Inicie em. Mostre SlideShares relacionados no final. GloriaGodinez Seguir. Full Name Comment goes here. Are you sure you want to Yes No. Sem downloads. Nenhuma nota no slide. We employed a process that has been used to develop ethics guidance on a variety of controversial biomedical topics such as embryonic stem cell research. Initially, four subgroups of participants identified GPFR activities that raise ethical concerns, which were then discussed with all of the attendees. A final session was devoted to organizing the lessons learned.
Issues were summarized during deliberations and captured on a flip chart. In addition, a research assistant took detailed notes during the summit.
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Following the summit, the planning committee prepared a draft of these issues and recommendations. The draft was circulated to all 29 participants for review and feedback in three iterative rounds. Although we sought and obtained general agreement, we did not endeavor to reach consensus among participants on all recommendations nor did we. Unresolved differences are noted below.
In this article, we have chosen to use the term GPFR. A variety of terms have been used to refer to this practice, including but not limited to grateful patient cultivation, grateful patient programs, patient-inspired philanthropy, patient prospecting, and wealth screening. Because small tokens of appreciation e. The ethical basis for GPFR is the mutual involvement of patients, physicians, and institutions working toward a common social good. Both philanthropy and clinical care share ethical commitments to professionalism, beneficence, and responsible stewardship. List 1 outlines the ethical issues first for physicians and other clinicians and then for development professionals and health care institutions.
In this article, we briefly delineate these issues and our corresponding recommendations for each, realizing that they are incompletely explicated here. Where available, citations are provided for those interested in particular matters.
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Discussions with patients about philanthropy have the potential to affect the physician—patient relation ship 11 , 13 , 19 , 20 , 23 —namely, trust and decision making. At any point, patients may express interest in philanthropy. We did not reach consensus about whether it is ethically acceptable for physicians to initiate discussions about philanthropy with their patients.
Some patients may not welcome discussions about philanthropy. Yet, some summit participants believed that there may be times when a physician-initiated GPFR discussion may be appropriate. This is similar to how vulnerability is often considered in regard to the capacity to provide informed consent. In other specialties e. GPFR can introduce conflicts of obligation between therapeutic and philanthropic goals. Some physicians are uncomfortable with the possibility that they may treat patients who make substantial financial gifts differently from those who do not.
Philanthropy allows donors to express their interests in ways meaningful to them. These long-standing relationships can take on a personal nature that, if not appropriately managed, may create potentially fraught situations, such as donors having expectations that development professionals cannot fulfill. Confidentiality and respect for privacy are long-standing expectations in health care. Nevertheless, revisions to the HIPAA Privacy Rule in permit development professionals to access certain types of health information.
For instance, patients may be unaware of these practices and may feel that they violate their privacy and confidentiality. Institutional conflicts of interest may arise in the course of GPFR. Philanthropy supports many types of medical research, including funding for early-career investigators, pursuit of unconventional hypotheses, and investigations into rare diseases. Institutions have priorities for an array of competing endeavors, any of which may or may not be in accord with the philanthropic intents of donors. In addition, institutions may have policies regarding the use of some part of any philanthropic gift for infrastructural support e.
Many physicians feel inadequately prepared for involvement in GPFR. While the recommendations we propose promise to mitigate some of the ethical issues associated with GPFR, they represent only an initial step toward achieving this goal. Important next steps include conducting research on GPFR, disseminating these recommendations, developing standardized training in GPFR, and revising these recommendations as warranted. For example, studies of patients who do not give are needed to improve understanding about how these patients feel about being asked to give, by whom, and when, as well as how they feel about wealth screening and special donor i.
Information about the views of all patients and the general public, including those who lack the capacity to give, regarding these activities is important to evaluate. In addition, it is not known whether assertions that philanthropy directly benefits patients are empirically borne out. Although research suggests that giving money and giving time are associated with better health and well-being, 7 we are not aware of research exploring how giving on the part of patients, specifically, is related to these outcomes.
Finally, direct assessments of the utility of these recommendations would help inform further specificity, implementation, and potential revision in the future. In the meantime, it will be important to disseminate the recommendations we distilled from the summit through professional organizations as well as to develop training materials on GPFR that incorporate these recommendations. Hopefully, national professional groups with a stake in GPFR will take the lead in such endeavors.
Ultimately, experience with considering and implementing these recommendations in diverse settings will help to refine them so that this important activity can proceed in an ethically acceptable manner. The authors thank Alan Regenberg for facilitating the scoping review, Catherine Mayhew for providing invaluable logistical support for the summit and coordinating reviews of the manuscript, and M.
Rani Mukherjee for providing administrative support with the scoping review, note-taking during the summit, and manuscript preparation. You may be trying to access this site from a secured browser on the server. Please enable scripts and reload this page. Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent.
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Some error has occurred while processing your request. Please try after some time. Discussions with patients about philanthropy. Physician-initiated discussions about philanthropy. Clinically vulnerable patients. Conflicts of obligation and equity regarding a physicia More work is required to answer several questions: What are the intended goals of disclosing to potential research participants?
Recent Activity. PURPOSE:To document the current state of institutional review board IRB and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. In February and March , using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest.
Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant.
Most of the AMCs' policies were consistent with the goal of protection from legal liability. The snippet could not be located in the article text. This may be because the snippet appears in a figure legend, contains special characters or spans different sections of the article. Acad Med. Author manuscript; available in PMC Mar PMID: Kevin P. Weinfurt , PhD, Michaela A. Dinan , BS, Jennifer S. Hall , JD, Kevin A. Mr Hall is Fred D. Dr Sugarman is Harvey M. Address for Correspondence : Kevin P. Copyright notice. The publisher's final edited version of this article is available at Acad Med.
See other articles in PMC that cite the published article. Abstract Many professional organizations and governmental bodies recommend disclosing financial conflicts of interest to potential research participants. Introduction Financial conflicts of interest present enormous challenges for the clinical research enterprise.
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Goal Definition Promote autonomy Provide people with information material to making informed decisions about participating in research. Avoid legal liability Meet basic legal or regulatory requirements without hindering research. Deterrence Discourage individuals and institutions from holding conflict of interests.
Open in a separate window. Content Coding To assess institutions' guidelines for disclosing conflicts of interest to potential research participants, we extracted and coded the information summarized in Table 2. Table 2 Information Extracted from Institutions' Documents. Whether disclosure of financial interests to potential research participants is mentioned explicitly in any document or policy.
Whether specific language for informed consent documents was proposed for example, in a guideline or template for creating informed consent documents. Whether the informed consent document guideline requires a specific description of relationship between the investigator and sponsor. Whether the informed consent document guideline requires stating that an administrative body for example, a conflict of interest committee has reviewed the conflict of interest. Whether the informed consent document guideline encourages discussion between investigators and participants about the financial relationship.
Details of the Financial Arrangement All policies required disclosure of the study sponsor, but there was great variability regarding the requirement for disclosing other details about financial arrangements.
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For example, one institution's guidance stated: If the study is receiving financial support from an external source, include a statement such as: [The university] is receiving financial support from [the sponsor] to assist in the conduct of this research study. A section should be added to the informed consent document as follows: Payment to Institution: This project is funded, in part, by a grant or contract from [the pharmaceutical company] to the Research Foundation of [the university], in support of the Investigators' work on this study.
Administrative Management of Conflicts of Interest Template disclosure statements from 2 institutions included a statement that the research protocol had been reviewed by an administrative body and that the financial arrangement in question was deemed acceptable: [Name of researcher] [then describe the nature of the financial interest, e. Dialogue Between Investigators and Potential Research Participants Two institutions encouraged or required a discussion between investigators and potential research participants regarding conflicts of interest.
Discussion There is little agreement about how conflicts of interest should be disclosed to potential research participants or how that process should be accomplished. Conclusion Disclosure to potential research participants is a frequently mentioned approach to the management of conflicts of interest. Notes 1. Managing conflicts of interest in the conduct of clinical trials.
Thompson DF. Understanding financial conflicts of interest. N Engl J Med. Implementation of financial disclosure policies to manage conflicts of interest. Health Aff. Ehringhaus S, Korn D.
A national survey of policies on disclosure of conflicts of interest in biomedical research. Financial conflict-of-interest policies in clinical research: issues for clinical investigators. Expanding disclosure of conflicts of interest: the views of stakeholders.
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Potential research participants' views regarding researcher and institutional conflicts of interest. J Med Ethics. Conflicts of interest in academic research: policies, processes, and attitudes. Account Res. Resnik DB. Disclosing conflicts of interest to research subjects: an ethical and legal analysis. Financial relationships and interests in research involving human subjects: guidance for human subject protection.
Fed Regist. Sage WM. Regulating through information: disclosure laws and American health care. Columbia Law Rev. Hall MA.
The theory and practice of disclosing HMO physician incentives. Law Contemp Probl. Grimes v.