FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W432095603> ?p ?o ?g. }

• W432095603 endingPage "15" @default.
• W432095603 startingPage "15" @default.
• W432095603 abstract "On March 31, 2003, the Department of Health and Human Services (HHS) published a notice in the Federal Register of new draft guidance on financial conflicts of interest (68 Fed. Reg. 15456). The document, Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, is the latest in a long line of guidance documents issued by federal regulators and professional associations on this subject in the last several years. The zoo3 Draft Guidance departs significantly from the prescriptive approach taken in the widely criticized zooi Draft Interim Guidance (Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing with Issues of Financial Interests and Human Subject Protection), and from the more stringent guidelines proposed by the Association of American Universities' Task Force on Research Accountability (Report on Individual and Institutional Financial Conflict of Interest, October 9, zoo2) and the Association of American Medical Colleges (AAMC) Task Force on Financial Conflicts of Interest in Clinical Research (reports on individual and institutional financial conflicts of interest, December zool and October Z002). The zoo1 Draft Interim Guidance proposed methods for institutions, investigators and institutional review boards (IRBs) for (1) identifying and managing financial conflicts of interest (both individual and institutional), (2) establishing the appropriate role of the IRB, and (3) disclosing potential conflicts of interest to subjects via the informed consent process. Focusing on investigator conflicts, the zool Draft Interim Guidance identified the IRB as the body that should be primarily responsible for collecting information regarding potential financial conflicts, evaluating the information, and determining whether the conflict can be managed, reduced or eliminated. Alternatively, if institutions preferred to use a Conflict of Interest Committee (COIC) to carry out these tasks, the zool Draft Interim Guidance stressed the importance of the COIC communicating its specific findings to the IRB so that the IRB could consider such information in its review of a research protocol. Some of the criticism leveled at the zool Draft Interim Guidance stemmed from the role assigned to the IRB. For example, HHS's National Human Research Protections Advisory Committee (NHRPAC) identified several reasons why IRBs should not be charged with the responsibility of collecting and analyzing financial information for the purpose of identifying conflicts of interest and of suggesting ways to manage such conflicts. NHRPAC contended that many IRBs do not have the expertise or staff support to allow them to undertake insightful analysis of financial interests and conflicts of interest and that because non-affiliated IRB members have no legal obligation to maintain the confidentiality of information derived from the IRB process, investigators may be subject to potential breaches of confidentiality regarding their personal financial information. Although the zoo3 Draft Guidance recommends IRB involvement in conflict of interest review and compliance, the recommended role of the IRB is more subdued, with a greater emphasis on COICs (or other persons or bodies designated to review financial interests) as the central body responsible for identifying and managing conflicts of interest and communicating relevant information to the IRB as necessary. The role of the IRB is focused primarily on incorporating financial conflict of interest information into the review and approval analysis required of IRBs under the Common Rule. According to the zoo3 Draft Guidance, IRBs should consider taking the following actions based on the particular circumstances of the research study: (1) determine whether methods being used to manage identified financial interests adequately protect the rights and welfare of subjects; (2) determine what additional information the IRB needs to evaluate the study in light of the financial interests of parties involved in the research; (3) determine what actions are necessary to minimize risks to subjects; and (4) determine the kind, amount and level of detail of Mark Barnes and Kate Gallin, HHS Draft Guidance on Financial Conflicts of Interest, IRB: Ethics & Human Research 25, No. 5 (2003): 15-16." @default.
• W432095603 created "2016-06-24" @default.
• W432095603 creator A5051459471 @default.
• W432095603 creator A5070925391 @default.
• W432095603 date "2003-09-01" @default.
• W432095603 modified "2023-09-25" @default.
• W432095603 title "HHS Draft Guidance on Financial Conflicts of Interest" @default.
• W432095603 doi "https://doi.org/10.2307/3564601" @default.
• W432095603 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/14870740" @default.
• W432095603 hasPublicationYear "2003" @default.
• W432095603 type Work @default.
• W432095603 sameAs 432095603 @default.
• W432095603 citedByCount "0" @default.
• W432095603 crossrefType "journal-article" @default.
• W432095603 hasAuthorship W432095603A5051459471 @default.
• W432095603 hasAuthorship W432095603A5070925391 @default.
• W432095603 hasConcept C10138342 @default.
• W432095603 hasConcept C144133560 @default.
• W432095603 hasConcept C2777276634 @default.
• W432095603 hasConceptScore W432095603C10138342 @default.
• W432095603 hasConceptScore W432095603C144133560 @default.
• W432095603 hasConceptScore W432095603C2777276634 @default.
• W432095603 hasIssue "5" @default.
• W432095603 hasLocation W4320956031 @default.
• W432095603 hasLocation W4320956032 @default.
• W432095603 hasOpenAccess W432095603 @default.
• W432095603 hasPrimaryLocation W4320956031 @default.
• W432095603 hasRelatedWork W2386187981 @default.
• W432095603 hasRelatedWork W2750896665 @default.
• W432095603 hasRelatedWork W2792274095 @default.
• W432095603 hasRelatedWork W2903749241 @default.
• W432095603 hasRelatedWork W2907801947 @default.
• W432095603 hasRelatedWork W2987740169 @default.
• W432095603 hasRelatedWork W3159245703 @default.
• W432095603 hasRelatedWork W648876851 @default.
• W432095603 hasRelatedWork W2187559042 @default.
• W432095603 hasRelatedWork W2258045193 @default.
• W432095603 hasVolume "25" @default.
• W432095603 isParatext "false" @default.
• W432095603 isRetracted "false" @default.
• W432095603 magId "432095603" @default.
• W432095603 workType "article" @default.