTSD?2CONSENSUS RECOMMENDATION 1: ThePUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
Work Group concludes that it is not only ethically permissible for VHAto support the conduct of research involving veterans with PTSD but VHA has an Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”rotection of human subjects in research?CONSENSUS RECOMMENDATION 2: The Work Group concludes that, as a group, veterans with PTSD are not categorically vulnerable and. therefore, do not require special protections in the form of new regulations, policy or guidance. Under current Federal regulations PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”and VA policy. Institutional Review Boards (IRB) are directed to scrutinize individual protocols to determine whether potential participants may havePUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
impaired decision-making capacity, an increased susceptibility to undue influence or coercion, or an increased susceptibility to the risks associated Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS” to certain veterans with PTSD who are involved in a particular research study. If an IRB determines that this is the case with respect to a particular research study, the IRB should give special consideration to protecting the welfare of those veterans with PTSD who are involved, and consider wheth PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”er special safeguards are needed to protect them, just as they would for any other study population.3QUESTION 3: Should veterans with a diagnosis of PPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
TSD be afforded special consideration and/or extra protections under VHA guidance to protect human subjects in research?a.If yes, what criteria would Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”rded, and what mechanism would be used to implement them?CONSENSUS RECOMMENDATION 3: The Work Group concludes that veterans with a diagnosis of PTSD should be afforded special consideration consistent with current regulation and policy if and when an IRB determines that these veterans have impaired PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”decision-making capacity, an increased susceptibility to undue influence or coercion, or an increased susceptibility to the risks associated with a paPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
rticular research study. Because veterans with a diagnosis of PTSD are not categorically vulnerable, no extra protections in the form of additional reShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”on to all veterans for the sacrifices they have made for our country including veterans who have developed PTSD and other disorders as a direct result of their military service. VHA. as part of its mission to advance the health and well-being of veterans, must adhere to the highest ethical standards PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS” in all of Its research practices. Investigators. IRBs, and research teams should apply existing regulations and guidance regarding protecting human sPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
ubjects with sensitivity to the needs and interests of veterans with PTSD within the context of the study under review.4In addition, the Work Group maShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”ublic.2The Work Group recommends that VHA'S Office of Research and Development conduct an educational needs assessment to determine what further information and resources, if any, researchers and IRBs need to implement the considerations and protections for vulnerable populations specified in regula PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”tion and policy. Such information may relate to PTSD specifically or to the assessment of vulnerability among subject populations more generally. ThePUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
assessment should have input from veterans who have participated in or been recruited for research.3IRBs should continue to review protocols involvingShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”to the protection of human research subjects, including ensuring that the review process is informed, as appropriate by both scientific/clinical expertise and expenential/advocacy expertise relating to veterans with PTSD.4If an IRB determines that veterans with a diagnosis of PTSD have an increased PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”susceptibility to the risks associated with a particular research study, as described under answer Charge Question 2 and Consensus Recommendation 2 abPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
ove, the IRB should add safeguards particular to the study to protect veterans with PTSD in that study.5INTRODUCTIONPost Traumatic Stress Disorder (PTShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”ng veterans who serve in a combat zone, it is estimated that 13 to 20 percent will eventually develop PTSD. Among veterans with a mental disorder who seek health care from the Veterans Health Administration (VHA), It is estimated that more than half have PTSD.PTSD in veterans is associated with sign PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”ificant societal costs, in terms of both health care resources and human suffering. Suffering can result both directly from the symptoms and indirectlPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
y from the toll these symptoms can take on family, career, and lifestyle. When PTSD results from military combat, it holds special significance in AmeShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for th PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”PTSD was well established as a mental disorder, veterans with PTSD were often misunderstood and even ostracized. Today it is recognized that the nation has a special obligation to veterans with PTSD - to understand their needs and assist in their recovery.As part of its mission to improve the health PUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS” and well-being of veterans. VHA conducts research into injuries and illnesses that are associated with military service in an effort to better undersPUBLIC COMPETENCE IN NORMATIVE AND EMPIRICAL THEORY NEGLECTED IMPLICATIONS OF “THE NATURE OF BELIEF SYSTEMS IN MASS PUBLICS”
tand these conditions, develop effective treatments, and improve the delivery of care. VHAs research portfolio currently includes over 500 studies invShould Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for thGọi ngay
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