Complying with the NIH Public Access Policy - Copyright Considerations and Options

On January 11, 2008, the National Institutes of Health ('NIH') adopted a revised Public Access Policy for peer-reviewed journal articles reporting research supported in whole or in part by NIH funds. Under the revised policy, the grantee shall ensure that a copy of the author's final manuscript, including any revisions made during the peer review process, be electronically submitted to the National Library of Medicine's PubMed Central ('PMC') archive and that the person submitting the manuscript will designate a time not later than 12 months after publication at which NIH may make the full text of the manuscript publicly accessible in PMC. NIH adopted this policy to implement a new statutory requirement under which: The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. This White Paper is written primarily for policymaking staff in universities and other institutional recipients of NIH support responsible for ensuring compliance with the Public Access Policy. The January 11, 2008, Public Access Policy imposes two new compliance mandates. First, the grantee must ensure proper manuscript submission. The version of the article to be submitted is the final version over which the author has control, which must include all revisions made after peer review. The statutory command directs that the manuscript be submitted to PMC 'upon acceptance for publication.' That is, the author's final manuscript should be submitted to PMC at the same time that it is sent to the publisher for final formatting and copy editing. Proper submission is a two-stage process. The electronic manuscript must first be submitted through a process that requires input of additional information concerning the article, the author(s), and the nature of NIH support for the research reported. NIH then formats the manuscript into a uniform, XML-based format used for PMC versions of articles. In the second stage of the submission process, NIH sends a notice to the Principal Investigator requesting that the PMC-formatted version be reviewed and approved. Only after such approval has grantee's manuscript submission obligation been satisfied. Second, the grantee also has a distinct obligation to grant NIH copyright permission to make the manuscript publicly accessible through PMC not later than 12 months after the date of publication. This obligation is connected to manuscript submission because the author, or the person submitting the manuscript on the author's behalf, must have the necessary rights under copyright at the time of submission to give NIH the copyright permission it requires. This White Paper explains and analyzes only the scope of the grantee's copyright-related obligations under the revised Public Access Policy and suggests six options for compliance with that aspect of the grantee's obligation. Time is of the essence for NIH grantees. As a practical matter, the grantee should have a compliance process in place no later than April 7, 2008. More specifically, the new Public Access Policy applies to any article accepted for publication on or after April 7, 2008 if the article arose under (1) an NIH Grant or Cooperative Agreement active in Fiscal Year 2008, (2) direct funding from an NIH Contract signed after April 7, 2008, (3) direct funding from the NIH Intramural Program, or (4) from an NIH employee. In addition, effective May 25, 2008, anyone submitting an application, proposal or progress report to the NIH must include the PMC reference number when citing articles arising from their NIH funded research. (This includes applications submitted to the NIH for the May 25, 2008 and subsequent due dates.) Conceptually, the compliance challenge that the Public Access Policy poses for grantees is easily described. The grantee must depend to some extent upon the author(s) to take the necessary actions to ensure that the grantee is in compliance with the Public Access Policy because the electronic manuscripts and the copyrights in those manuscripts are initially under the control of the author(s). As a result, any compliance option will require an explicit understanding between the author(s) and the grantee about how the manuscript and the copyright in the manuscript are managed. It is useful to conceptually keep separate the grantee's manuscript submission obligation from its copyright permission obligation because the compliance personnel concerned with manuscript management may differ from those responsible for overseeing the author's copyright management. With respect to copyright management, the grantee has the following six options: (1) rely on authors to manage copyright but also to request or to require that these authors take responsibility for amending publication agreements that call for transfer of too many rights to enable the author to grant NIH permission to make the manuscript publicly accessible ('the Public Access License'); (2) take a more active role in assisting authors in negotiating the scope of any copyright transfer to a publisher by (a) providing advice to authors concerning their negotiations or (b) by acting as the author's agent in such negotiations; (3) enter into a side agreement with NIH-funded authors that grants a non-exclusive copyright license to the grantee sufficient to grant NIH the Public Access License; (4) enter into a side agreement with NIH-funded authors that grants a non-exclusive copyright license to the grantee sufficient to grant NIH the Public Access License and also grants a license to the grantee to make certain uses of the article, including posting a copy in the grantee's publicly accessible digital archive or repository and authorizing the article to be used in connection with teaching by university faculty; (5) negotiate a more systematic and comprehensive agreement with the biomedical publishers to ensure either that the publisher has a binding obligation to submit the manuscript and to grant NIH permission to make the manuscript publicly accessible or that the author retains sufficient rights to do so; or (6) instruct NIH-funded authors to submit manuscripts only to journals with binding deposit agreements with NIH or to journals whose copyright agreements permit authors to retain sufficient rights to authorize NIH to make manuscripts publicly accessible.

The Framingham Heart Study 100K SNP genome-wide association study resource: overview of 17 phenotype working group reports

BACKGROUND:The Framingham Heart Study (FHS), founded in 1948 to examine the epidemiology of cardiovascular disease, is among the most comprehensively characterized multi-generational studies in the world. Many collected phenotypes have substantial genetic contributors; yet most genetic determinants remain to be identified. Using single nucleotide polymorphisms (SNPs) from a 100K genome-wide scan, we examine the associations of common polymorphisms with phenotypic variation in this community-based cohort and provide a full-disclosure, web-based resource of results for future replication studies.METHODS:Adult participants (n = 1345) of the largest 310 pedigrees in the FHS, many biologically related, were genotyped with the 100K Affymetrix GeneChip. These genotypes were used to assess their contribution to 987 phenotypes collected in FHS over 56 years of follow up, including: cardiovascular risk factors and biomarkers; subclinical and clinical cardiovascular disease; cancer and longevity traits; and traits in pulmonary, sleep, neurology, renal, and bone domains. We conducted genome-wide variance components linkage and population-based and family-based association tests.RESULTS:The participants were white of European descent and from the FHS Original and Offspring Cohorts (examination 1 Offspring mean age 32 +/- 9 years, 54% women). This overview summarizes the methods, selected findings and limitations of the results presented in the accompanying series of 17 manuscripts. The presented association results are based on 70,897 autosomal SNPs meeting the following criteria: minor allele frequency [greater than or equal to] 10%, genotype call rate [greater than or equal to] 80%, Hardy-Weinberg equilibrium p-value [greater than or equal to] 0.001, and satisfying Mendelian consistency. Linkage analyses are based on 11,200 SNPs and short-tandem repeats. Results of phenotype-genotype linkages and associations for all autosomal SNPs are posted on the NCBI dbGaP website at http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?id=phs000007.CONCLUSION:We have created a full-disclosure resource of results, posted on the dbGaP website, from a genome-wide association study in the FHS. Because we used three analytical approaches to examine the association and linkage of 987 phenotypes with thousands of SNPs, our results must be considered hypothesis-generating and need to be replicated. Results from the FHS 100K project with NCBI web posting provides a resource for investigators to identify high priority findings for replication.

Bulletin of the American Schools of Oriental Research (BASOR) Collection, 1919-1974

This file contains a finding aid for the Bulletin of the American Schools of Oriental Research (BASOR) Collection. To access the collection, please contact the archivist (asorarch@bu.edu) at the American Schools of Oriental Research, located at Boston University.

Khirbet et-Tannur Excavation Records

The Khirbet et-Tannur Excavation Records document the 1938 excavation of a Nabataean temple. The excavation was directed by Nelson Glueck. The collection includes level books, excavation diaries, artifacts, and photographs. The collection is being processed. A finding aid for the document portion of the collection is available.

Lámhscríbhinní gaeilge i leabharlanna sa tuaisceart

Accepted Version

A king for the queene: Samuel Sheppard's the faerie king and his reception of Spenser's epic authority

This thesis is the study of the use and abuse of Edmund Spenser as an authority in native English epic literature of the early seventeenth century, within fifty years of his death. It focuses on attempts to emulate or adapt his seminal text, The Faerie Queene (1596), and offers a comparative analysis of two such approaches by the liminal authors, Ralph Knevet and Samuel Sheppard. The former, a tutor to the wealthy Norfolk Paston family, produced his A Supplement of the Ferie Queene in the pre-Civil War period (c.1630-1635), while the latter wrote The Faerie King at the very end of the social upheaval of the war (c.1648-54). The thesis privileges the study of the holograph manuscripts (Cambridge University Library, MS Ee.3.53 and Bodleian Library MS Rawl. Poet. 28 respectively) over the basic editions of these neglected texts. It argues for the need to re-evaluate the significance of such texts within the Spenserian canon and, through new readings of the texts' structures and contexts, the thesis questions the legitimacy of canon formation and continuation, as well as the influence editorial policies and decision making can have on subsequent readers and receptions of the text

Stair na Gaeilge i gContae Thiobraid Árann 1700-1901

Stair na Gaeilge i gCo. Thiobraid Árann i rith na tréimhse 1700-1901 atá á ríomhadh sa tráchtas seo. Tar éis a cúlra agus a comhthéacs a shuíomh i gCaibidil a hAon, déantar scríobhaithe an cheantair a áireamh, fara tráchtaireacht orthu, i gCaibidil a Dó. I gCaibidlí a Trí agus a Ceathair, féachtar ar thionchar na hEaglaisí Caitlicí agus Eaglais na hÉireann (i measc eaglaisí Protastúnacha eile) ar an dteangain. I gCaibidil a Cúig, faightear spléachadh ar ghnéithe éagsúla de shaíocht an chontae, ag tabhairt léargais ar tháirgí na scríobhaithe, ar leabhair a clóbhualadh sa réigiún, agus ar fhilí móra na háite, leithéidí Liam Daill Uí Ifearnáin, ag sonrú limistéir faoi leith, an t-oirdheisceart, mar shampla. Léirítear éifeacht na gcumann Gaelach agus na ndíograiseoirí iomadúla a bhain leo. Ábhar suime, leis, feidhm na Gaeilge sna cúirteanna dlí. Tugtar faisnéis i gCaibidil a Sé ar fhianaise cuairteoirí ar an Ghaeilge mar urlabhra i dTiobraid Árann. Is anseo chomh maith a deintear anailís ar Dhaonáirimh na mblianta 1861-1901, le mórchuid adhmaid á baint as ceann 1901 go háirithe. Breactar as ainmneacha sagart agus múinteoirí le Gaeilge, agus tráchtar ar aicmí suntasacha eile, na póilíní agus na saighdiúirí a raibh an teanga sin ina mbéal acu. Tugtar le chéile dá réir na snáithíní difriúla eolais ar an dúiche ar bhealach nár tharla cheana don gcontae casta fairsing seo le haghaidh na tréimhse atá idir lámha ag an saothar.

Patient-based outcome assessment instruments in acupuncture research.

BACKGROUND: Outcome assessment can support the therapeutic process by providing a way to track symptoms and functionality over time, providing insights to clinicians and patients, as well as offering a common language to discuss patient behavior/functioning. OBJECTIVES: In this article, we examine the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The aims of this review were to assess and identify the commonly available PBOA measures, describe a framework for identifying appropriate sets of measures, and address the challenges associated with these measures and acupuncture. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. METHODS: This study was a systematic review. A total of 582 abstracts were reviewed using PubMed (from inception through April 2009). RESULTS: A total of 582 citations were identified. After screening of title/abstract, 212 articles were excluded. From the remaining 370 citations, 258 manuscripts identified explicit PBOA; 112 abstracts did not include any PBOA. The five most common PBOA instruments identified were the Visual Analog Scale, Symptom Diary, Numerical Pain Rating Scales, SF-36, and depression scales such as the Beck Depression Inventory. CONCLUSIONS: The way a questionnaire or scale is administered can have an effect on the outcome. Also, developing and validating outcome measures can be costly and difficult. Therefore, reviewing the literature on existing measures before creating or modifying PBOA instruments can significantly reduce the burden of developing a new measure.

Physical activity in US Blacks: a systematic review and critical examination of self-report instruments.

BACKGROUND: Physical activity self-report instruments in the US have largely been developed for and validated in White samples. Despite calls to validate existing instruments in more diverse samples, relatively few instruments have been validated in US Blacks. Emerging evidence suggests that these instruments may have differential validity in Black populations. PURPOSE: This report reviews and evaluates the validity and reliability of self-reported measures of physical activity in Blacks and makes recommendations for future directions. METHODS: A systematic literature review was conducted to identify published reports with construct or criterion validity evaluated in samples that included Blacks. Studies that reported results separately for Blacks were examined. RESULTS: The review identified 10 instruments validated in nine manuscripts. Criterion validity correlations tended to be low to moderate. No study has compared the validity of multiple instruments in a single sample of Blacks. CONCLUSION: There is a need for efforts validating self-report physical activity instruments in Blacks, particularly those evaluating the relative validity of instruments in a single sample.

Systematic review and metasummary of attitudes toward research in emergency medical conditions

Emergency departments are challenging research settings, where truly informed consent can be difficult to obtain. A deeper understanding of emergency medical patients' opinions about research is needed. We conducted a systematic review and meta-summary of quantitative and qualitative studies on which values, attitudes, or beliefs of emergent medical research participants influence research participation. We included studies of adults that investigated opinions toward emergency medicine research participation. We excluded studies focused on the association between demographics or consent document features and participation and those focused on non-emergency research. In August 2011, we searched the following databases: MEDLINE, EMBASE, Google Scholar, Scirus, PsycINFO, AgeLine and Global Health. Titles, abstracts and then full manuscripts were independently evaluated by two reviewers. Disagreements were resolved by consensus and adjudicated by a third author. Studies were evaluated for bias using standardised scores. We report themes associated with participation or refusal. Our initial search produced over 1800 articles. A total of 44 articles were extracted for full-manuscript analysis, and 14 were retained based on our eligibility criteria. Among factors favouring participation, altruism and personal health benefit had the highest frequency. Mistrust of researchers, feeling like a 'guinea pig' and risk were leading factors favouring refusal. Many studies noted limitations of informed consent processes in emergent conditions. We conclude that highlighting the benefits to the participant and society, mitigating risk and increasing public trust may increase research participation in emergency medical research. New methods for conducting informed consent in such studies are needed.

El reemplazo de pastizales anegadizos por plantaciones de álamos con suelos drenados en el Bajo Delta del río Paraná : cambios físicos y biogeoquímicos en el suelo y el ecosistema

En los humedales del Bajo del Paraná, el drenaje de los suelos, endicamiento y forestación constituyen el cambio de uso más característico. A partir del muestreo de suelos y vegetación en parcelas pareadas de pastizales anegadizos y plantaciones forestales que los reemplazaron tras el drenaje de los suelos, se exploraron los cambios en el volumen y contenido de materia orgánica del suelo y el balance del ecosistema de carbono, nitrógeno (N), fósforo (P), potasio, calcio y magnesio. El estrato de suelo orgánico original se redujo y el suelo mineral perdió volumen (-82 por ciento de porosidad en 0-10 cm de profundidad). Contrarrestó parcialmente estos efectos el aumento del contenido de materia orgánica (1,3 Mg C ha(-1) año(-1) favorecidos por el ingreso de raíces de álamos al suelo drenado (hídrico y libre de raíces en los pastizales). Comparadas con los pastizales, las forestaciones acumularon más carbono y nutrientes en la biomasa aérea y menos en broza y raíces. El balance final fue neutro para carbono y nitrógeno y negativo para fósforo (-0,7 Mg ha (-1) principalmente en los estratos profundos de suelo. Para el calcio, potasio y magnesio las ganancias en el suelo profundo, posiblemente asociadas a los cambios en el balance hídrico (mayor consumo freático, menor aporte superficial), determinaron balances positivos. La relación N/P en hojas de pastos y álamos (7 vs. 18) indicó el cambio de condiciones de limitación por nitrógeno a fósforo. En poco más de una década el drenaje, endicamiento y forestación de pastizales anegadizos redistribuyó el almacenamiento de carbono y nitrógeno sin afectar su magnitud, cambió las limitaciones nutricionales, y generó cambios físicos y químicos en los suelos. Estas modificaciones pueden acentuarse en plazos más largos influenciando la productividad y los servicios ecosistémicos de estos humedales.

Fermento natural de leche: efecto de su empleo sobre la calidad de quesos de leche de oveja

La fabricación de queso es esencialmente un proceso de deshidratación de la leche cuyo resultado final depende del tiempo de coagulación, tipo de fermento y período de maduración. La combinación de estos factores da lugar a una gran variedad de quesos, los que resultan de las diferentes técnicas empleadas en relación a los aspectos mencionados. El fermento es un cultivo de microorganismos cuyo crecimiento en la leche produce ácido láctico a partir de lactosa, acidificando el medio. Además durante la maduración del queso las enzimas bacterianas del inóculo utilizado intervendrán degradando los diferentes componentes de la leche liberando precursores de sustancias responsables de la textura, sabor y aroma del queso. Los fermentos utilizados pueden ser naturales preparados artesanalmente o comerciales seleccionados elaborados industrialmente. Se denominan naturales a aquellos elaborados a partir de la leche ordeñada y cobran especial interés cuando los volúmenes a procesar son pequeños. Su principal ventaja es que permiten aprovechar la ecología zonal bacteriana en la producción de un queso con características particulares, que puede reconocerse por su origen y que presenta características únicas eirrepetibles. El objetivo de este trabajo es evaluar la aptitud quesera de un fermento natural elaborado a partir de la leche de oveja cruza Frisona x Texel proveniente del tambo ovino de la Faculta de Agronomía de la Universidad de Buenos Aires (FAUBA). Para ello se analizaron sólidos totales y características organolépticas de quesos elaborados con fermento natural y se las contrastó con las de quesos elaborados con fermentos seleccionados comerciales. Los resultados del análisis de sólidos totales en quesos no mostraron diferencias significativas entre tratamientos, sin embargo la evaluación sensorial indicó, entre los atributos más destacables, que los quesos elaborados con fermento de leche tuvieron mayor intensidad de olor a oveja, aroma a manteca y leche cocida, sabor más picante y textura más untuosa que los elaborados con fermento comercial. En conclusión estos resultados sugieren que los atributos descriptos dan cuenta de un producto de características sensoriales distintivas. Esto indica la influencia diferencial que tuvo el fermento natural utilizado sobre las características sensoriales de los quesos a través de las enzimas aportadas por las bacterias durante el proceso de maduración.

Functional food production from the prymary sector : prospects and opportunities

p.9-18

Influencia del suelo y la fertilización nitrogenada sobre el contenido cuali - cuantitativo de alcaloides de Festuca c.v. El Palenque

p.69-77